|By PR Newswire||
|August 31, 2014 09:56 PM EDT||
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.
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
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 USA LLC
20 Waterview Boulevard
3rd Floor, Parsippany
NJ 08827-1229 USA
High-performing enterprise Software Quality Assurance (SQA) teams validate systems that are ready for use - getting most actively involved as components integrate and form complete systems. These teams catch and report on defects, making sure the customer gets the best software possible. SQA teams have leveraged automation and virtualization to execute more thorough testing in less time - bringing Dev and Ops together, ensuring production readiness. Does the emergence of DevOps mean the end of E...
Nov. 27, 2014 05:00 AM EST Reads: 1,190
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 27, 2014 04:00 AM EST Reads: 1,007
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
Nov. 27, 2014 04:00 AM EST Reads: 1,048
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Nov. 26, 2014 11:45 PM EST Reads: 1,140
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...
Nov. 26, 2014 11:30 PM EST Reads: 1,023
The Internet of Things will put IT to its ultimate test by creating infinite new opportunities to digitize products and services, generate and analyze new data to improve customer satisfaction, and discover new ways to gain a competitive advantage across nearly every industry. In order to help corporate business units to capitalize on the rapidly evolving IoT opportunities, IT must stand up to a new set of challenges. In his session at @ThingsExpo, Jeff Kaplan, Managing Director of THINKstrateg...
Nov. 26, 2014 09:00 PM EST Reads: 1,073
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water,...
Nov. 26, 2014 06:00 PM EST Reads: 1,062
DevOps is all about agility. However, you don't want to be on a high-speed bus to nowhere. The right DevOps approach controls velocity with a tight feedback loop that not only consists of operational data but also incorporates business context. With a business context in the decision making, the right business priorities are incorporated, which results in a higher value creation. In his session at DevOps Summit, Todd Rader, Solutions Architect at AppDynamics, discussed key monitoring techniques...
Nov. 26, 2014 04:45 PM EST Reads: 744
Want to enable self-service provisioning of application environments in minutes that mirror production? Can you automatically provide rich data with code-level detail back to the developers when issues occur in production? In his session at DevOps Summit, David Tesar, Microsoft Technical Evangelist on Microsoft Azure and DevOps, will discuss how to accomplish this and more utilizing technologies such as Microsoft Azure, Visual Studio online, and Application Insights in this demo-heavy session.
Nov. 26, 2014 04:45 PM EST Reads: 754
When an enterprise builds a hybrid IaaS cloud connecting its data center to one or more public clouds, security is often a major topic along with the other challenges involved. Security is closely intertwined with the networking choices made for the hybrid cloud. Traditional networking approaches for building a hybrid cloud try to kludge together the enterprise infrastructure with the public cloud. Consequently this approach requires risky, deep "surgery" including changes to firewalls, subnets...
Nov. 26, 2014 04:45 PM EST Reads: 740
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!
Nov. 26, 2014 04:00 PM EST Reads: 1,099
One of the biggest challenges when developing connected devices is identifying user value and delivering it through successful user experiences. In his session at Internet of @ThingsExpo, Mike Kuniavsky, Principal Scientist, Innovation Services at PARC, described an IoT-specific approach to user experience design that combines approaches from interaction design, industrial design and service design to create experiences that go beyond simple connected gadgets to create lasting, multi-device exp...
Nov. 26, 2014 03:45 PM EST Reads: 1,051
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...
Nov. 26, 2014 02:00 PM EST Reads: 1,512
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
Nov. 25, 2014 09:30 PM EST Reads: 1,266
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series dat...
Nov. 25, 2014 09:30 PM EST Reads: 1,327