 "Biocon rallies 6%, hits record high on favourable ruling from US PTAB")
Shares of Biocon rallied 6 per cent to hit a record high of Rs 377 on the BSE on Monday after its partner Mylan received a favourable ruling from US Patent and Trademark Appeal Board (PTAB) on Sanofi’s four device patents for Lantus SoloSTAR. The stock surpassed its previous high of Rs 368 touched on April 20, 2020.
“Te U.S. Patent and Trademark Appeal Board (PTAB) ruled in favour of Mylan, Biocon’s partner in inter-partes review (IPR) proceedings, finding all challenged claims of Sanofi’s Lantus SoloSTAR device patents unpatentable,” Biocon said in its press release.
The PTAB found three claims of patent unpatentable, and two claims to be patentable. However, Mylan and Biocon previously obtained a covenant not to sue from Sanofi on the patent and therefore this ruling does not impact Biocon and Mylan’s ability to commercialise Semglee (Insulin Glargine) upon final approval from the US Food and Drug Administration (USFDA), it added.
“The favourable ruling strengthens our resolve to provide high-quality, affordable Insulin Glargine to diabetic patients in the US and generate savings for their healthcare system. Our partner’s New Drug Application (NDA) for Semglee is under active review by the US FDA and this favourable ruling further clears the path for the anticipated launch of our Glargine in the U.S. in mid-CY20,” said Dr. Christiane Hamacher, CEO and Managing Director, Biocon Biologics.
Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar. Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR).
Sanofi's total IQVIA sales for the 12 months ending 31 March 2020, were approximately $1.71 billion for Lantus 100 Units/mL and about $4.32 billion for Lantus SoloSTAR, it added.
“Te U.S. Patent and Trademark Appeal Board (PTAB) ruled in favour of Mylan, Biocon’s partner in inter-partes review (IPR) proceedings, finding all challenged claims of Sanofi’s Lantus SoloSTAR device patents unpatentable,” Biocon said in its press release.
The PTAB found three claims of patent unpatentable, and two claims to be patentable. However, Mylan and Biocon previously obtained a covenant not to sue from Sanofi on the patent and therefore this ruling does not impact Biocon and Mylan’s ability to commercialise Semglee (Insulin Glargine) upon final approval from the US Food and Drug Administration (USFDA), it added.
“The favourable ruling strengthens our resolve to provide high-quality, affordable Insulin Glargine to diabetic patients in the US and generate savings for their healthcare system. Our partner’s New Drug Application (NDA) for Semglee is under active review by the US FDA and this favourable ruling further clears the path for the anticipated launch of our Glargine in the U.S. in mid-CY20,” said Dr. Christiane Hamacher, CEO and Managing Director, Biocon Biologics.
Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar. Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR).
Sanofi's total IQVIA sales for the 12 months ending 31 March 2020, were approximately $1.71 billion for Lantus 100 Units/mL and about $4.32 billion for Lantus SoloSTAR, it added.
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