Dr Reddy’s Laboratories to seek WHO pre-qualification on molnupiravir 

Drugmaker Dr Reddy’s Laboratories is pushing ahead with plans for Covid-19-linked products anti-viral molnupiravir and Russian vaccine Sputnik V.

The company will approach the World Health Organization for a pre-qualification that will pave the way for quicker adoption of molnupiravir, company officials said. Dr Reddy’s Laboratories has a tie-up with Merck (or Merck Sharpe Dohme, outside the US and Canada) on molnupiravir to sell in over 100 low and middle income countries.

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On safety concerns raised on the anti-viral, Deepak Sapra, CEO – API & Services, Dr Reddy’s Laboratories, said that regulatory authorities had approved the product with the necessary caution in place. Since the Omicron variant of the coronavirus was not resulting in high levels of hospitalisation, doctors were presently treating mild cases with a paracetamol, he said.

The company was however optimistic on the drug’s use and was seeking regulatory approvals in a handful of other countries, he added.

For adolescents

Responding to BusinessLine’s query on Sputnik M, Sapra said they had received data on the vaccine for adolescents (12 to 17 years) from Russia and were in the process of submitting data to the Indian regulator. A decision on a clinical trial for this age group would depend on guidance from the regulator.

Dr Reddy’s Laboratories has an alliance with the Russian Direct Investment Fund (RDIF) on bringing Sputnik V into India. Sapra said clinical trials on Sputnik Light (the first component of the two dose vaccine), now being seen as a universal booster, have been completed. He added that they were looking to be part of the government immunisation programme with the single dose vaccine.

On the heels of vaccines from Bharat Biotech and Serum Institute getting full market authorisation, Sapra indicated they too would seek similar approvals.

Q3 results

Earlier in the day, Dr Reddy’s Laboratories posted its financial results for the third quarter. It clocked a consolidated net profit of ₹707 crore for the quarter ended December 31, 2021, compared to ₹20 crore in the same period last year.

Consolidated revenues increased by 8 per cent to ₹5,320 crore during the quarter under review, against ₹4,930 crore in the same period last year.

On a sequential basis, however, consolidated net profit was down 29 per cent from ₹992 crore during the second quarter. Revenues also came down 8 per cent quarter-on-quarter from ₹5,763 crore during Q2 FY22.

This was due to higher Covid-related sales and proprietary product out-licencing deals in Q2 FY22, the company said.

G V Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, said in a statement the company continued to deliver a steady performance in the third quarter with healthy EBITDA and strong cash generation, while continuing to invest in building a pipeline of products across businesses.

The quarter’s growth in turnover was largely driven by the global generics and pharmaceutical services and active ingredients (PSAI) business.

The global generics segment grew 9 per cent at ₹4,451 crore (₹4,075 crore). However, sequentially it came down from ₹4,743 crore.

“The y-o-y growth of 9 per cent was primarily driven by new product launches and higher sales volume, offset partially due to price erosion in the base business. Sequential decline was due to lower volumes and price erosion in some of our products,” the company said.

The PSAI segment grew by four per cent y-o-y at ₹727 crore (₹701 crore).

“The y-o-y growth was driven majorly by new product launches. Sequential decline of 13 per cent on account of lower volumes of certain products including Covid-related products, offset partially due to new products launched,” Dr Reddy’s Laboratories said.

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