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Acorda Therapeutics today announced that Acorda has selected CMC ICOS as the contract manufacturer for GGF2, the lead molecule in Acorda’s neuregulin program
HAWTHORNE, NY, USA and COPENHAGEN, Denmark | April 9, 2008 | Acorda Therapeutics, Inc. (NASDAQ: ACOR - News) and CMC ICOS Biologics. Inc. today announced that Acorda has selected CMC ICOS as the contract manufacturer for GGF2, the lead molecule in Acorda’s neuregulin program. In preclinical studies, neuregulins have demonstrated potential for neurological protection in a number of indications, including models of MS and stroke. Neuregulins have also shown the potential to reduce and even reverse dysfunction in preclinical models of congestive heart failure by directly strengthening and protecting heart muscle cells.
“Scaling up and validating the manufacturing process of this compound is an important step toward advancing GGF2 from the lab to the clinic. We anticipate filing an Investigational New Drug, or IND, application to the U.S. Food and Drug Administration for GGF2 in late 2009, pending results of toxicology studies,” said Andrew R. Blight, Ph.D., Chief Scientific Officer of Acorda. “We chose to work with CMC ICOS because of their extensive expertise in cell culture and analytical methods in biologics manufacturing, and look forward to a productive partnership.”
CMC ICOS will be responsible for process development, manufacturing scale-up and current Good Manufacturing Practices (cGMP) manufacturing of GGF2. Acorda plans to use the supply of GGF2 produced by CMC ICOS for continued toxicology studies and early phase clinical trials.
“We are pleased to have the opportunity to work together with Acorda on their neuregulin program, and excited to welcome them to our recently acquired ICOS facilities in Seattle,” stated Mads Laustsen, Chief Executive Officer of CMC Biologics. “It is partnerships such as this one that enable CMC to continue to be a global leader in the field of protein production. Acorda also has the option to utilize the CMC proprietary CHEF1® expression technology, a system that rapidly generates production cell lines and provides our clients with the flexibility to quickly increase manufacturing capacity as needed.”
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda’s lead clinical product, Fampridine-SR, is in Phase 3 clinical trials to evaluate its safety and efficacy to improve walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
About CMC ICOS Biologics
CMC (www.cmcbio.com) is a leading contract development and manufacturing organization that provides fully integrated biopharmaceutical development and manufacturing services to clients around the world, from its facilities in Europe and the USA. The company specializes in custom services for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and in-market production. CMC’s wide range of integrated services includes cell line development using its proprietary CHEF1® system, process development and comprehensive analytical testing. CMC has fully segregated microbial fermentation and mammalian cell culture suites and offers both stirred tank and perfusion production processes. CMC Biologics A/S is located in Copenhagen, Denmark, and CMC ICOS Biologics Inc., is located in Seattle, WA.
Acorda Therapeutics, Inc. Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
SOURCE: Acorda Therapeutics |
