Ranbaxy first Indian co to launch NCE

Ranbaxy has completed the second phase of the clinical trial of a revolutionary anti-malarial drug that could enable it to be the nation's first pharmaceutical company to launch a New Chemical Entity  globally.

"We are now creating a new chemical entity, a new medicine for malaria. We have just finished phase II clinical trials and we are doing a phase II for the combination of that product," CEO and Managing Director of Ranbaxy Laboratories Ltd, Malvinder Mohan Singh said.

"Hopefully, if everything continues to be successful, by 2011, we shall have a New Chemical Entity in the market and will probably be India's first NCE out globally," Singh told PTI in an interview.

Although anti-malarial drugs have a large market, it is a market with very limited resources. Together with the challenges of drug resistance, poor health systems, lack of affordability, safe and convenient treatment options, malaria treatment represents one of the largest unmet medical needs, he said.

While two to three dozens new molecules are being developed for cardiovascular, arthritis, diabetes and oncology, there has been just two products launched in the last 30 years for malaria, he said.

"As a socially responsible organisation, we are going to leverage our capability to develop a NCE for malaria," Singh,
who heads the leading pharmaceutical company in India said.

Malaria claims the lives of more than one million people every year around the world. The majority of its victims are
children under the age of five and pregnant women in developing countries. 

"Based in a malaria endemic country and coming from an emerging market, we understand what it means. Therefore, we have taken the responsibility and do it for people who matter to us," Singh said.

Ranbaxy was committed to develop a drug that is not only safe and effective, but also affordable to people in India,
Africa and other disease endemic countries, he said. 

Arterolane, the potential anti-malarial candidate is currently undergoing Phase II b studies (dose range finding studies) in Africa, Thailand and India, the company website said.

Ranbaxy, in its endeavour to make Anti-Retrovirals accessible to patients around the world, had been leveraging its global network of offices, affiliates, joint ventures and alliances, Singh said.

With Ranbaxy products being marketed in over 125 countries and ground operations in 49 countries, the company provides pre and post sales support to institutions, NGOs, and ministries of health, making Ranbaxy ARVs available in their respective treatment programmes.

Several humanitarian and government programmes in Africa, where HIV-AIDS is more prevalent, have sourced ARVs from Ranbaxy.

In Latin America, Ranbaxy's ARVs have been registered in Brazil, Peru, Venezuela and Guatemala among other countries.

In South East Asia, ARVs are being marketed in Vietnam, Cambodia and Myanmar already. Besides, regulatory filings are on in several countries in these regions.

Encouraged by the positive response to its efforts to make quality anti-HIV generics, Ranbaxy is committed to work on all possible fronts and seeking partnerships to improve access to these medicines, Singh added.