Dr. Reddy's To File Two New NDAs Within A Year
By C. Rajan, contributing writer
India based pharmaceutical company, Dr. Reddy’s Laboratories (DRL), announced this week that it expects to file two new drug applications (NDAs) with the US FDA within one year’s time, reports The Economic Times of India.
The company plans to file at least one NDA by the end of this year and another NDA sometime in 2015. The company currently has several new drugs in clinical trials in the areas of neurology and dermatology, including one drug in a late stage Phase 3 clinical trial. DRL did not disclose which NDA would be filed first nor for which indication.
DRL is a leading maker of generic drugs for the U.S. and European markets, and India’s second largest drug maker. Besides its Global Generics arm, the company also has a Proprietary Products division, as well as a Pharmaceutical Services and Active Ingredients business.
The company’s COO, Abhijit Mukherjee, said, "For the Proprietary Products business, several assets are in the late stage registration trial. The portfolio of assets, both in dermatology and neurology, is quite robust. In dermatology, our assets are targeting the indications of steroid-response kits, dermatoses, acne, rosacea, and actinic keratosis. While in neurology, it is primarily migraine. We are targeting our first NDA filing by the end of this fiscal year."
DRL has reported that it is working on six new drugs for different indications, including metabolic and cardiovascular disorders, psoriasis, and migraine indications. The company currently has 21 active products in the pipeline of its proprietary products division, with six drugs already in clinical development.
The company intends to invest about $300 to $400 million on research and development in biologics and proprietary products in the coming years. DRL also mentioned that it expects to file at least one NDA every year starting in 2016.
Last week, DRL also announced that it has launched organ transplant drug, Sirolimus, in the US market. The drug, which is the generic version of Wyeth's Rapamune, is an immunosuppressant prescribed for the prevention of organ rejection in kidney transplant patients. According to the company’s press release, Rapamune earned approximately $206 million for Wyeth in the past year in the U.S. market.
In 2014 alone, DRL has launched nine generic drugs in the U.S. market, including generic versions of top selling brand name drugs like Antara (fenofibrate), Cymbalta (Duloxetine Delayed-Release Capsules), Caduet (amlodipine Besylate and atorvastatin calcium), Lunesta (eszopiclone), and Avelox (moxifloxacin).