News: Alkermes Presents Positive Data on Proprietary Molecules …
Alkermes, Inc. (NASDAQ: ALKS) today announced positive preclinical
results for three proprietary molecules targeting opioid receptors,
including ALKS 33. Data from two preclinical studies demonstrated that
the three molecules showed statistically superior oral efficacy as
well as evidence for improved metabolic and pharmacokinetic profiles
compared to an active control. The data were presented at the 2008
Research Society on Alcoholism/International Society for Biomedical
Research on Alcoholism (RSA/ISBRA) Joint Scientific Meeting in
Washington, D.C.
“We are encouraged by the compelling preclinical profiles emerging
for this series of orally active, proprietary molecules, which
represent multiple opportunities to advance novel drug candidates into
our pipeline,” stated Daniel Deaver, Ph.D., vice president,
non-clinical development of Alkermes. “These findings support the
continued development of next-generation therapeutics to treat a broad
range of diseases, including central nervous system disorders and
brain reward disorders, such as addiction, obesity and other
impulse-control disorders.”
The study results presented today included efficacy data from an
ethanol drinking behavior model in rodents, a well-characterized model
for evaluating the effects of potential therapeutics targeting opioid
receptors. Results showed that single, oral doses of Alkermes’ novel
molecules significantly reduced the ethanol drinking behavior in
rodents, with an average reduction from baseline ranging from 35
percent to 50 percent for the proprietary molecules compared to 10
percent for the active control (P less than 0.05). Details from an
evaluation of the in vivo pharmacology, pharmacokinetics and in vitro
metabolism were also presented. Data showed that the molecules have
improved metabolic stability compared to the active control when
cultured with human hepatocytes (liver cells), suggesting that they
are not readily metabolized by the liver. Pharmacokinetic results
showed that the oral bioavailability of ALKS 33 was significantly
greater than that of the active control.
“Alkermes is focused on developing pipeline candidates with a high
likelihood of success compared to traditional new chemical entities.
These proprietary molecules reflect the broadening of our strategy to
utilize chemistry to improve known molecules to enhance outcomes,”
said Elliot Ehrich, M.D., chief medical officer of Alkermes.
Opioid modulators can act as agonists, antagonists or partial
agonists at opioid receptors in the brain. In addition to the
treatment of opioid and alcohol dependence, opioid dependence and
other addictions, opioid modulators are thought to have a number of
clinical applications, including the treatment of central nervous
system disorders and impulse-control disorders.
About Alkermes
Alkermes, Inc., a biotechnology company committed to developing
innovative medicines to improve patients’ lives, manufactures
RISPERDAL(R) CONSTA(R) for schizophrenia and developed and
manufactures VIVITROL(R) for alcohol dependence. Alkermes’ robust
pipeline includes extended-release injectable, pulmonary and oral
products for the treatment of prevalent, chronic diseases, such as
central nervous system disorders, addiction and diabetes.
Headquartered in Cambridge, Massachusetts, Alkermes has research and
manufacturing facilities in Massachusetts and Ohio. For more
information about Alkermes, visit http://www.alkermes.com.
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to the potential
therapeutic value of Alkermes’ proprietary molecules targeting opioid
receptors and Alkermes’ plans to continue development of such
proprietary molecules. Although the company believes that such
statements are based on reasonable assumptions within the bounds of
its knowledge of its business and operations, the forward-looking
statements are neither promises nor guarantees and the company’s
business is subject to significant risk and uncertainties and there
can be no assurance that its actual results will not differ materially
from its expectations. For further information with respect to factors
that could cause the company’s actual results to differ materially
from expectations, reference is made to the reports the company filed
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended. The forward-looking statements made
in this release are made only as of the date hereof and the company
disclaims any intention or responsibility for updating predictions or
financial expectations contained in this release.
VIVITROL(R) is a registered trademark of Cephalon, Inc.;
RISPERDAL(R) CONSTA(R) is a registered trademark of Janssen-Cilag
group of companies.
