Societal CDMO Secures Manufacturing and Packaging Task Order Award from National Cancer Institute (NCI)
SAN DIEGO and GAINESVILLE, Ga., April 27, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), 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 manufacturing and packaging task order agreement by the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD). The new contract is an individual task order of more than $400,000 for the manufacture and packaging of ammonium tetrathiomolibdate (ATTM) capsules to support clinical development of the compound.
Under terms of the new task order award, Societal CDMO will develop and provide DCTD with a scalable manufacturing and packaging process for cGMP production of 100 mg ATTM capsules. This work will include production and packaging of an initial engineering batch of ATTM, followed by production and packaging of a larger cGMP batch of the capsules including a 36-month shelf-life stability study. ATTM acts to interfere with intestinal uptake of copper when administered with meals and binds plasma copper when taken between meals. Based on this mechanism of action, the compound is believed to have the potential to enhance the activity of platinum-based antitumor agents.
“We are pleased to support the NCI and the important research its scientists are undertaking on behalf of cancer patients. By delivering cGMP batches of ATTM to the DCTD, we will be playing an important role in activities designed to advance the battle against cancer, which aligns well with Societal CDMO’s mission and our tagline of ‘Bringing Science to Society,’” said David Enloe, chief executive officer of Societal CDMO. “It is validating to be chosen by the NCI to execute this work and we strongly value the trusted relationship we have established with a number of groups within the National Institutes of Health in recent years. We look forward to delivering the high quality process and product that our customers expect from Societal CDMO.”
This project is funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N98019D00058, Task Order 75N91022F00002. The content of this press release is solely the responsibility of Societal CDMO and does not necessarily represent the official views of the National Cancer Institute.
About Societal CDMO
Societal CDMO (NASDAQ: SCTL) 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, Societal CDMO 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, Societal CDMO 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.
Societal CDMO: Bringing Science to Society. For more information about Societal CDMO’s customer solutions, visit recrocdmo.com.
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. 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 firstname.lastname@example.org Tim Brons (Media) Vida Strategic Partners 415-675-7402 email@example.com Ryan D. Lake (CFO) Societal CDMO 770-531-8365 ryan.lake@recroCDMO.com
Released April 27, 2022