U.S. FDA Grants QIDP Status for Wockhardt Anti-Infective Drug Discovery Program

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Aug 31, 2014, 09:56 ET

PARSIPPANY, N.J., Aug. 31, 2014 /PRNewswire/ -- Wockhardt Limited today announces a major boost to the New Drug Discovery program in Anti-Infective research when two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from U.S. Food & Drug Administration (FDA). QIDP status is granted to drugs which act against pathogens which have a high degree of unmet need in their treatment and are identified by Centre for Disease Control (a top U.S. government health and safety body). QIDP status allows for fast track review of the drug application by U.S. FDA paving way for an early launch. This is the first instance of an Indian Pharmaceutical company receiving a QIDP status.

In this regard, Dr. Habil Khorakiwala, Wockhardt Founder & Chairman said "Globally there is a significant antibiotic vacuum due to dual impact of rise in new resistant pathogens and declining research in this area which causes over 50,000 deaths in USA and Europe combined despite having excellent healthcare services. The emerging world may as well be sitting on an antibiotic time-bomb ready to explode. Superficially the bacterial diseases can be divided in two categories, gram positive and gram negative and these pathogens have prevalence in both of them. Over the years Wockhardt has developed a strong anti-infective program which focuses on development of drugs which target this antibiotic gap in both gram positive and gram negative domains. These two drugs act against one of the globally rising class of pathogens MRSA (Methicillin-resistant Staphylococcus Aureus) which causes a range of diseases from the skin infection to severe respiratory infections. In case of severe infections like Hospital Acquired Pneumonia (HAP) current medical cure has a very limited reach causing a high unmet need and mortality. Both of these drugs are effective against MRSA and have shown potential in treatment of HAP. WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet, which is a significant positive for the drug development scenario as currently there is very little advance drug research in developing solid oral dosages. Most of the research is in developing intravenous drugs which requires significantly higher medical attention and increased rate of hospitalization wherein the chances of catching other infections is very high."

Dr. Khorakiwala further added, "In addition to the fast track review of its drug application, QIDP status also grants a 5 year extension to the drug patents in USA which is a major support for the commercial aspect of the drug. These drugs will be entering in their global Phase -3 clinical trials early next year."

Wockhardt started its Anti-infective program 17 years back in 1997 with single-minded focus on developing next generation antibiotics. Its new drug research pipeline targets some of the major infectious diseases which have limited cure available and has shown encouraging results for the same. Over the years it has significantly strengthened its new drug discovery R&D base and created strong clinical studies and regulatory team and infrastructure.

About Wockhardt:
Wockhardt is a highly technology intensive global pharmaceutical and biotechnology company. It's multi-disciplinary and innovative R&D programmes globally, are strongly focused on creating Intellectual Properties. It has 3 research centres globally and manufacturing facilities across India, USA, UK and Ireland. Wockhardt has a significant presence in USA, Europe and India, with 79% of its global revenues coming from international businesses. With a large pool of Patents and Intellectual Property knowhow, Wockhardt is home to 850 scientists, of whom 80 are doctorates. In all, Wockhardt has 284 Patents granted worldwide. In biotechnology research, it has built competent 'Concept to Market' capability in all facets of development and manufacture of recombinant biopharmaceuticals. Wockhardt boasts of a multi-ethnic workforce of more than 8,600 people from 21 different nationalities.

For more information, please visit www.Wockhardt.com

Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors.

Wockhardt Limited
Sunil Khera
Wockhardt USA LLC
20 Waterview Boulevard
3rd Floor, Parsippany
NJ 08827-1229 USA
Tel.: +1973-2574960
www.wockhardt.com

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