PharmaTher announces sales of ketamine ANDA

PharmaTher (PHRRF) entered into a definitive Asset Purchase Agreement for the sale of its Abbreviated New Drug Application for Ketamine Hydrochloride Injection USP to a well-established global pharmaceutical company specializing in sterile injectables and complex generics. Under the terms of the Agreement, PharmaTher will receive a confidential upfront cash payment at closing and is eligible for milestone payments based on cumulative sales thresholds, along with ongoing profit-sharing for a period of seven years following the first commercial sale. In total, the Agreement contemplates potential consideration of more than $25M; however, there can be no assurance that any or all of these payments will be realized, as they are contingent on the product’s commercial performance. The Buyer has requested confidentiality at this time for strategic business reasons, including competitive positioning in the U.S. ketamine and sterile injectable generics market. Investors should note that the Buyer is a credible, FDA-approved sterile-injectables manufacturer with an established track record of securing multiple ANDA approvals. Through its rapidly growing U.S. subsidiary, the Buyer is actively commercializing a portfolio of more than 40 approved ANDAs across the U.S., in addition to global operations. Its demonstrated expertise in developing, manufacturing, and commercializing of injectable medicines makes it a strong partner to unlock the commercial potential of ketamine in the U.S. The Agreement enables PharmaTher to participate in the potential long-term commercial success of the ANDA while maintaining meaningful exposure to the global ketamine market. It also allows the Company to focus on advancing next-generation ketamine programs, including long-acting injectables and novel delivery methods for potential psychiatric, pain, neurological, and orphan drug indications. The Agreement is subject to customary closing conditions, including required regulatory notifications, with the effective date of closing expected to occur in the near term.