Shares of Natco Pharma jumped 20 per cent on Monday after the drug maker said it has received approval from the US health regulator for the generic version of an anti-cancer drug and began Phase III clinical trials of Molnupiravir capsules for treatment of the patients of coronavirus disease (Covid-19). Natco Pharma shares surged to ₹1,188.95 in a new high on BSE in intraday trade on Monday.
Natco Pharma's stock was trading at ₹1,089.95, up ₹99.15 or 10.42 per cent at 11:05am on BSE. It touched a 52-week high of ₹1,188.95 and an intraday high of ₹1,188.95 and an intraday low of ₹1,087.80.
On Saturday, the Hyderabad-based firm said it has received approval from the US health regulator for generic Lenalidomide capsules indicated for treatment of adults with multiple myeloma, mantle cell lymphoma and myelodysplastic syndromes. Natco Pharma said in a regulatory filing it has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lenalidomide capsules in 5mg, 10mg, 15mg, and 25mg strengths, and tentative approval for the capsules in strengths of 2.5 mg and 20 mg.
In another filing, Natco Pharma said its marketing partner Breckenridge Pharmaceutical Inc has received final approval for its ANDA for Everolimus tablets from the US health regulator. The company said that Breckenridge Pharmaceutical Inc plans to launch the tablets in strengths of 0.25mg, 0.5mg and 0.75mg shortly. These strengths of Everolimus are indicated in the prophylaxis of organ rejection in kidney and liver transplants, Natco Pharma added.
{{/usCountry}}In another filing, Natco Pharma said its marketing partner Breckenridge Pharmaceutical Inc has received final approval for its ANDA for Everolimus tablets from the US health regulator. The company said that Breckenridge Pharmaceutical Inc plans to launch the tablets in strengths of 0.25mg, 0.5mg and 0.75mg shortly. These strengths of Everolimus are indicated in the prophylaxis of organ rejection in kidney and liver transplants, Natco Pharma added.
{{/usCountry}}The company said on Friday it has initiated phase-III clinical trials of Molnupiravir capsules to evaluate its efficacy in treating patients with mild Covid-19. Natco Pharma said the first dose under the phase-III trials was given to a patient in the city-based Yashoda Hospitals. The clinical trial is planned in 32 hospitals across the country. "Phase-III clinical trial is initiated to evaluate the efficacy and safety of Molnupiravir capsules in mild COVID-19 patients," Natco Pharma said in a regulatory filing.
Pre-clinical data has shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of Sars-CoV-2 replication, the firm said. Patients treated with Molnupiravir achieved response within five days of therapy, indicating that the duration of treatment with the drug is short, with the additional advantage of it being an oral therapy, it added.
(With agency inputs)