The share price of Natco Pharma rallied 20 percent to hit a 52-week high of Rs 1,188.95 apiece after the Drug Controller General of India (DCGI) approved the application of five companies including Natco to begin production of antifungal drug Amphotericin B liposomal injection, used for the treatment of Mucormycosis, also called 'Black Fungus'.
Natco Pharma on May 21 said that it has initiated phase-III clinical trials of Molnupiravir capsules in India. It said that the first patient was dosed in Yashoda Hospitals, Hyderabad.
"Phase-III clinical trial is initiated to evaluate the efficacy and safety of Molnupiravir capsules in mild COVID-19 patients. Natco’s clinical trial is planned in 32 hospitals across India," Natco Pharma said in a regulatory filing.
The company has also received final approval from the US Food and Drug Administration (US FDA) for abbreviated new drug applications (ANDA) for anti-cancer drug Lenalidomide capsule.
"Natco, along with its marketing partner Arrow International Limited (a U.S. affiliate of Teva Pharmaceutical Industries Ltd), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand-name REVLIMID®," the company said.
Natco and Arrow shall launch the product on agreed-upon launch dates in the future, it said.
In a separate release, Natco said its marketing partner, Breckenridge Pharmaceutical Inc (BPI), has received final approval for its ANDA for Everolimus tablets (generic for Zortress), from the regulator.
BPI plans to launch 0.25mg, 0.5mg and 0.75mg strengths of the product shortly, which are indicated in the prophylaxis of organ rejection in kidney transplantation and liver transplantation.
As per industry sales data, Zortress and its therapeutic equivalents had generated annual sales of $162 million during the twelve months ending March 2021 in the US, Natco said.
At 10:45 am, the stock was trading 9.92 percent higher at Rs 1,089.05 apiece on the BSE.