The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) requires that a marketing application for a “biological product,” that previously would have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, must now be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act. On March 23, 2020, a new requirement under the BPCI Act was enacted requiring that polypeptides larger than 40 amino acids in length, such as thymosin beta 4 (Tβ4), would now be regulated as biologics. Other such products formerly regulated as drugs, and now as biologics, include insulin and insulin analogs, human growth hormone, pancreatic enzymes, and reproductive hormones.

Pursuant to our most recent FDA meeting related to RGN-259, our product candidate for the treatment of neurotrophic keratitis (NK), we officially confirmed that since RGN-259 contains Tβ4 as the active ingredient it will now be approved under a BLA instead of under an NDA. In this regard, the team at ReGenTree LLC, our U.S. joint venture, has already been developing the chemistry, manufacturing, and controls (CMC) required for a BLA with top-tier CGMP manufacturers based in the U.S. and Europe. ReGenTree has received official confirmation from FDA that its CMC manufacturing and quality control standards and development directions would be appropriate to submit a BLA. Thus, we intend to proceed with development conforming to BLA standards as we move forward.

Importantly, unlike the previous 5-year exclusive period for new chemical entities approved under an NDA, section 7002 of the Patient Protection and Affordable Care Act (PPACA) provides 12 years of exclusivity for products approved under a BLA. Biologics can also receive orphan drug and pediatric exclusivities. Therefore, if RGN-259 (our Tβ4-based product) receives a license under a BLA, and with the Tβ4 patents already secured in the U.S, our exclusive market position would be expected to become even stronger.