Strides soars 11% on USFDA's tentative nod to generic HIV treatment drug

The company said it received a tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV

Shares of Strides Pharma Science hit a 52-week high of Rs 522.20, soaring 11 per cent on the BSE in Friday's intraday trade, after the company received a tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV.

In an exchange filing, Strides Pharma said after market hours on Thursday that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA). The Dolutegravir 50mg tablet has a market opportunity in the US of around $ 1,345 million as per IQVIA.
 

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.

"The Abbreviated New Drug Application (ANDA) is tentatively approved under USFDA's expedited review provision for the President's Emergency Plan for AIDS Relief, thereby qualifying the company to participate in global donor-funded programmes that procure this lifesaving medicine,: it said.

This product further strengthens the available offerings in HIV treatment from Strides, the company said.

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company. The approval adds to a list of products that Strides has approved under the PEPFAR pathway taking the total to 13 products.

At 10:49 AM, Strides was trading 9 per cent higher at Rs 508.35, as compared to 0.22 per cent rise in the S&P BSE Sensex. It surpassed its previous high of Rs 490 touched on September 8, 2023. Trading volumes on the counter jumped over five-fold today with a combined 4.4 million equity shares having changed hands on the NSE and BSE till the time of writing of this report.

Strides, a global pharmaceutical company, specialises in developing and manufacturing niche finished dosage formulations. The company’s product portfolio encompasses a range of technically complex pharmaceutical products, including liquids, creams, ointments, soft gels, sachets, tablets, and modified-release dosage formats.

Thus far in the financial year 2023-24 (FY24), the stock price of Strides has zoomed 82 per cent.

With further resetting of the existing businesses and accomplishing all the works that commenced at the beginning of the year, the company said it's building momentum for its businesses in FY 2023-24.

"The company is confident of increasing its Ebitda from current levels and intends to achieve net debt to Ebitda ratio of less than 3x. Key focus shall remain on manufacturing network optimisation, new product launches and market expansion. The company shall also continue to work on various cost improvement programs," Strides said in its FY23 annual report.