Recro Awarded Development and Manufacturing Contract by National Institutes of Health (NIH) to Support Novel Nasal Spray Analgesic
October 20 2021 - 7:00AM
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 RecroRecro (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 StatementsThis
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.
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
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