Identifying R&D as pivotal to upkeep its brand image, the Indian pharmaceutical industry has been aggressive in on this front especially during the last couple of years.
India's leading companies, viz., Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories, Sun Pharmaceuticals, Lupin, Nicholas Piramal, Glenmark, Jubilant Organosys, Aurobindo Pharma, Cadila Healthcare, Wockhardt, Orchid, Biocon, Ipca Laboratories, Torrent Pharma, etc., are spending significant amount on R&D. The Indian firm's R&D efforts are mainly focusing on new drug discovery programme, New Drug Discovery Systems (NDDS), recombinant biopharmaceuticals, clinical research, etc.
Ranbaxy Laboratories developed RBx 11160 molecule, a potential anti-malarial candidate, is under development in association with Geneva-based Medicines for Malaria Venture (MMV). It has completed phase I single and multiple rising dose studies in respect of RBx 9841 for urinary incontinence. The molecule is a potent and selective inhibitor of M3 (muscurinic) receptor. The molecule is also being investigated for other indications such as COPD and Asthma. In the area of infectious disease, it is working on a novel antibiotic to treat Community Acquired Respiratory Tract Infections (CARTI). It has undertaken two programmes with GlaxoSmithKline. The company has also built significant expertise in NDDR, Novel Drug Delivery systems research, Pharmaceutical research and chemical & fermentation research. The company is pursuing 10 research programmes with the help of over 300 scientists in the therapeutic areas of infectious diseases, urology, metabolic diseases and rheumatoid arthritis.
Cipla, a Rs 3000 crore Mumbai based pharma company, stepped up its R&D expenditure to Rs 155 crore during 2005-06 from Rs 98 crore in the previous year, a growth of more than 58 per cent. The company is focusing on developing and enhancing know-how for new drug delivery systems and manufacturing processes both for APIs and drug formulations. Cipla entered strategic alliance with Avestha Genegraine Technologies Pvt Ltd for the development of biotherapeutics.
Dr Reddy's Laboratories (DRL) has re-engineered its R&D activities and has built an even stronger pipeline for the future. It entered a deal in discovery research with Citigroup Venture and ICICI Venture to form an integrated drug development company called Perlecan Pharma Pvt Ltd. DRL has transferred all rights and titles of four discovery molecules in the area of cardiovascular and metabolic disorders.
DRL has also tie-up with Rheoscience A/S to co-partner the development of balaglitazone (DRF 2593) a partial PPR-gamma agonist for the treatment of Type 2 diabetes. Further, its five key NCEs advanced to clinical development and few are in pre-clinical stage.
Lupin Research Park at Pune, sprawling across 19 acres with a built up area of 1.50 lakh sq.fts., housing 320 scientists, is the hub of all research initiatives undertaken by the company. It has attained capabilities to develop quality APIs at productivity levels rivalling the best, value added finished products in the generic space based on platform technologies. Its R&D activity is vertically integrated, starting from process development of the API till the submission of dossiers for finished dosages. The company has identified cardiovascular and anti-diabetics as prominent growth drivers and focuses on them through a dedicated business division. Further, being a major player in TB drugs in the past, the company also entered various segments like anti-TB, anti-infective, anti-asthma, and CNS.
Wockhardt Ltd continues to focus on R&D and the creation of successful IPRs. Through R&D and discovery of new drugs, the company also has the potential power to address unmet medical needs and improve the lives and health of millions of people across the globe. The company is working on WCK 771, its proprietary compound, as a parenteral anti MRSA agent.
Nicholas Piramal India Ltd, among the top ten Indian companies, is currently strengthen its R&D activity by appointing 350 scientists for long-term exploratory and applied research programmes in chemistry, biology and natural product chemistry dedicated to discovery and development of new drugs for the global market. The company increased the number of drug candidates in its preclinical and clinical development pipeline. Its lead candidate, P-276-00 for cancer is undergoing phase I clinical trials in Canada and also received DCGI approval for start phase I trials in India. Its five pre-clinical candidates - four new chemical entities and one mono-herbal preparation have exhibited good progress during FY2006. The company's R&D expenditure declined to Rs 91.15 crore from Rs 108.44 crore in the previous year.
Glenmark's major drug development activities in pipeline includes study on oglemilast [GRC 3886] targeting PDE-4 inhibitor for primary indications like asthma, COPD is in the second phase trials. A compound, GRC 8200, targeting DPP-IV inhibitor for Type II diabetes is currently in phase II and both these molecules are expected to be launched by 2010.
Biocon has successfully commercialised its first human monoclonal antibody BIOMAb-EGFR in India. It is also exploring strategic collaboration to co-develop recombinant therapeutics, antibodies and a host of in-licensed products.
Orchid Chemicals & Pharma Ltd is consolidating its new drug discovery (NDD) research activities under a common umbrella. As part of this initiative, the company and Bexel Pharmaceuticals, Inc have reached an understanding by which the company would extend its ownership in Bexel from the current 74% to 100% for a cash consideration of US$ 3 million. Bexel's anti-diabetes molecule BLX-1002 has progressed the most among these, having completed phase I safety and tolerability studies in healthy human volunteers as well as safety and tolerability studies in diabetic patients. The phase I human clinical trials conducted in 4 stages so far have been successful without any adverse side effects being seen. Bexel and the company are now planning to conduct more elaborate phase II human clinical trials on BLX-1002 in the context of its efficacy in multiple indications. These will be conducted in two stages of a 28-day human clinical study followed by a 90-day study if necessary to generate significant additional data on the compound.
Furthermore, the Big Pharma, under tremendous pressure to lower the costs is exploring to Indian shores. Realizing India's potential as a manufacturing and research hub, several MNCs have already setup their R&D activities as well as manufacturing plants. With the help of excellent talent pool, cost effective manufacturing base and easy availability of cheap raw materials, the Indian pharma industry is set to tap new opportunities in the field of contract manufacturing, contract research, clinical trials and biotechnology. Several global firms have identified Indian companies as their preferred partners.