Dr Reddy's: 9 New Drugs In Clinical Development
By Lori Clapper
Dr. Reddy's Laboratories (DRL) announced last week that it has nine new drugs in the clinical development stage. The drugs range from metabolic disorders and cardiovascular disorders, to Psoriasis and migraine.
The company, which just received FDA approval to launch generic versions of CYMBALTA and ZEMPLAR last week, shared the status of these therapeutic studies:
- Metabolic and cardiovascular disorders, dermatitis/psoriasis and anti-infective research is currently in phase-II
- Migraine and psoriasis products are in phase-III
- In addition, there are three programs in pharmacokinetic, bioavailability, and bioequivalence studies in migraine and dermatologic therapeutics
In a filing with U.S. SEC, DRL also added as of March 2014, it actually had 20 active products in the proprietary products pipeline, stating it has built a pipeline that they hope will “produce a steady stream of investigational new drugs in the coming years.”
"Since repositioning our research activities in the years ended March 31, 2009 and 2010, our proprietary products segment has focused its efforts towards developing drugs to meet key unmet clinical needs,” DRL told the Business Standard.
Even with the number of potential drug products coming down the line, the company explained that the clinical trial process is not a quick one and can take up to 10 years or more to complete. Even then, there is no guarantee the data gathered will be in compliance with good clinical practice regulations, will prove the products’ safety and efficacy, or that they are pure and potent in keeping with the standards for biologic products. In the end, it’s not even clear if the information will support FDA approval of the product at all.
Even so, DRL has future plans for a $150 million investment into Biologics, as well as $300 million for proprietary products over the next three to four years — until these respective businesses become self-sufficient and cash accretive.