Dr. Reddy’s Laboratories and Its Subsidiary Promius PharmaTM Announce the Filing of Three NDAs With the USFDA

HYDERABAD, India & Princeton, N.J.--()--Dr. Reddy's Laboratories (NYSE:RDY) and its subsidiary, Promius Pharma™, LLC today announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the U.S. Food and Drug Administration (US FDA).

The three NDAs - DFD-01, DFD-09, and DFN-11, are in support of Dr. Reddy’s Proprietary Products group, focused on developing and commercializing therapies in dermatology and neurology.

DFD-01 and DFD-09 are the first dermatology applications submitted to the NDA that have been fully developed leveraging in-house capabilities.

  • DFD-01 is a corticosteroid delivered in a novel non-irritating spray platform, intended for the treatment of patients suffering from psoriasis.
  • DFD-09 is a modified release oral tetracycline intended for the treatment of rosacea.

DFN-11 is the first development program filed in support of a newly created vertical, focused on the US neurology market.

  • DFN-11 is a drug-device combination product intended to treat acute migraine episodes in certain patient populations who are inadequately managed with existing treatment regimens.

Commenting on the filings, Raghav Chari, Executive Vice President of Proprietary Products at Dr. Reddy’s and President of Promius Pharma™ said: “These products potentially represent new, compelling options for specific segments of patients suffering from Psoriasis, Rosacea and Migraine. They are also the first of a large basket of products targeting conditions predominantly treated by the medical dermatologist and neurologist. By focusing exclusively on these two specialty therapeutic areas, we intend to build a leading presence in them over time.”

Upon approval, the products will be commercialized by Promius Pharma™.

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infectives. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, Russia & CIS and India. For more information, log on to: www.drreddys.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or re organization, including related integration issues.

The company assumes no obligation to update any information contained herein.

Contacts

Dr. Reddy's Laboratories
Media Relations
CALVIN PRINTER, +91-40-49002121
calvinprinter@drreddys.com
or
Investor Relations
SAUNAK SAVLA, +91-40-49002135
saunaks@drreddys.com
or
Investor Relations
KEDAR UPADHYE, +91-40-66834297
kedaru@drreddys.com
or
Investor Relations
ASHISH GIROTRA (USA), +1 609-375-9805
ashishg@drreddys.com

Contacts

Dr. Reddy's Laboratories
Media Relations
CALVIN PRINTER, +91-40-49002121
calvinprinter@drreddys.com
or
Investor Relations
SAUNAK SAVLA, +91-40-49002135
saunaks@drreddys.com
or
Investor Relations
KEDAR UPADHYE, +91-40-66834297
kedaru@drreddys.com
or
Investor Relations
ASHISH GIROTRA (USA), +1 609-375-9805
ashishg@drreddys.com