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HOFFMANN-LA ROCHE ANNOUNCES AVAILABILITY OF HIVID FOR FIRST COMBINATION THERAPY FOR AIDS

 HOFFMANN-LA ROCHE ANNOUNCES AVAILABILITY OF HIVID
 FOR FIRST COMBINATION THERAPY FOR AIDS
 NUTLEY, N.J., June 22 /PRNewswire/ -- Hoffmann-La Roche Inc. announced today that HIVID(R) (zalcitabine), also known as ddC, the newest treatment option in the fight against AIDS, is now available for use in combination with zidovudine (Retrovir(R), registered trademark of Burroughs Wellcome Co.), formerly known as AZT. HIVID in combination with zidovudine is indicated for treatment of adult patients with advanced HIV infection (CD4 cell count of 300 cells/mm3 or less) who have demonstrated significant clinical or immunologic deterioration. This indication is based on limited data from two small studies. HIVID will be marketed by Roche Laboratories, the prescription drug division of Hoffmann-La Roche Inc., which has started immediate nationwide distribution of the drug.
 HIVID is the first drug product cleared for marketing through a new accelerated approval process recently proposed by the Food and Drug Administration (FDA). "The availability of HIVID for use in combination with zidovudine is an important milestone in the fight against AIDS," said Irwin Lerner, president and chief executive officer of Roche. "Since being selected by the U.S. government from more than 30 other companies to develop this drug, we have been working with government agencies, the academic community and patient groups to ensure that HIVID was developed and made available as quickly as possible."
 Phase I/II clinical trial data submitted to the FDA in October 1991, as part of the New Drug Application (NDA), showed that increases in CD4 cell counts were higher and more sustained in zidovudine-naive patients with advanced HIV disease treated with the combination of HIVID and zidovudine when compared to patients treated with zidovudine alone from another study. Additional data gathered by Burroughs Wellcome Co., during an unscheduled announcement of independent studies, confirmed significant increases in CD4 cell counts in patients taking both drugs. An increase in CD4 cell count may indicate that the body's disease fighting capability has been strengthened. At present there are no study results regarding the clinical benefits (such as survival and incidence of opportunistic infections) of HIVID and zidovudine combination therapy on the progression of HIV infection. Although controlled studies are ongoing, no data are currently available on the combined use of HIVID and zidovudine in patients who have previously received zidovudine monotherapy.
 "Combination therapy with HIVID and zidovudine is a major advance in the treatment of HIV infection," says Margaret A. Fischl, M.D., director of the Comprehensive AIDS Program and professor of medicine at the University of Miami School of Medicine. "The data from a small study have shown that combination therapy was well tolerated and that the side effects were no different than we would have anticipated with either drug alone."
 More than 10,000 individuals have received HIVID through Roche clinical trials and Expanded Access Programs. There are six ongoing clinical studies investigating combination therapy with HIVID and zidovudine. The results of the ongoing controlled clinical trials should indicate whether combination therapy is clinically effective in different patient populations.
 How HIVID Works
 HIVID inhibits the action of reverse transcriptase, a viral enzyme which is critical in the replication cycle of HIV, the AIDS virus. HIV replicates by infecting a T-cell, a type of blood cell that plays an important role in the body's immune system. When HIVID is present in the cell, it binds to reverse transcriptase and prevents the integration of the viral genetic material into the T-cell's genetic material. In this way, HIVID stops HIV replication before the T-cell is infected, preserving the T-cell's immunological function.
 "HIVID works by attacking the AIDS virus when it is trying to make new viruses or trying to infect a T-cell," says Whaijen Soo, M.D., Ph.D., assistant vice president and senior director of Clinical Virology and AIDS Research at Roche. "HIVID can prevent healthy T-cells from becoming infected. But once the cell is infected with the AIDS virus, HIVID cannot stop the progression of the disease. That is why Roche continues to conduct research on compounds that could inhibit HIV replication by other mechanisms."
 The major clinical toxicities of HIVID are peripheral neuropathy and, much less frequently, pancreatitis. Moderate or severe peripheral neuropathy, which for some patients was clinically disabling, occurred in 17 percent to 31 percent of patients treated with HIVID monotherapy depending on severity and presumed relationship to drug. It is unknown at this time whether the risk of peripheral neuropathy is increased with the use of combination therapy over that observed with HIVID monotherapy. Documented fatal pancreatitis has been observed with administration of HIVID alone or in combination with zidovudine. Overall, pancreatitis is an uncommon complication of HIVID monotherapy, occurring in less than one percent of patients.
 Pricing and Reimbursement
 Based upon the clinical trials and Expanded Access Programs, the average yearly cost of HIVID to the wholesaler will be $1,826. This reflects not only the investment in research, development, Expanded Access Programs, production and cost of future research programs at Roche, but also recognizes the financial burden placed on AIDS patients. The average annual cost of HIVID makes it the lowest priced of the three antiretroviral agents available on the market.
 Roche will continue its long-standing policy of making its medications available to individuals who need but cannot afford them. For HIVID, Roche has established ASSIST(TM), a telephone reference service for health care providers. Trained ASSIST representatives will give health care providers information to help their patients obtain reimbursement for HIVID treatment. This will include patients who have been receiving treatment through the Roche Expanded Access Programs and patients who are starting therapy with HIVID in combination with zidovudine. For patients without health insurance, ASSIST will help health care providers determine if their patients are eligible to receive HIVID through the Roche Indigent Patient Program. The Roche Indigent Patient Program, which first began in 1963, provides medication to those patients who have been identified by their physician as unable to pay for treatment.
 HIVID History
 Dideoxycytidine (ddC) was synthesized by Jerome Horwitz of the Michigan Cancer Foundation in 1967. Hiroaki Mitsuya and Samuel Broder of the National Cancer Institute discovered its anti-AIDS potential in 1985. In 1987, the U.S. government licensed ddC to Roche after holding an open competition with more than 30 other pharmaceutical companies to select the company best qualified to develop and market the new therapy. Since then, Roche has been aggressively pursuing the development of ddC.
 About Hoffmann-La Roche
 Headquartered in Nutley, Hoffmann-La Roche Inc. is the United States affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland. One of the world's leading research-intensive health care companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals. The company is also a major provider of diagnostic products and clinical testing services, home infusion therapy services, vitamins and fine chemicals for human and animal nutrition, and veterinary products. Roche is recognized for excellence in biotechnology as well as traditional chemistry, and is the world leader in the commercial development of polymerase chain reaction (PCR) technology, a revolutionary advance in diagnostics and other fields including biomedical research, forensics and environmental testing.
 -0- 6/22/92
 /CONTACT: Paul Oestreicher, 201-235-3370, or Darien E. Wilson, 201-235-4381, both of Hoffmann-La Roche, or Faye Peterson of the Food and Drug Administration, 301-443-3285/ CO: Hoffmann-La Roche ST: New Jersey IN: MTC SU: PDT


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