The PharmExec 2005 Pipeline Report - Pharmaceutical Executive

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The PharmExec 2005 Pipeline Report
Dry? Not quite. Instead of 1990s-style blockbusters, pharma's new molecules are niche drugs, cancer treatments and—at last—innovative mechanisms for troublesome targets.


Pharmaceutical Executive


"It's a bit of a mystery," says UBS' Molowa. "Revlimid is a highly effective agent, but it's not entirely clear how the drug works. If everything comes out well, it can be a $2 billion product."

Cheap Drugs, High Stakes

Artesunate/amodiaquine by Drugs for Neglected Diseases Initiative Foundation/Sanofi-Aventis

Artesunate/mefloquine by Drugs for Neglected Diseases Initiative Foundation

TARGET INDICATION
Malaria
LAUNCH DATE
2006

There is little malaria in the developed world. And where there is malaria, there is little money, and thus no profit motive to spur research. But because some 500 million people a year are exposed to plasmodium falciparum, the deadliest form of the mosquito-borne disease, and according to the World Health Organization, up to 2 million people die from malaria each year, researchers press ahead for new compounds.

The Drugs for Neglected Diseases Initiative Foundation, based in Switzerland, is developing two new fixed-dose single-tablet combination therapies using artesunate, a new semi-synthetic compound. They are currently in Phase III testing in Thailand, Brazil, and Burkina Faso.

"Artesunate is water soluble," says Thomas Lemke, professor of pharmacy at the University of Houston and co-editor of Foye's Principles of Medicinal Chemistry, a textbook. "That makes it unique. All the other anti-malarials are fat soluble, which puts some limitations on routes of administration, and raises stability issues."

One compound, co-developed by Sanofi-Aventis, combines 200 mg of artesunate with 270 mg of amodiaquone. The medication is expected to cost less than one dollar per adult dose and be available next year. The second blends 100 mg of artesunate with 200 mg of mefloquine.

HPV Vaccines

Gardasil by Merck

Cervarix by MedImmune/GSK

Two similar and eagerly awaited human papillomavirus (HPV) vaccines could greatly reduce cases of genital warts and cervical cancer, a disease that claims 4,000 lives each year in the United States and kills 250,000 women a year in developing countries. The two drugs use slightly different delivery procedures to introduce similar non-infective virus-like particles (VLPs) to mimic the function of HPV types 6, 11, 16, and 18. These strains, especially 16 and 18, are responsible for up to 70 percent of all cases of cervical cancer.

HPV is a sexually transmitted virus that may be carried by one-fourth of the world's population, says Paul Blumenthal, MD, of Johns Hopkins Medical Institutions, who is an advisor to a cervical-cancer screening program under development in six African nations. Since it is highly probable that most sexually active women will be exposed to the virus, some public health experts call for mass inoculations of pre-teen girls. This is expected to be an unpopular idea with many parents and some influential politicians, Blumenthal says.

However, Blumenthal argues, an effective program need not begin with children. Although the great majority of women have been exposed to the virus, almost all could still be effectively vaccinated after exposure, since the virus seldom penetrates the cellular DNA to produce the abnormal proteins that generate pre-cancerous growth. The vaccine is effective until dysplasia—the production of abnormal tissue—has begun.


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