Otsuka Pharmaceuticals could shell out over $400 million in total for the Asia-Pacific rights to 4D-150, which combines a VEGF-C inhibitory RNAi with Regeneron’s Eylea into a single ocular injection.
4D Molecular Therapeutics has signed an $85 million upfront deal with Japan’s Otsuka Pharmaceuticals to bring a genetic eye disease medicine to the Asia-Pacific region.
Besides the upfront payment, 4DMT will also receive $50 million in cost sharing and will be eligible for up to $336 million in milestone payments, plus royalties, according to a Thursday press release. In return, Otsuka has secured rights to develop 4D-150 in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) in the greater Asia-Pacific (APAC) region including Japan. 4DMT will keep the rights to 4D-150 outside the APAC region.
4DMT will continue with Phase III activities for the candidate, including in the APAC region, according to the release. The biotech expects sites to open sites in Asia for the late-stage test in wet AMD by the end of the year. U.S. sites opened in March.
4D-150 combines a VEGF-C inhibitory RNAi with Regeneron’s Eylea via a single, low-dose treatment that is injected into the eye. The therapy was developed by 4DMT via its Therapeutic Vector Evolution platform to provide a longer duration treatment for patients with wet AMD and DME.
Regeneron’s blockbuster Eylea is an injectable medicine that must be administered by an eye specialist every one to two months. The company is working on Eylea HD, which would be a longer-lasting pre-filled syringe of the medicine, but the new formulation has been plagued by manufacturing delays stemming from a third-party manufacturer and was rejected by the FDA earlier this week.
Sales of Eylea have been declining for Regeneron; it posted $1.11 billion for the third quarter, a 28% decline.
4DMT is not the only biotech coming after Regeneron’s Eylea crown. Ocular Therapeutix has an asset called Axpaxli that William Blair has heralded as “a significant advance” for the disease, however the therapy is still years away from the market. And Kalaris Therapeutics is in Phase I with TH103 for the condition, which is one of the leading causes of blindness.
Meanwhile, Eli Lilly just offered up to $261.7 million to acquire Adverum Therapeutics, which has a gene therapy candidate called Ixo-vec for wet AMD.
