Asieris Pharmaceuticals Enters Global License Agreement with Photocure for Cevira® Development and Commercialization

Arterial New Medicine (WeChat ID: biobeat1) has learned that Asieris Pharmaceuticals, a global innovative drug R&D company focused on anti-tumor and related diseases in the genitourinary system, and Photocure ASA (Photocure, PHO: OSE), a bladder cancer specialty company, announced today the signing of a global development and commercialization license agreement for Cevira®, a product for the treatment of human papillomavirus-induced cervical precancerous lesions.

“We are honored to reach this agreement with Asieris, which provides a roadmap for the global development and commercialization of Cevira,” said Daniel Schneider, President and Chief Executive Officer of Photocure. “Cevira has the potential to be developed as a standard treatment for human papillomavirus (HPV) infection and precancerous lesions, offering a non-invasive therapeutic option for many female patients. This agreement aligns with our vision of becoming a global bladder cancer specialty company by divesting non-core assets. We look forward to further collaboration with Asieris to bring Cevira to market.”

“Cevira aligns perfectly with Asieris’ strategy of focusing on the genitourinary system, particularly tumor-related diseases,” said Dr. Pan Ke, CEO of Asieris Pharmaceuticals. “Photocure is a global leader in the development of photo-dynamic activation therapies and diagnostic products. Asieris has established strong R&D capabilities in the genitourinary field in China and is rapidly building its global R&D strength. Through our collaboration with Photocure, we are committed to bringing this innovative, non-surgical therapeutic product to the global market to address a significant unmet need in women’s healthcare.”

Asieris Pharmaceuticals plans to initiate global clinical development, with a focus on the Chinese market, based on Photocure’s Phase 2b clinical study data and the Phase 3 clinical trial protocol previously agreed upon with the U.S. FDA. Upon confirmation of safety and efficacy from the Phase 3 clinical trials primarily involving Chinese patients (expected to be completed in 2022), regulatory development for the U.S. and EU markets will be launched. Asieris Pharmaceuticals will be responsible for the manufacturing of Cevira®, while Photocure will continue to oversee the production of the active pharmaceutical ingredient (API).

Under the license agreement, Asieris will pay Photocure a total signing fee of $5 million within six months after the agreement is signed. In addition, Photocure is eligible to receive cumulative milestone payments of $18 million upon achievement of specified clinical and regulatory milestones in China, and cumulative milestone payments of $36 million upon achievement of relevant clinical and regulatory milestones in the United States and the European Union. If Asieris obtains approval for a second indication of this product in China, the United States, and the European Union, Photocure may receive cumulative payments of $14 million. Furthermore, Photocure will receive global sales royalties for this product.

Cevira® is a combined photodynamic drug-device product being developed for the non-surgical treatment of high-grade cervical squamous intraepithelial lesions. Cevira® can be easily applied to the cervix by a gynecologist and removed by the patient herself, without interfering with daily activities. Patients require only one or two treatments with Cevira®.

High-grade squamous intraepithelial lesion (HSIL) of the cervix is a precancerous condition caused by persistent human papillomavirus (HPV) infection. HPV is a highly prevalent sexually transmitted infection that annually results in approximately 10 million cases of high-grade lesions and over 500,000 new cases of cervical cancer worldwide. In China, approximately 2% of women are diagnosed with HSIL each year. Currently, surgical excision is the most common treatment option offered to affected women. However, there is a significant unmet medical need among women of childbearing age for non-surgical therapies that can preserve cervical function. To date, no non-surgical therapeutic products have been approved globally.

Asieris Pharmaceuticals was established in March 2010 at China Medical City in Taizhou, Jiangsu Province, and has set up its R&D center in Shanghai. It is a domestic global innovative drug R&D company focused on anti-tumor and related diseases of the genitourinary system. Asieris is committed to becoming the most innovative, influential, respected, and trusted pharmaceutical enterprise in its specialized field. The company focuses on the genitourinary sector, rapidly establishing a leading position and implementing in-depth strategic layouts. By adopting a dual-engine drive model of “independent R&D” and “product in-licensing,” Asieris fully explores the global value of first-in-class new drugs with breakthrough therapeutic potential developed in-house, while simultaneously introducing new drugs that are in late-stage development or already marketed overseas into the Chinese market. This approach enhances the diversity and synergy of its product pipeline, enabling the company to quickly establish a leading position in the domestic market.

Photocure ASA is a company focused on bladder cancer, providing transformative solutions to improve the lives of patients with this disease. Photocure’s unique technology, which causes cancer cells to fluoresce pink, has led to better health outcomes for cancer patients worldwide. Headquartered in Oslo, Norway, Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Its U.S. headquarters is located in Princeton, New Jersey.