Florida-based Jupiter Neurosciences, Inc. (Nasdaq: JUNS) has signed a definitive license agreement with Vancouver-based PharmAla Biotech Holdings Inc. (CSE: MDMA) for perpetual, exclusive US rights to ALA-002, a patented non-racemic MDMA formulation carrying FDA Novel Chemical Entity designation. The transaction means Jupiter adds another CNS molecule to its previously single-program pipeline, the new asset joining its existing Phase IIa resveratrol program for Parkinson's disease.
The agreement follows a term sheet the two companies signed in May, which outlined the same headline value of over USD 100 million. PharmAla completed GMP manufacturing of ALA-002 drug substance earlier in July, shortly before the definitive agreement closed.
The agreement includes a USD 3.3 million upfront payment—USD 1.5 million in cash and USD 1.8 million in Jupiter shares—plus up to USD 96.7 million in development, regulatory and commercial milestones. PharmAla is also eligible for a 3% royalty on US sales after cumulative revenue reaches USD 2 billion. The company retained manufacturing rights and will supply ALA-002 to Jupiter under a separate commercial agreement while retaining all rights outside the United States.
ALA-002 is an enantiopure, non-racemic formulation of MDMA. Although its pharmacology is based on decades of clinical experience with racemic MDMA, the formulation received FDA Novel Chemical Entity designation, potentially qualifying it for five years of regulatory exclusivity upon approval. PharmAla has said the single-enantiomer composition may improve cardiovascular tolerability and reduce abuse liability relative to conventional racemic MDMA.