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 (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' (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.
SOURCE Forest Laboratories, Inc.; Microbia, Inc.
CONTACT: Charles E. Triano, Vice President-Investor Relations of Forest
Laboratories, Inc., 1-212-224-6714, Charles.Triano@frx.com; or Susan Brady,
Corporate Communications, Microbia, Inc., 617-621-8304, sbrady@microbia.com
Web site: http://www.frx.com
http://www.microbia.com
(FRX)