Acorda Therapeutics, Inc. (NASDAQ: ACOR) 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(R) 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(R) (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(R)
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.