Societal CDMO Selected By AmyriAD Pharma to Provide Clinical Trials Services to Support Pivotal Phase 3 Program For Alzheimer’s Disease Treatment, AD101

Rhea-AI Summary

Societal CDMO (SCTL) has been selected by AmyriAD Pharma for CDMO services supporting the clinical development of AD101, a novel treatment for Alzheimer’s disease, currently in Phase 3 trials. The contract, valued at nearly $1.0 million, includes clinical trial services such as packaging and distribution of the compound and its placebo. This collaboration highlights Societal's bi-coastal footprint, enhancing operational capabilities from its facilities in Georgia and California. The agreement signifies a critical growth opportunity for Societal's Clinical Trial Services segment.

Positive

• Secured a contract valued at nearly $1.0 million with AmyriAD Pharma.
• Collaboration for Phase 3 and Phase 4 clinical studies of AD101 demonstrates business growth potential.
• Utilizes both Georgia and California facilities, enhancing operational efficiency.

Negative

• None.

Activities Planned at Both Georgia and California Facilities, Highlighting Benefits of Societal’s Bi-Coastal Footprint

SAN DIEGO and GAINESVILLE, Ga., June 01, 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 selected by AmyriAD Pharma to provide CDMO services to support the ongoing clinical development of AD101. The compound, a novel T-type calcium channel modulator, is currently in clinical development for the treatment of Alzheimer’s disease (AD). AmyriAD has successfully completed Phase 2 clinical trials of AD101 and is planning to initiate two Phase 3 studies of the compound.

Under terms of the new contract, which is valued at nearly $1.0 million, Societal will execute a range of clinical trial services to support the initiation of Phase 3 and Phase 4 clinical studies of AD101. These activities will include packaging, carding, kitting and labeling AD101, matching placebo and an active comparator compound. Additionally, Societal will be responsible for storing the prepared materials and distributing them to clinical trial sites globally. These activities will be conducted in collaboration at Societal’s CDMO facilities in Georgia and California.

“The Clinical Trial Services segment of our suite of CDMO offerings represents a critical growth driver for Societal. Our new agreement with AmyriAD, which represents a significant CTS contract win for Societal, highlights the potential for this portion of our business to contribute as a key revenue source,” said David Enloe, chief executive officer of Societal CDMO. “Also notable about this collaboration with AmyriAD is that it will feature contributions from our both our East and West Coast facilities, offering strong evidence for the benefits of our expanded footprint and the seamless nature through which we can collaborate across the country. AmyriAD is undertaking important work in the hunt for effective Alzheimer’s disease treatments and we are honored to assist them in those efforts.”

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. 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 significance of the contract between Societal CDMO and AmyriAD Pharma?

The contract, worth nearly $1.0 million, supports the development of AD101 for Alzheimer's disease and signifies a growth opportunity for Societal CDMO.

What clinical phases is AD101 currently undergoing?

AD101 is currently in Phase 3 clinical trials after successfully completing Phase 2 trials.

How will Societal CDMO support the AD101 clinical trials?

Societal CDMO will provide packaging, labeling, and distribution services for AD101 and its placebo across global clinical trial sites.

What operational advantages does Societal CDMO leverage with its bi-coastal facilities?

Societal CDMO's operations utilize both Georgia and California facilities to enhance collaboration and efficiency in fulfilling CDMO services.

What is the market impact of Societal CDMO's recent contract win?

The contract win is expected to significantly contribute to Societal CDMO's revenue, validating its business model and service offerings in the clinical trial services sector.