London-based women’s health pharma Theramex has agreed to pay up to $250 million to license Shanghai-based Asieris’ first-in-class non-surgical treatment for cervical precancerous lesions associated with HPV.
So far, the drug-device combination, marketed as Cevira, is only approved in China, but reviews by other global regulators are in the works. Through the licensing agreement, Theramex will take over commercial efforts across Europe—including its U.K. home base—as well as in Australia, New Zealand and Turkey. Asieris will maintain rights for the rest of the world.
Should an EU approval go through, the deal allows Asieris to piggyback its global expansion on Theramex’s established women’s health infrastructure across Europe, while reserving high-value markets, like the U.S., for itself.
Theramex will kick off the exchange with $15 million upfront and another $11 million if near-term regulatory milestones are achieved. All told, additional commercial milestone payments and tiered royalties could bring the total potential deal value to more than $250 million, Asieris said in a release.
The upfront payment hinges on several conditions, including a signed supply agreement, successful audits of Cevira manufacturing sites, and clarification from the European Commission on the device’s clinical value.
The deal was struck while Cevira is under review with the European Medicines Agency. The treatment, which combines a photosensitizing drug with an intravaginal light delivery device, earned its first global approval in March from China’s National Medical Products Administration. For their decision, both agencies reviewed Asieris’ multicenter, international phase 3 trial, in which more than 20% of participants were European.
In the trial, patients with cervical intraepithelial neoplasia grade 2 (CIN2), a moderate grade precancerous lesion at risk of becoming cervical cancer, showed a nearly 50% response rate to the treatment compared to 23% on placebo. And by six months, 57.5% of patients treated with Cevira showed histopathological improvements, achieving either normal histology or low grade squamous intraepithelial lesions which are milder than CIN2.
“These findings indicate that after only one to two treatment courses, nearly 60% of patients may avoid surgical excision,” Asieris wrote in a March release. With the treatment, 60% of HPV infections were also cleared within 6 months.
To date, the prevailing treatment for CIN2 has been active surveillance, especially for younger patients, which includes regular exams every six months. And if the condition progresses or persists beyond two years, the abnormal tissue is removed by surgical excision or ablation.
Cevira, by contrast, is administered in the clinic by a gynecological health provider. Asieris said the device placement takes less than 10 minutes and requires no anesthesia. Patients can then return to their daily routine immediately after treatment, and remove the device themselves when treatment is finished. In addition to preserving cervical tissue and changing the model of care for female patients, Theramex said the nonsurgical approach has the potential to create meaningful cost savings for European healthcare systems.
Way back in 2015, the Shanghai drugmaker announced—with partner Photocure—that the FDA had approved a phase 3 trial design to support Cevira’s potential U.S. approval. But, so far no trial is underway.