Pharmaceutical Development Services
September 23, 2013, Nottingham: Pharmaceutical formulation development and manufacturing services provider Molecular Profiles Ltd., a subsidiary of Columbia Laboratories, Inc., (Nasdaq: CBRX) has been selected as the formulation development partner for a major pan-European collaborative project.
The UK-based company has been chosen by clinical stage biopharmaceutical company Telormedix SA (Telormedix) to develop both topical and solid dosage formulations for the use in the treatment of psoriasis.
The project, operating under the acronym PAT (Psoriasis Anti-inflammatory Treatment), will involve other consortium partners Biopta, Midatech Biogune and the University Hospital Zurich. Telormedix raised funding from the European Eurostars Programme to coordinate this international research project for one of its promising drug candidates, TMX-302, which will use Midatech’s glycan-coated gold nanoparticles formulated using Molecular Profiles’ expertise.
Dr. Johanna Holldack, CEO at Telormedix, said: “We are absolutely delighted to have secured this funding with such a world class consortium to bring TMX-302 to pre-clinical proof of concept. The team at Molecular Profiles will play a key role in developing new oral and topical formulations of TMX-302, both of which are viewed as practicable administration options for the treatment of psoriasis.”
The deal comes just weeks after Molecular Profiles announced the official opening of its new facility following a successful inspection from the Medical and Healthcare products Regulatory Agency (MHRA), and on the heels of its acquisition by Columbia Laboratories, a Boston-based company with a rich heritage in drug development.
Molecular Profiles’ chief executive officer Nikin Patel said: “We are pleased to have been chosen as the formulation development partner for this high-profile, multi-partner project. Our team is ready to apply our technologies to deliver a robust topical and oral formulation.”
“We anticipate that this is just the start of a longer-term clinical development and manufacturing initiative to support a future trial. Beyond the formulation work, our new facility gives Telormedix the reassurance we can also support their finished dosage form production requirements.”
Working with leading pharmaceutical companies across the globe, Molecular Profiles’ specialises in advanced characterisation, pre-clinical and clinical development, clinical manufacturing and analytical support. Its early-stage services extend from pre-formulation, formulation development and solid-state screening with specialist knowledge on developing challenging molecules.
Its new clinical manufacturing facility enables the company to handle a range of dosage forms such as solids, liquids, semi-solids and inhaled products. Supporting clients’ projects up to phase IIb, the company can manufacture controlled drugs and highly potent compounds up to OEB 4 level with batch scale of up to 30kg.
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Notes for editors:
The Eurostars Programme is the European funding and support programme specifically dedicated to stimulating international collaborative research and innovation projects of small and medium enterprises. For further information on the Eurostars Programme, please visit: www.eurostars-eureka.eu
Telormedix (www.telormedix.com), founded in October 2007, is a biopharmaceutical company focused on targeted immunity and modulation of the innate immune system for treating cancer and autoimmune diseases. The Company’s lead product, TMX-101, is currently in a Phase II clinical trial for the treatment of CIS (carcinoma in situ) in the bladder. In addition, Telormedix is developing novel TLR7-targeted agonists. One of these molecules, TMX-202, has recently been selected for pre-clinical study for the topical treatment of skin cancers and other indications. Telormedix also has a pipeline of programs for inflammatory and autoimmune diseases, which includes TMX-302, a TLR7-binding small molecule showing anti-inflammatory properties in vivo.
Located in Switzerland, Telormedix is led by a highly experienced management team and backed by an international consortium of venture capitalists including Aravis Venture (Basel, Switzerland) and Proquest Investments (Princeton-San Diego, USA).
TMX-302 belongs to a novel class of small molecule developed by Telormedix acting as Toll-like receptor 7 (TLR7) “weak agonists” to potently dampen the inflammatory response without inducing immunosuppression, thus potentially fulfilling the above requirements. In in vivo studies, these compounds have been shown to be well tolerated upon systemic administration and to exert a potent anti-inflammatory activity without inducing a state of immunosuppression. These TLR7 weak agonists hold the promise of generating improved anti-inflammatory responses in the treatment of psoriasis.
About Columbia Laboratories
Columbia Laboratories, Inc. is a profitable company with a rich heritage in drug development. The Company’s revenue streams include sales and royalty revenues from CRINONE® 8% (progesterone gel), which is marketed by Actavis, Inc. in the United States and by Merck Serono S.A. in over 60 other countries worldwide, and revenues from its wholly-owned subsidiary Molecular Profiles Ltd., a UK-based provider of pharmaceutical formulation development and manufacturing services. For more information, please visit www.columbialabs.com.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “intends,” “anticipates,” “potential,” “should,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ from the forward-looking statements include, but are not limited to, the following: the successful transfer of quality management and technical support for CRINONE® (progesterone gel) manufacturing activities to Molecular Profiles; Molecular Profiles’ ongoing ability to retain current and attract new customers; difficulties or delays in manufacturing; the availability and pricing of third-party sourced products and materials; successful compliance with U.S. Food and Drug Administration (FDA), MHRA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; changes in laws and regulations; the ability to obtain and enforce patents and other intellectual property rights; the impact of competitive products and pricing; the cost of evaluating potential strategic transactions; the strength of the United States dollar relative to international currencies, particularly the British pound and the euro; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia Laboratories' reports filed with the SEC including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2012. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.
CRINONE® is a registered trademark of Actavis, Inc. in the U.S. and of Merck Serono S.A. outside the U.S.
Molecular Profiles™ is a registered trademark of Molecular Profiles Ltd.