Two new drugs, WCK 2349 and WCK 771, developed by Mumbai based pharmaceutical company Wockhardt Ltd , received the US Food and Drug Administration's (FDA) approval on Sunday, making them the first Indian drug makers to get an assent for drugs created by their research.
The two drugs developed by Wockhardt have received the Qualified Infectious disease Product (QIDP) status from the FDA, which provided quite a boost to their stocks on Monday. The two drugs created by the Mumbai based pharmaceutical firm are intended to cure infections.
The new QIDP status extends Wockhardt's drug patents in the US by five years, giving a huge support to the commercialization of the two drugs. Additionally, this status allows the pharmaceutical company to fast-track the review of all of their drug applications in the US, giving them a considerable edge over other Indian drug manufacturers.
"These drugs will be entering their global Phase-3 clinical trials early next year," Habil Khorakiwala, Wockhardt group CEO (Chief Executive Officer) and founder chairman, told Mint.
As a result of this Wockhardt's shares experienced a 6.2 percent increase in trading, when markets opened on Monday. Wockhardt started trading 4.5 per cent higher, at 9.30 am at the rate of ₹721.75, according to The Economic Times. The pharmaceutical firm hit a low of ₹716.45, while getting to the highest point of ₹733.70, before stabilizing itself at around the ₹715 mark.
Compared to last week, the drug makers seem to have jumped back, after experiencing a fall since Thursday and Friday. The stock closed at ₹690.50 on Friday.
There is currently a fairly large deficiency of anti-infection drugs in the global market. The drugs that have a huge need in the global market, and can act against harmful pathogens are given the QIDP status by the FDA. This criterion is determined by the US Centres for Disease control (CDC), a government organization that monitors health and safety in the country.