BackCadila gets approval for diabetic dyslipidemia drug
Drug maker says it is the first Indian pharma company to develop a new molecule from its discovery pipeline
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Mumbai: Ahmedabad-based Cadila Healthcare Ltd, also known as Zydus Cadila, said it has made history by becoming the first Indian pharmaceutical company to develop a new molecule from its drug discovery pipeline, beating at least three multinationals to the finish and keeping expenses at less than one-quarter of what such endeavours usually cost.
The company said on Wednesday that it received Indian approval last week for saroglitazar, the world’s first drug that can treat diabetic dyslipidemia, a condition of high lipid and glucose levels in Type-2 diabetic patients. Globally, 80-90% of diabetes patients suffer from the condition and manage it through statins and other means.
“The company expects this to be a blockbuster drug, which means over $1 billion sales a year globally," said sector analyst Sarabjit Nangra, vice-president, research (pharma), at brokerage Angel Broking Ltd. “In India, the company expects to achieve sales of around ₹ 100 crore in the next three years. We expect the full impact of the drug to be visible in fiscal 2015."
Investors, however, didn’t appear to be enthused by the announcement, with the stock declining 4.42% to ₹ 778.45 on the BSE on Wednesday. The Sensex was little changed at 19,568.22 points.
That didn’t dampen the company’s celebratory tone.
“This is the first glitazar to be approved in the world and is the first new chemical entity discovered and developed indigenously by an Indian pharma company," said Pankaj R. Patel, chairman and managing director, Cadila Healthcare. “It has always been our dream to take a molecule right from the concept stage to its launch, and today we have realized the dream."
Experts said the news could act as a boost for the Indian drug industry, which has come under a cloud over questions regarding poor quality and the violation of rules after Ranbaxy Laboratories Ltd last month admitted to falsifying data and was forced to reach a $500 million settlement with the US Food and Drug Administration (FDA).
Soon after that revelation, the FDA imposed an “import alert" on a plant operated by generic drug maker Wockhardt Ltd.
Three multinational drug makers, including F Hoffmann-La Roche Ltd and Sanofi SA, are working on the discovery of molecules similar to the one announced by Cadila, which became the first to complete patient trials and successfully prove a superior safety profile.
The company started the discovery of the new molecule in 2004 and has spent about $250 million on the project. It expects to spend another $100 million to complete trials in developed markets in the next few months. This is below the average $2 billion discovery cost projected by multinational innovator companies for a new molecule. The process takes 12 years on average, compared with nine taken by Cadila.
“Cadila Healthcare launched the first NCE (new chemical entity) molecule in India, which is the world’s first drug for treating diabetic dyslipidemia and combines lipid- and glucose-lowering effects in one single molecule," Nangra of Angel Broking said. “The drug has been already approved in India and is expected to be launched in the local market by the end of the second quarter of 2014, and hence the full impact will be visible in the half fiscal (October-March )."
Cadila said it will sell the drug under the brand name Lipaglycin and that it has been patented in nearly all large markets globally. The estimated market size for this class of drug is about $33 billion worldwide. Cadila, which expects US and European approval by the end of the year for the drug, will announce international prices shortly.
Indian companies, reputed for generic drugs and manufacturing capabilities, haven’t introduced any new molecules in the market until now, though some had partially developed new drugs in the past.
Typically, Indian companies such as Dr Reddy’s Laboratories Ltd, Ranbaxy and Glenmark Pharmaceuticals Ltd have licensed out discovery molecules as development costs, especially human trials for global markets, are too high for Indian drug makers.
While such a development had been expected from Dr Reddy’s in the early 2000s, that anti-diabetic product was licensed out to Danish drug maker Novo Nordisk A/S midway. Research on the molecule ended due to failed safety tests.
Globally, there are estimated to be around 350 million people with diabetes, out of which 85%, or 300 million, have diabetic dyslipidemia. In India, about 6.5 crore people have diabetes and around 5.2 crore have diabetic dyslipidemia.
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