Biocon and Mylan have won patent litigation asserted by Sanofi for insulin glargine device patent in the US.
Biocon announced on Wednesday (11 March) that it has won a US court ruling that invalidated a Sanofi India 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 India against Biocon & Mylan's Insulin Glargine product 'not infringed' and 'invalid' for lack of written description. Separately, Sanofi India's formulation patents were previously affirmed to be invalid by the Federal Circuit, it added.
The New Drug Application (NDA) for Semglee is under active review by the US Food and Drug Administration (USFDA). 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 calendar year 2020. The market opportunity for Insulin Glargine in the US is estimated at $2.2 billion.
Dr Christiane Hamacher, the CEO of Biocon Biologics, has said that, "We are extremely pleased with the U.S. court ruling in favour of our Insulin Glargine device as this takes us closer towards bringing a more affordable Insulin Glargine for patients with diabetes in the U.S. Today, patients in parts of Europe, Australia, India and key emerging markets are already benefiting from our Insulin Glargine. Once approved and commercialized our Semglee will expand access to this therapy. This patent win endorses our commitment to innovation and value creation through incisive IP strategy. Biocon Biologics remains committed to use its science, scale and expertise to shift the access paradigm for patients in need of insulins across the globe."
Insulin Glargine is a long-acting insulin used to treat adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes for the control of high blood sugar.
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.
In October 2017, Sanofi had initiated patent infringement litigation against Biocon's NDA in the US District Court for the District of New Jersey that included the formulation patents covering Insulin Glargine as well as patent covering the Insulin Glargine injection pen, triggering a 30-month stay on the product's approval.
Shares of Biocon dropped 5.84% to Rs 279.10. The scrip traded in the range of Rs 277 to Rs 296 so far.
On a consolidated basis, net profit fell 6.6% to Rs 202.80 crore in Q3 December 2019 (Q3 FY20) from Rs 217.20 crore in Q3 December 2018 (Q3 FY19), due to higher R&D expenses and tax impact of an exceptional item. Profit before tax (PBT) stood at Rs 315.10 in Q3 FY20, up by 8.9% from Rs 289.30 crore in Q3 FY19.
Biocon is an innovation-led global bio-pharmaceuticals company.
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