Microbia and Forest Laboratories Announce Linaclotide Co-Development and Co-Marketing Collaboration
September 17 2007 - 8:03AM
PR Newswire (US)
CAMBRIDGE, Mass. and NEW YORK, Sept. 17 /PRNewswire-FirstCall/ --
Microbia, Inc. and Forest Laboratories, Inc. (NYSE:FRX), today
announced that they have entered into a 50/50 partnership in the
United States to co-develop and co-market Microbia's first-in-class
compound linaclotide. Linaclotide is currently being investigated
for the treatment of constipation-predominant irritable bowel
syndrome (IBS-C), chronic constipation (CC), and other
gastrointestinal disorders. (Logo:
http://www.newscom.com/cgi-bin/prnh/20070917/NYM031LOGO ) (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) Under the
terms of the agreement, Forest will initially pay Microbia $70
million in licensing fees. Microbia and Forest will jointly and
equally fund development and commercialization of linaclotide in
the United States, sharing profits equally. Additionally, Forest
will have exclusive rights in Canada and Mexico and will pay
Microbia a royalty on sales in these countries. Microbia retains
all rights to the product outside of North America. Total licensing
and milestone payments to Microbia if linaclotide is successfully
developed and commercialized in the United States could total $330
million over the term of the collaboration. Howard Solomon,
Chairman and Chief Executive Officer of Forest, said, "We are very
pleased to have entered into this collaboration with Microbia.
Linaclotide offers the possibility of genuine relief for the
millions of patients suffering from chronic constipation and IBS-C,
for which there are currently few treatment options. Chronic
constipation and IBS-C patients are treated largely by primary care
physicians, where the Forest sales force has already built
excellent relationships. We are particularly excited to be working
closely with Microbia, an innovative pharmaceutical company with a
strong and proven management and scientific team." Linaclotide is
currently undergoing Phase 2b clinical testing in patients with
IBS-C and CC. In earlier clinical studies, linaclotide demonstrated
improved bowel function in patients with IBS-C and CC. These
studies also showed linaclotide was well tolerated with a low
incidence of adverse events. Linaclotide is an agonist of the
guanylate cyclase type-C receptor found in the intestine and acts
by a mechanism distinct from previously developed products for
IBS-C and CC. Linaclotide is administered orally but acts locally
in the intestine with no measurable systemic exposure. Microbia and
Forest intend to initiate Phase 3 studies in the second half of
2008. "Joining forces with Forest is the best way to maximize
linaclotide's value for patients and investors," said Peter Hecht,
Microbia's Chief Executive Officer. "Forest uniquely combines
world-class primary care commercial capabilities and an
entrepreneurial and collaborative culture. Our companies share a
common vision and commitment for getting linaclotide to IBS-C and
CC sufferers." About Irritable Bowel Syndrome (IBS) One out of six
adults in developed countries suffers from IBS, a chronic condition
marked by abdominal pain and disturbed bowel function. IBS accounts
for 12% of adult visits to primary care physicians and is the most
common disorder diagnosed by gastroenterologists. Health care costs
associated with IBS exceed $25 billion annually. IBS patients fall
into three subgroups- constipation-predominant (IBS-C),
diarrhea-predominant (IBS-D), and alternating (IBS-A)-and 30% to
40% of these patients suffer from IBS-C. There are currently few
available therapies to treat the nine million U.S. patients
diagnosed with IBS-C. About Chronic Constipation (CC) As many as 26
million Americans suffer from CC. Patients with CC often experience
hard and lumpy stools, straining during defecation, a sensation of
incomplete evacuation, and fewer than three bowel movements per
week. The discomfort of CC significantly affects patients' quality
of life by impairing their ability to work and participate in
typical daily activities. About Linaclotide Linaclotide is a
first-in-class compound currently being tested for the treatment of
IBS-C, CC, and other gastrointestinal disorders. Linaclotide is an
agonist of guanylate cyclase type-C, a receptor found on the lining
of the intestine. In preclinical testing linaclotide was shown to
increase fluid secretion into the intestine, accelerate intestinal
transit, and decrease visceral pain. Linaclotide was designed to
exert its effect on the intestine with minimal systemic exposure.
In Phase 2 trials, linaclotide improved bowel function as measured
by both complete spontaneous bowel movements and spontaneous bowel
movements in patients with CC and IBS-C. Linaclotide is currently
being tested for these indications in a pair of Phase 2b trials,
which together will enroll 700 patients. A composition of matter
patent application is pending for linaclotide, which, if issued
would provide protection to 2024, subject to extension. About
Microbia Microbia (http://www.microbia.com/) is an entrepreneurial
pharmaceutical company dedicated to the science and art of great
drug-making. Three of the Company's drug candidates are in clinical
studies-linaclotide for the treatment of IBS-C, CC, and other
gastrointestinal disorders; and MD-0727 and MD-3124 for the
treatment of hypercholesterolemia. Microbia also has a growing
pipeline of additional drug candidates. Microbia Precision
Engineering, Inc., a majority-owned subsidiary of Microbia, Inc.,
is an industrial biotechnology company developing and
commercializing novel bioprocesses for the production of specialty
chemicals. Microbia has raised $231 million in private equity
financing and is located in Cambridge, Massachusetts. About Forest
Laboratories Inc. and Its Products: Forest Laboratories'
(http://www.frx.com/) is a US-based specialty pharmaceutical
company with a growing line of products, including: Lexapro(R)
(escitalopram oxalate), a selective serotonin reuptake inhibitor
(SSRI) antidepressant indicated for the initial and maintenance
treatment of major depressive disorder and for generalized anxiety
disorder in adults; Namenda(R) (memantine HCl), an N-
methyl-D-aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)*
(olmesartan medoxomil), an angiotensin receptor blocker indicated
for the treatment of hypertension; Benicar* HCT(R) (olmesartan
medoxomil hydrochlorothiazide), an angiotensin receptor blocker and
diuretic combination product indicated for the second- line
treatment of hypertension; and Campral(R)* (acamprosate calcium), a
glutamate receptor modulator, indicated for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation in combination with psychosocial
support. * Benicar is a registered trademark of Sankyo Pharma,
Inc., and Campral is a registered trademark under license from
Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
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. Because these
statements involve a number of risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to the difficulty of predicting FDA approvals, acceptance
and demand for new pharmaceutical products, challenges relating to
intellectual property protection, 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' SEC reports, including its Annual Reports on Form
10-K for the fiscal year ended March 31, 2007 and Quarterly Reports
on Form 10-Q for the period ended June 30, 2007.
http://www.newscom.com/cgi-bin/prnh/20070917/NYM031LOGO
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.;
Microbia, Inc. CONTACT: Charles E. Triano, Vice President-Investor
Relations of Forest Laboratories, Inc., +1-212-224-6714, ; or Susan
Brady, Corporate Communications, Microbia, Inc., 617-621-8304, Web
site: http://www.frx.com/ http://www.microbia.com/
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