New 500 mg Tablet Will Offer Improved Patient Convenience

Basel, June 22, 2004 � Roche today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market a new 500 mg tablet formulation of its HIV protease inhibitor Invirase � (saquinavir mesylate). The new 500 mg formulation will simplify the dosing regimen for patients by drastically decreasing their daily pill burden by more than half, from ten pills to four. It is also smaller in size than the currently available 200 mg capsule and has been specifically tailored to the standard �boosted' regimen of 1000 mg Invirase/100 mg ritonavir. A filing to market the new Invirase 500 mg formulation in Europe will be submitted to the European Medicines Agency (EMEA) within days of the U.S. filing.

The enhanced patient convenience of the new formulation together with the efficacy and safety of Invirase provides an improved treatment option for patients with HIV. Invirase is one of the recommended protease inhibitors in the World Health Organization (WHO) guidelines and the British HIV Association (BHIVA) treatment guidelines.

�It is important to develop anti-HIV therapies that are not only potent and well-tolerated but will also improve convenience for patients, which can help to maximize adherence to a treatment regimen,� said Nicholas Bellos, M.D., President, Southwest Infectious Disease Associates, Dallas, Texas.

�The 500 mg tablet is another important example of Roche's commitment to the treatment of HIV and to the continued optimization of dosing for Invirase. If approved, it will offer patients a smaller pill and the ability to take a full dose with fewer pills,� said Max Bucher, Global Head of Hospital Care Business, Roche. �We will extend our commitment to Invirase through a comprehensive clinical program that will further explore its role in the treatment of HIV.�

References

1.        Dragsted UB, Gerstoft J, Pedersen C et al. JID . 2003;188:635-642. [MaxCmin 1 trial]
2.        Youle M, Gerstoft J, Fox Z et al. 2 nd IAS . Paris , France , 2003; Poster LB23. [MaxCmin 2 trial]

Notes to editors:

MaxCmin 1 and MaxCmin 2 trials

Head-to-head trials of boosted protease inhibitors. In the trials saquinavir/r 1000/100 mg bid outperformed indinavir/r 800/100 mg bid in efficacy and showed comparable antiviral potency to lopinavir/r 400/100 mg bid .

Roche in HIV

Roche is at the forefront of efforts to combat HIV infection and AIDS, committed since 1986 to groundbreaking research and development of innovative new drugs and diagnostic technology.

Invirase (saquinavir) was the first protease inhibitor (PI) and was introduced by Roche in 1995. Invirase/r (saquinavir 1000/ritonavir 100mg) has shown high efficacy, an excellent safety and tolerability profile and is recommended in the new antiretroviral WHO guidelines. Invirase is used in double boosting, a new treatment trend which combines two PIs with a minidose ritonavir. Viracept (nelfinavir) has proven efficacy and safety in the treatment of HIV infection and is widely used as a first line early treatment. It has a unique cross-resistance profile, which is clinically proven to allow the future use of other drugs in its class. Roche Viracept 625mg provides reduced pill count and improved GI tolerability and received approval in Europe in May 2004. Viracept is supplied by Roche outside the USA , Canada , Japan and Korea .

FUZEON received approval from the US Food and Drug Administration (FDA) in March 2003, and from the European Commission and Switzerland in May 2003 and Canada in July 2003.

In addition, Roche successfully markets the AMPLICOR HIV-1 MONITOR TEST, version 1.5. This test from Roche Diagnostics is considered to be a highly sensitive measurement of the amount of HIV circulating in a patient's blood (�viral load�). With a limited number of treatment regimens available, the accurate monitoring of viral load levels is essential to establish and monitor the effectiveness of therapeutic regimens and assess the potential onset of drug resistance.

Roche is a committed partner of the Accelerating Access Initiative to increase access to HIV care in sub-Saharan Africa and the world's Least Developed Countries. For more information on Roche policy and pricing of HIV protease inhibitors for these regions and research in HIV, visit www.roche-hiv.com .

About Roche

Headquartered in Basel , Switzerland , Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

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