Wall street Journal - March 28, 2002
Rachel Zimmerman and Robert Frank, Staff Reporters of The Wall Street Jourmal

Thailand's state-run drug maker plans to market next month a pill combining three popular AIDS drugs at a cost of 20 baht, or 46 cents, a dose. The drugs -- stavudine, lamivudine and nevirapine -- are made separately elsewhere by three multinational companies that hold patents on them in many other countries. Each pill costs about $4 in the U.S.

Dr. Krisana, the operation's head of research and development, has figured out how to combine the drugs and produce the three-in-one therapy cheaply, making it accessible to many more of the 750,000 people in Thailand infected with HIV, the virus that causes AIDS. Indeed, the new pill is expected to cut significantly the cost of drugs for AIDS patients in Thailand to about $27.66 a month, or about $330 a year.

The combination drug, announced last week, is being hailed by activists as another step toward greater access to critical medicines, and it promises to intensify the battle over prescription-drug marketing in poor nations.

James Love, director of the consumer project on technology at Consumer Action, an advocacy group pushing for patent law changes, says the introduction of the three-in-one therapy is important in at least two respects: The simplicity of a combination drug should lead to greater compliance and reduce the chances that patients will skip doses and develop resistance. And because the pill is likely to be blocked in as many as two dozen poor countries by the companies that own patents on the three constituent drugs, it may put pressure on some governments to call for emergency drug licenses that could override patents.

The three-in-one drug is intended for sale only in Thailand, home to one of Asia's largest AIDS populations. But the humanitarian group Medecins Sans Frontieres, or Doctors Without Borders, suggests it may purchase supplies for distribution in other poor countries. That would revive the debate over patent protections and drug costs, which activists claim keep millions of AIDS patients from getting treated.

The three-in-one therapy is a combination of GlaxoSmithKline PLC's Epivir, Bristol-Myers Squibb Co.'s Zerit and Boehringer-Ingelheim GmbH's Viramune. The drug companies don't hold patents to the drugs in Thailand, but they do in many countries, including those across Africa.

"It's the simplest regimen available and now it's the cheapest product available," says Rachel Cohen, a spokeswoman for Doctors Without Borders.

The pill is one of several relatively new three-in-one AIDS therapies produced by generic-drug manufacturers, she adds. Two Indian generics makers, Cipla Ltd. and Ranbaxy Laboratories Ltd., say they are selling a comparable pill. The Cipla version sells for about $350 per year per patient, and the Ranbaxy product is $338 a year for a purchase of less than 1,000 tablets, according to Doctors Without Borders. The group says it is treating about 800 HIV-infected patients in nine sites.

Dr. Krisana, 49 years old, has taken on the drug industry before. With her swirling pompadour, aviator-style glasses and round-the-clock work habits, she is a different breed of health bureaucrat. The daughter of a prominent doctor and heiress to a large fortune, Dr. Krisana earned a chemistry doctorate in Scotland and England before returning to Bangkok to work for Thailand's Government Pharmaceutical Organization, or GPO. Most days, her lab churns out everyday generic consumer products, ranging from herbal cough medicines to facial creams. But a few times a week, Dr. Krisana opens a backroom for a more personal experiment -- lowering the price of AIDS drugs.

More than year ago, she started working on a lower-price powdered version of Videx, another Bristol-Myers AIDS drug, along with several other AIDS treatments. Bristol-Myers holds a patent for Videx in pill form in Thailand. Last year, a group of HIV-positive patients and activists seeking a cheaper form of the Videx pill filed a complaint challenging the Bristol-Myers patent. The suit is pending in Thai courts; Bristol-Myers is defending the patent.

Dr. Krisana began experimenting with the new three-in-one formulation in January last year. It took her four months to develop the product, and the GPO managed to patent it in Thailand in May, she says. There are no individual patents for the three ingredient drugs in Thailand, but Dr.

Krisana says she rushed to the government patent office anyway as soon as work on the new combination was finished. "I was afraid somebody else, some multinational, would try to patent it," she says, speaking from Geneva, where she joined dozens of health-care and consumer advocacy groups at a meeting to discuss intellectual property and patent rights.

The new pill comes in two strengths, and the Thai operation has studied it for safety and compatability in patients, for whom it is just like taking the three medicines separately, she says. The pill also will be studied at a large Bangkok hospital after it hits the market in April. Ms. Krisana says already she has received e-mail from officials in Nigeria, Uganda, and other countries expressing interest in buying it. Initial exports may begin in neighboring Southeast Asian countries, such as Cambodia, Vietnam, Myanmar and Laos, she speculates.

Nancy Pekarek, a spokeswoman for GlaxoSmithKline, confirms the British company has no patent for Epivir in Thailand. As far as the possibility of exporting the three-in-one pill out of Thailand, Ms. Pekarek says: "We would look at any patent infringement on a case-by-case basis." A spokesman for Bristol-Myers echoed that position.

Nevertheless, Dr. Krisana is working as an adviser to Doctors Without Borders and other groups on how to build generic-drug plants throughout Africa. "I get tired of fighting," she says. "But I won't stop until we have the ability to make these drugs for everyone who needs them."

Write to Rachel Zimmerman at rachel.zimmerman@wsj.com and Robert Frank at robert.frank@wsj.com

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