Biocon Limited has chalked out an aggressive plan to meet the growing global requirement of anti obesity drug, Orlistat, after the ban of Rimonabant by the DCGI. The company views good growth prospects with Orlistat and has developed a sizeable capacity to produce the drug for fat control.
The company has a US FDA audited facility and expertise in fermentation technology with a strong back up of synthetic chemistry to manufacture the drug. It is one of the few suppliers complying to ICH grade as both bulk drug and formulation.
Many formulators in India, Latin America, Middle East, Russia and South East Asia use Biocon's Orlistat. It offers the finished dosage form of Orlistat capsule in both 120 mg and 60 mg strength through its brand 'Olisat' which is available in the domestic market, stated Rakesh Bamzai, president, marketing, Biocon Ltd.
In recent years, obesity has become a major public health problem. Anti-obesity treatment is recommended for patients for whom lifestyle modification is unsuccessful. The two anti-obesity drugs currently licensed for long-term use are Orlistat and Sibutramine. The former is a gastrointestinal lipase inhibitor, which works by Inhibiting Pancreatic Lipase, an enzyme that breaks down fats in the intestine. Without this enzyme, fat from the diet is prevented from being absorbed and are excreted undigested.
Orlistat blocks absorption of about 25 per cent of fat in the meal. It decreases progression to diabetes in high-risk patients but gastrointestinal side effects are common.
The drug does not have the side effects which are associated with other products like Rimonabant like suicidal tendencies. Sibutramine is also reported to cause increased arterial blood pressure and heart rate. Orlistat is sold over the counter in USA under the brand name 'Alli' and as a drug by the brand name 'Xenical'.
Rimonabant, the first of the endocannabinoid receptor antagonists, though reduces weight by four to five kilograms on average and improves waist circumference and concentrations of HDL cholesterol and triglyceride has now been banned globally and in India because of an increased incidence of suicidal tendencies. Other promising anti-obesity drugs, including those acting within the central melanocortin pathway, are in development, but are years away from clinical use, stated Dr Vanita Sabhahit, of Product Development Team, Biocon Limited.
Orlistat has been approved for obesity treatment since 1998 and sold in over 70 countries globally. The global sale value of this molecule in December 2008, was $586 million.