Biocon had good news to share but the overall bearish mood on the markets, kept the stock in the red. In fact the stock has been losing for the past two days, falling almost 8% and today, it hit an intraday low at Rs.276.25, going down 7%.
The company announced yesterday that a US court ruling has invalidated a Sanofi patent on the Insulin Glargine device, removing a key legal hurdle to commercializing Semglee (Insulin Glargine) co-developed with Mylan, in the US.
The US District Court of New Jersey found the device patent claims asserted by Sanofi against Biocon and Mylan's Insulin Glargine product 'not infringed' and 'invalid' for lack of written description.
The 505(b)(2) New Drug Application (NDA) for Semglee is under active review by the
US Food and Drug Administration (FDA). The FDA has set a Target Action Date for our Insulin Glargine application in June 2020.
Biocon remains confident of being able to commercialize the product in the calendar year 2020. The market opportunity for Insulin Glargine in the US is estimated at US$ 2.2 bn.
Biocon's Insulin Glargine has received regulatory approval in 70 countries around the world and has also been commercialized in many emerging markets such as Brazil, Mexico, Malaysia, South Korea, UAE, as well as, developed markets like Japan, Australia and parts of Europe.