AHMEDABAD: Drug maker Cadila HealthcareBSE -4.42 % on Wednesday said that its new chemical entity (NCE), Lipaglyn , has been approved by the Drug Controller General of India (DCGI).
Lipaglyn is the world's first drug for treating diabetic dyslipidemia and combines lipid- and glucose-lowering effects in a single molecule. The drug, which is the first glitazar to be approved anywhere in the world and the first Indian NCE, is expected to be launched in India by 2014.
Diabetic dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol .
"Lipaglyn provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control," said Pankaj Patel, chairman and managing director , Zydus Cadila.
Patel dedicated the breakthrough to all the Indian research scientists in the field of drug discovery.
"Zydus has indicated that it needs to spend another $150 million to $200 million to launch the drug outside India. The company expects this to be a blockbuster drug, which means over $1 billion sales a year globally. In India, the company expects to achieve sales of around Rs 100 crore in the next three years. We expect the full impact of the drug to be visible in FY2015. On a conservative basis, the company can add Rs 30-50 crore in FY2015 on the sales front," said Sarabjit Kour Nangra, a pharma analyst.
Research has shown that diabetes is one of the major risk factors of cardiovascular diseases. India has a population of nearly 65 million diabetics and 77 million pre-diabetics , where 85-97 % of the diabetes patients suffer from dyslipidemia or lipid abnormalities.
Zydus Research Centre initiated the study in 2000. The company said that it will offer a dedicated Lipaglyn support programme to patients and caregivers to start and appropriately manage their disease and therapy over time.
BLOCKBUSTER IN MAKING
Lipaglyn is the world's first drug for treating diabetic dyslipidemia, a condition where a diabetic has elevated levels of cholesterol a Zydus Research Centre had initiated the study in 2000 a The drug is expected to be launched in India by 2014