Regulatory Beat: Manufacturers face Challenges Producing Treatments for AIDS, Third World Diseases

Assistance in identifying markets, technologies aims to spur biotech product development
Oct 01, 2005
Volume 18, Issue 10

Jill Wechsler
With millions of impoverished people suffering from AIDS, tuberculosis, malaria, and a host of deadly conditions, biopharmaceutical companies face unprecedented demand for safe and effective treatments for third-world diseases. US, European, and international organizations are pledging billions to curb global epidemics, including the President's Emergency Plan for AIDS Relief (PEPFAR), which plans to spend $15 billion over five years to treat two million individuals with AIDS.

While the immediate goal of donor organizations and AIDS programs is to provide care for infected patients, a broader aim is to encourage development of new therapies, formulations, and production methods to meet burgeoning demand. Biotech manufacturers stand to benefit from new funding or "push" mechanisms available from foundations, governments, and multilateral organizations. This surge in resources is critical for small biotech firms struggling to develop products for these important areas where it is difficult to earn a return on investment.


Vaccine Demand Spurs Production
The good news is that pressure on biopharmaceutical firms to reduce prices and cede patent rights does not seem to be curbing innovation. In July, Boehringer Ingelheim announced FDA approval of its new protease inhibitor Aptivus (tipranavir). Early clinical trial results issued by Massachusetts-based Panacos Pharmaceuticals indicate high efficacy from a new maturation inhibitor antiretroviral (ARV). New studies are examining whether ARVs may be effective in preventing HIV infection in the first place. Increased demand for new vaccines is spurring expansion of manufacturing facilities and new product development (see sidebar).

Advances in biotechnology are also producing new tools and treatments for fighting global infectious diseases. Sequencing of the plasmodium genome may help identify and validate new malaria drug targets, while genomic sequencing of additional pathogens promises to facilitate the development of more accurate diagnostics, safer vaccines, and new formulations of existing products. Manufacturers are developing needle-less powder injection vaccines for infant diarrhea, yellow fever, and TB, and handheld test devices using recombinant antigens may provide fast and accurate HIV testing.

The challenge for manufacturers is to identify testing, licensing, and distribution pathways for new products to treat third-world diseases. Many biotech companies are researching new treatments but often lack the resources and expertise to enter such high-risk areas. To address these concerns, the Bill & Melinda Gates Foundation recently awarded a $5.4 million four-year grant to BIO Ventures for Global Health (BVGH), an organization spun off from the Biotechnology Industry Organization last year to examine barriers in the market and the lab that may prevent promising new products from reaching patients.

BVGH seeks to identify markets that may support development of new technologies. The organization plans to provide companies with critical information on ways to improve product testing, production, and distribution so that manufacturers can build a business case that will attract outside investment or lead to public/private partnerships.

An initial project is to develop a series of business cases to identify key economic and technological mechanisms needed to drive development of safe and effective therapies and medical products. BVGH begins its efforts with a business case for developing a vaccine for tuberculosis. While pharma companies have been researching new multi-drug treatments for TB, there has been little action on the vaccine front. Now several biotech companies are exploring the field, and BVGH aims to spur their efforts by examining what is technically feasible scientifically and what kinds of markets would exist for a successful product.

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