MALVERN, Pa., Dec. 21, 2018 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (NASDAQ:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today announced an amendment to its global licensing agreement with Alkermes Pharma Ireland Limited (Alkermes) concerning the milestone payments for intravenous (IV) meloxicam. A New Drug Application (NDA) for IV meloxicam is currently under review by the U.S. Food and Drug Administration (FDA) and the Company is currently awaiting its assigned PDUFA goal date of March 24, 2019.
Under the prior agreement as amended, Recro Pharma owed Alkermes a milestone payment of $45 million upon approval of IV meloxicam by the FDA. This newly executed amendment provides that Recro Pharma will now pay to Alkermes $5 million within 30 calendar days following the amendment effective date, $5 million in April 2019, and $5 million within 180 days following approval of IV meloxicam by the FDA. Recro Pharma will then pay to Alkermes a total of $45 million in seven equal annual payments of $6.4 million each, commencing upon the first anniversary following FDA approval. In connection with the amendment Recro will also reprice the original warrants issued to Alkermes at market pricing plus a 20% premium, at a strike price of $8.26. The combined revised consideration for the amended milestone payment results in a net present value of $45M utilizing an approximate discount rate of 11%.
“We are extremely pleased to execute this new amendment with our partner Alkermes, providing greater financial flexibility as we prepare for the upcoming approval decision for IV meloxicam and subsequent planned product launch, if approved,” said Gerri Henwood, Recro Pharma's President and Chief Executive Officer. “The amendment will reduce our cash requirements for 2019 by approximately $30 million and extends the payments over a seven year period.”
About IV/IM Meloxicam
Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. IV meloxicam was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).
About Recro Pharma, Inc.
Recro Pharma is a specialty pharmaceutical company that operates through two business divisions, an Acute Care, hospital product division and a revenue-generating contract development and manufacturing, or CDMO division, located in Gainesville, GA. The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings. The Company’s lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam has successfully completed two pivotal Phase III clinical efficacy trials, a large double-blind placebo-controlled Phase III safety trial, four Phase II clinical efficacy trials, as well as other safety studies. Recro’s Complete Response to the CRL for IV meloxicam was accepted for filing by the FDA in early October 2018 and assigned a PDUFA date of March 24, 2019. As injectable meloxicam is in the non-opioid class of drugs, if approved, the Company believes it has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. The Company’s CDMO division leverages its formulation expertise to develop and manufacture pharmaceutical products using its proprietary delivery technologies and other manufacturing services for commercial and development-stage partners who commercialize or plan to commercialize these products. These collaborations can result in revenue streams including royalties, profit sharing, research and development and manufacturing fees, which support continued operations for its CDMO division, and it contributes non-dilutive funding for the development and pre-commercialization activities of its Acute Care division.
