Investor Update

Basel, 26 June 2006

U.S. FDA approval of boosted protease inhibitor enables potent new HIV drug combination with Fuzeon

Regimen combining Fuzeon and darunavir shown to provide unprecedented response rates in treatment-experienced HIV patients

The approval today of a ritonavir-boosted protease inhibitor (PI), darunavir, by the U.S. Food and Drug Administration (FDA) will enable physicians and patients to create a potent new treatment combination with Fuzeon (enfuvirtide) for people living with drug-resistant HIV. In pivotal clinical studies with darunavir, up to two-thirds of patients with extensive prior exposure to anti-HIV drugs achieved undetectable levels of HIV when the drug was used in combination with Fuzeon. Co-developed by Roche and Trimeris and first approved by the FDA in March 2003, Fuzeon is the only fusion inhibitor for the treatment of HIV and works in a way that is different from other types of anti-HIV drugs. A product of Tibotec Pharmaceuticals Ltd., darunavir, also known as TMC-114 and the trade name Prezista, is a member of the PI class and is reported to be active against virus that has developed resistance to other PIs.

With the concurrent availability of Fuzeon and darunavir, achieving undetectable HIV in a high proportion of patients with extensive prior exposure to antiretrovirals – an unprecedented result that was previously elusive to many such patients – is now not only realistic, but could quickly become a new standard of care. It is important for clinicians to recognize the potency that Fuzeon, as the only fusion inhibitor, can add to regimens with duranavir,” said Calvin J. Cohen, M.D., MSc., Research Director, Community Research Initiative of New England, Boston. “It may now be possible for many long-term HIV patients struggling against resistant HIV to achieve durable viral suppression with this combination.”

The goal of therapy in extensively treatment-experienced patients, as defined by the Antiretroviral Treatment Guidelines from the U.S. Department of Health and Human Services (DHHS), has evolved over the last several years as newer boosted protease inhibitors, such as duranavir, have entered late-stage clinical trials and become available for use in combinations with Fuzeon. As recently as 2003, the guidelines addressed the treatment of patients with extensive prior exposure to antiretrovirals by commenting that “viral suppression is often difficult or impossible to achieve,” and emphasizing the preservation of immune function and prevention of disease progression as the primary goals of therapy in these patients. In 2005-2006, the guidelines established maximal suppression of HIV as the goal of therapy in this patient population, and recommended the use of an entry inhibitor (such as Fuzeon) with an active ritonavir-boosted protease inhibitor (such as darunavir) as a strategy for achieving that goal.

The benefits of adding one new drug to a failing regimen could be short-lived and result in what is called ‘virtual monotherapy.' It is vitally important that patients who have developed resistance to a significant number of the available antiretroviral medications start at least two fully active drugs to maximize their chances for treatment response and survival, said Nelson Vergel, an HIV treatment advocate who founded SalvageTherapies.org and has been living with the disease for more than 20 years. “This principle has been further substantiated by the excellent clinical results with the combination of Fuzeon and darunavir.”

The results achieved with Fuzeon and darunavir add to an already substantial body of evidence supporting the use of Fuzeon with an active boosted protease inhibitor as the best opportunity for treatment-experienced patients to achieve undetectable levels of HIV. Data from the Fuzeon pivotal trials, TORO 1 and TORO 2, as well as the RESIST studies with tipranavir have consistently validated this approach.

About Fuzeon
Administered via one 90 mg injection twice-daily, Fuzeon is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, Fuzeon works outside the CD4 cell, blocking HIV from entering the cell.  For this reason, Fuzeon is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to Fuzeon. Fuzeon was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

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