Clinigene turns profitable

Clinigene International, a wholly-owned subsidiary of Biocon, has turned profitable and is eyeing revenues of Rs 100 crore before a public listing.

According to Kiran Mazumdar Shaw, chairperson and managing director, Biocon group, "Clinigene, has become profitable and the company will possibly take the same route as Syngene in the years to come. But Clinigene is still not at a stage where we can say it has reached critical mass."

"Clinical trials is a huge opportunity for India, and given the fact that there is a lot of pressure on big pharma firms to reduce its cost of drug development we are seeing Clinigene bag a lot of new clinical trial orders and business, and I think this is something which also will grow Clinigene with a good growth trajectory," she added. During the third quarter, the company had to take on the burden of the increased depreciation.

"The new facilities created for Clinigene and the full value of the business as a result of the expansions have not been captured this quarter. They will only be captured in the quarters going ahead," she said.

During the second quarter, Clinigene invested Rs 30 crore to set up a dedicated facility at Electronic City in Bangalore. "The new facility has 65,000 sq feet and enables the company to rapidly expand clinical development activities," she said.

The new facility is operational and has lab facilities for bio-equivalence and bio-availability studies (BE/BA) (BA is the condition in which different formulations of the same drug are equally absorbed when taken into the body, while BE is the the extent to which a nutrient or medication can be used by the body) and is equipped to provides services in clinical trials (Phase I to Phase IV), CAP accredited central laboratory services and data management, said Dr Arvind Attignal, chief operating officer, Clinigene.

The company has been conducting clinical studies in select diseases like the initial phase and include non-insulin dependant diabetes, asthma and lipidemia.

In 2005, Clinigene supported Biocon's insulin evaluation by completed post-marketing results of Insugen Evaluation (PRIDE) study. The study referred as Postmarketing Surveillance Studies (PMS) and also called Phase IV studies are done as part of regulatory requirement, to know primarily the safety of the drug in addition to the efficacy of the drug.

Phase IV studies the usage of drug by large populations and in natural settings unlike Phase III, where the drug is tested in a controlled environment.