AMRI (NASDAQ:AMRI) today announced the selection of a compound from its
proprietary obesity treatment research program for advanced preclinical
testing, with the goal of submitting an Investigational New Drug
Application (IND) with the U.S. Food and Drug Administration (FDA) in
2010.
AMRI’s drug candidate is a novel MCH-1 receptor antagonist offering a
promising new approach for the treatment of obesity. Melanin
concentrating hormone (MCH) is a potent appetite stimulating peptide
known to exert an effect on food intake and body weight regulation. In
preclinical disease models, AMRI’s small molecule antagonists of the
MCH-1 receptor have demonstrated efficacy in rodent models of obesity,
delivering weight loss that rivals currently available therapeutics,
suggesting the potential for improved therapy in humans.
Pending favorable results in toxicity and safety pharmacology testing,
AMRI estimates that it will submit an IND for this compound in the first
half of 2010. Subject to FDA review, the submission of an IND would
allow subsequent initiation of Phase I human clinical trials.
"We are pleased to announce this latest achievement emerging from our
R&D efforts. This development results from our strategy of deploying
dedicated resources and talent to create long term value for AMRI and
its stakeholders,” said Chairman, CEO and President Thomas E. D’Ambra,
Ph.D. "This research program leveraged AMRI’s exceptional strength in
medicinal chemistry and depth of expertise in metabolic diseases.”
AMRI has filed a series of patent applications to protect the
intellectual property associated with this program, and plans to
ultimately seek a licensee to commercialize the technology.
Today’s announcement marks the sixth AMRI compound transitioned into an
early stage preclinical candidate. Three of these candidates have moved
into Phase I clinical testing, including two compounds from AMRI’s
biogenic amines program being studied for the treatment of central
nervous system (CNS) disorders by Bristol-Myers Squibb Company
(NYSE:BMY) as part of a licensing arrangement, and one from AMRI’s
independent tubulin inhibitor program, which is currently in Phase I
testing in cancer patients.
About the MCH-1 Receptor
Antagonism of the MCH-1 receptor is a promising new approach for the
treatment of obesity. The endogenous peptide MCH is believed to regulate
energy homeostasis through neurons in the lateral hypothalamic area of
the central nervous system (CNS). It is known to stimulate feeding in
rats and promote increases in glucose, insulin and leptin levels,
mimicking the human metabolic syndrome. Antagonism of the MCH-1 receptor
has been shown to reduce food intake and hence reduce body weight,
selectively reducing fat stores. This target has been a focus of
interest in many pharmaceutical companies but most programs have stalled
in the face of preclinical safety challenges. AMRI’s candidate compound
has performed remarkably well in early preclinical safety studies and
has potential to demonstrate an appropriate balance of efficacy to
safety.
About AMRI
Founded in 1991, Albany Molecular Research, Inc. (AMRI) provides
scientific services, products and technologies focused on improving the
quality of life. AMRI works on drug discovery and development projects
and conducts manufacturing of active ingredients and pharmaceutical
intermediates for many of the world’s leading healthcare companies. As
an additional value added service to its customers, the company is also
investing in R&D in order to expand its contract services and to
identify novel early stage drug candidates with the goal to outlicense
to a strategic partner. With locations in the U.S., Europe, and Asia,
AMRI provides customers with a wide range of services, technologies and
cost models.
Forward-Looking Statement
Statements in this press release that are not historical facts are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties.
These statements may be identified by forward-looking words such as
"may," "could," "should," "would," "will," "intend," "expect,"
"anticipate," "believe" and "continue" or similar words and include,
without limitation, statements regarding the company's clinical
development plans for its proprietary compounds, the company’s research
programs and the license arrangement with BMS concerning the company’s
biogenic amines program. Readers should not place undue reliance on our
forward-looking statements. The company's actual results may differ
materially from such forward-looking statements as a result of numerous
factors, some of which the company may not be able to predict and may
not be within the company's control. Factors that could cause such
differences include, but are not limited to delay or denial of approvals
from the FDA, potential changes in the cost, scope and duration of
clinical trials as compared to the company’s current expectations, the
company's ability to attract and retain experienced scientists, trends
in pharmaceutical and biotechnology companies outsourcing of chemical
research and development, the company's ability to enforce its
intellectual property and technology rights, the risks posed by
international operations to the company, and the company's ability to
effectively manage its growth as well as those factors discussed in the
company's Annual Report on Form 10-K for the year ended December 31,
2008 as filed with the Securities and Exchange Commission on March 13,
2009 and the company's other SEC filings. The company does not undertake
any duty to and does not intend to update any forward-looking statements
contained in this press release after the date of this press release.