The company further diversifies its customer base with new clients and expands the scope of its work with existing clients
SAN DIEGO and GAINESVILLE, Ga., Sept. 29, 2022 (GLOBE NEWSWIRE) — CDMO Company, Inc. (“societal CDMO”; NASD: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges, primarily in the therapeutic development of small molecules, today announced that it has signed multiple CDMO service agreements with new and existing customers. The new contracts cover a range of analytical methods, technology transfer, formulation, manufacturing and packaging services designed to support ongoing clinical development programs, as well as planned commercial activities.
The first contract is focused on supporting a new Societal CDMO client’s preparations for the development and commercial manufacture of its new treatment for Attention Deficit/Hyperactivity Disorder (ADHD) after regulatory approval. The product uses a unique delivery system combining immediate release and sustained release formulations of the active ingredient in a single oral tablet. Under the terms of the contract, Societal CDMO will carry out the technology transfer, the manufacturing of the engineering and registration batches, and the packaging of the final product. Due to the complex formulation and manufacturing requirements of this product, Societal CDMO will dedicate a specific manufacturing suite within its Gainesville, GA facility and equip it with proprietary customer-supplied equipment.
Under the second new agreement, Societal CDMO will conduct a range of activities supporting a new customer’s continued development of several innovative topical therapies for inflammatory dermatological conditions and neuropathic pain. Services provided by Societal CDMO will include analytical development, manufacturing, filling, packaging/repackaging and labeling of clinical trial material, both active and placebo, for use in planned clinical studies. This work will cover three different development programs for three unique topical therapies.
“These latest contracts further underpin the impressive increase in new business backlog we are generating for the business. The efforts of the business development group, working side-by-side with the entire Societal CDMO team, are helping the company continue to significantly diversify its customer base, enabling us to play an increasingly important role in bringing important medicines to patients,” said David Enloe, CEO of Societal CDMO. “While winning new customers is key to our business development strategy, we are also focused on revenue growth by expanding the scope of work with our current customers. This is exemplified by our recently signed agreements, which include a contract to provide additional technology transfer work for one of our existing clients for whom we are already performing a technology transfer of a different product within their portfolio.
About the societal CDMO
Societal CDMO (NASDAQ: SCTL) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities ranging from 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 field of small molecules. With expertise in solving complex manufacturing issues, 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 to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and in the development and manufacturing of modified release dosage forms, Societal CDMO has the expertise to complete our clients’ pharmaceutical development and manufacturing projects, regardless of their level of complexity. We do all of this in our best facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing science to society. For more information on Societal CDMO’s customer solutions, visit societalcdmo.com.
Forward-looking statements
This press release contains 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” , “to come”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and expressions may be used to identify the forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are beyond our control, and any of which, or any combination thereof, could materially affect our results of operations and whether the statements forward-looking statements ultimately prove to be correct. Factors that could cause actual results of the business to differ materially from those expressed in or underlying such forward-looking statements include the risks and uncertainties associated with the consequences. ongoing economic and social events of the COVID-19 pandemic, including any negative impact on customer ordering habits. or rebalancing of inventory or disruption of raw materials or the supply chain; demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and commercial success of their products; changing inventory needs and customer manufacturing plans; decisions of customers and potential customers to proceed with the company’s manufacturing services; the average profitability, or combination, of the products produced by the company; the company’s ability to improve existing services or introduce new services on a timely basis; fluctuations in the cost, availability and suitability of components of products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers experience increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that could affect our business and future results presented herein, as well as the 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) Societal CDMO 770-531-8365 ryan.lake@societalcdmo.com
