Recro Pharma Announces Six-Year Extension of License and Supply Agreement Between Teva and Recro Gainesville
Company Continues Important, Strategic Relationship with Key Global Customer; Long-Term Contract Executed
Teva to Continue to be Exclusive Marketing Partner of Verapamil SR® Capsules with Same Revenue Economics as the Original Agreement
MALVERN, Pa., April 16, 2019 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (NASDAQ:REPH), a specialty pharmaceutical company with a high-performing revenue generating contract development and manufacturing (CDMO) division, today announced that Recro Gainesville LLC, its CDMO division, has amended its existing license and supply agreement with Teva Pharmaceutical to extend the agreement for six years, effective January 1, 2019.
Under the terms of the amended Agreement, Recro Gainesville will continue to supply Teva with Verapamil SR capsules through 2024 and Teva will continue to be Recro Gainesville’s exclusive United States distributor of the product, for which Recro Gainesville is the New Drug Application holder. The 2019 Teva Agreement provides to Recro Gainesville the same revenue economics as the original agreement, including both manufacturing and profit sharing components. Prior to this amendment, the license and supply agreement with Teva for Verapamil SR was renewable on a year-to-year basis.
“Teva is the largest generic pharmaceutical company in the world and continues to do a tremendous job as our exclusive marketing partner for Verapamil SR,” said Scott Rizzo, Senior Vice President, General Manager of Recro Gainesville. “The 2019 Teva Agreement both extends our baseline manufacturing business for a substantial period of time and serves as a solid foundation upon which to add new CDMO customers.”
Gerri Henwood, Recro Pharma's President and Chief Executive Officer, commented, “We have maintained a close working partnership with Teva and they have delivered strong product volume through their unparalleled distribution channels. This amendment underscores the commitment and dedication of our employees in Gainesville to maintain high quality standards and consistently deliver product on time to meet increasing demand. We are delighted Teva will continue to be our exclusive distributor in the United States for the next six years.”
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 the 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 and four Phase II clinical efficacy trials, as well as other safety studies. On March 22, 2019 Recro announced that FDA had provided a second CRL in response to the Company’s NDA for IV meloxicam. The Company is evaluating the path forward for IV meloxicam and plans to schedule a meeting with the FDA. 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.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Recro's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "may," "upcoming," "plan," "target," "intend" and "expect" and similar expressions, as they relate to Recro or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Recro as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Recro’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. Recro assumes no obligation to update any such forward-looking statements. Factors that could cause Recro’s actual performance to materially differ from those expressed in the forward-looking statements set forth in this press release include, without limitation: the Company’s ability to attract a strategic partner for the development and commercialization of IV meloxicam, the Company’s ability to adequately resolve the deficiencies identified by the FDA in the second CRL for IV meloxicam, and the time frame associated with any such resolution, including whether the FDA will require additional clinical studies and the time and cost of such studies; whether the Company will prepare an amended new drug application (NDA) for IV meloxicam and, whether the FDA will accept and approve any such resubmitted NDA and the labeling under any such approval; the Company’s ability to raise future financing for continued product development and IV meloxicam commercialization; with regard to the Company’s clinical trial results, whether there may be changes in the interpretation by the FDA of the data of the Company’s clinical trials and the length, cost and uncertain results and timing of our ongoing clinical trials; with regard to the potential commercial opportunity of IV meloxicam, whether any FDA approval of IV meloxicam will include labeling restrictions and the potential that IV meloxicam does not receive regulatory approval or does not receive reimbursement by third party payors, that IV meloxicam is not accepted by the medical community, including physicians, patients, health care providers and hospital formularies or that a commercial market for IV meloxicam does not develop; the Company’s ability to manage costs and execute on its operational and budget plans, the Company’s ability to achieve its financial goals, including financial guidance, the Company’s ability to pay its debt under its credit agreement; the Company’s ability to maintain relationships with CDMO commercial partners; and the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. The forward-looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro’s business and future results included in Recro’s filings with the Securities and Exchange Commission at www.sec.gov.
Recro Pharma, Inc.
Ryan D. Lake
Released April 16, 2019