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Price Freeze Announced for Nevirapine in AIDS Drug Assistance Program

RIDGEFIELD, Conn., April 25 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced a two-year price freeze on its antiretroviral drug VIRAMUNE® (nevirapine) for the AIDS Drug Assistance Program (ADAP). VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. ADAP provides HIV-related prescription drugs to underinsured and uninsured individuals living with HIV/AIDS.

"Boehringer Ingelheim currently provides VIRAMUNE to ADAP at a considerable discount. This discount, coupled with the two-year price freeze, are two significant components of our overall effort to help ensure patients in need have access to VIRAMUNE," said Sheldon Berkle, Executive Vice President Marketing and Sales, Prescription Medicines, Boehringer Ingelheim Pharmaceuticals, Inc. "We are empathetic to the current budget issues facing ADAP and are pleased to offer our assistance during this challenging time."

Another important consideration for ADAP may be the difference in price between VIRAMUNE and its main competitor, efavirenz. The average wholesale price of VIRAMUNE is nearly $2.75 less per day (approximately $1,000 per year, per patient) than efavirenz. A recent head-to-head trial, 2NN, found comparable efficacy between the drugs with respect to viral suppression and immune restoration(1). The most common adverse events reported in the trial were rash and hepatic events in the VIRAMUNE arms and rash and central nervous system/psychiatric events for efavirenz.

In addition, Boehringer Ingelheim continues to provide VIRAMUNE at no cost to patients with a demonstrated financial need through its Patient Assistance Program. For information on this program, or assistance with reimbursement issues, please call 1-800-556-8317.

VIRAMUNE

VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The most clinically important adverse events associated with VIRAMUNE are rash and hepatic events, including fatal cases of each. Cases of hypersensitivity reactions have been observed. The first 12-16 weeks of therapy with VIRAMUNE are a critical period during which it is essential that patients be intensively monitored. VIRAMUNE should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions. Other commonly reported events include fever, nausea and headache. Redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy. The cause and long-term health effects of these conditions are not known at this time.

The dose of VIRAMUNE for adults is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily.

For full prescribing information for VIRAMUNE, please visit http://www.viramune.com/.

Boehringer Ingelheim

Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. VIRAMUNE is a product of original research done at Boehringer Ingelheim Pharmaceuticals, Inc. VIRAMUNE was the first member of the NNRTI class of anti-HIV drugs. Boehringer Ingelheim is committed to the rapid development of the investigational non-peptidic protease inhibitor tipranavir. The company is involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.

Reference

(1) van Leth et al. The 2NN Study: A randomized comparative open label trial of first-line antiretroviral therapy with regimens containing either nevirapine, efavirenz, or both drugs combined in addition to stavudine and lamivudine. Oral presentation 10th Conference on Retroviruses and Opportunistic Infections, Abstract #176. Boston, MA. Feb 10-14, 2003.

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