Societal CDMO and Benuvia Sign Co-Marketing Agreement Designed to Promote Complementary CDMO and API Manufacturing Services to Drug Developers
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Insights
The co-marketing agreement between Societal CDMO and Benuvia Operations signifies a strategic alliance that can potentially accelerate growth in the burgeoning sectors of psychedelic and cannabinoid drug development. This partnership is poised to combine Societal CDMO's expertise in small molecule therapeutic development and cGMP manufacturing with Benuvia's specialization in the production of controlled substances, such as cannabinoids and psychedelics.
From a business perspective, this collaboration could enhance both companies' competitive edges by broadening their service offerings and potentially increasing their market share within these niche segments. The emphasis on the production of Schedule 1 psychedelic compounds, following Societal CDMO's recent DEA approval, indicates a proactive approach to capitalizing on the growing number of clinical trials in this therapeutic area. This move could attract investors interested in emerging markets and companies with forward-looking growth strategies.
For stakeholders, the immediate benefit lies in the expanded capabilities and streamlined service offerings that can lead to more efficient drug development processes. In the long-term, the success of this partnership may hinge on the regulatory landscape and the commercial viability of psychedelic and cannabinoid-based therapies. If these markets continue to grow, Societal CDMO and Benuvia could see significant returns on investment from their early positioning.
Within the context of clinical trials, the co-marketing agreement between Societal CDMO and Benuvia Operations is of particular importance. The ability to manufacture high-quality cGMP clinical supplies is critical for the execution of clinical trials, especially in the realm of psychedelics, where research is still in a nascent stage but rapidly expanding.
By combining their respective strengths, Societal CDMO and Benuvia are well-equipped to support the increasing demand for clinical trial materials. This support is essential not only for the conduct of trials but also for ensuring adherence to regulatory requirements. The expertise of Benuvia in controlled substances complements Societal's cGMP manufacturing processes, potentially leading to a more streamlined pathway from drug development to market.
The focus on psychedelics, given the recent changes in regulatory attitudes towards these compounds, could position the companies at the forefront of a new wave of therapeutic options. The success of their collaboration might influence the speed at which new psychedelic treatments become available to patients, pending regulatory approval and successful clinical outcomes.
The regulatory implications of the agreement between Societal CDMO and Benuvia Operations cannot be overstated. The manufacturing of controlled substances, such as cannabinoids and psychedelics, is heavily regulated by agencies like the DEA. Societal CDMO's extension of its DEA registration to include Schedule 1 psychedelic compounds demonstrates a significant regulatory milestone that could provide a strategic advantage in navigating the complex legal environment surrounding these substances.
Moreover, the co-marketing agreement may facilitate a more efficient regulatory submission process for new drugs by leveraging Benuvia's commercial drug master files, which are referenced in pharmaceutical New Drug Applications. This strategic move could reduce the time and resources needed for regulatory approvals, potentially leading to faster market entry for new therapies.
However, the success of this partnership will largely depend on the evolving regulatory framework for psychedelic and cannabinoid drugs. With the DEA's stringent regulations on controlled substances, both companies must maintain the highest compliance standards to avoid any legal or regulatory setbacks that could impact their operations and market reputation.
Agreement Broadly Applicable to All Therapeutic Areas with Specific Focus on the Growing Psychedelic and Cannabinoid Drug Development Markets
Complementary Capabilities Range from API Manufacturing through Process Development and cGMP Manufacturing to Fill/Finish
GAINESVILLE, Ga. and ROUND ROCK, Texas, Feb. 01, 2024 (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, and Benuvia Operations, LLC, a U.S.-based drug developer and manufacturer of active pharmaceutical ingredients (APIs) with a specialized expertise in controlled substances (cannabinoids and psychedelics), today announced the signing of a co-marketing agreement. The agreement is designed to allow the companies to promote each other’s complementary contract development and manufacturing services to their respective customer bases and new business prospects. As part of the agreement, the companies will highlight Benuvia’s specific expertise as a manufacturer of drug substance (API) and Societal’s focus on manufacturing drug product. While the agreement is not limited to any specific therapeutic indication or modality, the companies will specifically focus on leveraging their unique expertise in the area of psychedelics to address this expanding drug development market.
Societal CDMO possesses a broad range of CDMO capabilities spanning formulation development, analytical testing and manufacturing of oral solid dose finished drug products. The company has several decades of experience in manufacturing and handling controlled substances. In 2023, the company received U.S. Drug Enforcement Agency (DEA) approval to add certain Schedule 1 psychedelic compounds to its controlled substance manufacturing registration, expanding upon the Schedule 2 manufacturing registration it has held with the DEA for over 20 years. This expansion of its controlled substance capabilities has placed the company in a strong position to support customers with the manufacture of high-quality cGMP clinical supplies for the growing number of ongoing and planned clinical trials in the psychedelic drug development area.
Benuvia Operations, LLC, is an end-to-end CDMO with vertically integrated pharmaceutical services ranging from drug and formulation development, fully-integrated analytical services and manufacturing of oral liquid and aerosol solutions. The company excels in producing controlled substances (DEA schedule I-III), with a focus in the areas of cannabinoids and psychedelics. Distinguished by its commercial drug master files referenced in approved pharmaceutical New Drug Applications and as an established global supplier of controlled substances, Benuvia is rapidly expanding its influence in the emerging cannabinoid and psychedelic market. Benuvia’s journey is reaffirming its commitment to innovation and quality in pharmaceutical manufacturing as it embraces innovation and upholds the highest standards of production in serving the evolving needs of the global market.
“As we continue to establish Benuvia as a leader in the manufacture of psychedelics, we felt it was important to have a partner who could augment our end-to-end CDMO services when customer needs go beyond our current drug product manufacturing capabilities. Societal proved to be the perfect fit,” stated Darwin Richardson, chief executive officer of Benuvia. “We have a long history of drug, formulation, and process development in controlled substances, as well as cGMP manufacturing of clinical and commercial drug products. With both companies active in this area, our formalized partner agreement will open new opportunities to meet our customers’ unique needs.”
“We are excited about the strategic alignment offered by our new relationship with the Benuvia team. Our respective services and capabilities are completely complementary with little to no overlap. This allows us to aggressively promote and advocate for each other in the exciting and rapidly growing psychedelic drug development market,” said Scott Rizzo, senior vice president and chief operating officer of Societal CDMO. “Once we identified a desire to establish a relationship with a preferred partner in the psychedelic API manufacturing market, Benuvia quickly became our number one target based on its impressive reputation and track record of success. We are excited to be working alongside the company to drive the success of this co-marketing agreement.”
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, 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.
About Benuvia Operations, LLC.
Benuvia, Operations, LLC, specializes in the development and manufacturing of controlled substance APIs and drug products, with a focus in cannabinoids and psychedelics. Benuvia owns the FDA-approved cannabinoid drug product SYNDROS, an FDA-approved cannabinoid drug, designed to alleviate chemotherapy-induced nausea and vomiting (CINV) and anorexia in AIDS patients. Benuvia’s integrated services focus on the development and manufacturing of challenging APIs, with a focus on cannabinoids and psychedelics. We offer both APIs and complex finished dosage forms, from clinical trial material to high-value, low-volume commercial products. Operating out of an FDA-registered 83,000 square foot manufacturing facility and adhering to current Good Manufacturing Practices (cGMP), from research and route scouting to commercial products, Benuvia is your go to end-to-end development partner equipped to handle Schedule 1 to 3 controlled substances. Benuvia's commitment to innovation is reflected in its extensive portfolio of existing DMFs and pending patents, as it continues to seek new intellectual property avenues for its drug products.
Benuvia Operations, LLC: Alleviating Suffering. Transforming Lives. For more information about Benuvia visit www.benuvia.com
Forward-Looking Statements
This press release may include 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. These forward-looking statements should be considered together with 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.
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