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Wockhardt gains as USFDA grants QIDP status to two drugs

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Capital Market
Last Updated : Sep 01 2014 | 12:45 PM IST

Wockhardt advanced 3.84% to Rs 717 at 11:21 IST on BSE after the company said that two of its anti-infective drugs have received Qualified Infectious Disease Product status from the US Food and Drug Administration.

Meanwhile, the BSE Sensex was up 203.93 points, or 0.77%, to 26,842.04

On BSE, so far 2.64 lakh shares were traded in the counter, compared with an average volume of 4.38 lakh shares in the past one quarter.

The stock hit a high of Rs 733.70 and a low of Rs 713.20 so far during the day. The stock hit a 52-week high of Rs 847.95 on 29 April 2014. The stock hit a 52-week low of Rs 336.60 on 16 December 2013.

The stock had underperformed the market over the past one month till 28 August 2014, falling 0.17% compared with 2.49% rise in the Sensex. The scrip had also underperformed the market in past one quarter, rising 7.53% as against Sensex's 8.48% rise.

The mid-cap company has an equity capital of Rs 55 crore. Face value per share is Rs 5.

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Wockhardt on Sunday, 31 August 2014 said that New Drug Discovery program in Anti-Infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the Qualified Infectious Disease Product (QIDP) Status from the US Food and Drug Administration (USFDA). This is the first instance of an Indian Pharmaceutical company receiving a QIDP status, Wockhardt said in a statement.

A 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 the Centre for Disease Control, USA - a top US government health and safety body. QIDP status allows for fast track review of the drug application by US FDA paving way for an early launch.

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, Wockhardt said.

Commenting on the achievement, Dr. Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt Ltd, said, Not only does the status allow for fast track review of our drug application, it 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.

On a consolidated basis, Wockhardt's net profit slumped 93.8% to Rs 19.95 crore on 27% decline in net sales to Rs 991.19 crore in Q1 June 2014 over Q1 June 2013.

Wockhardt is a global pharmaceutical and biotechnology organisation, providing affordable, highly quality medicines for a healthier world. It is India's leading research-based global healthcare enterprise with relevance in the fields of Pharmaceuticals, Biotechnology and a chain of advanced Super Speciality Hospitals. Wockhardt has 3 research centres and 12 manufacturing plants, with businesses ranging from the manufacture and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APls) and Vaccine.

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First Published: Sep 01 2014 | 11:28 AM IST

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