FRX Forest Road Acquisition Corp

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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