Hvor mye vil prises produkter når de er ferdig med fase 2b og samtidig fase 3 studien + diverse studiekostnader og godkjenninger + markedsføringsutgifter + produksjonen dekkes? 0 kostnader + 0 emisjoner. Avtalen med kinesere er verdt over 2,1 mrd kroner + 10%-20% royalties og dette viser markedspotensiale til dette produktet. Cevira er ikke priset i aksjekursen nå. Kan vi si forsvinnende 650 mil eller ca.30 kroner per aksje akkurat nå når pasientgrunnlaget kan være 1 million? Med dagens aksjekurs pris Cysview til ca. 23,9 kroner per aksje.

Cevira
breakthrough technology for the treatment of persistent oncogenic HPV and precancerous lesions of the cervix.

Cevira has demonstrated statistically significant efficacy and safety in patients with HSIL, which has over 1 mill cases diagnosed annually in the US and EU, and might be an excellent first line treatment for these patients for several reasons:

-Non-invasive, targeted treatment of HPV infection and precancerous lesions
-Preserving cervical function
-Only local, transient self-limiting side effects
-Fewer monitoring visits to the gynecologist
-Easy and convenient procedure for both gynecologist and patient

https://photocure.com/products/product-pipeline/cevira/

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The phase 2b trial is a multicenter, randomized, double-blind placebo controlled trial in patients with histologically confirmed low to moderate grade cervical intraepithelial neoplasia (CIN1/2). The study enrolled 262 patients at 23 office or hospital based gynecology practices in the US and Europe.

The optimal dose of Cevira, 5%, demonstrated a statistically significant lesion response compared to placebo in patients with precancerous CIN2 lesions, 95% vs 57% respectively, (p<0.01). This was further supported by significant clearance of HPV types 16 and 18, which carry high oncogenic risk, in the CIN2 cohort of 83% vs 0%,(p<0.02). In the overall CIN1 and CIN2 study population, Cevira, at the optimal dose, showed a higher response (73% vs 60%, p=0.2) and clearance of high oncogenic risk in HPV types 16 and 18 (54% vs 11%, p=0.07) as compared to placebo.

Cevira was well tolerated and easy to use by both the gynecologists and patients. No treatment related serious adverse events were reported in the study. No patients withdrew from the study due to treatment related events. In addition, patients experienced only expected benign and self-limiting events.

https://photocure.com/news/cevira-phase-2b-results/

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The conclusion of a Phase 2 meeting with the FDA confirmed that the Phase 2 data supports the proposed Phase 3 program, and are sufficiently robust to continue the development of Cevira.

Cevira has the potential to treat HPV induced cervical high grade disease and prevent the development of cervical cancer which affects more than 500 000 women annually

https://www.europeanpharmaceuticalreview.com/news/28826/photocure-announces-end-phase-2-status-achieved-cevira-u-s/

NB: Tallet 500000 er kun i USA og EU. Med Kina + Asia + Latin Amerika kan være over 1 millioner.