Recro Pharma Announces Six-Year Extension of License and Supply Agreement Between Teva and Recro Gainesville
April 16 2019 - 7:00AM
Company Continues Important, Strategic
Relationship with Key Global Customer; Long-Term Contract
Executed
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.
CONTACT:
Investor Relations Contact: Argot PartnersSam Martin / Claudia
Styslinger(212) 600-1902sam@argotpartners.com
claudia@argotpartners.com
Recro Pharma, Inc. Ryan D. Lake (484) 395-2436
rlake@recropharma.com
Media Contact: Argot Partners David Rosen (212) 600-1902
david.rosen@argotpartners.com
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