Roche to discontinue the sale and distribution of Fortovase (saquinavir)

May 18 2005

Roche announced today that it has decided to discontinue the sale and distribution of Fortovase (saquinavir), as clinical demand for the drug has declined significantly due to the availability of a new formulation of Invirase (saquinavir mesylate), which increasingly has become the preferred formulation of saquinavir.

Invirase will remain on the market in both 500 mg tablets and 200 mg capsules, while Fortovase will be discontinued during the first quarter of 2006. The removal of Fortovase by Roche is completely voluntary and is not due to safety or efficacy issues.

The new Invirase 500 mg tablet offers patients key advantages over Fortovase, including lower bill burden, improved gastrointestinal tolerability, smaller capsule/tablet size and no need for refrigeration. In addition, Invirase boosted with ritonavir was listed as a recommended component of initial antiretroviral regimens in the most recent International AIDS Society-USA antiretroviral guidelines. The guidelines, published in the Journal of the American Medical Association, gave boosted Invirase the highest position in the guidelines.

"The Fortovase formulation no longer meets the demands of convenience and tolerability expected by patients today. In keeping with our research focus to optimize delivery of current therapies and develop novel treatments for people living with HIV/AIDS, we have determined that it is time to focus our resources on the availability of Invirase, which offers significant improvements in convenience and GI tolerance," said Frederick Schmid, Vice President of Virology/HIV at Roche. "We've taken great care to plan this discontinuation in such a manner as to allow physicians and patients adequate time to consider and transition to boosted Invirase."

A new 500 mg film-coated tablet formulation of Invirase was approved by the US Food and Drug Administration (FDA) in December 2004 and is designed for use in combination with a small dose of ritonavir and other anti-HIV drugs for the treatment of HIV infection. The new 500 mg formulation requires only four Invirase tablets daily -- two in the morning and two in the evening, taken with ritonavir.

Originally approved by the FDA in 1995, the introduction of Invirase as the first HIV protease inhibitor 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), which enhances therapeutic blood levels of Invirase and allows for twice-daily dosing.