Natco Pharma surges 20%, hits new high on USFDA nod for cancer drug

Shares of Natco Pharma surged 20 per cent to Rs 1,188.95, also its new high, on the BSE in intra-day trade on Monday after the company said it has received approval from the US health regulator for the generic version of Celgene's multiple myeloma drug, Revlimid (Lenalidomide) capsules in US. Lenalidomide capsule is indicated for treatment of adults with multiple myeloma, mantle cell lymphoma and myelodysplastic syndromes.

In the past three days, the stock has zoomed 30 per cent. At 09:48 am, Natco Pharma was trading 11 per cent higher at Rs 1,101 on the BSE, as compared to 0.24 per cent rise in the S&P BSE Sensex. The trading volumes on the counter jumped over five-fold with a combined 3.8 million equity shares changing hands on the NSE and BSE.

“The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lenalidomide capsules in 5 mg, 10 mg, 15 mg, and 25 mg strengths, and tentative approval for the capsules in strengths of 2.5 mg and 20 mg”, Natco Pharma said in a regulatory filing.

Natco, along with its marketing partner Arrow (Teva's affiliate), has already settled the Para IV litigation with Celgene in December 2015. Natco and Arrow shall launch the product on agreed-upon launch dates in the future.

In a separate regulatory filing, Natco Pharma said that its marketing partner, Breckenridge Pharmaceutical Inc (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus tablets (generic for Zortress), from the USFDA. 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, it said.

Meanwhile, Natco also said the company has initiated Phase-III clinical trial of Molnupiravir capsules in India. Pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication. Patients treated with Molnupiravir achieved response within 5 days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.

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. A few established hospitals locally include Yashoda Hospitals, Gleneagles Global Hospitals, KIMS Hospital in Secunderabad and Vizag, and Excel Hospital, where the trial is being conducted, it said.