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Roche (RHHBY) Release: New Treatment Guidelines Recommend VALCYTE(R) For AIDS-Related CMV Retinitis


10/19/2005 5:12:35 PM

NUTLEY, N.J., Jan. 31 /PRNewswire/ -- VALCYTE(R) (valganciclovir), a potent oral treatment for AIDS-related cytomegalovirus (CMV) retinitis, received positive recommendations in new treatment guidelines issued by the CDC, The National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. The guidelines state that VALCYTE is the preferred treatment for patients with peripheral lesions that are not immediately sight-threatening. Authors cite ease of administration and lack of surgical or catheter-associated complications as primary benefits of VALCYTE versus other treatments such as the ganciclovir intraocular implant, intravenous ganciclovir, or intravenous foscarnet.

The new guidelines, "Treating Opportunistic Infections Among HIV-Infected Adults and Adolescents," are intended for clinicians and other health-care providers and include evidence-based guidelines for the treatment of 28 opportunistic infections.

"Even though advances in HAART have transformed the HIV landscape, opportunistic infections are still a threat, due to increasing antiretroviral resistance and the large number of HIV positive people remaining undiagnosed and untreated," said W. Robert Lange, MD, Medical Director, Roche. "VALCYTE is a potent and convenient treatment option, both for the induction and maintenance phases of therapy."

The guidelines also state that the ganciclovir intraocular implant plus VALCYTE is superior to once daily intravenous ganciclovir for preventing relapse of retinitis. Additionally, recommendations on the treatment of small peripheral CMV retinitis lesions in patients about to initiate antiretroviral therapy state that these patients should undergo treatment until sufficient immune recovery occurs.

Cytomegalovirus (CMV) retinitis is a potentially devastating viral disease which damages eyesight and can lead to blindness in patients with AIDS. Once CMV retinitis is diagnosed, treatment can be life long and require long term use of an indwelling catheter. As a potent oral treatment, VALCYTE is more convenient for patients and does not cause problems that are associated with the use of a chronic indwelling catheter.

Approved by the U.S. Food and Drug Administration in March 2001 for the induction and maintenance treatment of CMV retinitis in patients with AIDS, VALCYTE is the leading oral anti-CMV medication with efficacy equivalent to that of the previous gold standard therapy, IV ganciclovir. VALCYTE works by enhancing the absorption of ganciclovir through the gastrointestinal tract. Once in the bloodstream, ganciclovir enters cells infected with CMV and inhibits replication of the virus. In patients who have CMV retinitis, VALCYTE stops viral replication, thus inhibiting further retinal damage and preserving vision.

The clinical toxicity of VALCYTE, which is metabolized to ganciclovir, includes granulocytopenia, anemia and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis. VALCYTE should not be administered if the absolute neutrophil count is less than 500 cells/uL, the platelet count is less than 25,000/uL or the hemoglobin is less than 8 g/dL. Didanosine blood levels can be significantly increased when didanosine is taken with VALCYTE. Cytopenias may be exacerbated by zidovudine. Other side effects occurring with a frequency of greater than or equal to 5% may include diarrhea, fever, nausea, neutropenia, headache, vomiting, insomnia, abdominal pain, retinal detachment, peripheral neuropathy and paresthesia.

About CMV

Cytomegalovirus (CMV), a member of the herpes family of viruses, infects approximately 50 to 75 percent of the U.S. adult population and 90 percent of people with HIV. In individuals with healthy immune systems, CMV exists in the body in a dormant state. However, among individuals with compromised immune systems, the virus can become active and cause disease. CMV retinitis, which damages eyesight and can cause blindness, is the most common CMV-related condition in people living with AIDS, affecting between 10 and 25 percent of persons with late-stage AIDS. When a person living with AIDS develops CMV retinitis, the infection usually gets worse over time, quickly in some patients and slowly in others. If the disease is not treated, patients may lose some or all of their vision. In early stages, patients may not perceive symptoms of CMV retinitis, but as the condition progresses, visual problems, such as blind spots, distorted vision and noticeable blurring occur. Because these problems can be associated with diseases other than CMV retinitis, an ophthalmologist must make the diagnosis of the condition.

About Roche -- More Than a Century in the U.S. and the World

Founded in 1896 and 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 one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as 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 many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to 'Fortune' magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com/ and U.S.: http://www.roche.us/).

For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at http://www.rocheusa.com/

Roche

CONTACT: Maureen Byrne of Roche, +1-973-562-2203,maureen.byrne@roche.com; or Noelle Boyd of Manning Selvage & Lee,+1-212-468-4313, noelle.boyd@mslpr.com, for Roche


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