Otsuka Pharmaceuticals Acquires Asia-Pacific Rights to 4DMT's Eye Disease Therapy for $85M Upfront

In a significant move within the ophthalmology drug development space, 4D Molecular Therapeutics has inked a deal with Japan's Otsuka Pharmaceuticals for the Asia-Pacific rights to its promising eye disease candidate, 4D-150. The agreement, announced on Thursday, involves an upfront payment of $85 million and could potentially exceed $400 million in total value.

Deal Structure and Financial Terms

The partnership between 4DMT and Otsuka Pharmaceuticals encompasses:

• An $85 million upfront payment to 4DMT
• $50 million in cost-sharing arrangements
• Up to $336 million in potential milestone payments
• Royalties on future sales in the Asia-Pacific region

This substantial investment underscores the growing interest in innovative treatments for ocular diseases, particularly wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

4D-150: A Novel Approach to Ocular Treatment

4D-150 represents a cutting-edge approach to treating wet AMD and DME, two leading causes of vision loss. The therapy combines:

1. A VEGF-C inhibitory RNAi
2. Regeneron's Eylea (aflibercept)

This unique formulation is designed to be administered as a single, low-dose ocular injection, potentially offering a longer-lasting treatment option compared to current standards of care. 4DMT developed 4D-150 using its proprietary Therapeutic Vector Evolution platform, aiming to address the need for less frequent injections in patients with chronic eye conditions.

Clinical Development and Market Landscape

4D Molecular Therapeutics is poised to advance 4D-150 into Phase III clinical trials, with study sites expected to open for wet AMD by the end of the year. The company will retain rights to the therapy outside the Asia-Pacific region, maintaining a significant stake in its global development.

This development comes at a time when the market leader, Regeneron's Eylea, is facing challenges:

• Eylea sales declined 28% in the third quarter, posting $1.11 billion
• Regeneron's attempt to introduce Eylea HD, a longer-lasting formulation, was recently rejected by the FDA due to manufacturing issues

The competitive landscape for wet AMD treatments is intensifying, with several companies vying to capture market share:

• Ocular Therapeutix is developing Axpaxli, described by analysts as "a significant advance"
• Kalaris Therapeutics has TH103 in Phase I trials
• Eli Lilly recently offered up to $261.7 million to acquire Adverum Therapeutics and its gene therapy candidate, Ixo-vec

As the pharmaceutical industry continues to innovate in the field of ophthalmology, the 4DMT-Otsuka deal represents a significant step towards bringing potentially transformative treatments to patients in the Asia-Pacific region.