News (Updated October 22,
2005)
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Dr Patrick Chikusu, principal investigator of clinical trials of traditional herbal remedies, said three herbal drugs had been selected for the trials, including a remedy mixed by former Works and Supply Minister Ludwig Sondashi, a lawyer.
"We have started clinical trials for three products on human beings. The process has undergone extensive research by our team and we have met World Health Organization (WHO) specifications," Chikusu told a news conference.
"The drugs show they are able to reduce the viral load and increase CD4 cells, which defend the body, and that is why we have proceeded with further trials. We have been using WHO 2003 guidelines on herbal remedies," Chikusu said. "They are also safe," he added.
CD4 cells are the front line of the body's immune system.
One in five Zambians is infected with HIV or is living with AIDS. The country has 10 million people.
Chikusu, a medical doctor, said 14 natural remedies were initially submitted for preliminary tests, but only three had made it to the final stage of clinical trials.
Health Minister Sylvia Masebo said the three drugs had been checked thoroughly to ensure they were not toxic.
"It is a momentous occasion for Zambia which establishes a partnership between conventional medicine and traditional medicine," Masebo told reporters at the same news conference.
Chikusu said 25 patients had been placed on the three herbal remedies on a three-month trial basis.
He identified the remedies as the Sondashi Formulation invented by the former minister, the Mailacin Formulation, which was developed by a school teacher, and the Mayeyanin Formulation.
Doctors say that despite some price rebates to poor countries and limited government assistance, Western-made life-prolonging antiretroviral drugs cost as much as $500 per monthly dose in Zambia, well beyond the reach of many poor people with HIV.
Like most countries across southern Africa, Zambia has been grappling with ways to reduce HIV infections. The country's treasury says AIDS is killing qualified professionals faster than it is able to train replacements.
Tuesday October 18, 5:11 pm ET
"The rescheduling is simply the result of Trimeris and its outside auditors requiring two additional days to complete the normal review of the financial results, and is not related to any accounting irregularities or extraordinary items," the company said in a statement.
Fuzeon sales for the quarter were $48.9 million, a 43 percent increase from a year ago, but a 9 percent decline from the second quarter.
Morrisville, N.C.-based Trimeris recognized royalty revenue of $2.6 million off the second-quarter sales. The company did not say how much royalty revenue it received in the latest quarter.
Trimeris said sales were down sequentially because of a large bulk purchase by the Brazilian government that inflated second-quarter sales and an expected seasonal decline. U.S. and Canadian sales rose 13 percent from the second quarter.
Trimeris postponed its report until Thursday.
Tuesday October 18, 4:40 pm ET
Gilead Sciences Third-Quarter Earnings Climb 58 Percent, Led by Truvada Uptake
The company's earnings increased to $179.2 million, or 38 cents per share, from $113.2 million, or 25 cents per share, a year ago.
Revenue grew 51 percent to $493.5 million from $326.2 million, led by higher sales of its Truvada HIV drug, along with its AmBisome antifungal therapy and its Hepsera treatment for hepatitis B.
Analysts polled by Thomson Financial expected slightly lower results -- earnings of 37 cents per share and sales of $487.6 million.
Overall HIV sales grew 59 percent to $363.5 million, with Truvada sales growing 32 percent to $162.4 million. The company's older Viread and Emtriva products posted sales declines as patients switched to Truvada, Gilead said.
AmBisome sales grew 10 percent to $54.7 million and Hepsera sales surged 58 percent to $46.9 million.
Gilead shares slipped $1.73, or 3.6 percent, to $46.50 in recent after-hours trading. Earlier, the stock closed up 50 cents to $48.23 on the Nasdaq.
Monday October 17, 4:37 pm ET
By Mark Sherman, Associated Press Writer
Eighty-five percent of prescriptions written for Serostim, accounting for roughly $615 million in sales, were unnecessary, said Michael Sullivan, the U.S. attorney in Boston who led the four-year federal investigation into the marketing of the drug.
The cost of many of those prescriptions, $21,000 for 12 weeks of treatment, was paid by Medicaid, the joint federal-state health program for the poor, and other government insurance plans.
Serostim is used to treat AIDS "wasting," an often-fatal condition involving severe weight loss. The demand for the drug diminished in the late 1990s with the advent of "cocktails" of AIDS drugs that made patients less susceptible to wasting.
Prosecutors began their investigation after several U.S. employees of Swiss-based Serono claimed fraud. The result, announced Monday at the Justice Department, was the third-largest health care fraud settlement: a criminal fine of $136.9 million and civil penalties of $567 million.
"Serono put its desire to sell more Serostim above the interests of patients and the public," Attorney General Alberto Gonzales said at a news conference.
As part of the plea, Serono Laboratories will be barred from participating in federal health programs for five years, although company officials said Serostim and other Serono products made by other company units will remain eligible for reimbursement under federal insurance programs.
Thomas G. Gunning, Serono's vice president and general counsel in the United States, said, "The activities described in the settlement were confined to one unit in our U.S. operations and cover a brief period in our history." The company's U.S. headquarters is in Rockland, Mass., a half-hour south of Boston.
Serostim, which contains the human growth hormone Somatropin, was approved by the Food and Drug Administration in 1996.
At about the time the FDA approved the drug, protease inhibitor drugs came on the market. Those drugs, when used in combinations or "cocktails," sharply curtailed the AIDS virus in patients, making them less prone to AIDS wasting.
When the demand for Serostim also was greatly diminished, Serono's U.S. operations sought to find new ways to get the costly drug into patients' hands.
Serono offered doctors free trips to the south of France in return for agreeing to write up to 30 new prescriptions for Serostim.
The company also conspired to introduce a test for AIDS wasting, despite not having FDA approval. The test diagnosed AIDS wasting even without weight loss, Sullivan said.
Prosecutors saw no evidence that anyone who was prescribed the drug unnecessarily was made sicker by it, he said.
No doctors have been charged. Sullivan would not comment on whether the ongoing investigation is looking at doctors' actions.
Five former Serono executives also have been indicted, he said. In addition, RJL Sciences, the company that made the testing devices, and its president, Rudolph Liedtke, pleaded guilty in April for their role in the conspiracy and are awaiting sentencing, Sullivan said.
Geneva-based Serono has eight biotechnology products on the market in the fields of reproductive health, neurology, dermatology and treatment of HIV-associated wasting and growth deficiencies.
The company earned $494 million on sales of $2.46 billion in 2004. Shares of its stock fell 1.2 percent to $649 in trading Monday on the Zurich exchange.
The federal investigation grew out of whistleblower lawsuits filed by U.S. employees of Serono. Five people will split $51 million as their share of the settlement, which is allowed under the federal False Claims Act, according to the settlement agreement.
Monday's settlement is the latest in a series of whistleblower claims that have resulted in more than $3 billion in payments from drug companies in recent years.
Last month, GlaxoSmithKline PLC said it will pay $150 million to settle claims it overcharged the government for two anti-nausea drugs.
Federal and state officials are looking into 150 price and marketing fraud cases involving more than 500 drugs, according to Peter Keisler, assistant attorney general in charge of the Justice Department's Civil Division.