Farma

JosefK
PHO 27.08.2018 kl 08:12 9393

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.

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