Company will seek approvals, look for partners for launch overseas

Pharma major Zydus Cadila is set to launch a niche dual-action drug that can lower both blood sugar and cholesterol levels.

Saroglitazar, sold as Lipalyn, is the first in its class of drugs called glitazars, besides being the first indigenously-developed drug, said Zydus Cadila Chairman and Managing Director Pankaj R. Patel, giving details of the drug and its 12-year research journey. The drug is slated for launch between October and December, but the company did not disclose the price.

A once-daily oral therapy that controls cholesterol and blood sugar, the drug also has a good safety profile, Patel said, adding that it showed no liver or kidney toxicity, besides being safe for the heart.

On the Indian pharmaceutical industry’s research calibre, he said, “Yes, India can do it. …Drugs will be discovered in the East and the West will benefit out of it.”

Dedicating the drug-discovery break-through to Indian research scientists, he said, the company would now set about getting global approvals in the emerging and developed markets, a process that could take between three and five years. This would include clinical trials overseas. When the product is close to approval, Zydus will look for a marketing partner in the global markets, he said.

Before the local launch, the drug had been tested through human trials in about 50 locations across the country, in about 1,000 patients. In fact, the Rs 6,300-crore Zydus plans to launch two more similar drugs in the market by 2020.

Global trials

Drug development of the new compound cost the company about $250 million and another $150 million will be spent on global trials, he added.

The drug treats diabetic dyslipidemia in type-II diabetes, when the illness develops later in life. Of the 350-million odd people across the world with diabetes, a large section also suffers from high cholesterol, said Sharvil P. Patel, Deputy Managing Director.

The company has set itself a revenue target of $3 billion by 2015, and , has a research pipeline of about nine molecules targeting diabetes, renal therapy and rabies, said Ganesh Nayak,Executive Director and Chief Operating Officer.

Explaining the importance of the drug, Shashank Joshi, endocrinologist with Mumbai’s Lilavati Hospital said that the medicine was an add-on to the existing medicines to treat diabetes.

The effort to bring out a new diabetes drug for the Indian population by an Indian company is commendable. But its heart-related outcome needs to be evaluated in the long run, he added. Glitazars developed by several companies across the world have not seen the light of day, and hence it is important to see how Lipaglyn would survive in the global market, he pointed out.

(This article was published on June 5, 2013)
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