Bristol-Myers Squibb

Mpilonhle Project is the community component for the HIV/AIDS anti-retroviral rollout (ARV) at Ladysmith Provincial Hospital in partnership with the Communicable Disease Clinic (CDC).The joint partnership is called Augmented Community HIV Action Project (ACHIVA), and is funded by Bristol-Myers Squibb (BMS) Secure the Future (STF) Program. Mpilonhle works to assist orphans and vulnerable children and people living with HIV and AIDS.

The health department has called for bids for the next AIDS-drug tender, a move keenly awaited by local pharmaceutical firms that invested heavily in developing capacity to make generic copies of patented antiretroviral medicines. SA has the worlds biggest caseload of HIV patients, with about 5,4-million people infected with the virus that causes AIDS.

African countries are facing serious financial and practical dilemmas over implementing recent World Health Organization (WHO) guidelines urging a shift away from d4T-based combinations for first-line antiretroviral treatment, the 2007 HIV Implementers' Meeting heard last week in Kigali, Rwanda.

The long struggle to get women to protect themselves against the HI virus received a major boost this week, when two global pharmaceutical companies signed agreements enabling researchers to create a microbicide using their promising anti-AIDS compounds.

The Medicines Control Council (MCC) has declared a generic version of antiretroviral (ARV) Duovir undesirable and ordered a recall, the manufacturer confirmed on Thursday.

The international courier DHL is the latest multinational company to join the ranks of those providing services at no profit to assist in the roll-out of antiretroviral therapy with the announcement on May 5th that it is to provide non-profit courier services to deliver antiretrovirals.

The World Health Organisation has published new draft treatment guidelines for use in resource-limited setting, with an emphasis on the use of fixed dose drug combinations wherever possible. The guidelines are designed to encourage the scale-up of antiretroviral therapy in the absence of comprehensive laboratory monitoring. The guidelines recommend that drug combinations should use either efavirenz or nevirapine as cornerstones, with either AZT/3TC or d4T/3TC as the nucleoside analogue backbone. The guidelines are intended to help countries choose which drugs to use as the lead regimen in national programmes, but in practical terms it is likely that countries will need to maintain a formulary of the five drugs in order to allow switching between nevirapine and efavirenz, and between AZT and d4T, and to accommodate patients with tuberculosis and pregnant women. In practical terms, it is likely that the WHO guidelines will encourage very wide use of generic antiretrovirals manufactured in India and South Africa. Two weeks ago the Clinton Foundation announced that it had reached agreement with Indian and South African manufacturers to sell a fixed dose combination of d4T, 3TC and nevirapine for $132 a year to Mozambique, Tanzania, Rwanda and South Africa and nine Caribbean states. WHO also recommends a three tier approach to monitoring. At community heath centre level, rapid HIV antibody testing, haemoglobin testing and pregnancy testing are the only tests recommended. Haemoglobin testing is only necessary if AZT is included in the regimen, and it can be done using a haemoglobin colour scale published by WHO. Haemoglobin testing for anaemia is necessary because the condition can worsen when AZT treatment begins. Pregnancy testing is only needed if efavirenz is included in the regimen. At district hospital level, rapid HIV antibody testing and confirmatory testing using a second method are recommended, together with CD4 counting. WHO says it is committed to working with member states to make CD4 counting as widely available as possible. Full blood counts and liver enzyme measurements are also encouraged, as is sputum smear testing for tuberculosis. A full blood count and differentials is preferred to haemoglobin in this setting for measuring anaemia and neutropenia, and for calculating total lymphocyte counts where CD4 cell counting is not possible. Total lymphocyte count is judged to be a useful measure of immune system damage in symptomatic patients, but cannot be used for monitoring responses to treatment. Treatment failure can be judged by the appearance of new symptoms (not to be confused with immune reconstitution syndrome), or the recurrence of a previous opportunistic infection. If CD4 counting is available, the guidelines recommend that treatment should be switched if the CD4 cell count falls below the pre-treatment baseline, or falls at least 50% below its peak level. In either case, clinicians should rule out the effects of tuberculosis. Reinfection with TB could occur without treatment failure. Second line treatment should be based on ddI plus tenofovir or abacavir and either lopinavir/saquinavir or saquinavir/ritonavir. However, both require a secure cold chain for storage of the ritonavir element. Atazanavir, a new protease inhibitor which can be taken once daily and which does not require cold storage, is judged to be too new for use in resource-limited settings.( Source:aidmap 5 November 2003). http://www.aidsmap.com/news/newsdisplay2.asp?newsId=2401 Links:http://www.who.int/hiv/pub/prev_care/draft/en/

JSE Securities Exchange listed pharmaceutical company Aspen Pharmacare (APN) has entered into an agreement with the US-based Clinton Foundation for the manufacture of antiretroviral (ARV) medicines. Former US President Bill Clinton announced in New York that his Foundation has reached an agreement with Aspen and selected other leading multinational generic drug manufacturers on a major reduction in the price of HIV/Aids medicine. As a result, it will be easier to make life-saving drugs widely available to people with HIV/Aids in the developing world, Aspen said in a statement on Friday. ARVs supplied by these companies have been certified to be of high quality by the World Health Organisation and the Medicines Control Council of South Africa (MCC). This agreement will allow the delivery of life-saving medicines to people who desperately need them, Clinton said. It represents a big breakthrough in our efforts to begin treatment programmes in places where, until now, there has been virtually no medicine, and therefore no hope. Stephen Saad, Aspen Group Chief Executive said: As Africa's largest generics manufacture, this agreement further endorses the Group's quality manufacturing, scientific and development capabilities, placing Aspen in a league with the leading international generic pharmaceutical manufacturers. Aspen has continually stated its commitment to contributing toward the fight against the HIV/Aids pandemic, and this was recently evidenced by the launch of Aspen Stavudine - the first generic ARV developed and manufactured in Africa, Saad said. This initial ARV demonstrates Aspen's commitment to healthcare in southern African and underlines the scientific and manufacturing capabilities that exist within the country at Aspen's Port Elizabeth based research and production facilities. He added that Aspen is presently in the process of enhancing its manufacturing facilities with the addition of a new multi-million rand oral solid dosage manufacturing facility to service both domestic and offshore markets. The agreement covers ARVs delivered to people in Africa and the Caribbean where the Clinton Foundation is working with governments and organisations to set up country-wide integrated care, treatment and prevention programs. Under the Clinton Foundation agreement, the price of one of the commonly used triple drug therapy combinations will be available for less than US$140 per person per yea - or 36-38 cents per person per day - a reduction of one- third to one-half in the current price of drugs in the developing world, said Clinton. Saad said Aspen's ARV offering should be bolstered shortly by the addition of Didanosine, Lamivudine, Zidovudine, the Lamivudine/Zidovudine combination and Nevirapine which have been submitted to the MCC for registration. These additional licenses were made available to Aspen through arrangements with Bristol-Myers Squibb, GlaxoSmithKline and Boehringer Ingelheim. As a result of the voluntary licenses secured, Aspen infringes no patent regulations. The Clinton Foundation has been working with the companies on this agreement over the course of the past nine months, focusing on ways to reduce their costs and scale up production of the so-called triple drug cocktails, which can substantially extend the lives of people living with Aids and help prevent mother-to-child transmission of HIV. ( Source: , Business Day 24 October 2003)

he first generic antiretroviral drug that can be sold without its manufacturer being sued will be on the shelves in South Africa shortly. Aspen Pharmacare, the country's largest generics company, is awaiting finalisation on details from the Medicine Control Council for Stavudine. Precious Matsoso, the registrar of medicines at the Medicine Control Council, confirmed this week that Stavudine, which trades as Zerit in the Bristol-Myers Squibb stable, has been registered. Generics need to overcome two hurdles in this country: they need to be registered by the council and obtain the go-ahead by the multinational should a patent still exist. Multinationals generally have 20-year patent protection of drugs in their stable. Bristol-Myers Squibb waived its rights to Stavudine, saying it would not sue Aspen if it manufactured the drug and sold it to about 43 countries in Africa. Aspen subsequently developed the generic version and has been awaiting approval from the council. Stavudine is one of three drugs necessary in a package comprising Stavudine, Limivudine and Nevirapine. A year's worth of Zerit (recently significantly discounted by Bristol-Myers) costs R554.64 including VAT in sub-Saharan AfricaLinda Philip, chief executive of Aspen Pharmacare Southern Africa, says the company will go to market at a lower price than the originator. Aspen also has voluntary licences from GlaxoSmithKline to develop generics of AZT and 3TC and Combivir (a combination of the two), as well as avoluntary licence from Boehringer Ingelheim to make a Nevirapine generic. These drugs are awaiting registration from the council. Philip says the event is symbolically important. We're hopeful it's close to market and that we'll have the first legal South African registered generic to market. Philip says that as more generics come to market, they could replace other components of Aids cocktail drugs, making the whole package cheaper. The drug will trade as Aspen Stavudine. The impact on Aspen's profitability will be through additional volumes, improving economies of scale. Other generic antiretrovirals have been registered in South Africa, but cannot be sold legally as this would override patent protection, a cornerstone of world trade law. Activist groups such as the Treatment Action Campaign are trying to push the government to issue compulsory licences, which would enable businesses in this country to produce the drugs, on the basis of a national emergency. They say loopholes exist in legislation that allow for violation of patent protection on this basis. German company Boehringer Ingelheim said recently it would not interfere with countries that issued compulsory licences. (Source: http://www.sundaytimes.co.za/2003/07/06/business/news

The Secure the Future Monitoring and Evaluation Unit is looking for a Post-Doctoral Fellow to be based at Yale University, Connecticut, USA. The Center for Interdisciplinary Research on AIDS (CIRA) based at Yale University has recently established a Monitoring and Evaluation (M&E) Unit for the Bristol-Myers Squibb Secure the Future (STF) initiative. CIRA supports research in HIV prevention and care undertaken by 50 University scientists with appointments in five of the University's graduate and professional schools. CIRA will bring this expertise to benefit Secure the Future's M& E Unit to monitor and evaluate progress of the more than 50 community based and medical research projects supported by STF. The MEU will analyse progress and field visit reports and provides the projects technical assistance as required. The M&E Unit is seeking to identify a post-doctoral fellow from one of the STF countries in Southern Africa, who will be based at CIRA for a one year period. The primary responsibilities of the post-doctoral fellow will be to serve as a resource from the Southern African region to Yale, and to help with the increasing amount of liaison work between Yale and the STF consultants, principle investigators and field staff in Southern and West Africa. The fellow will review progress reports of the STF projects, assist in linking scientific expertise at CIRA to the projects, and maintain a resource library for use by the principal investigators of the projects. The fellow will have an opportunity to attend classes at Yale and participate in the many activities and projects undertaken by CIRA. Interested candidates should have, within the past two years:- · completed medical training or · received a PhD in social, behavioural or management sciences, or · received a doctoral degree in public health The candidates should have demonstrated ability to design, carry out and analyze results of research projects and have an interest in pursuing a career in HIV/AIDS research. The Fellow will work with a team of evaluators and clinical monitors. All expenses associated with Fellowship will be paid by Secure the Future™. The Context SECURE THE FUTURETM is the US$115-million commitment by Bristol-Myers Squibb to find sustainable and relevant solutions for the management of HIV/AIDS in women and children and provide resources to improve community education and patient support in five countries in southern Africa and four in West Africa. It began as a five-year, $100 million commitment to southern Africa: South Africa, Botswana, Namibia, Lesotho and Swaziland. On March 14, 2001, Bristol-Myers Squibb pledged an additional $15 million for four countries in Western Africa: Senegal, Cote d'Ivoire, Mali and Burkina Faso. For more information visit Secure the FutureTM at www.securethefuture.com. To send your CV: Fax number: +27 11 456 6589 e-mail: annette.ackerman@yale.edu cc: phangisile.mtshali@bms.com 4. Closing Date Please send your CV before the closing date of 28 February 2002. Immediate applications will be preferred.