Strides Pharma surges 10% on USFDA's approval for Icosapent Ethyl capsules

Shares of Strides Pharma Science Ltd surged as much as 10% to hit a 52-week high of ₹549 on September 25 after the company received approval from the United States Food & Drug Administration (USFDA) for icosapent ethyl capsules.

The share price of Strides Pharma opened higher at ₹516.10 on Monday, up 0.19%, as against the closing price of the previous session at ₹498.65. During the session, the company’s market capitalisation stood at ₹4,793.06 crore, with more than 1.40 lakh shares exchanging hands on the BSE, as against the two-week average of 0.75 lakh shares. In the past one month, three months and one year, the company has given 20.73%, 28.7% and 65.2% in returns, respectively. The scrip closed 9.90% higher at ₹548. At present, the company's share price is trading 104.17% higher than the 52-week low of ₹268.40, which the company touched on March 21 this year.

According to the company, Strides Pharma Global Pte Limited, Singapore, which is a wholly-owned subsidiary of Strides Pharma, has received approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram, from the USFDA.  

“The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin®. The Icosapent Ethyl Capsules have a market size of $1.3Bn per IQVIA. The product will be manufactured at the Company’s facility in Bengaluru. The Company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The Company has set a target to launch ~ 60 new products over three years in the US,” says Strides Pharma.

Icosapent Ethyl Capsule is a prescription medication used in conjunction with other medicines like statins to reduce the risk of heart attack, stroke and heart issues in those afflicted with cardiovascular disease.

Earlier this month, the company received tentative USFDA approval for its new drug application (NDA) 505b2 of Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets.

Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets is a complete regimen for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.

The company also received approval from USFDA for Sevelamer Carbonate for Oral Suspension USP, 0.8gm and 2.4 gm this month. Sevelamer Carbonate for Oral Suspension is a medication used to manage elevated phosphate levels in the blood of patients with chronic kidney disease.  According to the company, the Sevelamer Carbonate market for tablets and oral suspension has a combined opportunity of ~$ 212 million per IQVIA.