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Sunday, June 16, 2013

Cadila launching new drug that lowers cholesterol in diabetic patients and helps in glycemic control

This story first appeared in DNA Money edition on Thursday, Jun 6, 2013.

Cadila Healthcare has announced the launch of the first new chemical entity (NCE) developed by an Indian pharmaceutical company — Lipaglyn — a drug that will help in lowering cholesterol in diabetic patients and in glycemic control.

The company expects the drug to be a blockbuster, garnering $1 billion in annual sales.

Pankaj R Patel, chairman and managing director, Zydus Cadila, said Lipaglyn is Cadila’s dream molecule to travel the lab-to-market drug discovery phases.
“We expect Lipaglyn to be a blockbuster drug reaching $1 billion in annual sales globally. While the pricing and distribution aspects are being currently worked out, we are looking to introduce it in India by third quarter of this fiscal,” said Patel.

The drug which has active ingredient Saroglitazar has been approved by the Drug Controller General of India. According to company officials, it is the first glitazar to be approved in the world and the first new chemical entity (NCE) discovered and developed indigenously by an Indian pharma company. Cadila will have a 20-year patent for Lipaglyn across the globe.

Lipaglyn is prescribed for Diabetic Dyslipidemia, a condition where diabetic has elevated levels of the total cholesterol.

Analysts, however, gave thumbs-down to the plan as they were expecting the company to out-license the molecule to a pharma MNC.

Ranjit Kapadia, senior vice-president - pharma, Centrum Broking, said, “Cadila would have received $10-15 million upfront payment if the management would have licenced the molecule to an MNC. Besides, the company will be marketing the product in India where patented products do not carry major premium as compared with Europe and US markets. As a result the upside is limited.”

Cadila officials said 1,000 clinical trials were conducted for the drug in India against 300 prescribed by the US Food and Drug Administration (FDA).
However, analysts said launching in India doesn’t mean much as clinical trials here are not as stringent as the developed markets.

“Standards of trials in India are not that great and it will be a long-drawn process to get it approved by the US FDA. A lot will also depend on the success of the molecule in the market,” said a pharma analyst from an international brokerage.

In India, the company expects Lipaglyn to be in the top 50 drugs in the segment with a targeted sales of Rs 100 crore in the next 3-5 years. Overseas, the company sees regulatory approvals in some emerging and developed markets coming in next 12-24 months.

“We will also initiate clinical trials for markets like Europe and US and have earmarked $150-200 million. We will look for a marketing partner for sales/distribution of this drug there,” said Ganesh Nayak, COO & ED, Cadila.

Cadila is also working on eight more molecules. It has thus far spent $250 million towards these developments, including Lipaglyn.

It will continue to spend 6-7% of its annual revenues on research and development apart from Rs 500 crore capital expenditure.

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