Allvivo: Progress in Ophthalmic Drug Licensing, Aiming to Complete Negotiations by Year-End

(Central News Agency, reporter He Xiuling, Taipei, 8th) Allvivo Biomedical Chairman Lin Chun stated that the Phase 2 clinical trial enrollment for its developmental new drug for treating neurotrophic keratitis is nearly complete. Several international pharmaceutical companies have entered the due diligence (DD) stage, and there is an opportunity to complete licensing negotiations by the end of this year. Furthermore, a regional licensing proposal has been received from an Asian pharmaceutical company for its new glaucoma drug, and progress is expected by the year-end.

Allvivo held a media briefing today. Chairman Lin Chun pointed out that the Phase 2 clinical trial for the developmental new drug BRM424, conducted in the United States and Brazil, has attracted attention from international pharmaceutical companies and potential licensing partners. Allvivo has begun compiling trial data and plans to apply for an End of Phase 2 (EOP2) Meeting with the U.S. FDA in the third quarter of this year to discuss the planning for the next pivotal clinical trial.

Allvivo plans to submit a Breakthrough Therapy designation application to the FDA and expand its application for Orphan Drug Designation to the European Medicines Agency (EMA) to accelerate the launch of the new drug.

Progress has also been made on the glaucoma drug BRM411. Chief Technology Officer Lin Chengwen stated that the Phase 2 clinical trial has been initiated, and nine clinical trial centers have been opened domestically to accelerate patient enrollment.

Chairman Lin Chun emphasized that Allvivo has been continuously conducting new drug licensing negotiations in recent years. During the Association for Research in Vision and Ophthalmology (ARVO) meeting in May this year, the team held face-to-face discussions with multiple pharmaceutical companies regarding the development status and preliminary clinical data of the two products, resulting in close attention and potential licensing interest from several international pharmaceutical companies.

Among these, BRM424 has entered the due diligence stage with pharmaceutical companies from Europe, the Americas, and Asia, with one company already in the negotiation stage for licensing terms. For BRM411, one Asian pharmaceutical company has submitted a regional licensing proposal.

He estimates that as the Phase 2 clinical trials for the two products gradually conclude, there will be an opportunity to complete global or regional licensing negotiations with international pharmaceutical companies by the end of this year, thereby accelerating the launch of the new drugs. (Editor: Chang Li Jen) 1150608