Biocon gains over 2% after subsidiary gets USFDA approval for chronic heart failure drug

Biocon Ltd informed the stock exchanges in a filing that its wholly-owned subsidiary, Biocon Pharma Ltd, has received approval from the United States Food and Drug Administration (USFDA) for its ANDA for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths.

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The medicine is also used to treat paediatric patients over the age of one year.

After opening on a firm note, the pharma stock rose by 2.47% to hit a high of ₹368 per share on the NSE in morning deals. More than 29 lakh shares of the company changed hands on the bourse.

However, Biocon Ltd shares later pared some of the early gains to close 0.81% higher at ₹362 apiece on the NSE.

The stock hit a 52-week high of ₹376.80 per share on July 26, 2024. It is trading around 4%, down from the year-high levels. So far in 2024, Biocon shares have rallied around 42%, while in the past year, the stock has gained around 101%.

The company stated that Sacubitril's USFDA approval would add to its portfolio of vertically integrated, complex drug products.

The company last week informed the bourses that its global biosimilars subsidiary Biocon Biologics Ltd signed a settlement and license agreement with Janssen group to clear the way for the commercialization of its Bmab 1200, a proposed biosimilar to Stelara, in Europe, the United Kingdom (UK), Canada and Japan.

Under the settlement agreement, Biocon Biologics resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada and Japan.