Evicenter
P&T meetings

4D-150

Neovascular age-related macular degeneration

Regulatory submission
Not announced
Launch
Not announced
Last updated
180 sources

Product information and disease descriptionProduct descriptionProduct information

Access and distribution

4 evidence topics · 4 sources

Current availability

“All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority.” (opens the source at this quote in a new tab)

Manufacturing capabilities and commercial supply

“Our current in-house manufacturing capabilities include GMP manufacturing (upstream, downstream and fill/finish), production capabilities for late-phase clinical trials, IND-enabling Good Laboratory Practice (“GLP”) toxicology studies, and research candidate production.” (opens the source at this quote in a new tab)

“In addition to our in-house facilities, we have established a partnership with a leading global commercial CDMO for potential commercialization of 4D-150. We have successfully completed the tech transfer of produced and released Phase 3 batches using our intended commercial processes at this CDMO.” (opens the source at this quote in a new tab)

Commercial rights in Asia-Pacific markets

“Under the terms of the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases, including wet AMD and DME, in Japan, China, Australia and other Asia-Pacific markets. Otsuka will lead all regulatory and commercialization activities in its licensed territories.” (opens the source at this quote in a new tab)

“4DMT retains full development and commercialization rights for 4D-150 outside the APAC region, including the U.S., Latin America and Europe.” (opens the source at this quote in a new tab)

Preparation for commercialization

“As CTO, Dr. Barglow will continue to oversee 4DMT’s transition to commercial manufacturing, with responsibility for CMC quality, supply chain, and technical operations.” (opens the source at this quote in a new tab)

Expanded access program, specialty distribution, and site qualification requirements

No evidence found.