On July 2, 2019 Asieris MediTech Co, Ltd (Asieris), a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases, and Photocure ASA (Photocure, PHO: OSE), The Bladder Cancer Company, reported that they have entered into a License Agreement for world-wide development and commercialization of Cevira for the treatment of HPV induced cervical precancerous lesions (Press release, Asieris Pharmaceuticals, JUL 2, 2019, View Source [SID1234561778]).
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"We are proud to announce this agreement with Asieris, providing a global roadmap for the development and commercialization of Cevira," said Daniel Schneider, President and CEO of Photocure. "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.We look forward to further cooperation with Asieris into bringing Cevira to the market."
"Cevira is a strategic fit for Asieris’ therapeutic focus on genitourinary (GU) diseases, particularly the oncological ones," said Kevin Pan, CEO of Asieris. "Photocure is a global leader in developing photodynamically activated therapeutic and diagnostic products. Asieris has built strong development capabilities in the GU area in China and is rapidly expanding its global capability. Through the partnership with Photocure, we will endeavour to bring this innovative, non-surgical product to global market to fulfil a substantial unmet medical need in Women’s Health."
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.
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 U.S. and the EU markets will follow when clinical data from the China focusedPhase 3 study confirm 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.
Under the License Agreement, Asieris will pay Photocure a total signing fee of USD 5 million within 6 months after signing. In addition, Photocure 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, USA and EU would result in payments of up to USD 14 million. Additionally, sales royalties will apply in all markets.
About Cevira
Cevira is a photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade cervical dysplasia. Cevira is easily placed on the cervix by the gynecologist and removed by the patient, with no disruption of normal daily activities. Only one or two treatments are needed.