Recro Wins $1.5 Million Formulation Development and CGMP Manufacturing Contract to Support Clinical Development of Topical Treatment for Skin Cancer Prevention

Rhea-AI Summary

Recro Pharma (REPH) announced a multi-year contract valued at $1.5 million from a U.S. government department to develop and manufacture a topical dermal treatment aimed at preventing skin cancer. The scope includes formulating a drug product with a specified active ingredient and placebo, along with associated services such as analytical method development and clinical trial material manufacturing. This contract signifies Recro's expanding role in clinical research for preventative therapies and highlights its capabilities in addressing complex pharmaceutical manufacturing challenges.

Positive

• Secured a $1.5 million contract for formulation development and cGMP manufacturing.
• Contract supports a clinical study for a topical drug aimed at skin cancer prevention.
• Demonstrates growing relationships with federal government agencies.

Negative

• None.

SAN DIEGO, and GAINESVILLE, Ga., Jan. 26, 2022 (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 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 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.

FAQ

What is the purpose of Recro Pharma's new contract announced on January 26, 2022?

The contract aims to support the clinical development of a topical dermal treatment for skin cancer prevention.

What is the value and duration of the contract awarded to Recro Pharma?

The contract is valued at $1.5 million and spans multiple years.

What activities will Recro Pharma undertake under this contract?

Recro will provide formulation, manufacturing, packaging, and labeling services for a clinical study on skin cancer prevention.

How does this contract impact Recro Pharma's business opportunities?

This contract enhances Recro's visibility and credibility in the government sector, potentially opening doors for future contracts.

What specific type of drug product will Recro Pharma develop for the clinical study?

Recro will develop a topical dermal drug product containing a specified active pharmaceutical ingredient and a matching placebo.