Basel, 20 December 2004

Roche's new Invirase 500 mg receives approval in US after priority review by FDA

Significant improvement of patient convenience by reducing pill count from 5 pills to 2 pills twice a day

Roche's new Invirase 500 mg formulation has received U.S. Food and Drug Administration (FDA) marketing approval today following a six-month priority review process. The new 500 mg formulation will significantly reduce Invirase's pill count by more than half, from 5 to 2 pills twice a day. With less tablets per day, Invirase now becomes an excellent choice for HIV-patients who require treatment with an HIV-protease inhibitor.

"With the new Invirase 500 mg tablet now available, pill burden is considerably reduced and we anticipate that this improved convenience together with boosted Invirase's record of convincing data will result in an expansion of its use in the earlier stages of HIV therapy" said William M. Burns, Head of the Roche Pharmaceutical Division.

Invirase (saquinavir mesylate) is an HIV protease inhibitor approved for use in combination with a small dose of ritonavir ('boosting') and other anti-HIV medicines for the treatment of HIV infection. Boosted Invirase has been shown to be highly efficacious, with an excellent safety and tolerability profile and is recommended as first choice boosted protease inhibitor in the International AIDS Society (IAS) guidelines.

"The FDA approval of Invirase 500 mg together with the recently reported results of the Staccato trial is good news for patients as they now have access to a more convenient dosing regimen of a potent and well tolerated HIV drug" said Michael S. Saag, MD, Professor of Medicine and Director, UAB AIDS Outpatient Clinic, Birmingham, Alabama, USA. "In the Staccato trial patients treated with saquinavir/ritonavir showed one of the highest response rates in a clinical trial; after 24 weeks of treatment the HIV-virus was undetectable in around 90% of patients (1) ."

About Boosted Invirase
Invirase, originally approved by the FDA in 1995, was the first HIV protease inhibitor on the market. Its introduction represented a major milestone in the treatment of HIV/AIDS. In December 2003, the FDA approved Invirase for use in boosted dosing regimens with ritonavir (1000 mg Invirase/100 mg ritonavir bid). Co-administering Invirase with ritonavir enhances therapeutic blood levels of the drug and enables simplified dosing.

Data from the Staccato clinical study show reductions in patients' HIV RNA recorded in the first 24 weeks on therapy that are the best ever seen in a large cohort of patients given HAART. Some 96% of patients achieved viral load reductions to <400 HIV RNA copies/ml and 91% were shown to have undetectable levels (<50 HIV RNA copies/ml). Over the 24 week induction phase of the study, these reductions in patient viral load were accompanied by a median increase of CD4 cells of 109 cells/mm3.

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 twice daily) has shown high efficacy, an excellent safety and tolerability profile and is recommended as first choice boosted protease inhibitor in the International AIDS Society (IAS) guidelines. Viracept (nelfinavir) has proven efficacy and safety in the treatment of HIV infection and has a unique cross-resistance profile, which is clinically proven to allow the future use of other drugs in its class. 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, 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/home/home.cfm

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative 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 is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

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(1) By an intent to treat analysis.

Notes to Editors
References
Ananworanich J, Ruxrungtham K, Siangphoe U et al. XV IAC, 2004, poster TuPeB4469

Media Relations Contacts
Phone: +41 61 688 88 88 / e-mail: basel.mediaoffice@roche.com
- Baschi D�rr
- Alexander Klauser
- Daniel Piller (Head Roche Group Media Office)
- Katja Prowald (Head Science Communications)
- Martina Rupp

With best regards,
Your Roche Media Team