Diabetes drug major USV eyes niche therapies abroad, targets Rs 50 bn sales

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USV, the country's largest manufacturer of oral anti-diabetes drugs, is stepping up focus on biosimilars and niche low-competition products in Europe and the US, as it looks for new growth opportunities to achieve Rs 50 billion (Rs 5,000 crore) revenue in the next five years. It would have an estimated Rs 30 billion (Rs 3,000 crore) turnover for the current financial year.

Privately-held USV earns around 80 per cent of its revenue from domestic market. Of this, about 40 per cent comes from diabetes portfolio which includes top selling Glycomet GP, India's third most valued drug brand at Rs 4 billion (Rs 400 crore) annual sales. Cardiovascular is another key segment. These two therapies contribute 80 per cent to its domestic business.

Last month the European Medical Agency accepted for review USV's application for biosimilar Pegfilgrastim, which is a copy of Amgen's $4 billion anti-cancer drug Neulasta. The company is also participating in public health tenders in Germany while in the US its focus is on niche low competition products.

“In the US market we do about $25 million of net sales. So that will grow since we have two three important products. We will take Pegfilgrastim to the US as well,” said Prashant Tewari, managing director of USV.

Mumbai based company promoted by V B Gandhi began manufacturing in India in 1960 as a joint venture with the US based drug maker US Vitamins & Pharmaceuticals Inc. In 1986 the Gandhi family took full control of the company following the exit of its American partner. Leena Gandhi Tewari, grand daughter of its founder promoter V B Gandhi is company's chairman.

USV made a foray in diabetes drugs from its early days and this first-mover advantage has allowed the company to establish a leadership position in the Rs 80 billion oral diabetes drugs segment ahead of larger companies including Sun Pharmaceutical Industries, MSD, Novartis, Lupin and others.

But now the company is looking for growth beyond its core segments to de-risk its sales and improve profit.

"We started early and remained focused," Tewari said. The company's legacy diabetes drugs still continue to drive growth. "These legacy drugs gave us 9-10 per cent unit growth. That's a solid growth as volumes are large," Tewari said. Along with its legacy products the company's portfolio also includes proprietary drugs like Vildagliptin which it sells under licence from Novartis.

Company is targeting the new growth areas to further accelerate its growth for achieving Rs 50 billion (Rs 5,000 crore) revenue target in the next five years. With these efforts, Tewari expects share of its overseas business to grow to 25 per cent in the next five years from current 20 per cent.

But much of the growth will be dependent on regulatory compliance and approval for biosimilar drugs which USV is developing for European and US markets. Last March the US Food and Drug Administration (USFDA) slapped a warning letter on the company's Daman plant for good manufacturing practices violations.

“Remediation has been done from our side. We had re-inspection, and in our view it was very good. Now we are awaiting a feedback. We have 24 abbreviated new drug applications (ANDAs) filed in the US and seven are approved which are only awaiting facility clearance,” he said.

Tewari said all the research and development expenses are being funded through internal accruals and the company had no share sale plans.