NEW YORK and SAN DIEGO, Oct. 23, 2008 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE: FRX) and Phenomix Corporation today announced
that they have entered into a definitive collaboration agreement to develop
and commercialize dutogliptin (PHX1149) in North America. Dutogliptin is
Phenomix' proprietary orally administered, small molecule
dipeptidyl-peptidase-4 (DPP-4) inhibitor currently undergoing Phase 3
clinical development in Type 2 diabetes mellitus.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Under the terms of the agreement, Forest will make an upfront payment
to Phenomix of $75 million. Phenomix and Forest will jointly develop and
commercialize dutogliptin in the United States, and the companies will
equally share profits and expenses. Upon commercialization, the parties
will co-promote the product in the United States, with Phenomix promoting
dutogliptin to endocrinologists and diabetologists and Forest promoting to
primary care and specialty physicians. Forest has exclusive rights to
develop and commercialize dutogliptin in Canada and Mexico, and Phenomix
will receive a royalty on sales in these countries in exchange for the
rights to use jointly funded trial data in those countries. Phenomix
retains development and commercialization rights to the product outside of
North America, and will pay Forest a royalty on net sales in these
territories. Phenomix could receive up to $340 million in upfront and
milestone payments for the successful development and commercialization of
dutogliptin in the United States over the term of the collaboration.
"Diabetes is a widespread and growing disease. We have been eager to
find a product with a promising and novel mechanism that we could acquire
to develop and market. We believe that Phenomix' DPP-4 inhibitor is a
valuable addition to the available treatments to help better control this
serious condition," said Howard Solomon, Chairman and Chief Executive
Officer of Forest. "Diabetes is treated to a large extent by primary care
physicians, with whom the Forest sales force has been particularly
successful. We are pleased to work with Phenomix, whose management and
scientific team have demonstrated ingenuity and commitment in bringing
dutogliptin from discovery into late-stage clinical development."
"Partnering with Forest is a very important next step for Phenomix in
working towards commercialization of dutogliptin for the treatment of
patients with Type 2 diabetes," said Laura K. Shawver, Ph.D., Phenomix'
Chief Executive Officer. "Forest has a demonstrated capability to develop
and commercialize late-stage, large-market compounds, which will help
ensure that dutogliptin will be a medically important and commercially
successful drug. We are excited that Forest shares our vision and
dedication to commercialize dutogliptin for the treatment of this
devastating disease."
By comparison to placebo, dutogliptin demonstrated significant
reductions in hemoglobin A1c (HbA1c) and fasting plasma glucose in a
12-week Phase 2b clinical study. The study also showed dutogliptin was well
tolerated with a low incidence of adverse events. Dutogliptin was
administered orally, once daily. Phenomix initiated a Phase 3 clinical
development program in the third quarter of 2008. A composition of matter
patent application has issued for dutogliptin, which provides protection to
2024, and is subject to extension.
About Diabetes
Diabetes is characterized by high levels of blood glucose due to
inadequate production or action of insulin. It can lead to serious medical
complications and death. In the United States, more than 10% of adults over
the age of 19 have diabetes, and rates are anticipated to increase in the
coming years. Type 2 diabetes is the predominant form of diabetes,
accounting for 90 to 95% of diagnosed cases.
About Dutogliptin
Dutogliptin is a small molecule inhibitor of the enzyme DPP-4. These
inhibitors prevent DPP-4 from breaking down the incretin hormone
glucagon-like peptide 1 (GLP-1), thereby increasing the levels of this
hormone in the digestive tract and the blood. The increased levels of GLP-1
stimulate insulin production by the pancreatic beta cells and reduce
glucagon production by the pancreas, both of which result in reduced blood
glucose levels.
In a double-blind, randomized, 12-week, 422 patient Phase 2b clinical
trial, dutogliptin met all primary and secondary endpoints, including
statistically significant reductions in HbA1c when administered once-daily
in combination with metformin, a glitazone, or metformin and a glitazone
for the treatment of Type 2 diabetes. The trial demonstrated dutogliptin's
excellent safety and tolerability profile. An ongoing two-year open label
extension study continues to evaluate the long-term safety profile of the
drug.
About Phenomix
Phenomix (http://www.Phenomix.com) is a biopharmaceutical company focused on
the discovery, development and commercialization of novel small molecule
product candidates directed toward clinically validated targets in
significant therapeutic markets. The company's internally discovered lead
product candidate, dutogliptin (PHX1149), is a DPP-4 inhibitor in Phase 3
development as an oral, once-daily treatment for Type 2 diabetes. The
company's second product candidate, PHX1766, is a protease inhibitor
currently in preclinical development for the treatment of hepatitis C
virus, or HCV, infection. Phenomix is located in San Diego, California.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a wide
range of therapeutic areas. The company is headquartered in New York, NY.
To learn more about Forest Laboratories, visit http://www.FRX.com.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
http://www.Phenomix.com
Photo Notes:Newscom:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com/
CONTACT:
Frank Murdolo, Vice President-Investor
Relations of Forest Laboratories, Inc., +1-212-224-6714,
frank.murdolo@frx.com; or Laura K. Shawver, Ph.D., Chief
Executive Officer, Phenomix Corporation, +1-858-731-5200; or
Parag Dave, Porter Novelli Life Sciences for Phenomix,
+1-619-849-5378, pdave@pnlifesciences.com
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