| GLENMARK PHARMACEUTICALS AND TEIJIN PHARMA LIMITED ANNOUNCE COLLABORATION AGREEMENT ON PDE4 INHIBITOR FOR ASTHMA AND COPD FOR THE TERRITORY OF JAPAN TOKYO and MUMBAI, INDIA, April 26, 2005 - Glenmark Pharmaceuticals S.A (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL), and Teijin Pharma Limited (Teijin Pharma), a wholly owned subsidiary of Teijin Limited (Teijin), have entered into a collaboration agreement for Glenmark's PDE4 inhibitor GRC 3886. GRC 3886 is a novel, orally available PDE4 inhibitor discovered by Glenmark. It is currently in development for Chronic Obstructive Pulmonary Disorder (COPD) and Asthma, and may also have utility in other inflammatory conditions such as Rheumatoid Arthritis. According to the NICE study (an epidemiological study on COPD in Japan (2001)), COPD affects potentially 5.3 million people in Japan, a population even larger than the 2.0 million who suffer from Asthma. Combined, these markets, albeit COPD going mostly undiagnosed and untreated at present, are currently about $2.0 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 dependent mechanism. In pre-clinical trials, GRC 3886 was shown to be a highly specific PDE4 inhibitor with potential for the indications of asthma and COPD. The Phase 1 studies were conducted in the UK by Quintiles, a Global Contract Research Organization (CRO) and have recently been completed. The Phase 1 studies have demonstrated that GRC 3886 is well tolerated and exhibits predictable pharmacokinetics in human volunteers. The molecule has been found to be non-emetic and without any apparent cardiovascular effects at the highest doses tested in the study. Additionally, the drug has exhibited a long half-life, suggesting a once-daily-dosing regimen may be possible in future studies in patients. Glenmark has built a strong, global patent portfolio around GRC3886 and has filed U.S., PCT and national stage filings for strategic territories around the world. Teijin Pharma will have the exclusive right to develop, register and commercialize GRC 3886 for all potential indications for which the product might receive approval in the Japanese market. Teijin Pharma will pay Glenmark a high up-front payment upon initiation of the agreement, and a further milestone on commencement of Phase I studies in Japan. Teijin Pharma will also pay Glenmark other milestones on crossing each successive stage in the development and commercialization of the product for the Japanese market. The cumulative value of these upfront and milestone payments could be up to $53 million if all the milestones are completed. Additionally, after commercial launch, Teijin Pharma will pay Glenmark annual sums that are marginally higher than the first quartile of net sales of the product in Japan, towards supply of the Active Pharmaceutical Ingredient (API) and royalties. Glenmark had announced a similar deal for the territory of North America with Forest Labs in September 2004. After these two collaborations, Glenmark retains rights to GRC 3886 for all markets excluding North America and Japan and is in discussions with potential collaboration partners for Europe as well. According to Glenn Saldanha, Managing Director and CEO of GPL, "This collaboration with Teijin Pharma is in line with our strategy of partnering with strong regional companies for the regulated markets of North America, Japan and Europe. We are happy to partner with a company of high repute like Teijin Pharma that has consistently demonstrated exceptional development, sales and marketing skills and has a strong presence in the Japanese market." Shigeo Ohyagi, President of Teijin Pharma said: "We have examined the preclinical and Phase I clinical data for GRC 3886 and are extremely excited by the molecule's potential to offer another important advance for the treatment of asthma and COPD. If approved, the product would offer an excellent profile in a therapeutic area in which we have had a great deal of experience in the Japanese market." 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 potentially 5.3 million Japanese, with another 2.0 million suffering 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. 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 2.0 million Japanese. The prevalence and healthcare burden of asthma is rising and is predicted to continue to rise in the coming years. 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 Glenmark: Glenmark Pharmaceuticals Limited is a global, fully integrated, research-based pharmaceutical company headquartered in Mumbai, India. The company has generic formulation and API business interests in over 65 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes. The company is also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation (Asthma/COPD etc) and metabolic disorders (Diabetes, Obesity etc). The company's recently announced licensing of its first Asthma/COPD molecule GRC 3886 to a US company (Forest Labs) was the largest of its kind from India. The company also has another compound targeting Diabetes (Type II) in late pre-clinical studies. About Teijin Group and its Pharmaceutical subsidiary The Teijin Group (http://www.teijin.co.jp/english/) is active in a wide range of businesses, including fibers, films, plastics, pharmaceuticals and home health care and information technology (IT)-related services. Teijin Pharma (http://www.teijin-pharma.co.jp/english/index.html), medical and pharmaceuticals business subsidiary of Teijin, focuses on the three key therapeutic areas: respiratory, bone/joint, and cardiovascular/metabolic diseases. In the respiratory field, Teijin Pharma has strong R&D and marketing position with pharmaceutical products and home oxygen therapy (HOT) business, which has a top market share in Japan. Teijin Pharma is now trying to expand its product pipeline for COPD/asthma by in-licensing as well as in-house R&D; it will continue to pursue providing total health care services for these patients through synergistic activities in the pharmaceuticals and HOT businesses.
| ||||||
Information in the press releases is current on the date of the announcement.
It is subject to change without prior notice.
