Biocon scripts multi-pronged strategy

Biotech major Biocon has developed a multi-pronged strategy to maintain growth and take in its stride the pressure on margins experienced by statins.

Addressing a press conference here on Wednesday, Kiran Mazumdar Shaw, chairman and managing director, Biocon Ltd, said the company is pursuing a strong innovation path that includes developing proprietary products and technologies with growth potential.

The company is also planning to significantly increase research and development (R&D) investments to support a discovery led research strategy, she added.

To insulate pricing pressure on statins, the company has embarked upon a two-pronged approach. One is technical and the other through building up volumes.

"Given the increased statin capacity coming in FY2005-06, we are confident of achieving healthy sales growth, despite the pricing pressure on our statins business," she said.

Biocon is also banking on research services (CRO), insulin, immunosupresants and monoclonal antibodies.

In financial year 2004-05, the company earned Rs 66 crore through custom reseach, as against Rs 39 crore in the pervious year. Enzymes earned Rs 90 crore (Rs 67 crore) and bio-pharma Rs 557 crore (Rs 435 crore).

The company after rolling out Insugen in the southern, western and northern markets, is preparing to enter east. For 2005-06 the company is targeting 10 per cent of the Rs 200 crore Indian insulin market in addition to regular exports, said Ajay Bharadwaj, president marketing, Biocon India.

In light of the new WTO-TRIPS compliant regime in India now, the company is embarking on building a long term, sustainable differentiated business model.

"We are developing products in collaboration with other partners, sharing or contributing a part of the development cost either by clinical development or process development like oncology monoclonal antibodies," said Kiran Mazumdar Shaw.

The company has made significant progress in various collaborative in-licence R&D programmes. For the cancer vaccines (h-R3) with CIMAB, the company has come half way through Phase IIb clinical trials for head and neck cancer.

There is a plan to extend indications to pancreatic and colo-rectal cancers, glioblastoma, non-small cell lung carcinoma and breast cancer.

"We will seek fast track approval based on phase IIb trials by end of the year," said Kiran Mazumdar Shaw.

With oral insulin, the company has commenced pre-clinical animal toxicity studies. This is being positioned for post prandial blood glucose control in both early and advanced Type 2 diabetics. This being developed with Nobex and the two companies are expecting to file an INDA with USFDA by the end of 2005.

The tie-up with Vaccinex for the monoclonal antibodies has also seen progress with BVX-10 (inflammation) and BVX-20 (oncology) being screened against validated targets.

"The products developed through oral insulin (Nobex) and human antibodies (Vaccinex) is expected to give the much needed impetus in tapping global opportunities in the next 3-4 years," said Kiran Mazumdar Shaw.

Biocon is also pursuing a de-risked research strategy in the biologicals sphere by selecting research programmes based on proven targets (EGFR) and proven molecules (insulin).