Mumbai, June 23: The Mumbai-based Cipla has commenced production of one of the most advanced anti-asthma drugs, fluticasone propionate, in India. This makes it the second company in the world to make the product right from the basic stage. The latest development comes close on the heels of Cipla's success with sildenafil citrate, the active ingredient of well-known anti-impotency drug, Viagra.Cipla director Amar Lulla told The Financial Express that the company had been working on the drug for over a year and had developed it using an indigenous process. "Cipla is the only Indian company to launch this drug (branded Flohale) and the molecule is available through conventional metered-dose inhalers and also a dry-powder inhaler system. The drug's exclusive properties provide it the potential to be the gold standard for asthma prophylaxis," he said.
Fluticasone propionate, besides being the most potent anti-asthma medication, is effective at half the doses of conventional inhaled corticosteroidsavailable in the country. Despite its high potency, the product can be used by children above the age of four.
The original molecule was launched by Glaxo in March 1993 and has been safely used by asthmatic children and adults over the last five years. Glaxo's fluticasone brand, Flovent, registered global sales of $226.6 million in the first-half of 1997, almost double that in the corresponding period of the previous year. Worldwide sales of inhaled fluticasone in 1997 was approximately $517 million, a 70.3 per cent growth over the previous year. Flohale, experts in the medical profession say, when compared to available agents, offers "greater air selectivity, rapid first-pass metabolism and an increased uptake and retention in the lungs".
"In the case of fluticasone, the inhaled steroids are deposited directly in the respiratory system, making it more effective and with a longer duration of action. So the steroid efficacy stays in the lungs," they said. Adverse effects are usually restricted tocandidiasis of the mouth and throat and in some cases hoarseness. Besides, there have been rare reports of cutaneous hypersensitivity to fluticasone propionate.
Cipla hopes to tap the vast non-product patent protected export markets in future and Lulla said that the company was targeting sales of around Rs 10 crore within the first two years of its launch. Meanwhile, the company is also on course to developing several new bulk drugs like atorvastatin, lamivudine, nelfinavir to take on international competion. While lamivudine and atorvastatin are in various stages of development, the company has already launched an anti-AIDS drug, stavudine, branded Stavi, in the domestic market. Atorvastatin is the key ingredient in Pfizer's Lipitor brand, a cradiovascular drug, while Glaxo is credited with being the patent-holder for lamivudine.
Copyright © 1998 Indian Express Newspapers (Bombay) Ltd.