HIV/AIDS Drugs: December 2006 Archives

APIWAT KWANGKAEW can still remember the day, nearly five years ago, when Thailand began producing nevirapine, a generic anti-retroviral drug. Within an hour of the announcement, hospital wards across the country were backed up with patients.

These were people who knew they were sick but could not afford treatment. With a population of 64 million, Thailand has more than 1 million people living with HIV/AIDS. Some believe the figure is much higher.

The drug helped save Mr Apiwat's life. Now he is fighting to save others, taking on the US pharmaceutical giant Merck for the right to break the patent on the anti-retroviral drug efavirenz, and produce another generic HIV-AIDS treatment.

Valeant Pharmaceuticals International (NYSE: VRX) announced the sale of certain of its discovery and preclinical assets to Ardea Biosciences, Inc. (formerly IntraBiotics Pharmaceuticals) (OTC: IBPI). The sale includes the rights to Valeant's HIV and cancer development programs.

Under the terms of the agreement, Ardea will make payments to Valeant upon the achievement of clinical milestones for both HIV and cancer programs. Valeant will retain an option, exercisable upon the completion of Phase 2b studies by Ardea, to reacquire rights to commercialize its HIV program outside of the United States and Canada upon Ardea's completion of Phase 3 trials. Ardea will pay Valeant development milestones and royalties upon its commercialization of the HIV and cancer programs. Valeant would make milestone and royalty payments to Ardea related to the clinical advancement and commercialization of the HIV program should Valeant exercise its option to this program.

source - StreetInsider 

St. Paul, Minn. — An AIDS research program at the University of Minnesota is being forced to close after 20 years of running clinical trials. The National Institutes of Health has cut back on domestic research funding for HIV/AIDS, but plans to perform clinical trials in developing nations.

The Minnesota ACTU is one of eight programs whose research grants have not been renewed by the NIH.

Hank Balfour is the principal investigator of the Minnesota ACTU and the University of Minnesota's International Center for Antiviral Research and Epidemiology. He says other public health concerns, like avian flu or bioterrorism, may be perceived to be greater threats.

source - Minnesota Public Radio

MONTREAL, QUEBEC -- December 19, 2006 -- Theratechnologies (TSX: TH) today announced positive top line results for its Phase 3 clinical trial, testing the Company's lead compound, TH9507, in patients with HIV-associated lipodystrophy, a serious medical condition common in HIV patients. The study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. After 26 weeks, patients on TH9507 achieved a 15% reduction in VAT versus baseline and a 20% difference versus placebo. Further, TH9507 was shown to be well tolerated by patients.

Yves Rosconi, President and Chief Executive Officer of Theratechnologies, stated, "We are very excited by the results that we are announcing today. These data add strong support to our clinical development plans for TH9507. The emerging efficacy/safety profile of TH9507 is exactly what we were hoping for. It has great prospects as a treatment for excess visceral fat accumulation in HIV patients, with potential advantages over other approaches being developed. The next step is to confirm these results through a second study. The preparations for the new study in North America and Europe are well advanced and we expect to enroll our first patients during the first quarter of 2007", Mr. Rosconi added.

A new US-funded clinic in downtown Johannesburg is giving hundreds of South African HIV sufferers a first chance to afford anti-retroviral drugs by offering them at a third of the market rate.

For years, patients with the AIDS virus have either had to dole out thousands of dollars a year for anti-retrovirals (ARVs) and accompanying treatment or else try their luck with the groaning public health system.

But now the Zuzimpilo medical centre, based in a rundown building at the heart of Johannesburg's inner city, aims to relieve some of the pressure on both cash-strapped patients and over-stretched hospitals.

The National Alliance of State and Territorial AIDS Directors on Tuesday released the latest ADAP Watch on AIDS Drug Assistance Programs, which are federal- and state-funded programs that provide HIV/AIDS-related medications to low-income, uninsured and underinsured HIV-positive individuals. A synopsis of the report appears below.

The report finds that as of Nov. 15, 340 individuals were on ADAP waiting lists in Alaska, Montana and South Carolina. Four states -- Alabama, Indiana, Oklahoma and South Carolina -- have instituted other cost-containment measures since the beginning of fiscal year 2006, the report says.

James Morris, the United Nations special envoy for southern Africa, hailed Malawi for expanding the rollout of anti-retroviral drugs to reach 70,000 AIDS sufferers by the end of this year.

"This is a dramatic increase of 70,000 from 8,000 two years ago... lives have been saved and it's possible to be productive citizens again," Morris, on the second leg of a five-nation visit, told reporters here.

Morris arrived here from Zambia for a two-day visit, the last to the region of his tenure, and will meet government officials, donor representatives, UN agencies and non-governmental organisations.

AIDS Healthcare Foundation (AHF), the US' largest provider of HIV/AIDS healthcare, education and prevention and operator of free AIDS treatment clinics in the US, Africa, Latin America/Caribbean and Asia, today joined scores of other global AIDS advocates in praising Thailand's Ministry of Health announcing its intention to issue a compulsory license for the lifesaving HIV/AIDS drug Efavirenz, made by Merck. World Trade Organization regulations include flexibilities, which allow governments to issue compulsory licenses without consulting the foreign patent owner.

"We applaud Thailand's Ministry of Health for courageously issuing this compulsory license to make an affordable version of the AIDS drug Efavirenz," said Michael Weinstein, President of AIDS Healthcare Foundation. "With this one move, Thailand has placed the health of its citizens ahead of drug company profits and now stands with Brazil and Malaysia as a model for countries around the world whose people are in need of lifesaving AIDS medicines. We call on governments in countries where people continue to lack access to urgently-needed AIDS drugs to follow Thailand's lead and pursue all tactics necessary to provide their citizens with lifesaving medicines."

source - Phama Lexicon 

International diabetes experts warn that one of South Africa's most commonly used anti-Aids drugs could, in the long term, send the country's diabetes rates spiralling.

The concern has prompted a local HIV and Aids expert, who referred to the drug as "the villain" among first-line treatment, to call on pharmaceutical companies to make alternatives more affordable.

Dutch diabetes expert Professor Peter Reiss raised the alarm on the second day of the World Diabetes Congress currently on in the city.

But he warned that the toxicity of d4T should not be used as an argument for withholding lifesaving treatment.

BEIJING, Dec. 6 (Xinhuanet) -- Thailand's public health ministry announced Wednesday it will issue a compulsory license for a patent held by the Merck pharmaceutical company for the AIDS treatment drug efavirenz.

Thailand is developing its own generic version of the drug using the country's public drug manufacturer, the Government Pharmaceutical Organization. Production is expected to begin next year, and the compulsory license will allow the importation of generic efavirenz from India in the meantime.

International organization Médecins Sans Frontières (Medicine Without Frontiers) welcomed the decision and urged the government to issue similar licenses for other essential medicines.

Indian pharmaceutical companies Cipla and Ranbaxy under an agreement with the Clinton Foundation will reduce the prices of 19 different pediatric antiretroviral drugs in 62 developing countries to an average of 45% less than what treatments currently cost in the countries, former President Clinton announced on Thursday ahead of World AIDS Day on Dec. 1, the AP/Forbes reports (George, AP/Forbes, 11/30).

One of the formulations, a new three-in-one treatment for children, will cost about 16 cents per day, or $60 annually, according to the foundation. (Clinton Foundation release, 11/30). The antiretrovirals will be supplied directly to countries' governments and then will be distributed through public health programs and HIV prevention programs (AP/Forbes, 11/30). 

Some of the world's biggest pharmaceutical companies, including FTSE 100 giant GlaxoSmithKline, have failed to sign a formal agreement that would ensure HIV and Aids patients in poor nations receive vital drugs.

The agreement was drawn up during three years of talks between companies and the International Federation of Chemical, Energy, Mine and General Workers' Unions (ICEM), which has 20 million members and 400 affiliated unions worldwide. As well as GSK, the other companies involved are Pfizer, Roche, Boehringer Ingelheim, Bristol Myers Squibb, Merck, Abbott Laboratories and Gilead Science.

The plan proposes that companies provide "high-quality HIV/Aids medicines and related products for impoverished people in sub-Saharan Africa and other least developed countries (LDCs) at no-profit prices".