Investor Update
Basel, 5 October 2006
Fuzeon combined with new investigational HIV drug results in remarkably high number of HIV patients achieving undetectable viral load
Results unveiled at ICAAC show that over 90% of treatment-experienced patients achieve treatment goal of undetectable viral load
Roche today announced new clinical data demonstrating that 90 to 95 percent of treatment-experienced HIV patients who initiate therapy with Fuzeon (enfuvirtide) and the investigational integrase inhibitor MK-0518 can achieve undetectable levels of HIV (less than 400 copies per mL of blood)1. Such response rates have never been achieved in clinical trials of HIV patients living with drug-resistant virus. This significant antiviral effect achieved by adding Fuzeon to other new drugs, known as the “Fuzeon effect”, has been consistently demonstrated across a number of studies2. These data were presented at the 46th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
“These remarkable results show us that by partnering Fuzeon and a novel integrase inhibitor, treatment-experienced patients can have a similar chance to achieve the ultimate goal of treatment, undetectable viral load, as treatment-naïve patients,” said Dr Anton Pozniak, the Chelsea and Westminster Hospital, London. “Today, we already see that using Fuzeon with darunavir or tipranavir, we have the right drugs to help us achieve the treatment goal of undetectable viral load in the majority of treatment-experienced patients. But more importantly we look set to achieve this goal of undetectable in more patients in the future with the availability of Fuzeon and exciting novel agents such as MK-0518.”
About the results presented at ICAAC
Investigators reported results of a 24-week, Phase II, Merck-sponsored study of MK-0518 in treatment-experienced patients with resistance to protease inhibitors, nucleoside analogues and non-nucleoside analogues. Patients received one of three doses of MK-0518 (200 mg, 400 mg or 600 mg) twice-daily in combination with an optimised background regimen of anti-HIV drugs. In the subset of patients who received Fuzeon for the first time in their drug regimen, 90 to 95 percent of 32 subjects achieved undetectable HIV, compared to 60 to 70 percent of 82 subjects who received MK-0518 without Fuzeon. Fuzeon usage was associated with dramatically increased response rates in the study by approximately 50 percent.
Compliment new treatment guidelines
These findings are consistent with the recently updated HIV treatment guidelines, which emphasise undetectability as the goal of therapy in treatment-experienced patients, as well as the need to initiate multiple active anti-HIV agents simultaneously in order to achieve this goal3-5. Recent clinical trials have convinced the authors of the guidelines that undetectable viral load should be the goal for all treatment-experienced patients. These trials, including POWER and RESIST, confirm the efficacy of the new drugs darunavir and tipranavir and emphasise that Fuzeon should be the cornerstone to achieve undetectable levels of virus for treatment-experienced patients.
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, a leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totaled 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).
Fuzeon combined with new investigational HIV drug results in remarkably high number of HIV patients achieving undetectable viral load
Results unveiled at ICAAC show that over 90% of treatment-experienced patients achieve treatment goal of undetectable viral load
Roche today announced new clinical data demonstrating that 90 to 95 percent of treatment-experienced HIV patients who initiate therapy with Fuzeon (enfuvirtide) and the investigational integrase inhibitor MK-0518 can achieve undetectable levels of HIV (less than 400 copies per mL of blood)1. Such response rates have never been achieved in clinical trials of HIV patients living with drug-resistant virus. This significant antiviral effect achieved by adding Fuzeon to other new drugs, known as the “Fuzeon effect”, has been consistently demonstrated across a number of studies2. These data were presented at the 46th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
“These remarkable results show us that by partnering Fuzeon and a novel integrase inhibitor, treatment-experienced patients can have a similar chance to achieve the ultimate goal of treatment, undetectable viral load, as treatment-naïve patients,” said Dr Anton Pozniak, the Chelsea and Westminster Hospital, London. “Today, we already see that using Fuzeon with darunavir or tipranavir, we have the right drugs to help us achieve the treatment goal of undetectable viral load in the majority of treatment-experienced patients. But more importantly we look set to achieve this goal of undetectable in more patients in the future with the availability of Fuzeon and exciting novel agents such as MK-0518.”
About the results presented at ICAAC
Investigators reported results of a 24-week, Phase II, Merck-sponsored study of MK-0518 in treatment-experienced patients with resistance to protease inhibitors, nucleoside analogues and non-nucleoside analogues. Patients received one of three doses of MK-0518 (200 mg, 400 mg or 600 mg) twice-daily in combination with an optimised background regimen of anti-HIV drugs. In the subset of patients who received Fuzeon for the first time in their drug regimen, 90 to 95 percent of 32 subjects achieved undetectable HIV, compared to 60 to 70 percent of 82 subjects who received MK-0518 without Fuzeon. Fuzeon usage was associated with dramatically increased response rates in the study by approximately 50 percent.
Compliment new treatment guidelines
These findings are consistent with the recently updated HIV treatment guidelines, which emphasise undetectability as the goal of therapy in treatment-experienced patients, as well as the need to initiate multiple active anti-HIV agents simultaneously in order to achieve this goal3-5. Recent clinical trials have convinced the authors of the guidelines that undetectable viral load should be the goal for all treatment-experienced patients. These trials, including POWER and RESIST, confirm the efficacy of the new drugs darunavir and tipranavir and emphasise that Fuzeon should be the cornerstone to achieve undetectable levels of virus for treatment-experienced patients.
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, a leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totaled 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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References:
1.
Grinsztejn, B, Nguyen, B-Y.; Katlama, C et al. Potent Antiretroviral Effect of MK-0518, a Novel HIV-1
Integrase Inhibitor, in Patients with Triple-class Resistant Virus: 24 Week Data. Data presented at
ICAAC 2006
2. Youle M, Staszewski S, Clotet B et al. Concomitant use of an active boosted
protease inhibitor with enfuvirtide in treatment-experienced, HIV-infected individuals: recent data
and consensus recommendations. HIV Clinical Trials 2006: 7: 86-96.
3. The Panel on Clinical
Practices for Treatment of HIV Infection convened by the Department of Health and Human Services (DHHS).
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. May 4, 2006
http://AIDSinfo.nih.gov (accessed August 10 2006).
4. Recommandations du groupe d’experts
sous la direction du Professeur Patrick Yeni réalisé avec le soutien du Ministère de la Santé et des
Solidarités. Prise en charge médicale des personnes infectées par le VIH. 2006: 46
5.
Hammer S, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society
– USA panel. JAMA, 2006;296:827-843