Recro Pharma Announces Five-Year Manufacturing and Supply Agreement Between Novartis and Recro Gainesville
Company Continues Long-Term, Strategic Relationship with Key Customer
Recro Gainesville to be Exclusive Supplier of Ritalin LA® and Focalin XR® Capsules with “Total Revenue Per Capsule Economics” Expected to be Similar to Prior Contracts
Recro Pharma, Inc. (NASDAQ:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for hospitals and other acute care settings, today announced that Recro Gainesville LLC, its contract development and manufacturing (CDMO) division, has entered into a five-year manufacturing and supply agreement with Novartis Pharma AG (“2019 Novartis Agreement”), effective January 1, 2019.
Under the terms of the agreement, Recro Gainesville will continue to be the exclusive global supplier to Novartis of Ritalin LA and Focalin XR capsules through 2023. The prior Novartis supply contracts for Ritalin LA and Focalin XR were set to expire in late 2019 and mid-2020, respectively, and provided for two revenue components, product manufacturing revenue and royalty revenue. These agreements were consolidated into the 2019 Novartis Agreement, which provides for product manufacturing revenue that is expected to provide similar “total revenue per capsule economics” as did the two prior revenue components combined.
“We are extremely proud to continue to be the strategic partner of choice for these dosage forms and provide high quality drug product for Novartis,” said Scott Rizzo, Senior Vice President, General Manager of Recro Gainesville. “Our Recro Gainesville team has a long track record of delivering the highest levels of service and value to our customers and supporting their growth objectives. We believe this new agreement is a result of that dedication and an illustration of our strong customer relationships.”
Gerri Henwood, Recro Pharma’s President and Chief Executive Officer, commented, “Our Gainesville facility has cultivated a close relationship with Novartis for nearly two decades and this new five-year contract extension underscores both the strength of our continued partnership as well as the value Recro Gainesville brings to our overall corporate enterprise.”
About Recro Gainesville
Recro Gainesville provides solid dosage form development, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. Specializing in extended release solid dose and DEA controlled substances, Recro has the experts to deliver clients’ most complex pharmaceutical development and manufacturing projects in its best-in-class, 120,000 square feet of manufacturing space. For more information about Recro’s flexible CDMO solutions, visit www.recrogainesville.com.
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. 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.
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: CDMO customer product performance and ordering patterns; the performance of CDMO third-party suppliers and manufacturers; the Company’s ability to maintain relationships with CDMO commercial partners; the Company’s ability to resolve the deficiencies identified by the FDA in the CRL for IV meloxicam; whether the FDA will approve the Company’s amended NDA for IV meloxicam and, if approved, the labeling under any such approval; if the FDA does not approve the Company’s amended NDA, the time frame otherwise associated with resolving the deficiencies identified by the FDA in the CRL and whether the FDA will require additional clinical studies to support the approval of IV meloxicam and the time and cost of such studies; the Company’s ability to successfully launch and commercialize IV meloxicam, if approved; the length, cost and uncertain results and timing of the Company’s clinical trials, including the Company’s Phase IIIb clinical trials and any additional clinical trials that the FDA may require in connection with IV meloxicam; the extent to which IV meloxicam, if approved, is accepted by the medical community, including physicians, patients, health care providers and hospital formularies; the availability of coverage and adequate and timely reimbursement for IV meloxicam, if approved; the Company’s ability to raise future financing for continued product development, IV meloxicam commercialization and the payment of milestones; the Company’s ability to achieve its financial goals, including financial guidance; the Company’s ability to access funding and pay its debt under its credit agreement; regulatory developments in the United States and foreign countries; the performance of third-party suppliers and manufacturers; and the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. In particular, there can be no assurance that the FDA will complete its review by the PDUFA goal date, that the FDA will not require changes or additional data with respect to the amended NDA or that the FDA will approve the amended NDA. 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.