Roche announced today that a positive opinion has been granted by the European Committee on Proprietary Medicinal Products (CPMP) recommending marketing authorization for a new convenient 625mg formulation of Viracept (nelfinavir), a widely used HIV drug. The final marketing approval is expected to follow later this year.
The new formulation will reduce Viracept�s pill count from 10 tablets per day to only 4 tablets per day offering patients a much simpler dosing regimen. Moreover, Viracept 625mg is reported to offer a marked reduction in the occurrence of diarrhea and was clearly preferred by patients in a recent study.
�The new Viracept 625mg formulation with less pills and less diarrhea is good news for patients and physicians. Our goal is always to reduce the pill burden for patients whilst still providing effective and well-tolerated therapy. Viracept with its unique resistance profile provides an excellent first-line option and the new formulation allows for an easier and simpler treatment regimen.� commented Prof. Bonaventura Clotet MD, PhD, Head of the HIV Unit and Director of Retrovirology �irsiCaixa� Foundation at the Hospital Universitari Germans Trias I Pujol, Barcelona, Spain.
In the study, 91% of patients who were switched from the current 250mg tablets to the new Viracept 625mg tablets preferred the new 625mg formulation. The main reasons for the preference were fewer tablets, the improved bowel function, better overall tolerability and the ease of swallowing the new pills.
The Viracept 625mg dossier was filed in May 2003 and we are eager to congratulate and thank all those who contributed to this development and outcome.
-ends-
References
Roche Viracept (nelfinavir) 625 mg film-coated tablets: investigation of safety and gastrointestinal tolerability of this new formulation in comparison with 250 mg film-coated tablets (Viracept�) in HIV patients. Nieto-Cisneros L, Johnson M, Horban A et al. 2nd IAS Conference on HIV Pathogenesis and Treatment. Paris, France, 13-16 July 2003; Poster 548.
Notes to editors:
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. Saquinavir was the first Protease Inhibitor (PI) and was first introduced by Roche in 1995 in the US.
As a consequence of Roche's continuous research and development, the combination of boosted saquinavir with ritonavir (1000/100 mg twice daily) has shown encouraging results in the MaxCmin 1 trial with high efficacy and an excellent safety and tolerability profile. Saquinavir/r was approved in the EU in August 2002. Viracept (nelfinavir), a leading PI is supplied by Roche outside the US and Canada. In first-line HIV therapy, Viracept delivers consistent long-term efficacy and safety. When used first line, Viracept also allows the subsequent use of both NNRTIs and other PIs for most patients due to its unique resistance pattern. 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. T-1249 is being co-developed by Roche and Trimeris.
The viral load measurements in the clinical trials for Fuzeon were performed using 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.
For further information please contact:
Dr Nina Hautzinger at F. Hoffmann-La Roche: Telephone: +41 (0) 61 688 13 65
Mobile: +41 (0) 79 593 43 07
