 "USFDA, drug maker, drugs, medicines")
Shares of Strides Pharma Science hit a 52-week high of Rs 538.65 as they rallied 8 per cent on the BSE in Monday's intraday trade after its subsidiary Strides Pharma Global Pte., Singapore received the United States Food & Drug Administration's (USFDA's) approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram.
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. The product complements Strides' range of approved soft gelatin capsules. The Icosapent Ethyl Capsules has a market size of around $1.3 billion per IQVIA.
Strides said the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin. The product will be manufactured at the company’s facility in Bengaluru.
"We have 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which over 230 ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US," it said in an exchange filing.
Meanwhile, the board of directors of Strides Pharma is scheduled to meet on September 25, 2023 to consider the combine Contract Development and Manufacturing Organisation (CDMO) interests of the group to become one of India’s top specialty pharmaceuticals CDMOs.
In the past five weeks, the stock of the pharmaceutical company has soared 30 per cent. Further, thus far in the calendar year 2023, it has zoomed 54 per cent as compared to 8 per cent rise in the S&P BSE Sensex.
Separately, Strides Pharma Global Pte Ltd Singapore received tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV early this month. Dolutegravir tablets belong to a class of medication knows as antiretrovirals. This medication is the first line of antiretroval therapy (ART) for treatment naïve patients. It works by preventing the multiplication of the virus in human cells.
Strides Pharma Global Pte Ltd Singapore has also received approval from the USFDA for its generic Sevelamer Carbonate for oral suspension indicated for patients with chronic kidney disease on dialysis to prevent dangerous increases in phosphates. The approval by the USFDA is for Sevelamer Carbonate for oral suspension of strengths 0.8g and 2.4g, Strides Pharma Science had said in a regulatory filing.
As regards to Stelis, from a business standpoint, the company received an encouraging regulatory outcome from the European Medicines Agency (EMA) and USFDA, propelling its business development efforts forward.
"While significant order wins have been concluded, the CDMO business' on boarding process takes longer. The new business would generate operating cash flow; however, revenue recognition will follow operational milestones and become consistent only after commercial supplies pick up. Consequently, in 12 to 18 months, Stelis anticipates a positive operating margin and sufficient cash flow to meet its obligations from CSA-driven revenue growth," Strides said in its FY23 annual report.
