Why was Cipla the top Nifty gainer? Here are the reasons
Drugmaker Cipla has received final approval for its Lanreotide injection from the United States Food and Drug Administration (US FDA).
The FDA approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. Lanreotide injection is supplied in 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL single-dose prefilled syringes. It is used for treating patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs).
“We are pleased to receive the final approval for Lanreotide injection from the US FDA. Enabling access to high-quality treatments is core to our purpose of “Caring for Life”. This approval is a significant step for our US business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs,” said Umang Vohra (MD and Global CEO, Cipla Limited).
The active ingredient, route of administration and strengths are the same as SOMATULINE DEPOT, from Ipsen Biopharmaceuticals Inc. According to IQVIA, SOMATULINE DEPOT had US sales of approximately USD 867 million for the 12 months ending October 2021.
Global brokerage Nomura report stated, “The approval is a positive surprise and is not factored explicitly into our earnings estimates. Further, being an early-mover, Cipla is likely to gain a healthy market share over the next 12 months. The annual sales for CIPLA could be USD 50-75 million. The firm said that assuming a gross margin of 60-65 per cent, the net earnings contribution from the development could be in the range of USD 25-35 million, translating into earnings per share of Rs 2.4-3.10."
Cipla opened at Rs 864, up by 1 per cent from the previous close and ended Monday's trading session at Rs 892.15, up by 3.71 per cent up.