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Dr Reddy’s Labs working on 20 new products
Dr Reddy’s Labs : Twenty New Products, City-based Dr Reddy\'s Laboratories said it has nine new drugs under various stages of clinical development.
The pharma major, in a filing with US SEC, says nine of them have reached clinical stage
Hyderabad: City-based Dr Reddy's Laboratories said it has nine new drugs under various stages of clinical development. These drugs are targeted at different therapeutic areas which include cardiovascular and metabolic disorders, besides psoriasis and migraine.
In a filing with Securities and Exchange Commission (SEC) of the US, the pharma major said its proprietary product pipeline comprised 20 active products as of March 31, 2014. Of them, nine are in clinical development stage.
"Since repositioning our research activities in the years ended on March 31, 2009 and 2010, our proprietary products segment has focused its efforts towards developing drugs to meet key unmet clinical needs,” the company said.
We have built a pipeline of assets that we expect to produce a steady stream of investigational new drugs in the coming years. As of March 31, 2014, we had 20 active products in our proprietary products pipeline, of which nine were in clinical development stage, it added.
Further, the company’s proprietary products segment focuses on building a pipeline in the therapeutic areas of neurology, pain management, dermatology and infectious diseases.
It said the new drug research on metabolic disorders/cardiovascular disorders, atopic dermatitis/psoriasis and anti-infective is in phase-II, while migraine and psoriasis ones are in phase-III. The remaining one is in phase-1 stage.
"In addition to the above, we have three programs which are in pharmacokinetic, bioavailability and bioequivalence studies in the migraine and dermatology therapeutic areas," it added.
New drug phase-III can be described as larger scale clinical studies conducted in patients to provide sufficient data for statistical proof of efficacy and safety while in phase-II clinical studies are conducted with groups of patients to determine preliminary efficacy, dosage and expanded evidence of safety.
The clinical trial process can take five to 10 years or more to complete, and there can be no assurance that the data collected will be in compliance with good clinical practice regulations, will demonstrate that the product is safe or effective, or, in the case of a biologic product, pure and potent, or will provide sufficient data to support USFDA approval of the product, Dr Reddy’s explained.
"We may cumulatively invest in biologics, nearly $150 million, and proprietary products nearly $300 million over next three to four years till these respective businesses become self sufficient and cash accretive," the latest DRL investor presentation said. The research and development expenses for FY 14 stood at Rs 1,240 crore, year-on-year increase of 62 per cent against Rs 767 crore.
