In a deal that will allow drug-maker Alkem Laboratories Ltd to market a new chemical entity (NCE) in India, the Mumbai-based company has formalised an agreement with Sweden's Karo Bio regarding its cholesterol-related product eprotirome.

Alkem will conduct the third phase of clinical trials on Karo Bio's eprotirome and the regulatory process to conduct these trials is under way, said Alkem's Chief Financial Officer and Chief Operating Officer, Mr Ravindra Y. Shenoy. Phase III trails involve testing the product on a large sample size of patients, as doctors monitor the drug for safety, efficacy and adverse impacts.

Alkem gets the opportunity to exclusively market the NCE in India, once the product gets commercialised, Mr Shenoy told Business Line , without outlining timelines. The company also has gets to market the drug in the Asia-Pacific and Africa markets.

Through this introduction, Alkem intends to strengthen its presence in the cardiovascular and metabolic disorders segments, having established its presence in the anti-infectives, gastro-intestinal and pain-management segments, said Mr B.N. Singh, Alkem's Managing Director, in a company statement.

Royalty

There will be a royalty payment to Karo, once revenues are generated on the patent protected product, Mr Shenoy said, without giving details. The intellectual property-protected data that gets generated during the clinical trials will be “mutually put to use”, he added.

With a turnover of over Rs 1,500 crore, Alkem is an unlisted company that spends about three to four per cent of its revenues on the generic component of its research, he said.

The deal with research-centric Karo is Alkem's first in the NCE space, Mr Shenoy said, adding that Karo too was looking at getting into commercialisation of products.

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