The company has entered into a License Agreement providing Asieris Meditech with a world-wide license to develop and commercialize Cevira for the treatment of HPV induced cervical precancerous lesions.
Asieris plans to launch a global clinical development program with an initial focus on the China market based on Photocure’s Phase 2b data and the Phase 3 study design elements agreed with the US FDA. The development for the US and EU markets will follow when clinical data from the China focused Phase 3 study confirms the safety and efficacy, estimated to be finished in 2022. Asieris will assume responsibility for the manufacture of the Cevira product while Photocure retains responsibility for the manufacture of the active pharmaceutical ingredient.
Revenue potential in the range of USD 250 million
Under the License Agreement, Photocure will receive a total signing fee of USD 5 million within 6 months after signing. In addition, the company may receive a total of USD 18 million based upon achievement of certain clinical and regulatory milestones in China and up to USD 36 million for certain clinical and regulatory milestones in USA and EU. Approval of a second indication in China, the US and the EU would result in payments of up to USD 14 million. Additionally, sales royalties will apply in all markets.
“We are proud to announce this agreement with Asieris, providing a global roadmap for the development and commercialization of Cevira. Cevira has the potential to be developed into the standard of care for the treatment of HPV infections and precancerous lesions, as a large population of women could benefit from a non-invasive treatment option for this condition. This agreement is in line with our vision of becoming a global bladder cancer company by divesting products that do not fit our therapeutic focus. This agreement provides Photocure with revenue potential from the development and global commercialization of Cevira in the range of USD 250 million including all payments and potential milestones, exclusive royalties of 10 to 20 per cent. We look forward to further cooperation with Asieris into bringing Cevira to the market,” says Daniel Schneider, President and CEO of Photocure.
A treatment for high grade cervical dysplasia
Cevira is in development as a treatment for high grade cervical dysplasia. It consists of a convenient, fully integrated drug delivery and light device to be applied intravaginally by the gynecologist. The patient can leave the physician office immediately and go back to daily activities, easily removing the device when the treatment is completed.
Photo of Daniel Schenieder: Photocure