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HIV-1 and HCV NAT Blood Screening Tests to be Supplied to Blood Bank Market By Both Chiron and Roche EMERYVILLE, Calif. -- Chiron Corporation (Nasdaq: CHIR) announced today that it has reached agreement on definitive licensing terms with F. Hoffmann-La Roche ("Roche") under its human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) intellectual property for nucleic acid testing (NAT) to screen blood, plasma, and blood products intended for transfusion. This agreement will replace the earlier interim licensing arrangement agreed to by Chiron and Roche in October 2000. Roche is now licensed to manufacture and sell probe-based HIV-1 and HCV blood screening tests worldwide, in both single donor and pooled formats, for the life of the patents. This license contains new royalty rates that are based on the number of donations tested and not on test kits sold. These rates will be phased-in during the remainder of 2001, so that by 2002 all probe-based HIV-1 and HCV blood screening tests sold by Roche worldwide will bear royalties under the new agreement. Chiron and Roche have agreed that in certain regions of the world, including Africa and most of Asia, the HIV-1 license will be free of royalties. In addition, the parties have agreed that the HCV royalties will be discounted in these regions. "The safety of blood products worldwide remains a corporate priority for Chiron," commented Sean Lance, Chiron's chairman and chief executive officer. "This agreement ensures that the tests will be provided by Chiron and Roche, guaranteeing a reliable supply structure," Lance continued. "A decade ago, Chiron pioneered HCV immunoassay screening of blood with our partner Johnson & Johnson and our licensee Abbott. Now NAT testing is offered by Chiron with our partner Gen-Probe and our licensee Roche," said Rajen Dalal, president of Chiron's Blood Testing Division. "Both technologies complement each other and help make the blood supply in Europe, North America, Japan, and areas in Asia/Pacific safer than it has ever been. Now our task is to make these tests available in regions where the need remains acute," Dalal continued. In October 2000, the two companies entered broad license agreements covering clinical diagnostics for HIV-1 and HCV. Under the previously announced agreements, Chiron granted Roche worldwide licenses to manufacture and sell probe-based HIV-1 and HCV clinical diagnostic tests covered by Chiron's HIV-1 and HCV patents. At that time, the companies entered into an interim NAT license agreement to permit Roche to continue to serve its blood screening customers while final terms were negotiated. Approximately 50 million units of whole blood are donated and screened annually in target markets throughout the world, including approximately 18 million in Europe, 13 million in the U.S., and 6 million in Japan. Of the 13 million annual whole blood donations in the U.S., 70% are tested with the Chiron Procleix™ HIV-1/HCV Assay, a nucleic acid amplification test, under an Investigational New Drug (IND) application. In March, the Biologics License Application (BLA) for the Chiron Procleix™ HIV-1/HCV Assay was accepted for review by the U.S. Food and Drug Administration (FDA). The Chiron Procleix™ System is in use in Australia, France, Italy, Portugal, Spain, and Singapore and commercial evaluations are ongoing elsewhere. The Chiron Procleix™ HIV-1/HCV Assay is designed to detect the presence of HIV-1 or HCV during the earliest stages of infection when an infectious agent appears in the blood but cannot yet be detected by current serological screening technologies. Utilizing state of the art transcription mediated amplification (TMA) technology developed by Gen-Probe Incorporated ("Gen-Probe"), a wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd. (Ticker Symbol: 4519, Exchanges: OSA TYO OTH), the assay may significantly reduce the time between infection and detection, known as the "window period." Industry data show that this window period can be reduced by as much as 85 percent in the case of HCV and 50 percent in the case of HIV-1. Chiron Blood Testing Chiron Blood Testing is a leading supplier to the blood banking industry worldwide. In 1998, Chiron and Gen-Probe began a collaboration for the development and marketing of improved infectious disease blood screening tests, such as HIV-1, HCV and hepatitis B virus (HBV), incorporating a novel and highly sensitive nucleic acid amplification technology. Chiron also develops and markets immunoassay screening and supplemental tests, including Chiron RIBA™ SIA confirmatory tests, as well as hepatitis and retroviral antigens through its joint business with Ortho-Clinical Diagnostics, Inc. (a Johnson & Johnson Company). Chiron's leadership in the field of HCV began with the company's discovery and successful cloning of the virus in 1987. In addition to licensing technology to Roche, Chiron has also licensed HCV technologies to other companies working to prevent and treat this disease as part of an active out-licensing program. Major licensees of Chiron HCV technology include Abbott Laboratories, Bayer AG, Ortho-Clinical Diagnostics (a Johnson & Johnson company), BioRad Laboratories and Gen-Probe for diagnostics, and Pharmacia, Glaxo Wellcome and others for therapeutic applications. About Chiron Chiron Corporation, headquartered in Emeryville, California, is a leading biotechnology company that participates in three global healthcare markets: biopharmaceuticals, vaccines, and blood testing. The company is applying an integrated scientific approach to the development of innovative products for preventing and treating cancer and infection. For more information about Chiron, visit the company's web site at http://www.chiron.com. This news release contains forward-looking statements that involve risks and uncertainties. Among the uncertainties related to the forward-looking statements made in this release are the regulatory approval and commercial acceptance of Chiron's products and Roche's products. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company files with the SEC, such as form 10-Q and 10-K. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review, manufacturing capabilities and marketing effectiveness. NOTE: Procleix and RIBA are trademarks of Chiron Corporation. Fonte: http://www.prnewswire.co.uk/cgi/news/release?id=67501 Consultado em 05/03/2007

SUMMARY: The battle over AIDS drug patents has moved to Brazil, where the government says Merck has threatened legal action over importation of a knockoff drug. U.S. drug maker Merck and Co Inc. has threatened to take Brazil's state-owned pharmaceutical firm to court for allegedly violating the patent on an AIDS drug, Brazilian officials said on Monday. Merck says Brazil's Far-Manguinhos laboratory violated its patent on Stocrin by importing a generic form of the drug known as Efavirenz from India. The company sent an informal letter to Far-Manguinhos requesting the purchase be stopped. Far-Manguinhos, which is part of the government's Oswaldo Cruz research foundation, said it imported only a small amount of the drug for research purposes, which is permitted under Brazilian law. It does not use the imported version of the drug commercially. "They are demanding that we cancel the purchase and halt our studies and if we don't they say they are going to take us to court," said Eloan dos Santos Pinheiro, director of drug technology at Far-Manguinhos. The Brazilian laboratory and research firm said the letter was sent at the beginning of the month and must be responded to by April 3. "We did send a letter ... asking them to reconsider that activity because from our view it would be a violation of the patent in Brazil," said Merck spokesman Gregory Reaves. Reaves declined to comment on whether Merck would take Far-Manguinhos to court if it does not stop purchasing the Indian-manufactured drug. Still, the latest standoff is just part of an ongoing feud between Brazil and U.S. pharmaceutical companies. Brazil openly admits that it is researching the make-up of Efavirenz so that it can violate Merck's patent starting in June if the company does not agree to lower its prices. "If they negotiate a lower price, we are not going to manufacture it, but if they don't, we want to be prepared," Pinheiro said. Model in AIDS Fight Brazil's controversial law allowing it to violate patents under certain conditions has helped make the country a model in the global AIDS fight. But it has also sparked criticism from the international pharmaceutical industry. U.S. drugs makers pushed the U.S. government to submit a request to the World Trade Organization (WTO) to establish a dispute panel to examine charges that Brazil's patent law discriminates against imports. Under Brazilian law, foreign firms are required to start manufacturing drugs locally within three years of winning a patent concession or they lose exclusive rights in Brazil. Local industry can also violate patents in emergency situations in "the interest of the public." "It would be in the interest of the public to manufacture Efavirenz if Brazil didn't have the capital to meet the high costs," said Maria Fernanda Macedo, one of Pinheiro's advisors at Far-Manguinhos. Starting in 1996, Brazil's government started making drugs to treat AIDS as part of its policy of free treatment for all patients. Brazil now legally makes eight of the 12 drugs used in the so-called AIDS cocktails. As a result, AIDS drug prices have plummeted more than 70 percent – a typical treatment for an AIDS patient in Brazil costs about $4,400 a year compared with up to $15,000 in the United States -- but prices on those like Efavirenz that do not face competition from locally produced versions have remained high. Efavirenz, which is only used in a relatively small number of cases, consumes more than 10 percent of Brazil's $305 million AIDS drugs budget. Still, Merck plans to offer Brazil "an extremely aggressive discount" on the drug in the very near future, Reaves said. "We believe that patent protection and affordable prices are compatible." At the beginning of the month, Merck said it would offer AIDS drugs at no profit to the poorest of the world's developing countries and to those where AIDS is infecting more than 1 percent of the population, although Brazil does not fall into those categories. In absolute numbers, Brazil suffers from a high rate of AIDS infection with 190,000 HIV cases registered, and 500,000 suspected cases. But only 0.6 percent of the adult population is infected compared to 35.8 percent in Botswana.  Fonte: http://lists.essential.org/pipermail/ip-health/2001-March/001138.html Acessado em 04/12/2006

A publicação do ISA (Instituto Socioambiental) traz o relato de dois seminários internos promovidos pela entidade no intuito de aprofundar a discussão entre seus membros sobre a proteção da biodiversidade e dos conhecimentos tradicion

A intenção deste fórum é congregar diversos atores – planejadores de políticas públicas, laboratórios farmacêuticos, cientistas, etc. – ligados à pesquisa sobre a Aids em pa&iacu

Os autores analisam as relações entre o setor público e o setor privado na produção e distribuição de medicamentos. Dentre as relações analisadas, vale destacar: as responsabilidades do Estado, os meca