WITH pharma biggies like Ranbaxy and Dr Reddy’s Lab announcing plans to tap the regulated biotech drug market, mid-sized players in the segment are harbouring such ambitions. Hyderabad-based Bharat Biotech International is finalising plans to roll out drugs in Europe and the US.

For starters, the company will initiate European trials on three products, which will be soon filed with the European Medicines Agency for regulatory approval. It is also in talks with a couple of US pharma companies to enter into a technology and marketing partnership.

Elaborating, Bharat Biotech International CMD Krishna M Ella said the company intended to carve out a niche in the wound-care segment for Europe and the US. “We will commence regulatory filings over the next six months,” he said.

The company has plans to launch its blockbuster product, ‘Regen-D,’ in Europe. The drug is India’s first recombinant human epidermal growth factor, used for treatment of diabetic foot ulcers, burns and skin grafts. However, the company declined to give names of the other two drugs shortlisted for Europe.

“The Phase III and post-marketing surveillance data for Regen-D has been recently published in noted journal ‘Wounds.’ We will also develop a fresh set of Phase III trial data for drugs in Europe. This will facilitate the regulatory process,” said Mr Ella.

As far as the US plans go, Bharat Biotech will enter into a tieup with a US biopharma company for joint drug development and marketing. “This will be mainly developing newer drug applications. As part of the negotiations, we will get a percentage of the sales. The deal should be finalised by this fiscal,” Mr Ella said.

Bharat Biotech exports its products to Kenya, Zambia, Peru, Bolivia, Philippines, Bangladesh, Kenya, Vietnam, Malaysia and Columbia. This apart, it has seven products in Phase II trials in areas like Japanese encephalitis, malaria vaccine, rotavirus vaccine and anti-infective. Future projects are in areas like combination vaccines, bio-antibiotics, combination probiotics and chikungunya vaccine.