Cipla surges 5% on USFDA approval for dimethyl fumarate DR capsules

The drug, indicated for treatment of relapsing forms of multiple sclerosis, had annual US sales of US$3.8 billion as per IQVIA MAT July 2020.

Shares of Cipla surged 5 per cent to Rs 772 on the BSE in the intra-day trade on Friday after the company said it has received US Food & Drug Administration (USFDA) approval for the generic version of Biogens Tecfidera (Dimethyl Fumarate) DR capsules in the US.

The drug, indicated for the treatment of relapsing forms of multiple sclerosis, had annual US sales of US$3.8 billion as per IQVIA MAT July 2020.

“Cipla’s Dimethyl Fumarate DR capsules 120mg, 240mg, and 120mg/240mg Starter Pak is AB-rated generic therapeutic equivalent version of Biogen IDEC Inc.’s Tecfidera,” the company said in a regulatory filing.

It is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, the company said.

Meanwhile, Cipla's shares hit a record high of Rs 819 on September 18, 2020, after Perrigo announced that it would recall its gProAir (Albuterol) MDI inhaler from the US market due to a potential defect in the inhalers. Perrigo’s gProAir sales were $73 million in 2QCY20.

“Cipla had acquired approval for its gProventil (Albuterol) product in April 2020. As per our initial estimates, we had expected Cipla to record USD50–60m annual sales for gProventil. With the disruption to Perrigo’s sales, we estimate an additional $15–20 million in Albuterol sales for Cipla in the US,” Motilal Oswal Securities said in a report. The brokerage firm has a target price of Rs 790 on the stock.

At 12:54 pm, Cipla was trading 4.5 per cent higher at Rs 766 on the BSE, as compared to a 1.82 per cent rise in the S&P BSE Sensex.