Company Secures Schedule 1 Controlled Substance Manufacturing License from Drug Enforcement Agency, Expands on 25 Years of Manufacturing of Schedule 2 Products
No Additional Investment Required to Support Clinical Trials for Psychedelic-Based Therapeutics
SAN DIEGO and GAINESVILLE, Ga., July 26, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced the expansion of its broad suite of CDMO services to address the biopharmaceutical industry’s expanding activity in the area of psychedelic drug development. This targeted expansion of capabilities is enabled by the company’s several decades of experience in manufacturing and handling controlled substances, thus positioning Societal to address the growing psychedelic therapy sector and supporting the growing number of ongoing and planned clinical trials in this area.
Societal has completed key regulatory requirements for moving forward with this work and is now positioned to support customers with the manufacture of high-quality cGMP clinical supplies. This is highlighted by the company rapidly receiving U.S. Drug Enforcement Agency (DEA) approval to add certain Schedule 1 psychedelic compounds to their controlled substance manufacturing registration, expanding upon the Schedule 2 manufacturing registration it has held with the DEA for over 20 years. Importantly, Societal is able to expand its capabilities into the psychedelic drug development market without committing any additional capital investment.
“With a long track record of successfully manufacturing controlled substances for a number of biopharmaceutical companies, the Societal team has amassed deep expertise in seamlessly and effectively navigating this strictly regulated segment of the drug development space. In doing so, we have built strong credibility with the DEA, which we believe allowed for an efficient path to add Schedule 1 substances to our manufacturing registration,” said Richard Sidwell, Ph.D., senior vice president and chief scientific officer. “As more and more companies are focusing research and development efforts on the therapeutic potential of psychedelic compounds, we are aligned well to partner with those groups to support their clinical development programs. To this end, we are already engaging in discussions with various drug developers that are working in this area and are encouraged both by the substance of these conversations and the overall increase in interest within this therapeutic sector.”
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 societalcdmo.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 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.
