Catalent to Supply Edenbridge Pharmaceuticals With a Fast-Dissolve Zydis Formulation of Glycopyrrolate Intended as Adjunctive Therapy for Patients With Peptic Ulcer

Catalent recently announced it has signed a commercial supply agreement with Edenbridge Pharmaceuticals, LLC, for a novel formulation of glycopyrrolate using Catalent’s proprietary Zydis orally disintegrating tablet (ODT) delivery technology intended for use as adjunctive therapy in the treatment of patients with peptic ulcer. The Zydis formulation of glycopyrrolate is awaiting US FDA approval, which is expected in December 2021.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water and is recognized as one of the world’s best-performing ODTs. Its ability to deliver the tablet without water may provide additional benefit to patient populations where fluid intake is to be limited. Catalent will manufacture the drug at its facility in Swindon, UK, and has worked on the program since 2017 and assisted in its regulatory submission.

“We are very excited to work with a world-class partner like Catalent to bring this product to patients across the US,” commented Ryan Collins, CEO at Edenbridge. “This product will satisfy a clear unmet need in the market.”

“The Zydis technology offers many advantages in formulation design and is ideal for patients who suffer from conditions that make swallowing a conventional dosage form challenging,” said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “This program with Edenbridge clearly demonstrates how a proven drug can be reformulated into a novel drug platform to address challenges in administration, including dysphagia and water-avoidance, and can help improve compliance in some patient groups.”

Catalent’s 250,000-square foot site in Swindon, UK, houses the company’s Zydis development and manufacturing operation, which produces more than one billion ODTs annually.

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 15,000 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com

Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the US prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings.  For more information, visit www.edenbridgepharma.com