Dr Reddy’s files applications for three new drugs with US FDA1 min read . Updated: 08 Apr 2015, 02:11 PM IST
The company said the products will be commercialized by its subsidiary Promius Pharma after their approval
Hyderabad: Dr Reddy’s Laboratories Ltd, India’s second-largest drug maker by sales, said on Wednesday that its subsidiary Promius Pharma Llc has applied to the US Food and Drug Administration (FDA) for approval of three new drugs to treat skin and nervous system disorders.
The company said the three new drug applications were for proprietary products named DFD-01, DFD-09 and DFN-11.
DFD-01 and DFD-09 are the first dermatology applications submitted to the regulator that have been fully developed through its in-house capabilities, Dr Reddy’s said in a statement. DFD-01 is a steroid delivered in a novel, non-irritating spray intended for the treatment of patients suffering from psoriasis, a chronic skin condition that causes skin cells to grow too fast, producing lesions.
DFD-09 is an oral antibiotic used to treat rosacea, a skin disease that causes redness and pimples on the face. DFN-11, focused on the US neurology market, is a drug-device combination therapy for treating acute migraine.
Dr Reddy’s said the products will be commercialized by Promius Pharma after their approval.
The Hyderabad-based drug maker also entered a binding agreement with US-based Taxus Cardium Pharmaceuticals Group Inc. for an exclusive territorial license covering the co-development, marketing and sales of Generx, a gene therapy being developed by Taxus for patients of cardiac disease.
The agreement initially covers certain territories and international markets, including Russia and its neighbours, Venezuela, Vietnam and Myanmar, and provides the right of first refusal for Dr Reddy’s to negotiate exclusive permit agreements to market and sell the product in over 30 other countries in Latin America and southeast Asia.
Angionetics Inc., a unit of Taxus Cardium, retains the full commercialization rights to Generx for North America, Europe, Japan, China, West Asia and Africa.
As an international co-development partner, Dr Reddy’s will assist with local country patient recruitment and relationship-building with key opinion leaders to accelerate international phase 3 clinical studies on the drug. In addition, Dr Reddy’s will assist with product registrations and regulatory compliance with health authorities.
The agreement provides for economic support that will be used to advance the international phase 3 clinical study, a cost-sharing arrangement for a planned phase 4 post-marketing clinical study (intended to expand product labelling), and volume-based royalties on net sales.
Shares of Dr Reddy’s gained 1.24% and were trading at ₹ 3,724 at 12.30pm on BSE, while the benchmark Sensex rose 0.66% to 28,709.89 points.