Going Global

Sep 01, 2009

Jill Wechsler
By now it's common knowledge that the future of pharma sales is the global marketplace. As a result, industry is running hard to develop new vaccines and therapies to combat infectious diseases that plague millions of people around the world. Public and private funding has increased over the last decade, bolstering healthcare systems in less developed countries and improving treatments for malaria, tuberculosis, and neglected tropical diseases.

Pharmaceutical companies are now supporting public–private partnerships (PPPs) to combine resources for medical product development. However, the international financial crisis has squeezed resources available for these efforts. US-based initiatives have suffered from delays in appointing a permanent director for the Agency for International Development (AID), and have been hampered by the specter of cuts in foreign aid. While there's a growing list of promising drug and vaccine candidates for neglected diseases, stiff competition among donor agencies and multiple PPPs might actually hinder success.

Shifting Attention

The slowdown in pharma sales growth in the industrialized world is encouraging manufacturers to expand their presence in emerging markets and adjacent developing nations. When announcing his company's quarterly earnings in July, GlaxoSmithKline chief executive Andrew Witty highlighted GSK's reduced reliance on "white pill/western market" sales, and pointed to rising investment in high growth regions. In addition, Pfizer has established an emerging markets business unit to build sales in Brazil, China, India, Mexico, Russia, and Turkey, and Sanofi-Aventis has made a series of acquisitions to expand its drug and vaccine portfolios in emerging markets. Other firms are taking similar tacks.

Companies also are contributing unused patents and expertise to combat obscure but lethal conditions. In June, Merck announced a collaboration with the Drugs for Neglected Diseases Initiative to provide propriety information on drug candidates for Chagas and leishmaniasis. Roche is working with the Institute for OneWorld Health to develop new treatments for diarrheal disease; the treatments are based on leads arising from Roche's cystic fibrosis research.

FDA is also doing its part to facilitate development of new therapies for these conditions—initiatives that may expand under commissioner Margaret Hamburg, who has a strong background in public health and gained experience with TB control as head of New York City's public health department in the 1990s. The agency has been encouraging research on new TB treatments to counter a resurgence in multi-drug resistant (MDR) and extensively drug resistant (XDR) TB strains. Current therapies are decades old, involve lengthy treatment courses, and result in poor compliance that generates resistant TB strains.

An FDA advisory committee meeting in June supported use of early end points (sputum bacterial counts) in studies on drugs to treat MRD TB, an approach that could accelerate development of compounds like the one being tested by Johnson & Johnson's Tibotec subsidiary with support from the Global Alliance for TB Drug Development (TB Alliance). An FDA workshop in July delved into noninferiority study designs, combination therapy regimens, and missing data problems for drug-susceptible TB.

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