Dabur Pharma Plans Para IV Filing For Oncology Product

<a href=www.financialexpress.com>The financial Express Pummy Kaul

New Delhi, April 1: In order to take advantage of ‘six months exclusivity’ in the overseas market, Dabur India’s newly demerged pharma entity Dabur Pharma Ltd plans to complete the para IV filing for one of its new oncology products soon. With the para IV filing, the company will be able to make inroads into the lucrative generic market segments the worldover, especially in the United States.

More precisely, the development will enable Dabur to get a six-month exclusivity for some of its oncology drugs. Companies like Dr Reddy’s and Ranbaxy have been able to get a 180-day marketing exclusivity for a few drugs after successfully completing their para IV filing.

Talking to FE, Dabur India vice-president (VP) and pharmaceuticals head Ajay Vij, said that the move is in line with the company’s focus to emerge as a global player in the space of oncology, develop comprehensive oncology franchise globally including the US and EU and focus on research in innovative molecules in Oncology.

Meanwhile, in the domestic market, the focus is to widen the product basket in oncology in addition to introducing new products in the anti-diabetic and cardiovascular segment. The company plans to introduce four to five new products in the last quarter of financial year 2003-04, Mr Viz said.

“The idea is to give equal thrust to the international as well as domestic markets,” said Mr Vij. “In the overseas markets, while we are looking at exploring the US and European markets, we will ensure a deeper penetration in markets of significance where we have already established our presence,” he added.

Dabur has set up a manufacturing facility in the UK for oncology injectibles at an investment of $15 million and commercial production is slated for late 2004.

The key challenge in the highly regulated markets in the developed world is in getting faster regulatory approval and the UK facility is expected to give the needed edge to penetrate effectively in these markets.

The company is looking for deeper penetration in its already established overseas destinations such as Phillipines, Malaysia, Thailand, Mexico, Brazil, Venezuela, Costa Rica, Peru, Russia, Belarus, Sri Lanka and Bangladesh besides some African countries.

Dabur India, last year, took an in-principle decision to demerge its pharma business into a separate company after incorporating the suggestions of Accenture into its corporate agenda.

The company has already virtually demerged pharma business and operationally separated it from the FMCG business. While the new entity comes into effect from April 1, 2003, Dabur expects to complete the legal formalities by in September 2003.