Phenomix and Forest Laboratories to Collaborate on Development and Commercialization of Dutogliptin in Diabetes
October 23 2008 - 8:00AM
PR Newswire (US)
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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Frank Murdolo, Vice President-Investor Relations of Forest
Laboratories, Inc., +1-212-224-6714, ; 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, Web Site: http://www.frx.com/
http://www.phenomix.com/
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