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U.S. FDA Grants QIDP Status for Wockhardt Anti-Infective Drug Discovery Program
Date:8/31/2014

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
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