AstraZeneca's Brennan Suggests Exclusivity As Carrot For Finding Drugs To Treat Neglected Diseases

Incoming president of IFPMA says the international pharmaceutical federation is looking for better financial mechanisms to encourage research in diseases of the developing world.

The opportunity to obtain extended exclusivity would be an effective method to spur research into drugs for diseases of the developing world, AstraZeneca CEO David Brennan suggested during a Nov. 10 press briefing at the 25 International Federation of Pharmaceutical Manufacturers & Associations Assembly in Washington, D.C.

Extended exclusivity has proven effective in the past, Brennan pointed out. "One of the areas where the industry's behavior changed was when pediatric exclusivity came along" and companies agreed to conduct pediatric studies in return for additional exclusivity, he said.

"I'm not talking about years," he said. "Something that's proportionate is an example of something that works well."

Finding better financial mechanisms to increase research into therapies for neglected diseases is a topic that drug industry executives discuss when they get together and is an important part of the IFPMA agenda, noted Brennan, who assumed the association's presidency during the meeting and will serve a two-year term.

In an attempt to encourage development of drugs for neglected and tropical diseases, the U.S. Congress created a voucher program in the FDA Amendments Act. The voucher, which is awarded when a neglected/tropical disease drug is approved, guarantees priority review for another drug of the sponsor's choice.

Brennan, however, was skeptical about the program's impact. Only one voucher has been awarded thus far [to Novartis, for Coartem] and it is difficult to put a value on it, he said. The price of redeeming a voucher will be millions of dollars in addition to the regular prescription drug user fee .

Though the voucher buys an expedited review, "I don't think that kind of activity necessarily drives behavioral change," Brennan contended. "It doesn't make me think in our research laboratories we should be doing more because we get a voucher. Whereas we do more when we know that there's a finite opportunity at the end."

Pipeline Grows For Neglected Disease Drugs

While industry and others seek ways to make research into diseases of the developing world more economically feasible, IFPMA released a report highlighting how its member companies have already increased their efforts in this area - from 84 drug and vaccine projects in 2009 to 102 in 2010.

The total was 49 in 2006. The projects are for the 10 priority diseases identified by the Programme for Research and Training in Tropical Diseases, an effort cosponsored by the World Bank and several United Nations agencies.

By disease, the number of projects rose from 25 to 31 for tuberculosis, from 34 to 41 for malaria and from 25 to 30 for the other diseases - sleeping sickness, leishmaniasis, dengue/dengue hemorrhagic fever, river blindness, Chagas disease, schistosomiasis, leprosy and lymphatic filariasis.

Having products for neglected and tropical diseases has another business incentive - it can give companies a foothold into emerging markets, an opportunity that Brennan's own AstraZeneca has been pursuing (Also see "AstraZeneca Outlines Branded Generics Strategy At Emerging Markets Event" - Pink Sheet, 22 Mar, 2010.).

-Cathy Dombrowski ([email protected])