Albany Molecular Research, Inc. (NASDAQ: AMRI) and its wholly owned
subsidiary, AMR Technology, Inc., announced that a settlement regarding
U.S. patent infringement litigation involving ALLEGRA® and
ALLEGRA®D-12
has been reached among them, Aventis
Pharmaceuticals, Inc., sanofi-aventis U.S. LLC, Teva Pharmaceuticals,
USA, Inc. and Barr Laboratories, Inc. The settlement agreement and
related licensing arrangements are subject to review by the Federal
Trade Commission and U.S. state Attorneys General.
As part of the settlement, AMRI has entered into an amendment to its
licensing agreement with sanofi-aventis U.S. LLC to allow sanofi-aventis
U.S. LLC to sublicense patents related to ALLEGRA® and ALLEGRA®D-12
to Teva Pharmaceuticals, USA, Inc. and Barr Laboratories, Inc. in
the United States. AMRI will receive an upfront sublicense fee from
sanofi-aventis U.S. LLC of $10 million.
Sanofi-aventis U.S. LLC will also provide royalties to AMRI on the sale
of products containing fexofenadine hydrochloride (the generic name for
the active ingredient in ALLEGRA® ) and products containing
fexofenadine hydrochloride and pseudoephedrine hydrochloride (generic
ALLEGRA®D-12) by Teva Pharmaceuticals, USA, Inc. and Barr
Laboratories, Inc. through 2015, along with additional considerations.
AMRI will continue to receive royalties from sanofi-aventis U.S. LLC for
the sale of products containing ALLEGRA®,
ALLEGRA®D-12
and authorized generics for the remaining term of the patents.
Royalties for the sale of products containing ALLEGRA® outside
of the United States were not part of this litigation and will continue
to be unaffected.
"This agreement to settle the patent litigation diversifies the number
of products from which AMRI will receive royalty payments, removes
uncertainty related to an at-risk launch of a generic version of ALLEGRA®D-12,
and affirms the validity of our patents,” said AMRI Chairman, President
and CEO Thomas E. D'Ambra.
Litigation will continue for patent infringement related to ALLEGRA®,
ALLEGRA®D-12, and ALLEGRA®D-24
for
other generic drug manufacturers in the United States and other
jurisdictions.
In March 2004, AMRI joined Aventis Pharmaceuticals, Inc. in filing
lawsuits pertaining to AMRI’s fexofenadine-related patents. Aventis
Pharmaceuticals, Inc. originally filed patent infringement actions in
the United States District Court for the District of New Jersey against
several generic pharmaceutical manufacturers in 2001 based on patents
relating to sanofi-aventis U.S. LLC’s ALLEGRA® and ALLEGRA®D-12
products.
Conference Call
The company will hold a conference call at 10:00 a.m. EST on November
19, 2008 to discuss the agreement. During the conference call, the
company may discuss information not previously disclosed to the public.
Individuals interested in listening to the conference call should dial
888-299-4099 (toll-free in the U.S.), 866-682-1172 (toll-free in Canada)
or 302-709-8337 (toll call for international calls) at 9:45 EST and
provide conference code VD38012. In addition, the call is being webcast
on the Internet and can be accessed on the company’s website at www.amriglobal.com.
Conference call materials, including a slide presentation, are also
available on the company’s website at www.amriglobal.com
and should be accessed prior to the start of the conference call.
Replays of the call will be available for seven days following the call
beginning at noon EST on November 19, 2008. To access the replay by
telephone, call 800-355-2355 (for domestic calls) or 402-220-2946 (for
international calls) and use passcode 38012#. In addition, replays of
the call will be available for three months on the company’s website at www.amriglobal.com.
About AMRI
Founded in 1991, Albany Molecular Research, Inc. 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 Statements
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. 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 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,
2007 as filed with the Securities and Exchange Commission on March 17,
2008 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.