Welcome!

News Feed Item

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

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.

Wockhardt

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
Every successful software product evolves from an idea to an enterprise system. Notably, the same way is passed by the product owner's company. In his session at 20th Cloud Expo, Oleg Lola, CEO of MobiDev, will provide a generalized overview of the evolution of a software product, the product owner, the needs that arise at various stages of this process, and the value brought by a software development partner to the product owner as a response to these needs.
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
While some vendors scramble to create and sell you a fancy solution for monitoring your spanking new Amazon Lambdas, hear how you can do it on the cheap using just built-in Java APIs yourself. By exploiting a little-known fact that Lambdas aren’t exactly single threaded, you can effectively identify hot spots in your serverless code. In his session at 20th Cloud Expo, David Martin, Principal Product Owner at CA Technologies, will give a live demonstration and code walkthrough, showing how to ov...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that Tappest will exhibit MooseFS at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. MooseFS is a breakthrough concept in the storage industry. It allows you to secure stored data with either duplication or erasure coding using any server. The newest – 4.0 version of the software enables users to maintain the redundancy level with even 50% less hard drive space required. The software func...
SYS-CON Events announced today that Outscale will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outscale's technology makes an automated and adaptable Cloud available to businesses, supporting them in the most complex IT projects while controlling their operational aspects. You boost your IT infrastructure's reactivity, with request responses that only take a few seconds.
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
SYS-CON Events announced today that EARP will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "We are a software house, so we perfectly understand challenges that other software houses face in their projects. We can augment a team, that will work with the same standards and processes as our partners' internal teams. Our teams will deliver the same quality within the required time and budget just as our partn...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory?
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software in the hope of capturing value in IoT. Although IoT is relatively new in the market, it has already gone through many promotional terms such as IoE, IoX, SDX, Edge/Fog, Mist Compute, etc. Ultimately, irrespective of the name, it is about deriving value from independent software assets participating in an ecosystem as one comprehensive solution.
SYS-CON Events announced today that A&I Solutions has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 1999, A&I Solutions is a leading information technology (IT) software and services provider focusing on best-in-class enterprise solutions. By partnering with industry leaders in technology, A&I assures customers high performance levels across all IT environments including: mai...