Emcure Pharmaceuticals Ltd, a leading Pune-based company, has launched Asomex 2.5mg, a formulation of S(-) amlodipine for hypertension. The product is the result of two years of collaborative research by the scientists of the National Chemical Laboratory (NCL), Pune and Emcure. The company has got a licence from NCL and the Drug Controller-General of India to manufacture and market the drug. NCL has filed a process patent for the 100 per cent indigenous drug in India, the US and the EU. The drug would be made available first to the medical fraternity.
Launching the drug in Hyderabad, a company spokesman said this was for the first time that a Chiral drug had been developed indigenously. The Chiral molecule of which S (-) Amlodipine is made has two components - one which cures hypertension and the other which causes side-effects. The researchers at NCL had removed the unwanted component, thus making it free of side-effects. The spokesman said so far Amlodipine was available in a crude form and now they were giving it in a pure form.
Although conventional Amlodipine is a proven therapy for the treatment of hypertension, the drug is commonly associated with adverse effects like peripheral edema (swelling of legs) and other side-effects like headache, dizziness, flushing& abdominal pain. But in the clinical trials of the new drug, none of the patients reported any of the adverse effects, the company claims. A key feature of the Chiral drug is that the patient is given only half the dose of 2.5mg as compared to the conventional Amlodipine 5mg. The reduced dosage provides the same efficacy as the conventional drug, besides reducing side-effects.
It has also been found, the company claims, that the LDL cholesterol lowering activity was more with the new drug. The drug is priced at Rs 19.50 per strip of 10 tablets as against Rs 23 to Rs 25 for the earlier racemic mixture of 5mg. The new tablet, to be taken only once a day, gradually reduces the blood pressure.
S-Amlodipine is the first of the many more Chirally pure drugs on which the NCL and Emcure scientists are working together. According to the company''''s press release it has been one of the fastest growing pharma companies in India. As part of its strategy to take a quantum leap and to get ready to face the challenges of the patent regime, Emcure has been working closely with NCL. The company''''s new manufacturing facility at Hinjewadi, Pune, is fast nearing completion. With the stringent quality standards, Emcure is working towards obtaining approvals from the UK MCA and the US FDA. Such approvals would open the regulated markets to Emcure for exports. Emcure is also very active in its R&D efforts to develop novel drug delivery systems and new formulations. Its state-of-the-art R&D facility enjoys the CSIR approval.
A Rs 350-crore company, Emcure manufactures cardiovascular products, antibiotics, anti-inflammables and a range of other formulations. The company is also in the field of biotechnology with one molecule already in the market.