Alkem, Sweden's Karo Bio to develop cholesterol drug

Drug maker Alkem Laboratories today said it has entered into an agreement with Sweden's Karo Bio AB for development and licensing of eprotirome, which is currently in late-stage trials for treating high cholesterol.

As per the pact, Alkem will participate in Karo Bio's phase III clinical trials for eprotirome by conducting a pivotal study in India.

Further, the Swedish firm will also grant Alkem exclusive rights to commercialise the new molecule in India and certain other countries in Asia Pacific and Africa once the molecule is successfully developed.

Commenting on the development, Alkem Managing Director B N Singh told PTI: "This collaboration is a win-win for both the partners. Alkem gets to work on the phase III and then market a NCE in India. It enables us to participate and contribute to the new dimension in the Indian pharma Industry."

 

Phase III clinical trials are tests done on a large number of human samples (about 300-3,000) to check the efficacy and side effects of the molecule under development.
    
Eprotirome is being tested for the treatment of dyslipidemia. In three clinical phase II trials, it has been found to lower several important risk factors associated with cardiovascular disease in patients with high blood lipids, the company said.
    
Alkem's clinical trials for eprotirome will comprise patients with primary lipid disorder with a high risk for cardiovascular disease, mainly patients who are already suffering from it.
    
"This collaboration enables Alkem to introduce a novel compound into the Indian as well as Asia-Pacific and African markets," Singh said, adding successful addition of the product in its portfolio would strengthen the firm's presence in the cardiovascular and metabolic disorders segments.
    
The company already has a strong presence in anti- infectives, gastro intestinal and pain management segments.