Subject: Roche to Enhance Availability, Price Of Its AIDS Drug 
Date: Published: 2/21/92 (55 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    Roche to Enhance
    Availability, Price
    Of Its AIDS Drug
    ----
    By Robin Goldwyn Blumenthal
    Staff Reporter of The Wall Street Journal

    NUTLEY, N. J. -- Hoffmann-La Roche Inc. said it was adding
 two new programs to make its experimental AIDS drug more
 widely available and free of charge to qualifying patients.
    Earlier this month, the Food and Drug Administration urged
 sales of an unauthorized copy of Hoffmann-La Roche's Hivid
 drug be discontinued because of large variations in potency
 and quality.  The health-care company said many of those
 infected with the AIDS virus have used the underground drug
 in combination with Wellcome PLC's AIDS treatment, AZT.  
    Hoffmann-La Roche said it would make Hivid available in
 the next two weeks through a so-called "open-label" program,
 in which the physician and patient will know they have the
 drug and not a placebo, which is commonly used as a control
 in experiments for a drug's effectiveness.  A spokesman for
 the company, a unit of Roche Holding Ltd., of Basel,
 Switzerland, said the FDA was currently writing a protocol
 for the open-label program.
    The spokesman said the guidelines for availability of the
 experimental drug would be fairly wide, and that it would be
 provided free.  He said there are currently about 8,000 people
 in Hoffmann-La Roche's experimental treatment programs, and
 that it wasn't possible to determine how many more people
 would take advantage of the new programs.  The spokesman said
 reports indicate between 5,000 and 10,000 people are using
 the underground versions of the drug, also know by its
 generic name zalcitabine, or DDC.  
    Hoffmann-La Roche has applied to the FDA for approval of
 the drug.
    The company said one criterion for participation in the
 first new program would depend on a certain blood cell count
 in patients that is lower the level required for proper
 immune system function.  It also is designing a second program
 with input from the AIDS community and the government to
 provide Hivid for combination therapy in healthier
 HIV-infected individuals.  The company said it will work with
 several community research groups to initiate a trial that
 could potentially involve thousands of patients.
    Hoffmann-La Roche said physicians should call
 1-800-332-2144 for information on enrollment.

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