India’s Advinus Signs On With Genzyme In Malaria Research

Anti-malarial drug research involving Genzyme and others is set to expand with the help of new Indian partner Advinus, just taken on board to develop early-stage candidates.

Bangalore-based Advinus Therapeutics will be optimizing lead compounds that act against certain enzymes essential for the survival of the malaria parasite, the firms said August 25.

The compounds surfaced through a three-year-old research collaboration involving Genzyme, Harvard University and the Broad Institute of MIT. Swiss non-profit Medicines for Malaria Venture joined the team two years ago.

Research has focused on discovering drugs for life-threatening, severe strains of malaria caused by resistance to widely-used treatments. Pregnant women and children particularly are at risk for the most deadly forms of the disease.

Through the collaboration, university researchers discovered new drugs while Genzyme's role lay in screening the candidates.

Out of hundreds of thousands of compounds subjected to high-throughput screening, one in particular has been identified for clinical development, said James Geraghty, senior vice president of Cambridge, Mass.-based Genzyme. Some research involving this candidate is set to be presented at the 2008 American Society of Tropical Medicine and Hygiene meeting, he added.

Recruitment of Advinus reflects plans to expand the collaboration's work significantly, after MMV deemed research to date promising, Geraghty said in an interview.

After leads with potential are identified through the screening process, Advinus will handle optimization, including pharmacokinetic and pharmacodynamic tests, as well as remodeling to ensure the right mix of efficacy and reduced toxicity. Separately, Advinus is involved in a research collaboration agreement with Merck to develop programs for metabolic diseases (Also see "Merck Targeting Metabolic Disorders With Advinus Deal" - Scrip, 16 Nov, 2006.).

Tropical Disease Voucher Could Offer Additional Incentive

Genzyme's participation in the malaria research group falls under its Humanitarian Assistance for Neglected Diseases initiative. Late last year, the company set up a presence in India to expand its footprint and "actively work at collaborating with private and public institutions in the region."

From a small office in India, with about 20 employees based in Gurgoan, outside Delhi, Genzyme markets its own therapies for rare genetic diseases and also runs a small compassionate-use program allowing access to treatment for Indian children suffering from Gaucher disease.

"We hope to make an important contribution to health care in India with our products for rare diseases and make a contribution to malaria, which is much more widespread," Geraghty said. "We are earning respect and support of policy-makers in India," the exec added.

At this point, no regulatory strategy has been set for approval of the compounds in development for malaria. It's possible Genzyme could qualify for a priority review voucher from FDA under the tropical disease incentive part of the 2007 Food & Drug Administration Amendments Act.

The incentive program rewards sponsors who receive approval for a new drug to treat disease of the developing world with a priority review voucher. The voucher can be redeemed at FDA for faster six-month review for a subsequent application.

"Our primary goal here is not to take [the compounds] through FDA review. Our primary goal is to get them into countries that need the product. We could work directly with FDA equivalents in countries where malaria is endemic," Geraghty said.

This month, the World Bank pledged more than $500 million for disease prevention and treatment in India, with a special focus on malaria, known to afflict an estimated 2 million people in the country annually. Wide use of the treatment chloroquine has left India vulnerable to serious problems with treatment-resistance, and policy-makers have called for access to more treatments.

In July, six drug companies (Calyx, Cipla, Holleypharm, Ipca Laboratories, Mangalam Drugs and PIDI Standard) agreed to cut the price of a leading artemisinin-based combination treatment by almost one-third, in a deal brokered by former President Clinton (PharmAsia News, Aug. 14, 2008).

With about 100 anti-malarial partnerships under its belt, MMV has five compounds in clinical stages, including three ACT therapies headed for market authorization within the next year and a half.

- Emily Hayes ([email protected])

[Editor's note: This article also appeared in 'The Pink Sheet' DAILY - Aug. 26, 2008.]