BOSTON and NOTTINGHAM, England, July 31, 2014 -- Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced that its subsidiary, Molecular Profiles Ltd., and XenoGesis Ltd., have announced a collaboration that will support pharmaceutical and biotech drug developers during the pre-clinical and formulation development stage. Molecular Profiles' pharmaceutical development services will be supported by XenoGesis' expertise in preclinical drug metabolism and pharmacokinetics (DMPK) to give clients a smarter route into formulation development and a better understanding of a compound's bioavailability. This strategic alliance will allow the Nottingham-based companies to help drug developers in the initial design and selection of compounds for key DMPK and ADME (absorption, distribution, metabolism and elimination) studies, as well as supporting lead candidates which have solubility issues during formulation development.
"We are very pleased to have struck this collaboration with the team at XenoGesis," said Frank Condella, President and Chief Executive Officer of Columbia Laboratories. "We have complementary service offerings which allow us to apply a science-driven, collective approach to overcome the complexities of challenging molecules. It also adds a vital pK service to our enabling technologies package.
"For us, this will build-upon the very successful drug development alliances we already have in place. We can now seamlessly offer a comprehensive service from initial drug discovery through to clinical supplies with best-in-class companies," concluded Mr. Condella.
XenoGesis was founded by its managing director, Richard Weaver Ph.D., after a 15-year career at AstraZeneca. The company specializes in studying research compounds from a chemical and biological perspective to inform clients on how they will behave in the body.
Dr. Weaver commented, "Combining our skills in DMPK with the chemical knowledge at Molecular Profiles will provide a solid platform to support clients. We will be able to give them a better understanding of their compounds during pre-clinical work, which in turn, will reduce cost and provide a quicker route to market."
Working with leading drug development companies across the world, Columbia Laboratories' Molecular Profiles subsidiary specializes in advanced characterisation, pharmaceutical product development, clinical trials manufacturing and analytical support. The company recently created a new enabling technologies team and invested in GMP hot melt extrusion (HME) technology at its clinical manufacturing facility to further enhance its expertise in the processing of difficult-to-progress molecules.
Alongside its development capabilities, its MHRA-licensed site enables the company to manufacture a range of dosage forms for clinical trials spanning solids, liquids, semi-solids and inhaled products, including potent compounds and controlled drugs.
About Columbia Laboratories
Columbia Laboratories, Inc. provides pharmaceutical development, clinical trial manufacturing, and advanced analytical and consulting services to the pharmaceutical industry. The Company has a successful heritage in pharmaceutical research and development, particularly in women's healthcare and drug delivery. Its most successful product to date, CRINONE® 8% (progesterone gel), is marketed by Actavis, Inc. in the U.S. and by Merck Serono S.A. in over 60 additional countries worldwide. For more information, please visit www.columbialabs.com.
About Molecular Profiles
Molecular Profiles Ltd., a wholly owned subsidiary of Columbia Laboratories, Inc., is a contract development and manufacturing organization (CDMO) that specializes in early phase pharmaceutical development. Its early phase services extend from pre-formulation and formulation development to clinical trial manufacturing, with specialist knowledge on developing challenging molecules and complex compounds. Molecular Profiles is also renowned for its expertise and toolkit to analytically resolve some of the toughest issues during development and relating to intellectual property issues. The company's services are dedicated to pharmaceutical, biopharmaceutical and healthcare companies across the globe. For more information please visit www.molprofiles.co.uk
XenoGesis Limited, a contract research organization (CRO), specializes in expert DMPK/ADME laboratory services and interpretation and Drug Discovery consultancy. The XenoGesis team has significant experience and a track record of delivering candidate drugs to man from their careers at AstraZeneca R&D Charnwood. XenoGesis supports the Drug Discovery activities of Biotechnology and Pharmaceutical companies and academic units. For more information please visit www.xenogesis.com
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