Wockhardt Limited has announced 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.