Glenmark Pharmaceuticals and Forest Laboratories Announce Collaboration Agreement on PDE4 Inhibitor for Asthma and COPD
September 23 2004 - 9:00AM
PR Newswire (US)
Glenmark Pharmaceuticals and Forest Laboratories Announce
Collaboration Agreement on PDE4 Inhibitor for Asthma and COPD NEW
YORK and MUMBAI, India, Sept. 23 /PRNewswire-FirstCall/ -- Glenmark
Pharmaceuticals S.A (Switzerland), a wholly owned subsidiary of
Glenmark Pharmaceuticals India (GPL), and Forest Laboratories, Inc.
(NYSE:FRX) have entered into a collaboration agreement for
Glenmark's PDE4 inhibitor GRC 3886. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) GRC 3886
is a novel, orally available PDE4 inhibitor in development for
Chronic Obstructive Pulmonary Disorder (COPD) and Asthma, and may
also have utility in other conditions. According to the Centers for
Disease Control, COPD affects approximately 24 million people in
the United States and Asthma affects approximately 20 million.
Combined, these markets are worth over $10 billion and are growing
at a significant rate. PDE4 inhibitors target the underlying cause
of both COPD and Asthma by blocking inflammation through a
non-steroid dependant mechanism. GRC 3886 is currently entering
Phase I clinical trials in the UK. In preclinical studies, the
compound appears to be effective and well tolerated when given at
pharmacological doses. GRC 3886 is currently claimed by U.S. patent
applications which, if issued, will expire in 2024. Forest will
develop, register and commercialize GRC 3886 for the North American
market, while Glenmark will retain commercialization rights for the
rest of the world. Forest will pay Glenmark an up-front payment
upon initiation of the agreement, and other milestones if the
development and commercialization of the product is successfully
completed in the North American market; the total value of these
payments could be $190 million. Additionally, after commercial
launch, Glenmark will earn a mid-teens royalty from Forest on net
sales of the product, and, in addition, will supply all API for
sale by Forest. According to Glenn Saldanha, MD and CEO of GPL,
"This deal is the largest licensing deal concluded by any Indian
Pharmaceutical company to date. Forest has consistently
demonstrated exceptional development, sales and marketing skills
and we are very excited to partner with them on this product."
Howard Solomon, Chairman and Chief Executive Officer of Forest
said: "We are especially pleased to have entered into this
agreement with Glenmark for several reasons. We believe that
Glenmark's PDE4 inhibitor may offer another important advance for
the treatment of asthma and COPD with a recognized target and an
excellent product profile in a therapeutic area in which we have
had a great deal of experience. In addition, we believe that more
and more innovative drug discovery will be coming from companies in
India and that Glenmark has the skill and foresight to become one
of the leading discovery companies. We highly value our
relationship with Glenmark which we hope will expand into some of
the other interesting areas that they are exploring. This agreement
marks our fourth product development collaboration announced this
year and we continue to see additional interesting product
opportunities which we are pursuing." About COPD and Asthma
Phosphodiesterase-IV (PDE4) inhibitors represent a promising new
class of drugs that are being studied for their effects in COPD and
Asthma as well as other conditions. COPD is a debilitating
respiratory condition that includes two related lung diseases:
chronic bronchitis and emphysema. It affects approximately 24
million Americans, a population even larger than the 20 million who
suffer from asthma. However, COPD frequently goes undiagnosed and
untreated because it is difficult to identify in its early stages.
The primary cause of COPD is prolonged cigarette smoking. It is the
4th leading cause of death in the United States after heart
disease, cancer, and stroke. According to the National Heart, Lung,
and Blood Institute, COPD's prevalence and death rate are rising.
In 2020, COPD is projected to become the 3rd leading cause of death
in the United States. Today, the economic burden of COPD on the
U.S. healthcare system is substantial, estimated at over $30
billion annually. Bronchodilators and anticholinergics are the most
commonly prescribed therapies in COPD, but do not address the
underlying inflammation. PDE4 inhibitors represent a new class of
drugs that are interesting because they have the potential to relax
the smooth muscles of the airway (cause bronchodilation) as well as
inhibit inflammatory cell activity, thus providing both short term
relief and control over the progression of the disease. Asthma is a
disease of the airways with an underlying inflammatory component.
It is the most common chronic lung disease in both the developed
and developing world and affects approximately 20 million
Americans. The prevalence and healthcare burden of asthma are
rising and are predicted to continue to rise in the coming years.
According to the National Heart, Lung, and Blood Institute, the
economic cost of asthma is $14 billion annually in the United
States. Asthma is one of the leading causes of missed school days
and can have a significant impact on quality of life if left
uncontrolled. Two types of medications are currently used in asthma
care: controller medications such as inhaled steroids and
leukotriene antagonists that are taken chronically for the
prevention and treatment of asthma, and reliever medications such
as short acting beta agonists that work rapidly to treat
bronchospasm. There continues to be a need, however, for novel,
safe treatments to address the underlying inflammation that
characterizes asthma pathology. About Forest Laboratories and Its
Products Forest Laboratories' growing line of products includes:
Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor
antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; Lexapro(R) (escitalopram oxalate), an SSRI
antidepressant indicated for the initial and maintenance treatment
of major depressive disorder and for generalized anxiety disorder;
Celexa(R) (citalopram HBr), an antidepressant; Benicar(R) *
(olmesartan medoxomil), an angiotensin receptor blocker indicated
for the treatment of hypertension; Benicar HCT(TM) (olmesartan
medoxomil hydrochlorothiazide), an angiotensin receptor blocker and
diuretic combination product indicated for the second-line
treatment of hypertension; 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 when used in combination with
psychosocial support; Aerobid(R) (flunisolide), an inhaled steroid
indicated for the treatment of asthma; and Tiazac(R) (diltiazem
HCl), a once-daily diltiazem, indicated for the treatment of angina
and hypertension. Forest Laboratories, Inc. had net sales of $2.65
Billion in the fiscal year ended March 31, 2004. *Benicar(R) is a
registered trademark of Sankyo Pharma, Inc. Except for the
historical information contained herein, this release contains
"forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to
risks and uncertainties that affect our business, including risk
factors listed from time to time in the Company's SEC reports,
including the Company's Annual Report on Form 10-K for the fiscal
year ended March 31, 2004, and on form 10-Q for the period ended
June 30, 2004. Actual results may differ materially from those
projected.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Jeff Weiss, CEO of Glenmark
Pharmaceuticals, Inc. USA, +1-609-514-1444, ; or Charles E. Triano,
Vice President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, Web site: http://www.frx.com/
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