The company considered combining Viramune and Combivir (lamivudine+zidovudine) but concluded that FDCs "turn into a regulatory
nightmare," and that it doesn't know "how to make it happen, given the anti-trust laws." Instead, BI and GSK co-packaged Viramune
and Combivir, and licensed it to Aspen Pharmacare to distribute in Africa. However, the manufacturer should resolve its FDC
issues, since Aptivus (tipranavir), an AIDS drug for resistant patients, must be co-administered with Norvir. It also ready
to ship continue to research pediatric AIDS formulations—but gains top ranking for its pricing strategies on child dosages.
[Focus on TB]
Given its size, the scope of AstraZeneca's developing-country philanthropy and neglected-disease research efforts lags behind
competitors. However, while the company doesn't study AIDS drugs, it is developing a TB treatment in its Bangalore, India
facility, and has the potential to make a significant contribution to finding new treatments for tuberculosis.
[Partnership Breeds First FDC]
BMS shows flexibility on licensing and patents, continues to make significant research commitments in HIV/AIDS (but not other
areas of neglected diseases), and creates effective partnerships. In particular, BMS, Gilead Sciences, and Merck have created
the first branded FDC Atripla (efavirenz/tenofovir/emtricitabine). More is needed: Reyataz is considered especially effective
when used with Abbott's ritonavir.
The royalty-free voluntary licenses and technology transfers for Reyataz with Aspen Pharmacare and India's Emcure came less
than two years after the US launch of the drug, but BMS needs more licensees to comply fully with best practice.
BMS' core need is more effective reporting, with quantitative goals. For example, BMS hired the International Association
of Physicians in AIDS Care to evaluate its philanthropic Secure the Future program in 2001. But no new full-scale evaluation
has been completed. The lack of information on the accessibility of BMS' new FDC, including pricing schemes, registration
efforts, and timelines for new pediatric formulations, must be addressed.
[Wanted: Drugs for Kids]
Gilead is a nimble company that has helped develop the new FDC Atripla. But to overcome criticism, it must focus on pediatric
formulations and drug registration in the developing world.
An oral pediatric solution of Emtriva is not scheduled to be available in developing countries. Gilead is not yet marketing
pediatric formulations of Viread or Atripla.The company has not yet researched low-dose or scored tablets.
Gilead is strong on patent rights, and has applied for a patent of tenofovir in India under the country's new laws. In a major
challenge to the new Indian legislation, advocacy groups oppose the application, which gives Gilead 12 years of exclusivity.
Gilead does not disclose political contributions. That is particularly problematic because it has high-profile political figures
as current (George Schultz) or former (Donald Rumsfeld) directors.
GSK is an industry leader in reporting, licensing, and research. It has the most substantial neglected-disease research program
in the industry, with 13 clinical programs targeting eight diseases relevant to developing countries, and has recently brought
to market Rotarix vaccine, which treats severe diarrhea in infants.