AstraZeneca Pharma India will conduct clinical trials in India before the end of 2003 for its Symbicort Turbuhaler, a new combination therapy for the treatment of asthma.

Although the product is just launched in India, its active pharmaceutical ingredient (API) budesonide and formoterol are already sold as generics by other pharma companies in the country.

The company is planning to conduct post marketing surveillance of Symbicort Turbuhaler, before the end of 2003. AstraZeneca did not have to conduct registration clinical trials in India since both the molecules in the brand, namely budesonide and formoterol have approval in India. The approval for Symbicort Turbuhaler was given by the DCGI (Drugs Control General of India) on the basis of international data submitted on the product and the novel inhaler device, Turbuhaler, according to officials from AstraZeneca.

The novel Turbuhaler, which combines patient convenience and effective drug delivery, is the world's most prescribed dry powder inhaler for the treatment of asthma. "Symbicort Turbuhaler priced at Rs. 1,000 allows patients under physician guidance to easily adjust the dosage and mange the asthma symptoms. No other current asthma therapy provides this degree of control and flexibility in a single inhaler, which has two key components of asthma therapy-budesonide and formoterol used to treat inflammation of airways and provide quick relief for patients, said Dr. Swashraya Shah, medical director AstraZeneca Pharma India. Symbicort Turbuhaler is manufactured in Sweden under a sterile environment control facility specially identified for the product.

The total value of the anti asthmatic market in India is pegged at Rs.350 crore with a growth rate between 11 to 12 per cent. The anti asthmatic market includes oral formulations and inhalers having an equal value share of Rs.175 crore each. AstraZeneca's share in the inhaler segment is currently Rs. 6 crore with Pulmicort, Bricanyl and Rhinocort.

"We are ambitious about our sales with Symbicort Turbuhaler," Lars Walan, managing director, AstraZeneca Pharma India said asserting that in no way he could reveal any sales targets or revenues expected from the product as a part of the company's policy.

Globally more than 100-150 million asthma patients and over one fifth are in India. AstraZeneca Pharma India's key focus in India is on cardiovascular, oncology and respiratory diseases in addition to maternal health and pain-infection management diseases.