"Orchid Chemicals & pharmaceuticals Ltd"
Orchid Chemicals & pharmaceuticals Ltd Media release Orchid’s US drug discovery JV progresses well on lead antidiabetic molecule BLX 1002 Presents 2 Posters and a published abstract at the ADA session Chennai, India – July 01, 2003: Orchid Chemicals & Pharmaceuticals Ltd., the Chennai based pharma major today announced that its joint venture in the US, Bexel Pharmaccuticals Inc. (BPI) has made notable strides in its drug discovery activities over the last few months. The JV’s lead molecule for diabetes (BLX 1002) has demonstrated excellent results and potential both in in-vitro and in-vivo toxicological and pharmacological studies. Based on the results obtained so far, Orchid believes that this lead molecule for diabetes would be very well positioned not only for its exceptional efficacy and safety, but more importantly for its anti-weight gain property, Virtually all diabetes drugs have the problem of associated weight gain. Development of a molecule with anti-obesity properties would be a major stride in the new generation therapy of diabetes. Orchid has, over the last few months, supported the fast-tracking of the molecule in terms of optimising the process and providing GLP batches for various studies in the US. Orchid expects the synergies between its chemistry, molecular modelling and pre-clinical capabilities and Bexel’s innovative structure design and biological experimentation to yield a richer drug candidate pipeline in the future. According to a communication from the company, the molecule in now presently undergoing US FDA compliant toxicity studies which would be part of an eventual IND (Investigational New Drug) submission to the US FDA, Orchid expects the results of these studies to be available by August 2003 enabling commissioning of Phase I clinical studies thereafter. Given the potential of this molecule, it is planned to complete Phase I and Phase II (a) human clinical studies before considering licensing opportunities. The molecule also received good response and enquiries from several leading MNCs when it was showcased by BPI in the American Diabetes Association (ADA) tow weeks ago. Orchid and Bexel have chalked out an aggressive plan to complete Phase I studies this calendar year, followed by Phase II proof-of-concept studies early next year. Company Profile Orchid chemicals & Pharmaceuticals Ltd., is a leading pharmaceutical company headquartered in Chennai, India involved in the manufacture of cephalosporin and non-cephalosporin bulk actives, formulations and nutraceuticals. With exports spanning more than 75 countries, Orchid is the largest manufacturer-exporter of cephalosporin bulk actives in India and is ranked amongst the Top-5 cephalosporin in the world. Orchid’s world-class manufacturing facilities for bulk actives, including the latest USFDA compliant facilities, are located in Alathur, a little away from Chennai and in Aurangabad, 400 kms from Mumbai. Orchid also has dedicated manufacturing facilities for nutraceutical bulk active ingredients and formulations in alathur. Orchid’s R&D facility located at Sholinganallur in Chennai is considered among the most advanced and state-of-the-art centre for applied research and analytical development. It also houses the New Drug discovery infrastructure and a world-class pre-clinical toxicology and pharmacology centre, just commissioned. Orchid’s flagship product Cephalexin was recently approved by the USFDA. Orchid has also been awarded Certificates of suitability (CoS) from the European Directorate for the Quality of Medicines (EDQM) for three of its products. Orchid is one of the few pharmaceutical companies of its size and scale to have received the ISO 9001:2000 and ISO 14001 certifications for its world-class quality and environmental management systems respectively. For further information on this release or on Orchid, please contact: Ch. Ram Corporate Communications Orchid Chemicals & pharmaceuticals Ltd ‘Orchid Towers’ #152, Village road, Nungambakkam, Chennai – 600 034. INDIA Phone: 91-44-28211000 Extn. 908 Fax:91-44-28211002 Mobile: 98410 41241 Mail ID : email@example.com www.orchidpharma.com