Recro Awarded Development and Manufacturing Contract by National Institutes of Health (NIH) to Support Novel Nasal Spray Analgesic
New $1.87 Million Task Order Falls Under Existing Parent “Drug Formulation and Manufacturing” Contract with NIH
GAINESVILLE, Ga. and SAN DIEGO, Oct. 20, 2021 (GLOBE NEWSWIRE) — Recro Pharma, Inc. (“Recro”; NASD: REPH), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been awarded a new development and manufacturing contract by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The contract, “Dosage Form Development, Manufacture, and Stability Studies of NES-100 Nasal Spray,” focuses on NES-100, a novel nasal spray analgesic.
The new contract is an individual $1.87 million task order that falls under an existing NIH parent contract (N01TR-17-2003) that was previously awarded to IriSys, the San Diego-based CDMO that was recently acquired by Recro. Under terms of the new contract, the company will support Chemistry, Manufacturing and Controls (CMC) development of NES-100, a microparticle dosage form of leu-enkephalin (LENK) that is prepared by the encapsulation of LENK in a patent-protected molecular enveloped technology (MET) and delivered via a nasal spray device. The polymer particles encapsulating LENK are able to transport LENK to the brain via the intranasal route with little to no peripheral exposure.
“This is a great win for the company and highlights the impressive capabilities and expertise possessed by our San Diego team in the development and manufacture of sophisticated therapeutic formulations. At the same time, this also showcases the significant traction that we are generating as we rapidly integrate our new West Coast operations and continue to grow the overall business,” said David Enloe, chief executive officer of Recro. “We are pleased to have been selected by NIH for this important project and are grateful for the strong working relationship that has been established between the company and the agency in recent years. Our broad-ranging parent contract with NIH remains in effect for several more years and we look forward to applying for and winning additional key projects during that time.”
This project is funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN2712017000201. The content of this press release is solely the responsibility of Recro and does not necessarily represent the official views of the National Institutes of Health.
About NES100 (Envelta™)
NES100 (Envelta™) is an investigational intranasal formulation being developed by Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX) intended to improve enkephalin transport to the brain. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. NES100 uses a preassembled device and cartridge to propel the enkephalin formulation through the nose to the brain by flowing along the olfactory nerve pathway. The Molecular Envelope Technology is designed to protect the drug and help carry it to the brain, enabling it to cross the blood-brain barrier to suppress pain by binding to the delta-opioid receptors. NES100 has demonstrated analgesic potential in animal models without developing opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with the use of morphine.
About Recro
Recro (NASD: REPH) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Recro is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
For more information about Recro’s CDMO solutions, visit recrocdmo.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, the Company’s expectations regarding the completion of the proposed public offering, the Company’s use of proceeds from the proposed offering, and other statements. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the customer ordering patterns or inventory rebalancing or disruption in raw materials or supply chain; demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the company’s manufacturing services; the average profitability, or mix, of the products the company manufactures; the company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
CONTACT: Contacts: Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com Ryan D. Lake (CFO) Recro 770-531-8365 ryan.lake@recroCDMO.com
