Europe approves new Invirase 500 mg tablet for the treatment of HIV

Main Category: HIV / AIDS
Article Date: 27 May 2005 - 12:00 PDT

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Roche announced today the European marketing approval for its new 500 mg formulation of Invirase (saquinavir mesylate), an effective and well tolerated protease inhibitor used in the treatment of HIV infection. The new 500 mg tablet will simplify the dosing regimen for patients by reducing the daily tablet count by more than half, from five tablets twice-daily to two tablets twice-daily.

Antiretroviral therapies have become more and more effective and have transformed HIV infection into more of a chronic disease with patients living much longer than before. As such it is particularly important to offer effective therapies to patients that are both well tolerated and convenient. The new Invirase 500 mg formulation will meet the needs of patients by offering a simpler and more convenient treatment option with excellent efficacy and a well established tolerability profile. Patients can easily switch from the current 200 mg tablets to the new 500 mg tablets, continuing to benefit from Invirase's high antiviral efficacy but with far more convenience.

"The launch of the 500 mg tablet is a further example of Roche's continuing commitment not only to the treatment of HIV but also to the development of medicines that more closely meet the needs of patients" said William M. Burns, CEO of Roche's Pharmaceutical Division.

"The reduced pill burden offered by the new Invirase 500 mg tablet will make boosted Invirase a much more attractive treatment option for patients and will encourage its use in early as well as advanced stages of HIV disease, " said Dr Anton Pozniak, Consultant Physician and Senior Lecturer at Chelsea and Westminster Hospital, London UK.

Invirase is approved for use in combination with a low dose of another protease inhibitor (PI), ritonavir in combination with other antiretroviral drugs. Boosted Invirase has been shown in numerous clinical trials 2, 3 to be highly potent with an excellent tolerability profile and limited toxicity. Invirase is recommended as a first line boosted PI in the International AIDS Society (IAS) guidelines which gave it the highest possible clinical evidence based rating 4. Invirase® 500 mg received FDA approval in the USA after priority review on December 18th, 2004.

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. Introduction of Invirase 500 mg

The new Invirase 500 mg tablet has a film coating for ease of swallowing and is comparable in size to the small Invirase 200 mg capsule. The 200 mg formulation of Invirase will remain available for those patients who want to continue to use it. Timelines for the launch of the new Invirase 500 mg tablet will differ from country to country depending on local regulations.

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

References:
1. UNAIDS. AIDS Epidemic: Update 2004 and World AIDS Day 2004 (UNAIDS/WHO, December 2004)
2. Dragsted UB, Gerstoft J, Pedersen C et al. JID. 2003;188:635-642.
3. Youle M, Gerstoft J, Fox Z et al. 2nd IAS. Paris, France, 2003; Poster LB23
4. Yeni PG, Hammer SM, Hirsch MS et al. JAMA 2004; 292/2:251-265.

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. For further information: http://www.roche.com

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