PRNewswire - Tuesday December 1, 1998

The price, announced today on World AIDS Day '98, is expected to enable state ADAPs to quickly add Ziagen to state formularies following accelerated approval. While Glaxo Wellcome's price to wholesalers for a year's worth of Ziagen comes to $3,540 (retail prices paid by patients will be different), the price to ADAP programs is 15 percent less, or approximately $3,000 annually. Ziagen will be dosed as one 300-mg tablet twice daily with no food or water restrictions. In clinical trials, Ziagen is being studied in a variety of combination regimens due to its profile of antiviral activity and a low likelihood of drug interactions with other antiretrovirals.

"There is some evidence today that a constructive dialogue between representatives in the HIV community and representatives from the pharmaceutical industry can result in outcomes that are in the best interests of patients with HIV and AIDS," said Bill Arnold, chairman of the AIDS Drug Assistance Program Working Group. "While the issues facing ADAP programs continue to be daunting, decisions which help to contain the rising cost of AIDS drug combination therapy can only be viewed as positive."

Following the FDA advisory committee meeting held on November 2, company representatives met with leaders in the HIV treatment advocacy community, as well as ADAP administrators, in order to hear their concerns related to pricing of new HIV drugs. The meeting, held as a result of requests from the HIV treatment community, also served to update the company on the current HIV treatment funding environment.

"Glaxo Wellcome clearly listened to our concerns and has sent a message that they share those concerns as they relate to pricing of new agents," said Martin Delaney, founding director of San Francisco-based Project Inform, and a leader of the ad-hoc Fair Price Working Group. "While drug prices in general are still too high, Glaxo Wellcome is to be commended for its decision in an environment which has been destabilized recently by pricing of other new agents.

Furthermore, the company deserves credit for engaging in a process with patient advocates that allowed the sharing of viewpoints directly with decision-makers prior to a final decision on pricing."

Ziagen has been studied in trials that have included previously untreated patients as well as heavily pre-treated patients -- including a large, well-controlled study in pre-treated children. Studies suggest that combinations containing Ziagen may have significant antiviral activity in patients who have not previously received antiretroviral therapy. Preliminary results of one such ongoing study (as presented at an FDA Advisory Committee meeting on November 2) suggest similar antiviral effects -- at 16 and 24 weeks of treatment -- of a regimen containing Ziagen+Combivir«(lamivudine/ zidovudine) and a regimen containing Crixivan«(protease inhibitor; Merck)+Combivir on the surrogate endpoints of the proportion of patients with viral loads below the limit of detection of a standard assay (less than 400 copies/mL) and the average increase of infection-fighting CD4 cells. And, though the likelihood and degree of antiretroviral effect of combinations containing Ziagen is less in treatment experienced patients, as is the case with all antiretroviral drugs, studies suggest that combinations containing Ziagen may provide a benefit in some of these patients as well. Long term effects of Ziagen in combination therapies are still under evaluation.

"The insights provided by community representatives and ADAP administrators were one of many factors considered in the ultimate decision related to pricing of Ziagen," said Dean Mitchell, general manager of specialty divisions at Glaxo Wellcome. "This price represents a win-win-win situation in that it should greatly enhance patient access to an important new drug, should not unduly affect ADAP budgets, and supports the company's unparalleled long-term commitment to the field of HIV/AIDS."

In clinical trials to date, Ziagen -- primarily taken with Epivir« (lamivudine), also known as 3TC«, and Retrovir«(zidovudine; AZT) -- has appeared to be generally well tolerated with the most commonly reported adverse events consisting of headache, nausea, vomiting, malaise and diarrhea. All of the nucleoside reverse transcriptase inhibitors, including Epivir, Retrovir, Zerit«(stavudine; d4T; Bristol-Myers Squibb), Videx«(didanosine; ddI; Bristol-Myers Squibb), Hivid«(zalcitabine; ddC; Hoffman La Roche), and Ziagen, have been associated with lactic acidosis and severe hepatomegaly with steatosis, including fatal cases.

The most serious adverse event associated with Ziagen is a hypersensitivity reaction that can be life threatening and has been fatal in some cases. The hypersensitivity reaction has been observed in approximately 3 percent (0-5 percent in clinical trials) of patients receiving Ziagen and is generally characterized by fever with nausea and/or malaise, and, possibly an accompanying skin rash. The symptoms of this reaction get progressively worse if treatment continues. Patients experiencing these symptoms must contact a physician immediately and must suspend taking Ziagen until an evaluation can be completed. Symptoms of this reaction generally resolve following discontinuation of Ziagen. The potentially life-threatening danger usually occurs when a patient has experienced the hypersensitivity reaction, stops treatment, and then resumes treatment with Ziagen after the initial symptoms have resolved. Accordingly, patients experiencing this reaction must not take Ziagen again as restarting the drug after a hypersensitivity reaction has resulted in cases of life-threatening and fatal reactions.

Ziagen was discovered and is being developed by Glaxo Wellcome. The rights to related compounds and technology, including intermediates used in the manufacture of Ziagen, resulting from the research by Dr. Robert Vince, et. al, were licensed to Glaxo Wellcome by the University of Minnesota.

Glaxo Wellcome is the pharmaceutical industry leader in HIV research and therapies. In addition to Ziagen, Glaxo Wellcome also recently submitted a New Drug Application to the FDA for the investigational protease inhibitor AgeneraseÖ (amprenavir). Glaxo Wellcome also manufactures and markets the widely used anti-HIV medicines Epivir, Retrovir and Combivir, which brings together Epivir and Retrovir into one tablet. Glaxo Wellcome is currently conducting expanded access programs for both Ziagen and Agenerase, is engaged in basic research programs designed to investigate new targets to treat HIV, and is continuing to lead the way in pioneering efforts to study the viability of increasing access to HIV therapies in the developing world.

For complete prescribing information for Epivir, Retrovir or Combivir, call 919-483-2311

SOURCE: Glaxo Wellcome
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