Recro Wins $1.5 Million Formulation Development and CGMP Manufacturing Contract to Support Clinical Development of Topical Treatment for Skin Cancer Prevention
January 26 2022 - 6:00AM
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 formulation development and cGMP manufacturing
contract from a key department of the United States government. The
contract focuses on supporting clinical development of a topical
dermal treatment for the prevention of skin cancer.
Under terms of the new, multi-year, $1.5 million
contract, the company will formulate, manufacture and supply a
topical dermal drug product containing a prespecified active
pharmaceutical ingredient, as well as a matching placebo, for a
planned cancer prevention clinical study. These activities will
include analytical method development, formulation, cGMP clinical
trial material manufacturing, packaging and labeling services to
support the planned clinical trial, which is designed to evaluate
the effects of chemoprevention with the investigational compound on
the recurrence of basal cell carcinoma.
“We are pleased to have been selected to support
this important clinical research program focused on a preventative
skin cancer therapy. The scope of work associated with this new
contract will allow Recro to call upon a broad range of our
capabilities from analytical development and formulation through to
key clinical trial material manufacturing and packaging,” said
David Enloe, chief executive officer of Recro. “This agreement is
the latest evidence of the traction our sales team is generating in
growing our base of business, which includes key relationships with
not only pharmaceutical and biotech companies but also important
federal government agencies.”
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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