Healthcare Industry News:  influenza 

Biopharmaceuticals HIV/AIDS

 News Release - February 6, 2006

Roche to Focus Resources on Availability of INVIRASE(R), Now Preferred Formulation of Saquinavir

Company Voluntarily Ceases Sale and Distribution of Fortovase(R) In the U.S.

NUTLEY, N.J., Feb. 6 (HSMN NewsFeed) -- Roche today announced that effective February 15, 2006, the company will discontinue the U.S. sale and distribution of Fortovase®, the soft-gel formulation of the HIV protease inhibitor saquinavir, due to the continued availability of the INVIRASE® 500 mg tablet formulation -- a decision previously communicated by the company in mid-2005. INVIRASE is the optimal formulation for patients because it requires fewer pills each day and is associated with fewer stomach-related side effects, and does not require refrigeration. The INVIRASE 500 mg tablet formulation requires only four tablets daily -- two in the morning and two in the evening, taken with ritonavir. INVIRASE, which must be taken with a small dose (100 mg) of ritonavir, will continue to be available in both 500 mg tablets and 200 mg capsules. The removal of Fortovase by Roche is completely voluntary and is not due to any safety or efficacy issues.

INVIRASE/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 INVIRASE/ritonavir the highest rating, based on the strength of its clinical data. In addition, in an article published in the Jan. 6, 2005 issue of the New England Journal of Medicine, authors Grinspoon et al. list a change to an INVIRASE-containing regimen as a potential intervention for patients who need an alternative PI regimen due to hyperlipidemia.

Roche has taken this action due to a significant decline in the demand for Fortovase as well as in response to the updated HIV treatment guidelines from the U.S. Department of Health and Human Services (DHHS), which no longer recommend Fortovase as a component of a preferred or alternative initial treatment regimen. Roche first announced the discontinuation of Fortovase in May 2005 to allow physicians and patients adequate time to consider a transition to boosted INVIRASE or alternative treatment options, and to give pharmacists and wholesalers sufficient lead time to adjust their stock. Since that time, Roche has been actively encouraging physicians to refrain from starting Fortovase treatment in their HIV-positive patients.

"The Fortovase formulation of saquinavir 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, Virology/HIV, 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 or other therapies."

Since it was approved as the first protease inhibitor in December 1995, more than a decade of continued research and development have helped establish INVIRASE as an important treatment option for HIV-infected individuals. In 2003, INVIRASE was approved for twice-daily, "boosted" dosing in combination with ritonavir (1,000 mg INVIRASE with 100 mg ritonavir). Boosting is a treatment strategy which provides potent levels of INVIRASE in the blood and allows for twice-daily dosing. The most recent development in December 2004 was approval of the INVIRASE 500 mg film-coated tablet.

About INVIRASE

INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection. The twice-daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCMin 1 study and pharmacokinetic data. The efficacy of INVIRASE with ritonavir or Fortovase (with or without ritonavir coadministration) has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.

INVIRASE® (saquinavir mesylate) capsules and Fortovase® (saquinavir) soft gelatin capsules are not bioequivalent and cannot be used interchangeably. INVIRASE may be used only if it is combined with ritonavir, which significantly inhibits saquinavir's metabolism to provide plasma saquinavir levels at least equal to those achieved with Fortovase. When using saquinavir as the sole protease inhibitor in an antiviral regimen, Fortovase is the recommended formulation.

INVIRASE is contraindicated in patients with clinically significant hypersensitivity to saquinavir or to any of the components contained in the capsule. INVIRASE/ritonavir should not be administered concurrently with terfenadine, cisapride, astemizole, pimozide, triazolam, midazolam or ergot derivatives. Inhibition of CYP3A4 by saquinavir could result in elevated plasma concentrations of these drugs, potentially causing serious or life- threatening reactions, such as cardiac arrhythmias or prolonged sedation.

INVIRASE when administered with ritonavir is contraindicated in patients with severe hepatic impairment. Patients with hepatic impairment have not been studied and caution should be exercised when prescribing saquinavir in this population. Concomitant use of INVIRASE with lovastatin or simvastatin is not recommended. Caution should be exercised if HIV protease inhibitors, including INVIRASE, are used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (eg, atorvastatin).

Concomitant use of INVIRASE and St. John's wort (hypericum perforatum) or products containing St. John's wort is not recommended. Garlic capsules should not be used while taking saquinavir as the sole protease inhibitor, due to the risk of decreased saquinavir plasma concentrations. For a complete list of drugs that should not be taken with saquinavir, please see TABLE 5 in the summary of complete product information.

New-onset diabetes mellitus, exacerbation of preexisting diabetes mellitus and hyperglycemia have been reported during postmarketing surveillance in HIV-infected patients receiving protease-inhibitor therapy. No initial dose adjustment is necessary for patients with renal impairment. However, patients with severe renal impairment have not been studied, and caution should be exercised when prescribing saquinavir in this population. There have been reports of spontaneous bleeding in patients with hemophilia A and B treated with protease inhibitors.

Elevated cholesterol and/or triglyceride levels have been observed in some patients taking saquinavir in combination with ritonavir. Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. A causal relationship between protease- inhibitor therapy and these events has not been established, and the long-term consequences are currently unknown.

Varying degrees of cross-resistance among protease inhibitors have been observed. In clinical trials with saquinavir (1000 mg) in combination with ritonavir (100 mg) and other antiretrovirals, the grade 2, 3 and 4 adverse events occurring in greater than or equal to 2% of 148 patients (considered at least possibly related to study drug or of unknown relationship): abdominal pain (6.1%), back pain (2%), bronchitis (2.7%), constipation (2%), diarrhea (8.1%), diabetes mellitus/hyperglycemia (2.7%), dry lips/skin (2%), eczema (2%), fatigue (6.1%), fever (3.4%), influenza (2.7%), lipodystrophy (5.4%), nausea (10.8%), pneumonia (5.4%), pruritus (3.4%), rash (3.4%), sinusitis (2.7%) and vomiting (7.4%).

INVIRASE is not a cure for HIV infection or AIDS. INVIRASE does not prevent the transmission of HIV.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.

Ritonavir is manufactured by Abbott Laboratories.


Source: Roche

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