Highlights

  • 4DMT to receive USD 85 million upfront and USD 50 million in development cost sharing.
  • Agreement includes up to USD 336 million in milestone payments and tiered royalties.
  • Partnership to support global Phase 3 trial in DME and wet AMD.

4D Molecular Therapeutics (Nasdaq:FDMT) announced an exclusive licensing agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of 4D-150 in the Asia-Pacific (APAC) region, including Japan, China, Australia, and other markets.

Strategic Collaboration to Expand Global Reach

This collaboration combines 4DMT’s expertise in AAV genetic medicine and retinal disease therapy with Otsuka’s established regulatory and commercial infrastructure in APAC. The companies aim to achieve global marketing approvals for 4D-150, a potential long-term treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) — two leading causes of vision loss worldwide.

Key Terms of the Agreement

Under the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases in the APAC region. Otsuka will handle all regulatory and commercialization activities within its licensed territories, while 4DMT will continue to lead global Phase 3 clinical trials and manufacturing.

4DMT will receive USD 85 million upfront and at least USD 50 million in cost sharing over the next three years. The company is also eligible for up to USD 336 million in potential regulatory and commercial milestone payments, along with tiered double-digit royalties on net sales in Otsuka’s territories. 4DMT will retain full development and commercialization rights outside the APAC region, including in the U.S., Europe, and Latin America.

Management Comments

“We are thrilled to announce this strategic partnership with Otsuka, a leading global pharmaceutical company with a strong presence in the APAC region, reflecting our shared long-term commitment to improving outcomes for patients with retinal vascular diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “This partnership is a key pillar of our global strategy, with 4DMT continuing to lead Phase 3 clinical trial and manufacturing activities globally, in addition to pre-commercial and commercial activities outside the APAC region.

Otsuka has created new value that contributes to the well-being of patients in Japan and around the world through both in-house and collaborative research,” said Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. “By introducing 4D-150 to the markets in Japan, and elsewhere in Asia and Oceania, we aim to help prevent vision loss through a single, potentially lifelong administration.”

About 4D-150 and Target Diseases

4D-150 is designed to provide multi-year delivery of anti-VEGF therapies from a single intravitreal injection using a customized AAV vector developed by 4DMT. The therapy targets wet AMD and DME, conditions that affect millions of people globally and often require frequent injections under current treatment options.