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Aventis Pharma undertaking major clinical trials in India
Sanjay Pingle, Mumbai | Tuesday, June 12, 2007, 08:00 Hrs  [IST]

Aventis Pharma, a part of sanofi-aventis, third largest pharma company in the world, is undertaking several clinical trials in India to generate new evidence or to strengthen existing indications. The company has completed a large scale practice survey of diabetes management across the country as a first wave in over 100 centres coving 1300 patients. The second wave of this study will be conducted in 2007 in another 80 diabetic centres.

Aventis has also completed another clinical survey in patients of gastric cancer in over 300 cases in four cancer hospitals in India. Two major studies to evaluate the prophylactic use of its product Clexane in immobilised patients, who are at high risk of developing thromboembolism, was completed in over 400 patients. Another study was carried out in over 500 diabetic patients in India who failed to respond to oral treatment to observe the effects of insulin treatments including company's product Lantus. A study of Lantus in fasting patients of diabetes demonstrated its safety and the results were presented in an international conference held in Morocco.

The company launched one new product and two line extensions - Allegra Suspension, Cetapin 500 mg XR and Cetapin 1g XR, and Daonil M during the second half of 2006. India is being the first country to have Allegra Suspension product from sanofi-aventis Group. Allegra (fexofenadine hydrochloride) is the world's leading antihistamine in the management of allergies such as allergic rhinitis and urticaria. Aventis launched this product in July 2006 for paediatric patients in a palatable raspberry-vanilla flavour.

The company has launched Daonil M, a line extension of the gold standard brand Daonil which has been the leading portfolio or the last 34 years. Daonil M is a fixed dose combination of Daonil and metformin. This brand is likely to contribute significantly to its diabetes portfolio in 2007. The company is expanding its presence in larger geographies in India. Its 11 major products achieved a growth of 17 per cent during 2006 and contributed to around 79 per cent o the domestic sales. The rest of the portfolio on comparable basis grew by 14 per cent. Its 32 per cent product portfolio is coming under the purview of the current Drug Price Control Order (DPCO) and under the mandatory price control regime.

The company has completed expansion program for manufacture of Combiflam tablets in Ankleshwar. Combiflam was also earlier being manufactured in two external manufacturing sites. At full capacity this would be one of the biggest plants in India as well as in the sanofi-aventis Group and would produce approximately 4 billion tablets in a year. Further, Aventis has completed manufacture of validation batches of Paracetamol in Goa and commence exports during first quarter of 2007. The company's gross fixed assets reached at Rs 284.11 crore as at the end of December 2006 and its capital work-in-progress and advances on capital account amounted to Rs 13.20 crore.

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