PHO - De viktigste nyhetene som er børsmeldt siden 01.12.2017
Her kommer en påminnelse om de viktigste hendelsene som har skjedd i PHO de siste 11 månedene, og dette er bare det som er børsmeldt.
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Blue Light Flexible Cystoscopy with Cysview® Phase 3 study: New data presented at Society of Urological Oncology
Oslo, Norway, December 1, 2017 Photocure ASA (OSE: PHO) announced today that more detailed data from the Phase 3 study data was presented at the prestigious Society of Urologic Oncology, Annual Meeting November 29 - December 01, 2017 in Washington D.C., USA. Four separate posters were presented, including one using patient reported outcomes (PRO) data from this study demonstrated the positive impact of Cysview on patient Quality of Life
The plenary presentation titled "Efficacy and Safety of Flexible Blue Light Cystoscopy with Hexaminolevinulate (HAL) in the Surveillance of Bladder Cancer: A Phase 3, comparative, Multi-Center Study" was presented by Dr. Siamak Daneshmand, Associate Professor of Urology (Clinical Scholar), Director of Urologic Oncology, at the University of Southern California Institute of Urology and study investigator. As previously announced, results from the study showed a highly statistically significant improvement (p <0.0001) in the detection of patients with recurrence of bladder cancer using BLC(TM)with Cysview®with a flexible cystoscope, compared to white light (WL) alone in patients with non-muscle invasive bladder cancer (NMIBC).
https://photocure.com/news/-efficacy-and-safety-of-flexible-blue-light-cystoscopy-with-hexaminolevinulate-hal-in-the-surveillance-of-bladder-cancer-a-phase-3-comparative-multi-center-study/
________________________________________________________________________________________________________________
Blue Light Flexible Cystoscopy with Cysview® Phase 3 study: New data presented at Society of Urological Oncology
Oslo, Norway, December 1, 2017 Photocure ASA (OSE: PHO) announced today that more detailed data from the Phase 3 study data was presented at the prestigious Society of Urologic Oncology, Annual Meeting November 29 - December 01, 2017 in Washington D.C., USA. Four separate posters were presented, including one using patient reported outcomes (PRO) data from this study demonstrated the positive impact of Cysview on patient Quality of Life
The plenary presentation titled "Efficacy and Safety of Flexible Blue Light Cystoscopy with Hexaminolevinulate (HAL) in the Surveillance of Bladder Cancer: A Phase 3, comparative, Multi-Center Study" was presented by Dr. Siamak Daneshmand, Associate Professor of Urology (Clinical Scholar), Director of Urologic Oncology, at the University of Southern California Institute of Urology and study investigator. As previously announced, results from the study showed a highly statistically significant improvement (p <0.0001) in the detection of patients with recurrence of bladder cancer using BLC(TM)with Cysview®with a flexible cystoscope, compared to white light (WL) alone in patients with non-muscle invasive bladder cancer (NMIBC).
https://photocure.com/news/-efficacy-and-safety-of-flexible-blue-light-cystoscopy-with-hexaminolevinulate-hal-in-the-surveillance-of-bladder-cancer-a-phase-3-comparative-multi-center-study/
Redigert 21.01.2021 kl 08:44
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Landmark Blue Light Cystoscopy with Cysview® study is published in the Journal of Urology
Oslo, Norway, December 8, 2017: Photocure ASA (Photocure, PHO: OSE), today announced that the official Journal of the American Urologic Association (AUA), the Journal of Urology, published the efficacy results from a Phase 3 trial investigating the efficacy of Blue Light Cystoscopy (BLCTM) with Cysview® for surveillance with a flexible cystoscope. In 20,6 percent of patient's recurrence was seen only with BLC with Cysview and missed with WLC (p<0.0001).>
https://photocure.com/news/landmark-blue-light-cystoscopy-with-cysview/
Oslo, Norway, December 8, 2017: Photocure ASA (Photocure, PHO: OSE), today announced that the official Journal of the American Urologic Association (AUA), the Journal of Urology, published the efficacy results from a Phase 3 trial investigating the efficacy of Blue Light Cystoscopy (BLCTM) with Cysview® for surveillance with a flexible cystoscope. In 20,6 percent of patient's recurrence was seen only with BLC with Cysview and missed with WLC (p<0.0001).>
https://photocure.com/news/landmark-blue-light-cystoscopy-with-cysview/
Redigert 21.01.2021 kl 08:44
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Role of blue light cystoscopy to detect bladder cancer
BLC with Cysview featured in Urology Time article January 26, 2018: “Role of blue light cystoscopy to detect bladder cancer”. Increased tumor detection, reduced recurrence/progression support its use in NMIBC patients.
Dr. Zachary Smith is a Society of Urologic Oncology fellow at The University of Chicago Medicine, Chicago. Dr. Norm Smith is professor of surgery/urology and co-director of urologic oncology at The University of Chicago Medicine, Chicago. Section Editor Christopher M. Gonzalez, MD, MBA, is professor and chairman of urology at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine, Cleveland. They have shared their experiences with BLC with Cysview in this article http://bit.ly/2E7yf4y.
https://photocure.com/news/role-of-blue-light-cystoscopy-to-detect-bladder-cancer2/
BLC with Cysview featured in Urology Time article January 26, 2018: “Role of blue light cystoscopy to detect bladder cancer”. Increased tumor detection, reduced recurrence/progression support its use in NMIBC patients.
Dr. Zachary Smith is a Society of Urologic Oncology fellow at The University of Chicago Medicine, Chicago. Dr. Norm Smith is professor of surgery/urology and co-director of urologic oncology at The University of Chicago Medicine, Chicago. Section Editor Christopher M. Gonzalez, MD, MBA, is professor and chairman of urology at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine, Cleveland. They have shared their experiences with BLC with Cysview in this article http://bit.ly/2E7yf4y.
https://photocure.com/news/role-of-blue-light-cystoscopy-to-detect-bladder-cancer2/
Redigert 21.01.2021 kl 08:44
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Photocure Announces U.S. FDA Approval of New Indications for Blue Light Cystoscopy with Cysview®
Oslo, Norway, February 16, 2018 Photocure ASA (OSE: PHO), announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer. This is the only combination of drug and device approved for the detection of bladder cancer.
The approval of this new indication is based on the results from a large Phase 3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This study showed that BLC™ significantly (p<0.0001) improves detection of patients with recurrent bladder cancer.
“This approval is an important milestone for Photocure. With 1.2 million surveillance cystoscopies performed annually in the U.S., this represents a significant opportunity for the company and allows us to bring solutions to current clinical challenges,” said Kjetil Hestdal M.D. Ph.D., President & CEO. “The expanded label now allows repetitive use in the same patient which enables physicians to provide an improved continuum of care to their bladder cancer patients and should lead to reduced cost.”
https://photocure.com/news/fda-approval-snda-cysview/
Oslo, Norway, February 16, 2018 Photocure ASA (OSE: PHO), announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer. This is the only combination of drug and device approved for the detection of bladder cancer.
The approval of this new indication is based on the results from a large Phase 3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This study showed that BLC™ significantly (p<0.0001) improves detection of patients with recurrent bladder cancer.
“This approval is an important milestone for Photocure. With 1.2 million surveillance cystoscopies performed annually in the U.S., this represents a significant opportunity for the company and allows us to bring solutions to current clinical challenges,” said Kjetil Hestdal M.D. Ph.D., President & CEO. “The expanded label now allows repetitive use in the same patient which enables physicians to provide an improved continuum of care to their bladder cancer patients and should lead to reduced cost.”
https://photocure.com/news/fda-approval-snda-cysview/
Redigert 21.01.2021 kl 08:44
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Litt på siden fra Heghnar Forsiden 16.02.2018.
Photocure er en av dagens store vinnere på Oslo Børs etter at selskapet har av fått godkjent sin supplementære nye legemiddel-søknad (sNDA) av U.S. Food and Drug Administration (FDA) for å utvide indikasjonene for Blue Light Cystoscopy (BLC) med Cysview til å inkludere «Flexible Cystoscopes».
http://www.hegnar.no/Nyheter/Boers-finans/2018/02/Milepael-gir-boershopp-for-Photocure
- Denne godkjenningen er en viktig milepæl for Photocure. Med 1,2 millioner overvåknings-cystoscopier utført årlig i USA, representerer dette en signifikant mulighet for selskapet, sier Kjetil Hestdal, konsernsjef i selskapet.
Photocure er en av dagens store vinnere på Oslo Børs etter at selskapet har av fått godkjent sin supplementære nye legemiddel-søknad (sNDA) av U.S. Food and Drug Administration (FDA) for å utvide indikasjonene for Blue Light Cystoscopy (BLC) med Cysview til å inkludere «Flexible Cystoscopes».
http://www.hegnar.no/Nyheter/Boers-finans/2018/02/Milepael-gir-boershopp-for-Photocure
- Denne godkjenningen er en viktig milepæl for Photocure. Med 1,2 millioner overvåknings-cystoscopier utført årlig i USA, representerer dette en signifikant mulighet for selskapet, sier Kjetil Hestdal, konsernsjef i selskapet.
Redigert 21.01.2021 kl 08:44
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Oslo, Norway, March 20, 2018: Photocure ASA (OSE: PHO), is pleased to announce
that Blue Light Cystoscopy (BLC(TM)) with Hexvix® was featured during the EAU
annual meeting held in Copenhagen, Denmark, March 16th - 20th. The EAU is one of
the largest international meetings in urology, attended by more than 12,000
urologists and exhibitors from over 110 countries.
Blue Light Cystoscopy (BLC(TM)) with Hexvix® was featured through abstract
presentations, a symposium hosted by Ipsen, our strategic partner in Europe
except the Nordic, and exhibited both at the Ipsen and Photocure booths.
Ditte Drejer, Aarhus University Hospital, Denmark, presented base line results
from the Da-Bla-Ca 11 trial: Photodynamic diagnosis in flexible cystoscopy -
initial findings in a randomized controlled trial (abstract 1140). 605 patients
were enrolled from three urological departments in Denmark. The initial results
indicate that Blue Light flexible cystoscopy with Hexvix can reduce the need of
TURBT when biopsy and fulguration of small tumors is possible in the
outpatient/office clinic. Further follow-up data on recurrences is ongoing and
will be needed to estimate the clinical impact on reduction of recurrence risk
and repeated procedures.
Dr. Siamak Daneshmand, University of Southern California Institute of Urology
presented data from a registry study with 533 patients, 1632 identified lesions
from 641 BLC(TM) procedures across 9 different centers: Blue light cystoscopy
for diagnosis of urothelial bladder cancer: Results from a multicenter registry
(abstract 1139). BLC with Cysview increases detection rates of all tumor types
compared to standard white light, especially CIS lesions (43%), and changed the
management in about 14% of patients. Furthermore, recent BCG therapy did not
appear to impact the BLC accuracy.
Professor Morgan Roupret, Academic Department of Urology of Pitié-Salpétrière,
Paris, France presented "Predicting the future of PDD - blue skies or dark
clouds" at the Ipsen hosted symposium Saturday March 17. This presentation
challenged the continuing role of photodynamic-diagnosis amidst the emerging
trends in NMIBC management. It concluded that combined with biomarker testing
and targeted biopsies, PDD will remain key to optimal treatment and patient
follow-up.
Kjetil Hestdal, President and CEO comments: "It was a great pleasure to be
present at the EAU congress in one of the European countries where we market
Hexvix ourselves, and see the engagement and activities at our booth in addition
to the new data on BLC with Hexvix/Cysview being presented. With the recent FDA
approval of Cysview with flexible scopes it is especially encouraging with the
initial data from the Danish investigator initiated trial indicating how BLC
with flexible scopes might change the patient pathway and reduce the burden on
health care costs and make life better for the patients".
About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLC(TM)).
BLC(TM) with Hexvix® /Cysview® improves the detection of tumors and leads to
more complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region, and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further
information on our commercial partners.
http://www.newsweb.no/index.jsp?messageId=446967
that Blue Light Cystoscopy (BLC(TM)) with Hexvix® was featured during the EAU
annual meeting held in Copenhagen, Denmark, March 16th - 20th. The EAU is one of
the largest international meetings in urology, attended by more than 12,000
urologists and exhibitors from over 110 countries.
Blue Light Cystoscopy (BLC(TM)) with Hexvix® was featured through abstract
presentations, a symposium hosted by Ipsen, our strategic partner in Europe
except the Nordic, and exhibited both at the Ipsen and Photocure booths.
Ditte Drejer, Aarhus University Hospital, Denmark, presented base line results
from the Da-Bla-Ca 11 trial: Photodynamic diagnosis in flexible cystoscopy -
initial findings in a randomized controlled trial (abstract 1140). 605 patients
were enrolled from three urological departments in Denmark. The initial results
indicate that Blue Light flexible cystoscopy with Hexvix can reduce the need of
TURBT when biopsy and fulguration of small tumors is possible in the
outpatient/office clinic. Further follow-up data on recurrences is ongoing and
will be needed to estimate the clinical impact on reduction of recurrence risk
and repeated procedures.
Dr. Siamak Daneshmand, University of Southern California Institute of Urology
presented data from a registry study with 533 patients, 1632 identified lesions
from 641 BLC(TM) procedures across 9 different centers: Blue light cystoscopy
for diagnosis of urothelial bladder cancer: Results from a multicenter registry
(abstract 1139). BLC with Cysview increases detection rates of all tumor types
compared to standard white light, especially CIS lesions (43%), and changed the
management in about 14% of patients. Furthermore, recent BCG therapy did not
appear to impact the BLC accuracy.
Professor Morgan Roupret, Academic Department of Urology of Pitié-Salpétrière,
Paris, France presented "Predicting the future of PDD - blue skies or dark
clouds" at the Ipsen hosted symposium Saturday March 17. This presentation
challenged the continuing role of photodynamic-diagnosis amidst the emerging
trends in NMIBC management. It concluded that combined with biomarker testing
and targeted biopsies, PDD will remain key to optimal treatment and patient
follow-up.
Kjetil Hestdal, President and CEO comments: "It was a great pleasure to be
present at the EAU congress in one of the European countries where we market
Hexvix ourselves, and see the engagement and activities at our booth in addition
to the new data on BLC with Hexvix/Cysview being presented. With the recent FDA
approval of Cysview with flexible scopes it is especially encouraging with the
initial data from the Danish investigator initiated trial indicating how BLC
with flexible scopes might change the patient pathway and reduce the burden on
health care costs and make life better for the patients".
About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLC(TM)).
BLC(TM) with Hexvix® /Cysview® improves the detection of tumors and leads to
more complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region, and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further
information on our commercial partners.
http://www.newsweb.no/index.jsp?messageId=446967
Redigert 21.01.2021 kl 08:44
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03/04-2018 08:00:02: (PHO) Blue Light Flexible Cystoscopy followed by tumor treatment with Laser results in less patient burden, improved satisfaction and cost reduction.
Oslo, Norway, April 3rd, 2018, Photocure ASA (OSE: PHO), is pleased to announce
that a new study on Blue Light Cystoscopy (BLCTM) with Hexvix® using the KARL
STORZ flexible videoscope system in the outpatient setting for the laser
treatment of Low-Grade bladder tumors was published in Scandinavian Journal of
Urology, link to publication: https://bit.ly/2IlpylQ. This study, by Drs
Hermann, Mogensen and Susanne Rosthoj, MSc, established that the method of
removing lesions with the laser diode in an outpatient setting provides a well
tolerated treatment of low-grade non-invasive tumor recurrences, and allows for
the patients to leave immediately after treatment.
The study involved 21 patients who had histology verified, low-grade bladder
tumors smaller than 1.5 cm in the bladder identified during outpatient
surveillance flexible cystoscopy. Patients underwent the BLC with Hexvix
assisted laser procedure and had a 1-month follow-up cystoscopy and biopsy
guided by Blue Light Cystoscopy (BLCTM) and the KARL STORZ flexible videoscope.
Follow up of patients was for 12-16 months. The measurement of pain was with a
validated visual analog method from the European Organization for the Research
and treatment of Cancer Quality of Life Questionnaire for the Non-Muscle
Invasive Bladder Cancer.
"Use of BLCTM with Hexvix® to identify the tumors when they are small makes it
possible to treat more patients in the office setting. The laser treatment of
lesions caused limited pain and patients were able to return to their daily
activities immediately after the procedure. We found that this method is
effective for the treatment of Ta low-grade tumors. Treating more patients on an
outpatient basis results in considerable quality of life benefits to the
patients and economic benefits to the health care system. Following the results
of this methods validation study we are now evaluating the method in a
randomized controlled trial," said Dr Gregers G. Hermann, Consultant Urologist,
DM Sc. F.E.B.U. Herlev and Gentofte Hospital, University of Copenhagen and main
investigator of the study.
"In this proof of principle study of BLCTM with Hexvix® to detect and control,
and the laser technique to remove Ta low-grade lesions in the outpatient
setting, it was estimated that 25% of the TURBT procedures could be performed in
the outpatient (office) basis without general anesthesia. This resulted in an
estimated direct cost savings of EUR140,976 per million inhabitants. Using Blue
Light Flexible cystoscopy during this procedure makes the urologists confident
that all tumors are detected and removed and patients can avoid an operating
room surgery while receiving effective treatment for this recurrent and
progressive disease. It is exciting to see the emerging developments in bladder
cancer and the new role that Hexvix can play to offer patients improved
management of their disease," said Kjetil Hestdal, M.D., Ph.D., President and
CEO, Photocure ASA.
About Bladder Cancer
There are 167 000 new cases of bladder cancer in Europe and more than 59 000
deaths from the disease annually. Approx. 75% of all bladder cancer cases occur
in men1. It has a high recurrence rate with an average of 61% in year one and
78% over five years, making the lifetime costs of managing bladder cancer one of
the highest amongst all. Bladder cancer is a costly, potentially progressive
disease for which patients have to undergo multiple cystoscopies due to the high
risk of recurrence3,4. A recent paper on the economic burden of bladder cancer
across the European Union estimates that bladder cancer cost the EU 4.9 Billion
Euro in 20122. Bladder cancer is a costly, potentially progressive disease for
which patients have to undergo multiple cystoscopies due to the high risk of
recurrence. There is an urgent need to improve both the diagnosis and the
management of bladder cancer for the benefit of patients and healthcare systems
alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall. NMIBC remains in the inner layer of cells lining
the bladder. These cancers are the most common (75%) of all BC cases and include
the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer
has grown into deeper layers of the bladder wall. These cancers, including
subtypes T2, T3 and T4, are more likely to spread and are harder to treat.5
1. Globocan. Incidence/mortality by population. Available at:
http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2. Leal et al, Eur Urol 2016; 69: 438-447
3. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al.
EAU Guidelines on non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol.
2016 Guidelines Edition:1-40.
4. Sievert KD et al. World J Urol 2009;27:295-300
5. Bladder Cancer. American Cancer Society
https://www.cancer.org/cancer/bladder-cancer.html About Bladder
About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM
with Hexvix®/Cysview® improves the detection of tumors and leads to more
complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region, and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further
information on our commercial partners.
About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company
focusing on urology. Based on its unique proprietary Photocure Technology®
platform, Photocure is committed to developing and commercializing highly
selective and minimally invasive solutions to improve health outcomes for
patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO).
More information about Photocure is available at www.photocure.com,
www.hexvix.com, www.cysview.com
For more information, please contact:
Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: e
Ekstern link: http://www.newsweb.no/index.jsp?messageId=447921
Oslo, Norway, April 3rd, 2018, Photocure ASA (OSE: PHO), is pleased to announce
that a new study on Blue Light Cystoscopy (BLCTM) with Hexvix® using the KARL
STORZ flexible videoscope system in the outpatient setting for the laser
treatment of Low-Grade bladder tumors was published in Scandinavian Journal of
Urology, link to publication: https://bit.ly/2IlpylQ. This study, by Drs
Hermann, Mogensen and Susanne Rosthoj, MSc, established that the method of
removing lesions with the laser diode in an outpatient setting provides a well
tolerated treatment of low-grade non-invasive tumor recurrences, and allows for
the patients to leave immediately after treatment.
The study involved 21 patients who had histology verified, low-grade bladder
tumors smaller than 1.5 cm in the bladder identified during outpatient
surveillance flexible cystoscopy. Patients underwent the BLC with Hexvix
assisted laser procedure and had a 1-month follow-up cystoscopy and biopsy
guided by Blue Light Cystoscopy (BLCTM) and the KARL STORZ flexible videoscope.
Follow up of patients was for 12-16 months. The measurement of pain was with a
validated visual analog method from the European Organization for the Research
and treatment of Cancer Quality of Life Questionnaire for the Non-Muscle
Invasive Bladder Cancer.
"Use of BLCTM with Hexvix® to identify the tumors when they are small makes it
possible to treat more patients in the office setting. The laser treatment of
lesions caused limited pain and patients were able to return to their daily
activities immediately after the procedure. We found that this method is
effective for the treatment of Ta low-grade tumors. Treating more patients on an
outpatient basis results in considerable quality of life benefits to the
patients and economic benefits to the health care system. Following the results
of this methods validation study we are now evaluating the method in a
randomized controlled trial," said Dr Gregers G. Hermann, Consultant Urologist,
DM Sc. F.E.B.U. Herlev and Gentofte Hospital, University of Copenhagen and main
investigator of the study.
"In this proof of principle study of BLCTM with Hexvix® to detect and control,
and the laser technique to remove Ta low-grade lesions in the outpatient
setting, it was estimated that 25% of the TURBT procedures could be performed in
the outpatient (office) basis without general anesthesia. This resulted in an
estimated direct cost savings of EUR140,976 per million inhabitants. Using Blue
Light Flexible cystoscopy during this procedure makes the urologists confident
that all tumors are detected and removed and patients can avoid an operating
room surgery while receiving effective treatment for this recurrent and
progressive disease. It is exciting to see the emerging developments in bladder
cancer and the new role that Hexvix can play to offer patients improved
management of their disease," said Kjetil Hestdal, M.D., Ph.D., President and
CEO, Photocure ASA.
About Bladder Cancer
There are 167 000 new cases of bladder cancer in Europe and more than 59 000
deaths from the disease annually. Approx. 75% of all bladder cancer cases occur
in men1. It has a high recurrence rate with an average of 61% in year one and
78% over five years, making the lifetime costs of managing bladder cancer one of
the highest amongst all. Bladder cancer is a costly, potentially progressive
disease for which patients have to undergo multiple cystoscopies due to the high
risk of recurrence3,4. A recent paper on the economic burden of bladder cancer
across the European Union estimates that bladder cancer cost the EU 4.9 Billion
Euro in 20122. Bladder cancer is a costly, potentially progressive disease for
which patients have to undergo multiple cystoscopies due to the high risk of
recurrence. There is an urgent need to improve both the diagnosis and the
management of bladder cancer for the benefit of patients and healthcare systems
alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall. NMIBC remains in the inner layer of cells lining
the bladder. These cancers are the most common (75%) of all BC cases and include
the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer
has grown into deeper layers of the bladder wall. These cancers, including
subtypes T2, T3 and T4, are more likely to spread and are harder to treat.5
1. Globocan. Incidence/mortality by population. Available at:
http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2. Leal et al, Eur Urol 2016; 69: 438-447
3. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al.
EAU Guidelines on non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol.
2016 Guidelines Edition:1-40.
4. Sievert KD et al. World J Urol 2009;27:295-300
5. Bladder Cancer. American Cancer Society
https://www.cancer.org/cancer/bladder-cancer.html About Bladder
About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM
with Hexvix®/Cysview® improves the detection of tumors and leads to more
complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region, and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further
information on our commercial partners.
About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company
focusing on urology. Based on its unique proprietary Photocure Technology®
platform, Photocure is committed to developing and commercializing highly
selective and minimally invasive solutions to improve health outcomes for
patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO).
More information about Photocure is available at www.photocure.com,
www.hexvix.com, www.cysview.com
For more information, please contact:
Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: e
Ekstern link: http://www.newsweb.no/index.jsp?messageId=447921
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03/05-2018 08:30:02: (PHO) Photocure to present at J.P. Morgan - BioNJ Eight Annual Bio-Partnering conference
Princeton, New Jersey, May 3, 2018: Photocure ASA (OSE: PHO) is pleased to
announce that Photocure will be presenting at the J.P. Morgan - Bio New Jersey
Bio-Partnering meeting conference. The presentation will be held by Ambaw
Bellete, President, Photocure Inc.
The presentation will be available on Photocure's website (www.photocure.com) in
the investor relations section. In addition, Photocure will be conducting
investor meetings during the conference.
The meeting will take place on Thursday, May 3, 2018 at The Palace at Somerset
Park, Somerset, New Jersey, USA.
About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is taken up selectively by cancer cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLC(TM)).
BLC(TM) with Hexvix® /Cysview® improves the detection of tumors and leads to
more complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further
information on our commercial partners.
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US.[1],[2],[3] In 2016, it is
estimated that 76,960 new cases of bladder cancer will occur along with 16,390
deaths due to bladder cancer.
Bladder cancer is one of the most expensive cancers to manage, accounting for
approximately $3.7 billion in direct costs each year.[4],[5]
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.[2] NMIBC remains in the inner layer of cells
lining the bladder. These cancers are the most common (75%) of all BC cases and
include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when
the cancer has grown into deeper layers of the bladder wall. These cancers,
including subtypes T2, T3 and T4, are more likely to spread and are harder to
treat.[2]
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com, www.cysview.com.
https://www.hegnar.no/Marked/?s=pho
Princeton, New Jersey, May 3, 2018: Photocure ASA (OSE: PHO) is pleased to
announce that Photocure will be presenting at the J.P. Morgan - Bio New Jersey
Bio-Partnering meeting conference. The presentation will be held by Ambaw
Bellete, President, Photocure Inc.
The presentation will be available on Photocure's website (www.photocure.com) in
the investor relations section. In addition, Photocure will be conducting
investor meetings during the conference.
The meeting will take place on Thursday, May 3, 2018 at The Palace at Somerset
Park, Somerset, New Jersey, USA.
About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is taken up selectively by cancer cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLC(TM)).
BLC(TM) with Hexvix® /Cysview® improves the detection of tumors and leads to
more complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further
information on our commercial partners.
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US.[1],[2],[3] In 2016, it is
estimated that 76,960 new cases of bladder cancer will occur along with 16,390
deaths due to bladder cancer.
Bladder cancer is one of the most expensive cancers to manage, accounting for
approximately $3.7 billion in direct costs each year.[4],[5]
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.[2] NMIBC remains in the inner layer of cells
lining the bladder. These cancers are the most common (75%) of all BC cases and
include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when
the cancer has grown into deeper layers of the bladder wall. These cancers,
including subtypes T2, T3 and T4, are more likely to spread and are harder to
treat.[2]
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com, www.cysview.com.
https://www.hegnar.no/Marked/?s=pho
Redigert 21.01.2021 kl 08:44
Du må logge inn for å svare
14/05-2018 09:58:10: (PHO) Photocure to Present New Data on Cysview® at the 2018 American Urological Association Annual Meetin
Oslo, Norway, May 14th, 2018: Photocure ASA (PHO:OSE) announced today that
Photocure will be exhibiting Blue Light Cystoscopy (BLC(TM)) with Cysview in
Booth 1825, during the American Urological Association Meeting (AUA 2018) in San
Francisco, CA.
New data on Cysview will be presented (see details below): in at least three
posters, of which two are on registry studies using real world longitudinal
data, a plenary session on Patient Reported Outcomes and during the Bladder
Cancer Surgical Technique session Dr. James McKiernan will present on "Enhanced
Cystoscopy: BLC - TURBT + Surveillance Video". Earlier this year BLC with
Cysview was approved by the FDA for use in surveillance cystoscopy (in addition
to the already existing approval for TURBT's (Trans Urethral Resection of the
Bladder)). "I have been using BLC with Cysview for both TURBT's and
surveillance. I am looking forward to sharing my experience. Using these new
techniques more broadly should result in improved patient outcomes," said Dr.
James McKiernan, John K Lattimer Professor and Chairman of Urology at Columbia
University and Urologist-in-Chief New York Presbyterian Hospital New York.
Photocure is also unveiling the company's strategic focus, exhibiting as The
Bladder Cancer Company. "In this, the Bladder Cancer Awareness month, we are
excited to announce our continued focus on bladder cancer and look forward to
working with the bladder cancer community to increase awareness of Bladder
Cancer and our breakthrough technology, BLC with Cysview," says Kjetil Hestdal,
MD, PhD, President and CEO, Photocure ASA.
Key Activities featuring Cysview during the meeting include:
May 18, 2018 (FRIDAY) 9:30 AM to 11:30AM - Location: MCC WEST, 3006
- Blue Light Cystoscopy Improves Detection Rates: Updated Results From A
Prospective Multicenter Registry
- How is outpatient blue light cystoscopy used in clinical routine? First
results from the Nordic registry
- The impact of Blue Light Cystoscopy on response of induction BCG in patients
with high-grade non-muscle invasive bladder cancer
May 19, 2018 (SATURDAY) - 4:33 PM to 4:42 PM - Location: MCC South, 208
- Assessment of Blue Light Flexible Cystoscopy with Cysview on Patient Reported
Outcomes- by Dr. Angela Smith, University of North Carolina
May 20, 2018 (SUNDAY) 7:00 AM to 9:00AM - Location: MCC WEST, 2005
- Blue light in combination with Cysview Leads to Bladder Cancer Cell Death in
an in vitro Mode
2:00 PM to 2:45 PM - MCC SOUTH, Esplanade (Plenary Session)
- Surgical Techniques: Tips & Tricks: Bladder Cancer: Moderator: Dr. Kristen
Scarpato - Vanderbilt University with other Panel Members: Dr. Joe Liao - VA
Palo Alto and Dr. Bernie Bochner including: Dr. James McKiernan, New York
Presbyterian, Columbia University, who will present on Enhanced Cystoscopy - BLC
- TURBT + Surveillance Video plus moderated presentation
May 17 and 18 (THURSDAY and FRIDAY), Photocure will be exhibiting at the AUA
Office Practice Management Conference - Location: MCC North, 22
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US 1, 2, 3. In 2018, it is
estimated that there will be 81,190 new cases of bladder cancer will occur along
with 17,240 deaths due to bladder cancer. Risk factors for bladder cancer
include advancing age, cigarette smoking, occupational exposure to dyes, tar,
rubber and solvent, chronic bladder irritation and infections, and prior
diagnosis of bladder cancer. Bladder cancer is one of the most expensive cancers
to manage, accounting for approximately $3.7 billion in direct costs each
year.4,5
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.2 NMIBC is still in the inner layer of cells. These
cancers are the most common (75%) of all BC cases and include the subtypes Ta,
carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into
deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and
T4, are more likely to spread and are harder to treat.2
About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydrochloride) is a drug that is
selectively taken up by cancer cells in the bladder making them glow bright pink
during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix® /Cysview® improves the
detection of tumors and leads to more complete resection, less residual tumors
and better management decisions.
Hexvix® is the tradename in Europe, Cysview® in US and Canada. Hexvix® is
marketed and sold by Photocure in the Nordic countries and in the US with the
trade name Cysview®. Photocure has a strategic partnership with Ipsen for the
commercialization of Hexvix in Europe, excluding the Nordic region. Please refer
to http://bit.ly/PHO-Partnering for further information on our commercial
partners.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in
Princeton, New Jersey. For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
For more information, please contact:
Company contacts:
Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
Media Relations:
Amanda Hudson
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: amandah@mcspr.com
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.
Bethesda, MD. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2018.
2. Bladder Cancer. American Cancer Society.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2018.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle
Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178
(6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of treating bladder
cancer and associated complications. Urology. 2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of treating bladder cancer:
a comprehensive review of the published literature. Pharmacoeconomics. 2003;
21:3
Ekstern link: http://www.newsweb.no/index.jsp?messageId=451274
Oslo, Norway, May 14th, 2018: Photocure ASA (PHO:OSE) announced today that
Photocure will be exhibiting Blue Light Cystoscopy (BLC(TM)) with Cysview in
Booth 1825, during the American Urological Association Meeting (AUA 2018) in San
Francisco, CA.
New data on Cysview will be presented (see details below): in at least three
posters, of which two are on registry studies using real world longitudinal
data, a plenary session on Patient Reported Outcomes and during the Bladder
Cancer Surgical Technique session Dr. James McKiernan will present on "Enhanced
Cystoscopy: BLC - TURBT + Surveillance Video". Earlier this year BLC with
Cysview was approved by the FDA for use in surveillance cystoscopy (in addition
to the already existing approval for TURBT's (Trans Urethral Resection of the
Bladder)). "I have been using BLC with Cysview for both TURBT's and
surveillance. I am looking forward to sharing my experience. Using these new
techniques more broadly should result in improved patient outcomes," said Dr.
James McKiernan, John K Lattimer Professor and Chairman of Urology at Columbia
University and Urologist-in-Chief New York Presbyterian Hospital New York.
Photocure is also unveiling the company's strategic focus, exhibiting as The
Bladder Cancer Company. "In this, the Bladder Cancer Awareness month, we are
excited to announce our continued focus on bladder cancer and look forward to
working with the bladder cancer community to increase awareness of Bladder
Cancer and our breakthrough technology, BLC with Cysview," says Kjetil Hestdal,
MD, PhD, President and CEO, Photocure ASA.
Key Activities featuring Cysview during the meeting include:
May 18, 2018 (FRIDAY) 9:30 AM to 11:30AM - Location: MCC WEST, 3006
- Blue Light Cystoscopy Improves Detection Rates: Updated Results From A
Prospective Multicenter Registry
- How is outpatient blue light cystoscopy used in clinical routine? First
results from the Nordic registry
- The impact of Blue Light Cystoscopy on response of induction BCG in patients
with high-grade non-muscle invasive bladder cancer
May 19, 2018 (SATURDAY) - 4:33 PM to 4:42 PM - Location: MCC South, 208
- Assessment of Blue Light Flexible Cystoscopy with Cysview on Patient Reported
Outcomes- by Dr. Angela Smith, University of North Carolina
May 20, 2018 (SUNDAY) 7:00 AM to 9:00AM - Location: MCC WEST, 2005
- Blue light in combination with Cysview Leads to Bladder Cancer Cell Death in
an in vitro Mode
2:00 PM to 2:45 PM - MCC SOUTH, Esplanade (Plenary Session)
- Surgical Techniques: Tips & Tricks: Bladder Cancer: Moderator: Dr. Kristen
Scarpato - Vanderbilt University with other Panel Members: Dr. Joe Liao - VA
Palo Alto and Dr. Bernie Bochner including: Dr. James McKiernan, New York
Presbyterian, Columbia University, who will present on Enhanced Cystoscopy - BLC
- TURBT + Surveillance Video plus moderated presentation
May 17 and 18 (THURSDAY and FRIDAY), Photocure will be exhibiting at the AUA
Office Practice Management Conference - Location: MCC North, 22
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US 1, 2, 3. In 2018, it is
estimated that there will be 81,190 new cases of bladder cancer will occur along
with 17,240 deaths due to bladder cancer. Risk factors for bladder cancer
include advancing age, cigarette smoking, occupational exposure to dyes, tar,
rubber and solvent, chronic bladder irritation and infections, and prior
diagnosis of bladder cancer. Bladder cancer is one of the most expensive cancers
to manage, accounting for approximately $3.7 billion in direct costs each
year.4,5
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.2 NMIBC is still in the inner layer of cells. These
cancers are the most common (75%) of all BC cases and include the subtypes Ta,
carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into
deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and
T4, are more likely to spread and are harder to treat.2
About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydrochloride) is a drug that is
selectively taken up by cancer cells in the bladder making them glow bright pink
during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix® /Cysview® improves the
detection of tumors and leads to more complete resection, less residual tumors
and better management decisions.
Hexvix® is the tradename in Europe, Cysview® in US and Canada. Hexvix® is
marketed and sold by Photocure in the Nordic countries and in the US with the
trade name Cysview®. Photocure has a strategic partnership with Ipsen for the
commercialization of Hexvix in Europe, excluding the Nordic region. Please refer
to http://bit.ly/PHO-Partnering for further information on our commercial
partners.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in
Princeton, New Jersey. For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
For more information, please contact:
Company contacts:
Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
Media Relations:
Amanda Hudson
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: amandah@mcspr.com
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.
Bethesda, MD. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2018.
2. Bladder Cancer. American Cancer Society.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2018.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle
Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178
(6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of treating bladder
cancer and associated complications. Urology. 2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of treating bladder cancer:
a comprehensive review of the published literature. Pharmacoeconomics. 2003;
21:3
Ekstern link: http://www.newsweb.no/index.jsp?messageId=451274
Redigert 21.01.2021 kl 08:44
Du må logge inn for å svare
16/05-2018 08:30:00: (PHO) Photocure Announces Blue Light Cystoscopy with Cysview® now available for surveillance of bladder cance
Oslo, Norway, Photocure ASA (OSE: PHO), May 16, 2018, announced today the launch
of Blue Light Cystoscopy (BLC(TM)) with Cysview for a new indication of
surveillance cystoscopy of bladder cancer.
The new FDA approved indication was a result of a large Phase 3 study using blue
light rigid and flexible cystoscopes from KARL STORZ Endoscopy of America Inc.,
which showed that BLC with Cysview significantly (p<0.0001) improves detection
of patients with recurrent bladder cancer. Click here for the Prescribing
Information.
"We are pleased that we have commenced the first commercial sale of Cysview for
surveillance cystoscopy. This launch into the flexible cystoscopy segment is an
important milestone for patients with bladder cancer and the urology community.
The availability of Blue Light Cystoscopy with Cysview, for rigid and flexible
cystoscopy means that Cysview can now be used for both Bladder Cancer surgery
and follow-up cystoscopy, allowing physicians to detect patients with the
disease earlier and manage it more appropriately," says Kjetil Hestdal, MD, PhD,
President and CEO, Photocure ASA. "I would like to thank all the investigators,
our partner KARL STORZ Endoscopy of America Inc. and the patients who made the
approval of this new indication possible."
Both companies are exhibiting at the 2018 American Urological Association Annual
meeting, in San Francisco, May 18 to 21, Photocure on booth 1825.
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US1, 2, 3. It is estimated that in
2018 there will be 81,190 new cases of bladder cancer will occur along with
17,240 deaths due to bladder cancer. Risk factors for bladder cancer include
advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and
solvent, chronic bladder irritation and infections, and prior diagnosis of
bladder cancer. Bladder cancer is one of the most expensive cancers to manage,
accounting for approximately $3.7 billion in direct costs each year.4,5
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.2 NMIBC is still in the inner layer of cells. These
cancers are the most common (75%) of all BC cases and include the subtypes Ta,
carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into
deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and
T4, are more likely to spread and are harder to treat.2
About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride), is an optical imaging
agent used in the diagnosis and management of non-muscle-invasive bladder
cancer. It is designed to selectively target malignant cells in the bladder and
induce fluorescence during a cystoscopic procedure using a blue light enabled
cystoscope. Using Cysview® as an adjunct to standard white light cystoscopy
enables the urologist to better detect and remove lesions, leading to a reduced
risk of recurrence.
Hexvix® is the tradename in Europe, Cysview® in US and Canada. Hexvix® is
marketed and sold by Photocure in the Nordic countries and in the US with the
trade name Cysview®. Photocure has a strategic partnership with Ipsen for the
commercialization of Hexvix in Europe, excluding the Nordic region. Please refer
to http://bit.ly/PHO-Partnering for further information on our commercial
partners.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in
Princeton, New Jersey. For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
About KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ GmbH & Co. KG,
an international leader for more than 70 years in reusable endoscope technology,
encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL
STORZ GmbH & Co. KG is a family-owned company that designs, engineers,
manufactures, and markets all its products with an emphasis on visionary design,
precision craftsmanship and clinical effectiveness. For more information, call
(800) 421-0837 or visit the company's website at www.karlstorz.com.
For more information, please contact:
Company contacts:
Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
US President:
Ambaw Bellete
President
Photocure Inc.,
Tel: + 1-609-759-6515
Email: ab@photocure.com
Media Relations:
Amanda Hudson
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: amandah@mcspr.com
References:
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.
Bethesda, MD. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2018.
2. Bladder Cancer. American Cancer Society.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2018.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle
Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178
(6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of treating bladder
cancer and associated complications. Urology. 2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of treating bladder cancer:
a comprehensive review of the published literature. Pharmacoeconomics. 2003;
21:31
Ekstern link: http://www.newsweb.no/index.jsp?messageId=451554
Oslo, Norway, Photocure ASA (OSE: PHO), May 16, 2018, announced today the launch
of Blue Light Cystoscopy (BLC(TM)) with Cysview for a new indication of
surveillance cystoscopy of bladder cancer.
The new FDA approved indication was a result of a large Phase 3 study using blue
light rigid and flexible cystoscopes from KARL STORZ Endoscopy of America Inc.,
which showed that BLC with Cysview significantly (p<0.0001) improves detection
of patients with recurrent bladder cancer. Click here for the Prescribing
Information.
"We are pleased that we have commenced the first commercial sale of Cysview for
surveillance cystoscopy. This launch into the flexible cystoscopy segment is an
important milestone for patients with bladder cancer and the urology community.
The availability of Blue Light Cystoscopy with Cysview, for rigid and flexible
cystoscopy means that Cysview can now be used for both Bladder Cancer surgery
and follow-up cystoscopy, allowing physicians to detect patients with the
disease earlier and manage it more appropriately," says Kjetil Hestdal, MD, PhD,
President and CEO, Photocure ASA. "I would like to thank all the investigators,
our partner KARL STORZ Endoscopy of America Inc. and the patients who made the
approval of this new indication possible."
Both companies are exhibiting at the 2018 American Urological Association Annual
meeting, in San Francisco, May 18 to 21, Photocure on booth 1825.
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US1, 2, 3. It is estimated that in
2018 there will be 81,190 new cases of bladder cancer will occur along with
17,240 deaths due to bladder cancer. Risk factors for bladder cancer include
advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and
solvent, chronic bladder irritation and infections, and prior diagnosis of
bladder cancer. Bladder cancer is one of the most expensive cancers to manage,
accounting for approximately $3.7 billion in direct costs each year.4,5
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.2 NMIBC is still in the inner layer of cells. These
cancers are the most common (75%) of all BC cases and include the subtypes Ta,
carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into
deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and
T4, are more likely to spread and are harder to treat.2
About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride), is an optical imaging
agent used in the diagnosis and management of non-muscle-invasive bladder
cancer. It is designed to selectively target malignant cells in the bladder and
induce fluorescence during a cystoscopic procedure using a blue light enabled
cystoscope. Using Cysview® as an adjunct to standard white light cystoscopy
enables the urologist to better detect and remove lesions, leading to a reduced
risk of recurrence.
Hexvix® is the tradename in Europe, Cysview® in US and Canada. Hexvix® is
marketed and sold by Photocure in the Nordic countries and in the US with the
trade name Cysview®. Photocure has a strategic partnership with Ipsen for the
commercialization of Hexvix in Europe, excluding the Nordic region. Please refer
to http://bit.ly/PHO-Partnering for further information on our commercial
partners.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in
Princeton, New Jersey. For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
About KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ GmbH & Co. KG,
an international leader for more than 70 years in reusable endoscope technology,
encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL
STORZ GmbH & Co. KG is a family-owned company that designs, engineers,
manufactures, and markets all its products with an emphasis on visionary design,
precision craftsmanship and clinical effectiveness. For more information, call
(800) 421-0837 or visit the company's website at www.karlstorz.com.
For more information, please contact:
Company contacts:
Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
US President:
Ambaw Bellete
President
Photocure Inc.,
Tel: + 1-609-759-6515
Email: ab@photocure.com
Media Relations:
Amanda Hudson
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: amandah@mcspr.com
References:
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.
Bethesda, MD. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2018.
2. Bladder Cancer. American Cancer Society.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2018.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle
Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178
(6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of treating bladder
cancer and associated complications. Urology. 2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of treating bladder cancer:
a comprehensive review of the published literature. Pharmacoeconomics. 2003;
21:31
Ekstern link: http://www.newsweb.no/index.jsp?messageId=451554
Redigert 21.01.2021 kl 08:44
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31/05-2018 13:29:11: (PHO) Photocure: Positive results from BLC with Cysview® registry published in the Urologic Oncology Journa
Oslo, Norway, May 31, 2018: Photocure ASA (PHO:OSE) announced today that results
from the Blue Light Cystoscopy (BLC(TM)) with Cysview® Registry Study was
published on-line, in the prestigious official journal of the Society of
Urological Oncology. Data from the publication showed that BLC significantly
increases detection rates of flat, aggressive Carcinoma in Situ lesions (CIS)
and papillary lesions compared to WLC alone and can result in upstaging or
upgrading in about 14% of patients and that repeat use is safe.
The publication is on results from a Prospective Multicenter Registry Study that
is the largest Bladder Cancer Registry Study ever done in the US. This study is
ongoing, and results were also presented at the annual AUA meeting held in San
Francisco. Link to abstract: http://bit.ly/AUA2018BLCRegistry
"It has been very exciting to see the on-going increase in real world data as a
result of this registry study. This publication based on data collected from
2014 to 2016, 9 referral sites, 1632 samples and 533 patients, show that the
combination of White Light and Blue Light with Cysview increased the detection
on papillary disease by 12%, CIS lesions by 43% and most importantly, resulted
in change of management in 14% of patients. This means that patients are staged
more accurately, which is very likely to impact their outcomes," says Dr. Siamak
Daneshmand, Associate Professor of Urology (Clinical Scholar), Director of
Urologic Oncology, at the University of Southern California Institute of Urology
and study investigator. Link to the publication:
http://bit.ly/BLC-Registry-Publication
The group has now expanded and has data from 1084 patients. "We look forward to
continuing to learn from the results from this study and how the recent
commercial launch of Cysview for use with flexible cystoscopes will further
change the management of bladder cancer patients," says Kjetil Hestdal, MD, PhD,
President and CEO, Photocure ASA., "I also want to thank the many investigators,
their staff and patients for their participation in the study. The Registry
Group has worked hard to bring this Real World Study forward and has brought a
high level of scientific rigor which has resulted in many publications from this
study."
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US 1, 2, 3. It is estimated that
in 2018 there will be 81,190 new cases of bladder cancer will occur along with
17,240 deaths due to bladder cancer. Bladder cancer is one of the most expensive
cancers to manage, accounting for approximately $3.7 billion in direct costs
each year.4
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.2 NMIBC is still in the inner layer of cells. These
cancers are the most common (75%) of all BC cases and include the subtypes Ta,
carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into
deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and
T4, are more likely to spread and are harder to treat.2
About Hexvix®/Cysview®
Hexvix® is a drug that is taken-up selectively by cancer cells in the bladder
making them glow bright pink during Blue Light Cystoscopy (BLC(TM)). BLC(TM)
with Hexvix® improves the detection of tumors and leads to more complete
resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region, and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to http://bit.ly/PHO-Partnering for further information on our commercial
partners.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in
Princeton, New Jersey. For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
For more information, please contact:
Company contacts:
Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
Ambaw Bellete
President
Photocure Inc.,
Tel: + 1-609-759-6515
Email: ab@photocure.com
References:
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.
Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2018.
2. Bladder Cancer. American Cancer Society
https://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2018.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle
Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178
(6):2314-2330.
4. Lotan Y, Kamat A M, et al. Key Concerns About the Current State of Bladder
Cancer: Cancer Sept 2009;
Ekstern link: http://www.newsweb.no/index.jsp?messageId=452632
Oslo, Norway, May 31, 2018: Photocure ASA (PHO:OSE) announced today that results
from the Blue Light Cystoscopy (BLC(TM)) with Cysview® Registry Study was
published on-line, in the prestigious official journal of the Society of
Urological Oncology. Data from the publication showed that BLC significantly
increases detection rates of flat, aggressive Carcinoma in Situ lesions (CIS)
and papillary lesions compared to WLC alone and can result in upstaging or
upgrading in about 14% of patients and that repeat use is safe.
The publication is on results from a Prospective Multicenter Registry Study that
is the largest Bladder Cancer Registry Study ever done in the US. This study is
ongoing, and results were also presented at the annual AUA meeting held in San
Francisco. Link to abstract: http://bit.ly/AUA2018BLCRegistry
"It has been very exciting to see the on-going increase in real world data as a
result of this registry study. This publication based on data collected from
2014 to 2016, 9 referral sites, 1632 samples and 533 patients, show that the
combination of White Light and Blue Light with Cysview increased the detection
on papillary disease by 12%, CIS lesions by 43% and most importantly, resulted
in change of management in 14% of patients. This means that patients are staged
more accurately, which is very likely to impact their outcomes," says Dr. Siamak
Daneshmand, Associate Professor of Urology (Clinical Scholar), Director of
Urologic Oncology, at the University of Southern California Institute of Urology
and study investigator. Link to the publication:
http://bit.ly/BLC-Registry-Publication
The group has now expanded and has data from 1084 patients. "We look forward to
continuing to learn from the results from this study and how the recent
commercial launch of Cysview for use with flexible cystoscopes will further
change the management of bladder cancer patients," says Kjetil Hestdal, MD, PhD,
President and CEO, Photocure ASA., "I also want to thank the many investigators,
their staff and patients for their participation in the study. The Registry
Group has worked hard to bring this Real World Study forward and has brought a
high level of scientific rigor which has resulted in many publications from this
study."
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the
fourth most common cancer found in men in the US 1, 2, 3. It is estimated that
in 2018 there will be 81,190 new cases of bladder cancer will occur along with
17,240 deaths due to bladder cancer. Bladder cancer is one of the most expensive
cancers to manage, accounting for approximately $3.7 billion in direct costs
each year.4
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall.2 NMIBC is still in the inner layer of cells. These
cancers are the most common (75%) of all BC cases and include the subtypes Ta,
carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into
deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and
T4, are more likely to spread and are harder to treat.2
About Hexvix®/Cysview®
Hexvix® is a drug that is taken-up selectively by cancer cells in the bladder
making them glow bright pink during Blue Light Cystoscopy (BLC(TM)). BLC(TM)
with Hexvix® improves the detection of tumors and leads to more complete
resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US
and the Nordic region, and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to http://bit.ly/PHO-Partnering for further information on our commercial
partners.
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in
Princeton, New Jersey. For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com
For more information, please contact:
Company contacts:
Kjetil Hestdal
President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
Ambaw Bellete
President
Photocure Inc.,
Tel: + 1-609-759-6515
Email: ab@photocure.com
References:
1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.
Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2018.
2. Bladder Cancer. American Cancer Society
https://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2018.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle
Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178
(6):2314-2330.
4. Lotan Y, Kamat A M, et al. Key Concerns About the Current State of Bladder
Cancer: Cancer Sept 2009;
Ekstern link: http://www.newsweb.no/index.jsp?messageId=452632
Redigert 21.01.2021 kl 08:44
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07/06-2018 16:51:18: (PHO) Photocure ASA: Mandatory notification of trade
Jan H. Egberts, Chairperson of the Board of Photocure ASA and primary insider in
Photocure ASA, has on 7 June 2018 purchased 12,500 shares in Photocure ASA at a
price of NOK 27.6687 per share.
Following the transaction, Jan H. Egberts holds 12,500 shares in Photocure ASA.
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Ekstern link: http://www.newsweb.no/index.jsp?messageId=453216
Nyheten er levert av OBI.
Jan H. Egberts, Chairperson of the Board of Photocure ASA and primary insider in
Photocure ASA, has on 7 June 2018 purchased 12,500 shares in Photocure ASA at a
price of NOK 27.6687 per share.
Following the transaction, Jan H. Egberts holds 12,500 shares in Photocure ASA.
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Ekstern link: http://www.newsweb.no/index.jsp?messageId=453216
Nyheten er levert av OBI.
Redigert 21.01.2021 kl 08:44
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26/06-2018 15:02:12: (PHO) Photocure ASA: Kjetil Hestdal steps down as CEO
Oslo, Norway, 26 June 2018: Photocure ASA (OSE: PHO), announces today that President and Chief Executive Officer, Kjetil Hestdal, will step down effective 1 July 2018 as the company is entering a new growth phase with focus on global commercial development. The Board of Directors has initiated a search for his replacement and Chief Financial Officer Erik Dahl is appointed as interim CEO. Mr. Hestdal will be available to the company until 30 December 2018.
"Photocure has developed a leading position in the field of bladder cancer and is entering a period of accelerated growth, especially in the important U.S. market, were we have a strong commercial focus to leverage on the opportunities arising from the company's unique technology, products and excellent clinical results. Kjetil has been instrumental in developing the company to this stage with ambitions to become a leading bladder cancer company and we have jointly agreed that the time is right for a commercially experienced CEO to lead the company's next growth phase. I have enjoyed working with Kjetil and greatly appreciates his contributions to the company over two decades. We wish him all the best in his future endeavors", says Jan H. Egberts, Chairperson of the Board.
"As Photocure is entering a phase with vast growth opportunities and an ambition to expand the global commercial footprint, the timing is right to inform all stakeholders that I will not lead Photocure in the company's next era. I am proud of having been part of a company that has helped tens of thousands of bladder cancer patients in fighting their disease. Photocure is a great company with excellent people, world leading technology and products, and is perfectly positioned to be a true industry leader within the field of bladder cancer", says Kjetil Hestdal.
For further information, please contact:
Photocure
Jan Egberts
Chairperson of the Board
Nyheten er levert av
GlobeNewswire
Oslo, Norway, 26 June 2018: Photocure ASA (OSE: PHO), announces today that President and Chief Executive Officer, Kjetil Hestdal, will step down effective 1 July 2018 as the company is entering a new growth phase with focus on global commercial development. The Board of Directors has initiated a search for his replacement and Chief Financial Officer Erik Dahl is appointed as interim CEO. Mr. Hestdal will be available to the company until 30 December 2018.
"Photocure has developed a leading position in the field of bladder cancer and is entering a period of accelerated growth, especially in the important U.S. market, were we have a strong commercial focus to leverage on the opportunities arising from the company's unique technology, products and excellent clinical results. Kjetil has been instrumental in developing the company to this stage with ambitions to become a leading bladder cancer company and we have jointly agreed that the time is right for a commercially experienced CEO to lead the company's next growth phase. I have enjoyed working with Kjetil and greatly appreciates his contributions to the company over two decades. We wish him all the best in his future endeavors", says Jan H. Egberts, Chairperson of the Board.
"As Photocure is entering a phase with vast growth opportunities and an ambition to expand the global commercial footprint, the timing is right to inform all stakeholders that I will not lead Photocure in the company's next era. I am proud of having been part of a company that has helped tens of thousands of bladder cancer patients in fighting their disease. Photocure is a great company with excellent people, world leading technology and products, and is perfectly positioned to be a true industry leader within the field of bladder cancer", says Kjetil Hestdal.
For further information, please contact:
Photocure
Jan Egberts
Chairperson of the Board
Nyheten er levert av
GlobeNewswire
Redigert 21.01.2021 kl 08:44
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16/07-2018 08:24:06: (PHO) New publication shows that 91% of patients would recommend Blue Light Cystoscopy with Cysview
See attachement on www.newsweb.no
Ekstern link: http://www.newsweb.no/index.jsp?messageId=455658
Nyheten er levert av OBI.
See attachement on www.newsweb.no
Ekstern link: http://www.newsweb.no/index.jsp?messageId=455658
Nyheten er levert av OBI.
Redigert 21.01.2021 kl 08:44
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27/08-2018 07:54:12: (PHO) Photocure ASA: Exclusive Nordic distribution agreement for innovative drug delivery system for bladder cancer patients
Oslo, Norway, August 27, 2018: Photocure ASA, The Bladder Cancer Company, announces today that an exclusive distribution agreement for the Nordic area for an innovative and patented medical device has been signed with Combat Medical (www.combat-medical.com). The device is designed for the delivery of Hyperthermic Intra-Vesical Chemotherapy (HIVEC®) for non-muscle invasive bladder cancer and has a strong strategic and synergistic fit with current business.
"The distribution agreement with Combat Medical is a milestone for Photocure as it represents the first step in expanding our portfolio and our footprint in the bladder cancer field. We are proud to be a recognized player in the field and chosen as a partner for an innovative drug delivery device. It is also a significant step towards our vision: Driving Change in Bladder Cancer Management. The delivery system represents an excellent strategic fit to our expertise and current Blue Light Cystoscopy with Hexvix® business. More than 7000 patients are diagnosed with non-muscle invasive bladder cancer in the Nordic area every year, and approximately 50% of them will undergo repeat instillation therapy," says Erik Dahl, CFO and Interim CEO of Photocure.
Hyperthermia has been shown to significantly increase the effectiveness of chemotherapy1,2,3. HIVEC® using the Combat BRS has the potential to become an attractive alternative to other instillation treatments for medium- and high-risk patients4. Clinical hyperthermia is defined as the therapeutic use of temperature between 41°C to 44°C2. At 43°C the cytotoxicity increases by 10 times, without any increase in the toxicity to the patient3. The highly automated medical device system is conveniently integrated in the out-patient clinic.
"We are delighted to have Photocure as our partner in the Nordic area. In addition to their bladder cancer expertise they also have a proven track record in introducing new technologies, requiring both disease and clinical expertise, as well as competence in maneuvering the complex hospital organizations and facilitating training of the urologists and nurses in the use of new devices. We very much look forward to collaborating with Photocure and sharing our expertise and experiences from the countries where our delivery system is already in routine use," says Edward Bruce-White, CEO of Combat Medical.
The patented hyperthermic delivery solution consists of a recirculation unit ensuring effective temperature control and specifically designed disposable catheter. An extensive clinical program to further document safety and effectiveness is underway. Photocure is Combat Medical's exclusive commercialization partner for the Nordic area and will use the existing specialist team, target exactly the same health care providers, hospitals and patients as with Hexvix.
"We are proud to be the first hospital in the Nordic area who got the chance to use this promising technology to treat our patients. We are currently generating and collecting data and assessing the convenience of introducing the technology into our facility. The procedure is highly automated and can easily be performed by trained nurses. We look forward to collaborating with Photocure on this new technology which could potentially become a new tool for better management of bladder cancer patients, just like Hexvix has proven to be over the last 10 years", says Professor Jørgen Bjerggaard Jensen, Aarhus University Hospital, Denmark.
Photocure will leverage on the extensive Hexvix infrastructure in the Nordics for implementation of the Combat Medical distribution agreement and expects commercial sales to commence from the first quarter of 2019.
About the Combat BRS and HIVEC® treatment
The Combat BRS delivers HIVEC® to optimize the chemotherapy installation for non-muscle invasive bladder cancer patients. Maximizing the efficacy of the treatment by harnessing the proven combined effects of chemotherapy and hyperthermia 1,2,3
The patented, technically innovative device has been in clinical use since 2011. Safety, tolerability and efficacy data from over 500 patients have already been presented as part of the ongoing extensive clinical programme.4,5,6
The System is easy to integrate into clinical practice, it requires minimal additional resources for the healthcare provider whilst maximising outcomes for patients with this type of bladder cancer.
References
1. G Schooneveldt, A Bakker, E Balidemaj, R Chopra, J, Crezee, ED Geijsen,J, Hartmann, MC Hulshof, HP Kok, MM paulides, A Sousa -Escandon, PR Stauffer, PR Maccarini. Thermal dosimetry for bladder hyperthermia treatment. An overview. International journal of Hyperthermia. 2016 Jun;32 (4):417-33
2. Dahl, O., Dalene, R., Schem, B. C. & Mella, O. Status of clinical hyperthermia. Acta Oncol. 38, 863-73 (1999)
3. Teicher, B. A., Kowal, C. D., Kennedy, K. A. & Sartorelli, A. C. Enhancement by Hyperthermia of the in Vitro Cytotoxicity of Mitomycin C toward Hypoxic Tumor Cells. Cancer Res. 41, 1096-1099 (1981).
4. Plata BA, Garcia AC,Villacampa F,GonzalezD, Llanes L, Diaz Goizueta J, Rios E,RimingtonP, castillo JM, Castillo DJ,Pontones JL,Nzeh C, Brisuda , Leon J, Sousa A, Chiancone F, Fedelini P,Hendricksen K, Vögeli TA, Frank, E, Wilby D, Chemohyperthermia with Mitomycin C and COMBAT System, A new alternative to BCG in High Risk Non Muscle Invasive Bladder Cancer. The Journal of Urology, Vol 199, issue 4, e1119, April 2018
5. WS Tan, J palou, J Kelly, safety & Tolerability analysis of hyperthermic intravesical mitomycin to mitomycin alone in HIVEc I and II: an interim analyiss of 307 patients.
6. A Sousa, I Pineiro, S Rodroguez, V Aparici, V Monserrat, P Neira, E carro, C Murias, C Uribarri. Recirculant Hyperthermic IntraVesical chemotherapy (HIVEC) in intermediate-high risk non muscle invasive bladder cancer, International Journal of Hyperthermia, 2016 Vol32,No4,374-380
About Bladder Cancer in the Nordic area
There are more than 7 000 new cases of bladder cancer in the Nordic and more than 2 000 deaths from the disease annually. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years2. Bladder cancer has the highest lifetime treatment costs per patient of all cancers3.
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4
1. Globocan. Incidence/mortality by population. Available at: http://globocan.iarc.fr/Default.aspx
2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on non- muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40.
3. Sievert KD et al. World J Urol 2009;27:295-300
4. Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
About Combat Medical
Combat Medical is an innovative specialist hyperthermic medical device company which is leading the way in the development of hyperthermic cancer treatments, together with a multidisciplinary team of experts. Combat's systems for the treatment of cancer of the bladder, peritoneum, ovaries and abdominal organs are currently used in more than 250 centres in over 35 countries worldwide.
For more information please visit us at https://hivec.co.uk/company/
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com
Oslo, Norway, August 27, 2018: Photocure ASA, The Bladder Cancer Company, announces today that an exclusive distribution agreement for the Nordic area for an innovative and patented medical device has been signed with Combat Medical (www.combat-medical.com). The device is designed for the delivery of Hyperthermic Intra-Vesical Chemotherapy (HIVEC®) for non-muscle invasive bladder cancer and has a strong strategic and synergistic fit with current business.
"The distribution agreement with Combat Medical is a milestone for Photocure as it represents the first step in expanding our portfolio and our footprint in the bladder cancer field. We are proud to be a recognized player in the field and chosen as a partner for an innovative drug delivery device. It is also a significant step towards our vision: Driving Change in Bladder Cancer Management. The delivery system represents an excellent strategic fit to our expertise and current Blue Light Cystoscopy with Hexvix® business. More than 7000 patients are diagnosed with non-muscle invasive bladder cancer in the Nordic area every year, and approximately 50% of them will undergo repeat instillation therapy," says Erik Dahl, CFO and Interim CEO of Photocure.
Hyperthermia has been shown to significantly increase the effectiveness of chemotherapy1,2,3. HIVEC® using the Combat BRS has the potential to become an attractive alternative to other instillation treatments for medium- and high-risk patients4. Clinical hyperthermia is defined as the therapeutic use of temperature between 41°C to 44°C2. At 43°C the cytotoxicity increases by 10 times, without any increase in the toxicity to the patient3. The highly automated medical device system is conveniently integrated in the out-patient clinic.
"We are delighted to have Photocure as our partner in the Nordic area. In addition to their bladder cancer expertise they also have a proven track record in introducing new technologies, requiring both disease and clinical expertise, as well as competence in maneuvering the complex hospital organizations and facilitating training of the urologists and nurses in the use of new devices. We very much look forward to collaborating with Photocure and sharing our expertise and experiences from the countries where our delivery system is already in routine use," says Edward Bruce-White, CEO of Combat Medical.
The patented hyperthermic delivery solution consists of a recirculation unit ensuring effective temperature control and specifically designed disposable catheter. An extensive clinical program to further document safety and effectiveness is underway. Photocure is Combat Medical's exclusive commercialization partner for the Nordic area and will use the existing specialist team, target exactly the same health care providers, hospitals and patients as with Hexvix.
"We are proud to be the first hospital in the Nordic area who got the chance to use this promising technology to treat our patients. We are currently generating and collecting data and assessing the convenience of introducing the technology into our facility. The procedure is highly automated and can easily be performed by trained nurses. We look forward to collaborating with Photocure on this new technology which could potentially become a new tool for better management of bladder cancer patients, just like Hexvix has proven to be over the last 10 years", says Professor Jørgen Bjerggaard Jensen, Aarhus University Hospital, Denmark.
Photocure will leverage on the extensive Hexvix infrastructure in the Nordics for implementation of the Combat Medical distribution agreement and expects commercial sales to commence from the first quarter of 2019.
About the Combat BRS and HIVEC® treatment
The Combat BRS delivers HIVEC® to optimize the chemotherapy installation for non-muscle invasive bladder cancer patients. Maximizing the efficacy of the treatment by harnessing the proven combined effects of chemotherapy and hyperthermia 1,2,3
The patented, technically innovative device has been in clinical use since 2011. Safety, tolerability and efficacy data from over 500 patients have already been presented as part of the ongoing extensive clinical programme.4,5,6
The System is easy to integrate into clinical practice, it requires minimal additional resources for the healthcare provider whilst maximising outcomes for patients with this type of bladder cancer.
References
1. G Schooneveldt, A Bakker, E Balidemaj, R Chopra, J, Crezee, ED Geijsen,J, Hartmann, MC Hulshof, HP Kok, MM paulides, A Sousa -Escandon, PR Stauffer, PR Maccarini. Thermal dosimetry for bladder hyperthermia treatment. An overview. International journal of Hyperthermia. 2016 Jun;32 (4):417-33
2. Dahl, O., Dalene, R., Schem, B. C. & Mella, O. Status of clinical hyperthermia. Acta Oncol. 38, 863-73 (1999)
3. Teicher, B. A., Kowal, C. D., Kennedy, K. A. & Sartorelli, A. C. Enhancement by Hyperthermia of the in Vitro Cytotoxicity of Mitomycin C toward Hypoxic Tumor Cells. Cancer Res. 41, 1096-1099 (1981).
4. Plata BA, Garcia AC,Villacampa F,GonzalezD, Llanes L, Diaz Goizueta J, Rios E,RimingtonP, castillo JM, Castillo DJ,Pontones JL,Nzeh C, Brisuda , Leon J, Sousa A, Chiancone F, Fedelini P,Hendricksen K, Vögeli TA, Frank, E, Wilby D, Chemohyperthermia with Mitomycin C and COMBAT System, A new alternative to BCG in High Risk Non Muscle Invasive Bladder Cancer. The Journal of Urology, Vol 199, issue 4, e1119, April 2018
5. WS Tan, J palou, J Kelly, safety & Tolerability analysis of hyperthermic intravesical mitomycin to mitomycin alone in HIVEc I and II: an interim analyiss of 307 patients.
6. A Sousa, I Pineiro, S Rodroguez, V Aparici, V Monserrat, P Neira, E carro, C Murias, C Uribarri. Recirculant Hyperthermic IntraVesical chemotherapy (HIVEC) in intermediate-high risk non muscle invasive bladder cancer, International Journal of Hyperthermia, 2016 Vol32,No4,374-380
About Bladder Cancer in the Nordic area
There are more than 7 000 new cases of bladder cancer in the Nordic and more than 2 000 deaths from the disease annually. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years2. Bladder cancer has the highest lifetime treatment costs per patient of all cancers3.
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4
1. Globocan. Incidence/mortality by population. Available at: http://globocan.iarc.fr/Default.aspx
2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on non- muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40.
3. Sievert KD et al. World J Urol 2009;27:295-300
4. Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
About Combat Medical
Combat Medical is an innovative specialist hyperthermic medical device company which is leading the way in the development of hyperthermic cancer treatments, together with a multidisciplinary team of experts. Combat's systems for the treatment of cancer of the bladder, peritoneum, ovaries and abdominal organs are currently used in more than 250 centres in over 35 countries worldwide.
For more information please visit us at https://hivec.co.uk/company/
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com
Redigert 21.01.2021 kl 08:44
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Litt på siden.
___________
Dobling i Photocure: - Oppgangen har såvidt begynt
Alexander Hansson avfeier spekulasjoner om aksjesalg: - Å selge seg ut er helt utelukket, sier han
Artikkel av: Are Strandli
31. august 2018 - 13.10
Lest av
11175
Legemiddelselskapet Photocure ble en av torsdagens store vinnere på Oslo Børs med en oppgang på 11,81 prosent til 52,80 kroner.
Oppturen fortsetter fredag, og dermed har Photocure-aksjen mer enn doblet seg siden årsskiftet, til stor glede for investorene.
Spesielt for største aksjonær Alexander Hansson, som eier rundt 10,3 prosent gjennom selskapet High Seas AS, betyr det en solid gevinst.
Bare siden nyttår har familieselskapets 2,22 millioner aksjer steget med rundt 62 millioner kroner i verdi.
Avfeier spekulasjoner
Den seneste tids kraftige kursoppgang har imidlertid også ført til at flere tror at Hansson-familien vil ta gevinst, ifølge Hansson.
- Det har vært mye spekulasjoner om at vi skal selge oss ut, sier han til Hegnar.no.
Hansson har tidligere avfeid tilsvarende rykter med begrunnelsen om at han har stor tro på selskapet.
Det gjør han også denne gang.
- Å selge seg ut er helt utelukket. Oppgangen har så vidt begynt.
https://www.hegnar.no/Nyheter/Boers-finans/2018/08/Dobling-i-Photocure-Oppgangen-har-saavidt-begynt
___________
Dobling i Photocure: - Oppgangen har såvidt begynt
Alexander Hansson avfeier spekulasjoner om aksjesalg: - Å selge seg ut er helt utelukket, sier han
Artikkel av: Are Strandli
31. august 2018 - 13.10
Lest av
11175
Legemiddelselskapet Photocure ble en av torsdagens store vinnere på Oslo Børs med en oppgang på 11,81 prosent til 52,80 kroner.
Oppturen fortsetter fredag, og dermed har Photocure-aksjen mer enn doblet seg siden årsskiftet, til stor glede for investorene.
Spesielt for største aksjonær Alexander Hansson, som eier rundt 10,3 prosent gjennom selskapet High Seas AS, betyr det en solid gevinst.
Bare siden nyttår har familieselskapets 2,22 millioner aksjer steget med rundt 62 millioner kroner i verdi.
Avfeier spekulasjoner
Den seneste tids kraftige kursoppgang har imidlertid også ført til at flere tror at Hansson-familien vil ta gevinst, ifølge Hansson.
- Det har vært mye spekulasjoner om at vi skal selge oss ut, sier han til Hegnar.no.
Hansson har tidligere avfeid tilsvarende rykter med begrunnelsen om at han har stor tro på selskapet.
Det gjør han også denne gang.
- Å selge seg ut er helt utelukket. Oppgangen har så vidt begynt.
https://www.hegnar.no/Nyheter/Boers-finans/2018/08/Dobling-i-Photocure-Oppgangen-har-saavidt-begynt
Redigert 21.01.2021 kl 08:44
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Markedsplasser > Norge > Oslo Børs > Photocure
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Forsinkede kurser. Sist oppdatert: tirsdag 6. november
20/09-2018 08:30:07: (PHO) Photocure ASA: Daniel Schneider appointed Chief Executive Officer
Oslo, Norway, 20 September 2018: Photocure ASA (OSE: PHO), announces today that Daniel Schneider has been appointed President and Chief Executive Officer of Photocure. Mr Schneider joins Photocure from the position of General Manager for Ablynx N.V. in North America.
"I am pleased to announce Dan Schneider as our new President and Chief Executive Officer. Photocure is entering a period of accelerated growth in the important U.S. market with strengthened focus on commercial development. Dan brings over 25 years of experience in developing and expanding rapidly growing healthcare companies in the U.S. He will further leverage on the opportunities arising from Photocure's unique position in the bladder cancer market. I look forward working with Dan to develop Photocure into becoming the leading bladder cancer company", says Jan H. Egberts, M.D. Chairman of the Board.
Mr Schneider is a U.S. citizen and holds an MBA from Washington University and a Bachelor of Science degree in Business Administration from St. Louis University with a double major in Finance and Marketing. Mr Schneider brings extensive commercial experience from the U.S. healthcare industry, including his previous position as General Manager for Ablynx N.V. in North America. Mr Schneider has also held executive management positions in other pharmaceutical and biotech companies, including BTG International, Somaxon Pharmaceuticals and Sepracor.
"The Photocure team has built a unique company within the field of bladder cancer, with excellent people, world leading technology and high-potential products. The company has developed a solid infrastructure in key regions, especially in the U.S. We will continue to scale and leverage on this growth platform to deliver on the commercial opportunities in the bladder cancer markets. I look forward to work with the team to expand the commercial footprint and to embark on the growth journey for Photocure", says Mr Schneider.
Mr Schneider will commence the position upon further agreement, expected prior to 1 November 2018. Erik Dahl will continue to serve as the acting Chief Executive Officer until Mr Schneider's commencement of his position, after which Mr Dahl will resume his previous role as the Chief Financial Officer of Photocure.
For further information, please contact:
Photocure
Jan H. Egberts
Chairperson of the Board
Tel: +31 614672518
Email: janegberts@aol.com
Notes to editors
Navigering:
Forsinkede kurser. Sist oppdatert: tirsdag 6. november
20/09-2018 08:30:07: (PHO) Photocure ASA: Daniel Schneider appointed Chief Executive Officer
Oslo, Norway, 20 September 2018: Photocure ASA (OSE: PHO), announces today that Daniel Schneider has been appointed President and Chief Executive Officer of Photocure. Mr Schneider joins Photocure from the position of General Manager for Ablynx N.V. in North America.
"I am pleased to announce Dan Schneider as our new President and Chief Executive Officer. Photocure is entering a period of accelerated growth in the important U.S. market with strengthened focus on commercial development. Dan brings over 25 years of experience in developing and expanding rapidly growing healthcare companies in the U.S. He will further leverage on the opportunities arising from Photocure's unique position in the bladder cancer market. I look forward working with Dan to develop Photocure into becoming the leading bladder cancer company", says Jan H. Egberts, M.D. Chairman of the Board.
Mr Schneider is a U.S. citizen and holds an MBA from Washington University and a Bachelor of Science degree in Business Administration from St. Louis University with a double major in Finance and Marketing. Mr Schneider brings extensive commercial experience from the U.S. healthcare industry, including his previous position as General Manager for Ablynx N.V. in North America. Mr Schneider has also held executive management positions in other pharmaceutical and biotech companies, including BTG International, Somaxon Pharmaceuticals and Sepracor.
"The Photocure team has built a unique company within the field of bladder cancer, with excellent people, world leading technology and high-potential products. The company has developed a solid infrastructure in key regions, especially in the U.S. We will continue to scale and leverage on this growth platform to deliver on the commercial opportunities in the bladder cancer markets. I look forward to work with the team to expand the commercial footprint and to embark on the growth journey for Photocure", says Mr Schneider.
Mr Schneider will commence the position upon further agreement, expected prior to 1 November 2018. Erik Dahl will continue to serve as the acting Chief Executive Officer until Mr Schneider's commencement of his position, after which Mr Dahl will resume his previous role as the Chief Financial Officer of Photocure.
For further information, please contact:
Photocure
Jan H. Egberts
Chairperson of the Board
Tel: +31 614672518
Email: janegberts@aol.com
Notes to editors
Redigert 21.01.2021 kl 08:44
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Londonmannen
07.11.2018 kl 08:10
6671
OK
Takk for en grundig, oversiktelig og overbevisende opplisting av viktige hendelser. Her finnes ikke et eneste negativt utviklingstrinn, men derimot en solid manifestasjon over hvilke milepæler som er oppnådd og hvordan selskapet har utviklet seg i positiv retning gjennom 11 måneder. Det har forsåvidt også aksjekursen reflektert. Men utviklingen har stanset opp den siste tiden. Det hevdes å være flere årsaker til dette; generelt dårlig børsklima internasjonalt, lite fokus på farmasiaksjer, penger flyttet fra PHomog over i andre farmasiaksjer og mangel på oppdateringer fra selskapet.
Men dersom man tar seg tid og leser gjennom listen OK har tatt seg tid å utarbeide, så burde det ikke være vanskelig å finne den røde tråden. Og den er svært positiv, for å si det mildt, og er hovedårsaken til at mange av oss gleder oss til hva som kommer på presentasjonen av Q3.
For sammenholder man utviklingen av det fundamentale i PHO med kursutviklingen, så synes det absolutt som det har kladdet litt de siste ukene. Selskapet har et enormt potensial, bare i det amerikanske markedet, men prises kun til 1,1 milliarder. Det til tross for at risikoen i PHO er betydelig mindre enn hva man finner i mange andre farmasiselskaper. Så ingen grad ledelsen i leverer varene i morgen, så tror jeg det kan ligge an til en meget hyggelig reprising av PHO.
Vi skal heller ikke glemme at i dette bilder ligger det en short på 200k aksjer. Positiv presentasjon i morgen, som utløser reprising, vil resultere inatvselgerne forsvinner som dugg for solen, og da kan denne shorten både koste den ansvarlige dyrt og bidra til et voldsomt kursbyks.
Skulle nesten tro det var lillejulaften i dag. ;-))
Takk for en grundig, oversiktelig og overbevisende opplisting av viktige hendelser. Her finnes ikke et eneste negativt utviklingstrinn, men derimot en solid manifestasjon over hvilke milepæler som er oppnådd og hvordan selskapet har utviklet seg i positiv retning gjennom 11 måneder. Det har forsåvidt også aksjekursen reflektert. Men utviklingen har stanset opp den siste tiden. Det hevdes å være flere årsaker til dette; generelt dårlig børsklima internasjonalt, lite fokus på farmasiaksjer, penger flyttet fra PHomog over i andre farmasiaksjer og mangel på oppdateringer fra selskapet.
Men dersom man tar seg tid og leser gjennom listen OK har tatt seg tid å utarbeide, så burde det ikke være vanskelig å finne den røde tråden. Og den er svært positiv, for å si det mildt, og er hovedårsaken til at mange av oss gleder oss til hva som kommer på presentasjonen av Q3.
For sammenholder man utviklingen av det fundamentale i PHO med kursutviklingen, så synes det absolutt som det har kladdet litt de siste ukene. Selskapet har et enormt potensial, bare i det amerikanske markedet, men prises kun til 1,1 milliarder. Det til tross for at risikoen i PHO er betydelig mindre enn hva man finner i mange andre farmasiselskaper. Så ingen grad ledelsen i leverer varene i morgen, så tror jeg det kan ligge an til en meget hyggelig reprising av PHO.
Vi skal heller ikke glemme at i dette bilder ligger det en short på 200k aksjer. Positiv presentasjon i morgen, som utløser reprising, vil resultere inatvselgerne forsvinner som dugg for solen, og da kan denne shorten både koste den ansvarlige dyrt og bidra til et voldsomt kursbyks.
Skulle nesten tro det var lillejulaften i dag. ;-))
Redigert 21.01.2021 kl 08:44
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Vi skal heller ikke glemme det særskilte faktum at de 4 øverste toppene i selskapet samlet skal presentere selskapet på presentasjonen i morgen tidlig, og 2 av dem kommer over fra USA.
Ikke for å hausse, men dette har jeg aldri sett i noe annet børsnotert selskap ved en kvartals-presentasjon tidligere.
Det er bare 4 og en halv time til å handle aksjer før fasit foreligger.
Lykke til
Ikke for å hausse, men dette har jeg aldri sett i noe annet børsnotert selskap ved en kvartals-presentasjon tidligere.
Det er bare 4 og en halv time til å handle aksjer før fasit foreligger.
Lykke til
Redigert 21.01.2021 kl 08:44
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En solid presentasjon i morgen kan utgjøre 5-10 kr på kursen pluss inndekning fra MW.
Redigert 21.01.2021 kl 08:44
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Drøye timen igjen før vi stenger godteri-sjappa..!!
Redigert 21.01.2021 kl 08:44
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Londonmannen
07.11.2018 kl 15:25
6346
Fåglane må vite hvor vi åpner ballet i morgen. Mulig at Moen ønsker å skremme ut noen småaksjonærer på åpningen og at vi slik sett åpner i rødt. Men her tror jeg det blir viktig å holde fokus på de fundamentale tallene, og da tenker jeg ikke på bunnlinjen i denne fasen, mennbrukerfrekvensen og antall scope. Dersom de to tallene viser akselererende vekst så bør man holde fingrene langt borte fra slagsknappen. Da har ledelsen bekreftet at selskapet gjør gjennombrudd i USA og med det markedet vil the sky be the limit!
Lykke til!
Lykke til!
Redigert 21.01.2021 kl 08:44
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LM
Det blir nok en digg dag i morgen med selskapets 4 topper på podiet, derav 2 sendt fra USA.
At Bellete blir med denne gangen også, garanterer nesten for begeistring i etterkant av presentasjonen.
Jeg tipper ingenting, men sa i går at vi ikke skulle bli veldig overrasket om vi avslutter på 65 på fredag med en sliten Marshall W halvveis inndekt
Det blir nok en digg dag i morgen med selskapets 4 topper på podiet, derav 2 sendt fra USA.
At Bellete blir med denne gangen også, garanterer nesten for begeistring i etterkant av presentasjonen.
Jeg tipper ingenting, men sa i går at vi ikke skulle bli veldig overrasket om vi avslutter på 65 på fredag med en sliten Marshall W halvveis inndekt
Redigert 21.01.2021 kl 08:44
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Kalleklovn
07.11.2018 kl 15:39
6306
Så mye hausing og diverse annet fjas tyder på att mange er fullastet til ripa med aksjer her nå. Å kursen har stanget rundt 50 lappen de siste uker vil bety en veldig kortvarig oppgang ved gode og ok nyheter imorgen.
Husk å selg før kl 10.
Ved litt dårlige og dårlige nyheter imorgen så ser vi 40 i løpet av neste uke.
Husk å selg før kl 10.
Ved litt dårlige og dårlige nyheter imorgen så ser vi 40 i løpet av neste uke.
Redigert 21.01.2021 kl 08:44
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sjerkyll
07.11.2018 kl 15:53
6262
Klovnen,
PHO har vært en lang ørkenvandrer. Det har vært peaks på 50 og vaking rundt 40 for to år siden. I morgen kan gå begge veier, men fra det jeg har lest meg opp på så mener jeg det ligger mer til rette for positiv-oppsving i morgen enn kursras.
PHO har vært en lang ørkenvandrer. Det har vært peaks på 50 og vaking rundt 40 for to år siden. I morgen kan gå begge veier, men fra det jeg har lest meg opp på så mener jeg det ligger mer til rette for positiv-oppsving i morgen enn kursras.
Redigert 21.01.2021 kl 08:44
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Mental Mania
07.11.2018 kl 15:56
6249
Tror dagen i dag bare er en liten forsmak på hva vi har i vente for morgendagen.
Redigert 21.01.2021 kl 08:44
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ITinvest
07.11.2018 kl 15:57
6236
aksjer er morro
Redigert 21.01.2021 kl 08:44
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focuss
07.11.2018 kl 16:00
6223
Photocure er en " no-brainer" ser man ikke det caset så sliter man på børs.
Redigert 21.01.2021 kl 08:44
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hkirk
07.11.2018 kl 16:48
6126
Kalleklovn.
En som formulerer seg så blærete og er så dårlig i rettskrivning tror jeg ikke at jeg tar særlig alvorlig.
En som formulerer seg så blærete og er så dårlig i rettskrivning tror jeg ikke at jeg tar særlig alvorlig.
Redigert 21.01.2021 kl 08:44
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Londonmannen
07.11.2018 kl 16:52
6113
Dersom ledelsen leverer overraskende gode nyheter i morgen/uttaler seg optimistisk og fremoverlent, ja da vil jeg ikke utelukke at vi kan få en heidundrende fredag med kurser tett opp mot 70 tallet. Jeg sier ikke AT vi får det, men blir IKKE overrasket om så skjer.
Redigert 21.01.2021 kl 08:44
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Kalleklovn,
Ser ut som du er eksponert i pcib. Unødvendig å la din frustrasjon og bitterhet gå utover pho trådene.
Vi klarer oss utmerket godt uten innblanding fra deg.
Mange typer mennesker her på forumet gitt.
Ser ut som du er eksponert i pcib. Unødvendig å la din frustrasjon og bitterhet gå utover pho trådene.
Vi klarer oss utmerket godt uten innblanding fra deg.
Mange typer mennesker her på forumet gitt.
Redigert 21.01.2021 kl 08:44
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Legoland
07.11.2018 kl 22:13
5897
Nedkokt utgave av traaden: Vi venter paa at behandling med Hexvix/Cys skal faa status som SOC. I mellomtiden slaar vi tiden ihjel med skriverier paa HO om haap, tro og kjärlighet.
Redigert 21.01.2021 kl 08:44
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Kalleklovn
08.11.2018 kl 08:47
5755
Jeg delte bare mine tanker, hadde selv en post med aksjer her. kan bli veldig bra på sikt dette her.
Mente att det å kjøpe god opp på 50 tallet fort kunne bli dyrt.
Men langsiktig så ser det lovende ut.
Mente att det å kjøpe god opp på 50 tallet fort kunne bli dyrt.
Men langsiktig så ser det lovende ut.
Redigert 21.01.2021 kl 08:44
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Kalleklovn
08.11.2018 kl 13:34
5660
Ja da fikk jeg også kjøpt aksjer, litt billigere enn igår :)
Redigert 21.01.2021 kl 08:44
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JosefK
08.11.2018 kl 13:38
5648
Jepp! Vi lar oss begeistre og hygger os med 20% mindre å skatte for... Tusen takk, Belete!
Redigert 21.01.2021 kl 08:44
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