Basel, February 21, 2005. Roche announced today that the European CHMP (The Committee for Medicinal Products for Human Use) has delivered a positive opinion 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 Invirase pill burden by more than half to two pills twice daily.
Invirase is a highly efficacious protease inhibitor which needs to be taken in a �boosted regime� in combination with a low dose of another protease inhibitor, ritonavir, to improve its power against the HIV virus. Boosted Invirase has been shown to be highly potent with an excellent safety and tolerability profile in numerous clinical trials and is recommended with strongest evidence rating in the International AIDS Society (IAS) guidelines for those patients who start therapy with a boosted protease inhibitor.
�We are delighted to get this positive opinion towards marketing Invirase 500 mg in Europe� said Malte Schutz MD, International Medical Manager for Roche�s Invirase. �The significantly reduced pill count of the new tablet means that patients can benefit from boosted Invirase�s remarkable combination of power and tolerability in a more convenient dosage, making boosted Invirase an attractive option for patients in early as well as advanced stages of treatment.�
�With less tablets per day, Invirase will become an excellent choice for HIV-patients� commented Dr Anton Pozniak, Chelsea and Westminster Hospital, London UK. �A reduced pill burden will provide patients with a more convenient regimen of a well tolerated HIV drug and encourage greater compliance.�
Roche hopes to receive final EMEA marketing approval in the coming months. Invirase 500 mg has received approval in the USA by the FDA after priority review on December 18th, 2004.
For further information please contact:
Dr. Nina Hautzinger at Roche:
Office: +41 61 688 1365
Mobile:+41 79 593 4307
Dr. Diane Lorton at Galliard Healthcare Communication:
Office: +44 20 7663 2265
Mobile:+44 7811 358 698
Notes to Editors
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 89% 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 the website.
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 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 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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