Navigation Links
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 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

Logo - http://photos.prnewswire.com/prnh/20120615/NY25710LOGO


'/>"/>
SOURCE Wockhardt
Copyright©2014 PR Newswire.
All rights reserved

Related biology technology :

1. Free Job Training: 55 Grants Available to Retrain Workers for Biofuels Industry
2. Elsevier Foundation Awards 2011 Grants to Advance Women in Science and Support Libraries in Developing Countries
3. Maryland Stem Cell Research Commission Announces New Program for Pre-Clinical and Clinical Research Grants
4. NSF CAREER grants support ocean energy, microforming, computer planning
5. Heptares Grants Shire an Exclusive Worldwide Licence to Develop and Commercialise Novel Drug Candidate for CNS Disorders
6. FDA Grants Lexicon Orphan Drug Designation for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
7. Enox Biopharma, Inc. Grants TTA LTD License To Wound Care Applications
8. USPTO Grants Butamax a Further KARI Enzyme Patent
9. The Leukemia & Lymphoma Society Awards $12 Million in Research Grants in Four Critical Areas of Unmet Medical Need
10. Symphogen Grants Exclusive Worldwide License of Phase II Oncology Drug Candidate Sym004 to Merck KGaA
11. SomaGenics Announces Issue of Key Patent for Its sshRNA Technology and Receipt of Two New Small Business Innovation NIH Grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... OTTAWA, ON (PRWEB) , ... June 23, 2016 , ... ... former DNA Technical Leader at the Arkansas State Crime Laboratory, has joined STACS DNA ... joining the STACS DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. ...
(Date:6/23/2016)... , June 23, 2016 Apellis Pharmaceuticals, ... 1 clinical trials of its complement C3 inhibitor, ... and multiple ascending dose studies designed to assess ... of subcutaneous injection in healthy adult volunteers. ... either as a single dose (ranging from 45 ...
(Date:6/23/2016)... June 23, 2016 ... 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 Published recently ... peer-reviewed journal from touchONCOLOGY, Andrew D Zelenetz ... of cancer care is placing an increasing burden ... expensive biologic therapies. With the patents on many ...
(Date:6/23/2016)... ... June 23, 2016 , ... ClinCapture, ... Pennsylvania Convention Center and will showcase its product’s latest features from June 26 ... presenting a scientific poster on Disrupting Clinical Trials in The Cloud during the ...
Breaking Biology Technology:
(Date:6/2/2016)... 2, 2016   The Weather Company , an IBM ... an industry-first capability in which consumers will be able to ... ask questions via voice or text and receive relevant information ... Marketers have long sought an advertising solution that ... be personal, relevant and valuable; and can scale across millions ...
(Date:5/24/2016)... 2016 Ampronix facilitates superior patient care by providing unparalleled technology to leaders ... is the latest premium product recently added to the range of products distributed by ... ... ... LCD Medical Display- Ampronix News ...
(Date:5/12/2016)... WearablesResearch.com , a brand of Troubadour ... from the Q1 wave of its quarterly wearables survey. ... receptivity to a program where they would receive discounts ... company. "We were surprised to see that ... LaColla , CEO of Troubadour Research, "primarily because there ...
Breaking Biology News(10 mins):