In parallel with the development of Fuzeon and T-1249, Roche highlights its commitment to fighting HIV/AIDS
Basel, February 17 � New data show that Roche�s investigational protease inhibitor (PI), known as RO0334649, has promising pre-clinical results against PI-resistant HIV. The pre-clinical results are very encouraging in terms of potency and selectivity against HIV, alongside a favourable pharmacokinetic profile. Roche also confirmed that Phase I trials have commenced.
There is a growing unmet need in the treatment of people living with HIV who have developed resistance to existing anti- HIV drugs. Meeting this increasingly urgent need requires new treatments to be developed both in the form of novel compounds, such as Fuzeon (enfuvirtide), and additional drugs from existing classes, such as RO0334649. RO0334649 has been chosen for further development due to its potent antiviral activity against both wild-type and PI-resistant HIV isolates tested in the laboratory. It selectively targets HIV protease enzyme compared with human protease enzymes.
�The early stages of development of RO0334649 are very encouraging� said Dr Nick Cammack, Head of Viral Diseases Research at Roche . �This is exciting for Roche and the HIV community, as there is an ongoing need to find new treatment options for patients living in the shadow of drug resistance. While we recognise this is an early stage, we are hopeful that this compound will join other treatment options in years to come following the successful research programme and filings for approval of Fuzeon.�
In the pre-clinical studies, RO0334649 demonstrated activity equivalent to that against wild-type virus, for a panel of protease-inhibitor resistant viruses containing multiple mutations. In addition, RO0334649 had very favourable activity against a panel of 50 �worst-case� PI-resistant isolates.
Roche is committed to significant investment in the development of new and innovative treatments for people with HIV who are faced with reduced treatment options owing to the development of resistance. RO0334649 is one of a number of compounds in development by Roche for people living with resistant HIV. The most clinically advanced of these compounds is Fuzeon. Fuzeon�s mechanism of action is not comparable to any existing HIV drugs as, unlike existing anti-HIV drugs that work inside the cell, it is designed to block HIV from entering healthy human immune cells.
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For more information please contact:
Lucy Heaton
Ketchum , London
Mobile: + 44 7939 037 108
Telephone: + 44 20 7611 3859
E-Mail: lucy.heaton@ketchum.com
Maria Vigneau
International Communications Manager, Roche, Basel
Mobile: + 41 79 506 9941
Telephone: + 41 61 688 9291
E-Mail: maria.vigneau@roche.com
Notes to editors
Resistance to HIV drugs
It is estimated that in a single untreated person the virus can mutate to form around a billion new and potentially different versions of HIV in just 24 hours. The incidence of drug resistant HIV among already treated patients is increasing at a disturbing rate, with up to 78 percent of patients in North America and Europe infected with a strain of the virus that has developed resistance to one or more anti-HIV drug.
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), another 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 and T-1249 are being co-developed by Roche and Trimeris.
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 therapies- including a paediatric formulation- for these regions and research in HIV, visit the www.roche-hiv.com website.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals and diagnostics. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well being and quality of life.
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