sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úand ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô Announce Successful Collaboration to Facilitate Expedited Clinical Development Timelines
- sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úand ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô have reached a milestone in a joint Chemistry, Manufacturing and Controls development project for the reformulation of an investigational medicine to improve its bioavailability
- sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úprovides its integrated development platforms to facilitate trials and accelerate early development to help ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô progress its R&D portfolio.
SOMERSET, N.J., and AACHEN, Germany – March 15, 2023 — Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, and ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô, an international science-driven pharmaceutical company and a global leader in pain research and management, today announced their successful formulation design and clinical-phase manufacturing collaboration for an orally dosed small molecule in ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô’s pipeline.
Positive preclinical results from the molecule have allowed ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô to progress its development program to first-in-human studies. In this phase, sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úsupported ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô with the development of a bioavailability enhanced formulation, which, moving forward, enables expedited clinical development timelines.
The two companies have been working together on this program since 2021. sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úhas assisted ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô in reformulating the molecule using a lipid-based drug delivery system formulated in softgel technology to improve its bioavailability. Scientific experts at Catalent’s facilities in Beinheim, France, and Nottingham, U.K., carried out this development work using its OptiForm Solution Suite® platform, which allowed the rapid characterization and screening of dose forms and formulation technologies to optimize dose design.
Phase 1 studies of the molecule will be supported by scientists from Beinheim using the sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿ÚXpress Pharmaceuticsâ„¢ platform, which provides rapid development of clinical formulations and on-demand manufacturing of dose forms at the clinical research organization undertaking the trials. Trials will be run for both single ascending dose (SAD) and multiple ascending dose (MAD) studies based on the real-time results of the adaptive study protocol.
“The OptiForm Solution Suite provides an efficient approach to expedite innovative candidates into first-in-human studies. It does this through assessing a broad range of technical solutions to identify the most suitable formulation for the specific candidate,” said Stephan Bulat, Head of Chemistry, Manufacturing and Controls at ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô. “The sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿ÚXpress Pharmaceutics platform provides the flexibility to efficiently manage our candidates through early clinical development studies, supporting our ambition to achieve best-in-class development timelines.”
“With innovators demanding shortened drug development timeframes, sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úoffers a number of integrated solutions to ensure programs can be accelerated to, and through, clinical phases as quickly and safely as possible, while providing design and delivery technology support to give molecules the greatest chance of success,” said Ricky Hopson, President, Division Head for Clinical Development and Supply, Catalent. “Working with ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô, we have been able to leverage multiple services that have not only reduced Phase 1 development timelines substantially, but have done so using a formulation and delivery technology that is scalable for future clinical and commercial needs as the program progresses.”
³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô is dedicated to creating innovative non-opioid pain treatments that address unmet medical needs. For R&D, ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô executes a distinctive therapeutic area strategy and focuses on four key pain indications: peripheral neuropathic pain, chronic post-surgical pain, chronic low back pain, and osteoarthritis. ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô seeks collaborations in these areas to develop life-changing treatments for patients, independent of the modality and their stage of development. To date, the company has launched six treatment options for patients suffering from pain.
NOTES FOR EDITORS
About ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô
³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.
³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2021, ³Ò°ùü²Ô±ð²Ô³Ù³ó²¹±ô employed around 4,500 people and achieved sales of € 1.5 bn.
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ABOUT CATALENT
sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úis the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úis a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
sa¹ú¼Ê´«Ã½¹ÙÍøÍøÒ³Èë¿Úhelps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians.
Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit .
More products. Better treatments. Reliably supplied.â„¢
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