Gilead Sciences and Aspen Pharmacare sign letter of intent to establish non-exclusive Licensing and Distribution Agreement for antiretrovirals aruvada and viread in developing world countries
Foster City, CA, and Johannesburg, South Africa, April 25, 2005 - Gilead Sciences, Inc. (Nasdaq: GILD) and JSE Securities Exchange listed Aspen Pharmacare (APN) today announced that the companies have signed a letter of intent under which they have committed to enter into a non-exclusive licensing and distribution agreement for Gilead's antiretroviral (ARV) products Truvada (emtricitabine and tenofovir disoproxil fumarate) and Viread (tenofovir disoproxil fumarate).
Anti-retrovirals (ARVs) could cost South Africans as little as about R100 a month and local manufacturing of generics could start as early as next month, it was announced on Tuesday.
The study on anti-retroviral therapy conducted by the Luisa Guidotti Hospital at All Souls Mission in Mutoko for people living with HIV provides new insights into the HIV and Aids disease that can point to new research directions in Zimbabwe.
A session on tuberculosis and HIV at the South African AIDS Conference in Durban last week, sponsored by CAPRISA - the Centre for the AIDS Programme of Research in South Africa - was largely given over to discussing a pilot project at the Prince Cyril Zulu Communicable Diseases Clinic (formerly, the Durban Chest Clinic), which could form the basis for a large scale programme to integrate ARV treatment with TB care. The pilot study for the planned START trial, as presented by Dr Chris Jack, enrolled 20 patients diagnosed with TB and HIV, 15 of them female, 5 male, to look at the feasibility of combining a once-daily triple combination of ARVs with a fixed-dose four-drug TB treatment regimen. The ARV regimen consists of ddI (didanosine), 3TC (lamivudine) and efavirenz, provided by the Indian generic company Cipla in a single blister pack as ‘Odivir’. The TB treatment, for the initial stage of treatment, was with 'Rifafour', containing rifampicin, isoniazid, pyrazinamide and ethambutol. Some patients also received co-trimoxazole prophylaxis, which is in fact recommended for all co-infected people and may be especially important when the CD4 count is below 200 (in this study, 6 of the patients were in that category). A presentation by two medical students highlighted the impact of the pilot treatment study on patients and staff at the clinic, making an important point about infrastructure for ARV delivery in South Africa and other countries. The majority of patients treated for TB in KwaZulu Natal are HIV positive. At present, if they survive to the end of six months treatment for TB, many die soon after, of other infectious diseases. This has demoralised both patients and staff, and led to poor completion rates for treatment. On the other hand, even the limited prospect of expanding access to ARVs represented by the planned trial has given new hope and a stronger incentive to persevere with TB treatment. A high proportion of patients at the clinic express willingness to take ARVs and the availability of ARVs definitely affects their readiness to be tested for HIV. Reviewing drug interactions, Dr Andy Gray observed that the clinical significance of the reduced blood levels of efavirenz seen when it is co-administered with rifampicin was sufficiently unclear, that clinical trials might be justified. Dr Quarraisha Abdool Karim, who introduced the session, observed that treatment for people with HIV who are coinfected with TB would be an essential strategy for targeting ARV treatment to those South Africans who could benefit most from it, and where the benefit to public health would be greatest. (Source: Julian Meldrum, AIDSMAP,12 August 2003) * For other news from the AIDS conference as reported by AIDSMAP see http://www.aidsmap.com
The Director of the pharmaceutical company, Cipla, confirmed that the UK-based Glaxo Wellcome had written to Cipla in August this year suggesting that it stop exports of Duovir, a brand containing anti-viral drugs lamivudine and zidovudine, to Ghana as both drugs were under patent to Glaxo Wellcome. The two anti-viral drugs are given to patients suffering from the Acquired Immuno Deficiency Syndrome, which has reached epidemic proportions in Africa. The African continent is currently a hotbed of controversy and debate on whether manufacturers other than patent holders should be given licenses by the government to mass-produce AIDS drugs at lower costs. Cipla has replied to Glaxo contesting the claim. The company says certain patent applications were filed prior to 1993 and the law of the land does not allow such patents to be enforceable.