Biocon Ltd , India’s largest biotechnology company, said it will introduce a drug to treat the skin disease psoriasis later this year after obtaining regulatory clearances from the Drugs Controller General of India (DCGI).
The drug will be launched in the second quarter (July-September) and the company expects it to add revenue of Rs.100 crore in the next four years, said Kiran Mazumdar-Shaw, chairman and managing director of Biocon.
“Alzumab has been developed at a little less than Rs.100 crore and we hope to recoup that investment in the next four years”, she said.
The DCGI approval came after a 52-week phase-III study conducted in India. The global market for psoriasis treatment is estimated to almost double to $7.4 billion in 2020 from $3.9 billion in 2010, according to a 2011 study by Decision Resources, a US-based consultant.
Having received a marketing licence from DCGI, the company will seek to acquire a manufacturing licence in India, Shaw said. The drug will be produced at its manufacturing facility in Bangalore.
The company is also scouting for a partner in the US to undertake clinical trials and sell the product globally, she said.
Biocon has completed the second part of the phase-III clinical trials for its biosimilar insulin in the European Union. (A phase-III trial involves testing effectiveness of the drug on large groups of people, usually 1,000-3000 people.)
The firm will now prepare and submit a dossier and the product should be ready in another two years, Shaw said. “We continue to gain market share for biosimilar insulins in rest of world markets which now account for a significant part of our business,” she said.
The company has also signed an option agreement with Bristol-Myers Squibb Co. for insulin products. This allows Bristol-Myers Squibb the right to exercise an option for an exclusive worldwide licence after the completion of the clinical trials.
Commenting on December quarter earnings, Shaw said the company has seen strong growth in both revenue and net profit. Biocon reported profit rose 8% to Rs.260 crore in the quarter ended December from a year earlier. Revenue rose 23% to Rs.1,899 crore.
“We have very little licensing income this quarter, and, therefore, the results show that our core business is very strong,” she said. The company has done well despite an increase in research and development investment, a hike in power procurement, and an increase in the cost of raw materials, she said.
Growth in profit and revenue accelerated from 5% and 18%, respectively, in the September quarter.
The Indian biotech industry generates $4 billion of revenue annually, with Biocon accounting for about half a billion dollars of that. The industry is expected to grow to $11 billion by 2017.
While the biopharma division generated Rs.409 crore, research services and branded formulations generated Rs.140 crore and Rs.86 crore, respectively, in this quarter.
The company has performed well across businesses, with the biopharma segment, which comprises 60% of revenue, growing at a healthy 33%, said Harith Ahamed, analyst at Spark Capital Advisors (India) Pvt Ltd.
“This is impressive since licensing income in this quarter is also negligible. Overall, Biocon has done slightly better than expected,” he said. He also said that margins, which had shown a decline in the previous two quarters, improved during the quarter.