Morristown, N.J. and Livingston, UK – December 17, 2013– Encap Drug Delivery, part of Capsugel’s Dosage Form Solutions (DFS) business unit and the leader in liquid-fill hard capsule development and manufacturing, today announced a collaboration with Lipocine Inc. to manufacture Phase 3 clinical trial and ICH stability registration batches of Lipocine’s oral testosterone product, LPCN 1021. Following the recent announcement that Lipocine had raised funding to advance its oral testosterone product, it selected Encap as its partner based on Encap’s industry-recognized focus and experience in the development, scale-up and commercial manufacturing of this particular oral dosage form. The product will be manufactured in the company’s high-potency suite at the Livingston, Scotland, R&D site.
Lipocine Inc. is a specialty pharmaceutical company developing innovative products for use in men’s and women’s health utilizing its proprietary drug delivery techniques. LPCN 1021 is under development as a testosterone product to treat symptoms related to currently marketed testosterone replacement products. The investigational drug is designed for twice-daily oral dosing.
“We are delighted to have been chosen by Lipocine for the manufacture of this important product,” said Dr. Stephen Brown, Managing Director at Encap Drug Delivery. “Encap has built its profile over the last few years in product development and clinical trial manufacturing. This collaboration highlights our long-standing and significant expertise in commercial-scale manufacturing and our ability to handle high-potent active pharmaceutical ingredients.”
In a matter of a few months, Encap has completed the transfer of the manufacturing process and validation of all related test methods (in-process and finished product) for LPCN 1021 to its site in Livingston, Scotland. Further, Encap has successfully manufactured all the Investigational New Drug (IND) registration batches for the upcoming Phase 3 clinical supply and stability registration at this dedicated high-potency facility that opened in 2008.
Leveraging multiple development centers around the world, Capsugel’s DFS business unit is working on a broad array of client projects ranging from the earlier stages of formulation and clinical development to late-stage clinical studies, as well as several products that are already approved for commercial sale. Encap’s Livingston site alone currently has five development client projects in late Phase 3 or submission phases that are scheduled to become commercial products in the near term.
Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care industry. The company’s Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian and other specialized capsule technologies. Capsugel’s Dosage Form Solutions (DFS) business solves customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. Capsugel DFS accelerates and improves product development through an array of proprietary technologies including lipids and liquids, spray-dried dispersions, hot-melt extrusions, and through specialized manufacturing including FDA/MHRA-accredited finished dosage sites that can handle highly potent, controlled substance, hormonal and oncology compounds. Headquartered in Morristown, N.J., Capsugel serves more than 4,000 customers in more than 100 countries. For additional information, visit www.capsugel.com.