Full Press Release Details
| April 2, 2018 | ||
| Corporate Relationship Department | National Stock Exchange of India Ltd. | |
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| Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Please find enclosed a Press Release on
"Dr. Reddy's Laboratories and its U.S. subsidiary Promius Pharma announce the filing of an NDA for its migraine candidate."
This is for your information.
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code: RDY)
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| DR. REDDY'S LABORATORIES LTD. 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | Investor relationS | Media relationS |
| Saunak SAVLA saunaks@drreddys.com (Ph: +91-40-49002135) | Calvin Printer calvinprinter@drreddys.com (Ph: +91-40- 49002121) |
Laboratories and its U.S. subsidiary Promius Pharma
announce the filing of an NDA for its migraine candidate.
Hyderabad, India and Princeton, NJ, USA. April 2, 2018 -
Dr. Reddy's Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and its subsidiary, Promius Pharma, LLC today announced
the filing of New Drug Application (NDA) for its migraine candidate DFN-02 with the U.S. Food and Drug Administration (USFDA).
According to Dr. Anil Namboodiripad, Senior Vice President,
Proprietary Products and President, Promius Pharma, the NDA for DFN-02 is an important step forward in the company's mission
to bring solutions that address unmet needs.
"The filing of DFN-02 NDA represents our continuing commitment
to bring innovative solutions in migraine treatment," explains Dr. Namboodiripad. "Acute migraine attacks are typically
associated with pain and symptoms, such as nausea, photophobia, and phonophobia. It is important that an effective migraine treatment
helps address associated symptoms. Equally important is having a well-tolerated treatment that provides patients a satisfactory
resolution of their migraine attack."
In a multicenter, double-blind, randomized, placebo controlled
study with 107 subjects (Clinicaltrials.gov # NCT02856802), DFN-02 has demonstrated that it can effectively treat pain and associated
symptoms during a migraine attack and reduce attack-related functional disability. Data from this study show that there was a significantly
higher proportion of subjects who experienced 2-hour pain freedom with DFN-02 compared with placebo: 43.8% (n=48) versus 22.5%
(n=40), p<.05). DFN-02 was also significantly better than placebo at alleviating the patients' most bothersome symptom
(MBS), including nausea, photophobia, and phonophobia (70.7% versus 39.5% MBS free at 2 hours postdose; p<.01. DFN-02 was well
tolerated, with the following Treatment-Emergent Adverse Events: dysgeusia (n = 4), application site pain (n = 2), chest discomfort,
burning sensation, rhinorrhea and malaise (n = 1 each), all mild to moderate.
Upon approval, the product will be commercialized by Promius
DFN-02 is a novel intranasal spray formulation currently patented
in 11 countries (total of 13 issued patents) composed of sumatriptan 10 mg and Aegis Therapeutics, LLC permeation-enhancing technology
known as Intravail . DFN-02 is a novel investigational intranasal formulation in development for the acute treatment of migraine
with or without aura. This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation, and it
exhibits pharmacokinetics comparable to subcutaneously administered sumatriptan.
Intravail is a registered trademark of Aegis Therapeutics,
About Promius Pharma LLC
Promius Pharma is a wholly owned subsidiary of Dr. Reddy's
Laboratories, one of the largest and most respected pharmaceutical companies in the world. With a robust commercial infrastructure
and extensive research and development capabilities through its parent company, Promius Pharma is committed to bringing new products
to market that meet patients' needs in dermatology and neurology. For more information, visit www.promiuspharma.com
About Dr. Reddy's: Dr. Reddy's
Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, 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
gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets
across the globe. Our major markets include - USA, India, Russia & CIS countries, and Europe. For more information,
log on to: www.drreddys.com
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