Subject: Technology:  FDA to Clear AIDS Aerosol By LyphoMed
Date: Published: 2/2/89 (104 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology:  
    FDA to Clear
    AIDS Aerosol
    By LyphoMed
    ---
    Drug Will Be Used to Block
    Pneumonia, Killer of 80%
    Of Patients, Sources Say
    ----   
    By Bill Richards
    Staff Reporter of The Wall Street Journal

    CHICAGO -- Federal regulators are set to give approval to
 LyphoMed Inc. to sell an experimental aerosol drug that can
 prevent a form of pneumonia that kills nearly 80% of all AIDS
 patients.
    Medical sources said the U. S. Food and Drug Administration
 will approve an aerosol form of the drug pentamidine next
 week.  The drug has been found to head off repeat attacks of
 pneumocystis carinii pneumonia, a lethal AIDS-related form of
 the disease.  Doctors who have tested the aerosol said it may
 also prevent the pneumonia from developing in patients who
 haven't yet developed AIDS, but have been infected with the
 virus that causes acquired immune deficiency syndrome.  The
 findings come from an 18-month study of the aerosol drug on
 400 AIDS patients in San Francisco.
    Both the FDA and LyphoMed declined to comment yesterday,
 but the company said it intended to hold a news conference
 next week to discuss its testing of the aerosol.  An FDA
 official, who asked not to be named, said the drug would be
 cleared.
    Reports of the expected approval caused LyphoMed's shares
 to jump $1.625 to close at $14.75 in national
 over-the-counter trading yesterday.  More than 2.7 million
 shares changed hands.
    Medical and industry experts yesterday called the aerosol
 version of pentamidine a major breakthrough in curbing a
 primary source of AIDS deaths.  As many as 80% of all AIDS
 patients die from pneumocystis carinii pneumonia; 20% die of
 it the first time they get it.  "This is one of the big
 killers," said Dr. A. Bruce Montgomery, an assistant
 professor of medicine at the State University of New York at
 Stony Brook.  Dr. Montgomery, a principal investigator in the
 San Francisco research, said the aerosol might be used by as
 many as 100,000 patients, depending on the level of the FDA's
 approval.
    LyphoMed, which is based in Rosemont, Ill., has marketed
 an intravenous form of pentamidine known as pentamidine 300
 since 1984.  But that form of the drug has been limited to
 patients who have AIDS-related pneumonia and has had severe
 side effects.  Doctors who tested the aerosol version of
 pentamidine say they have seen almost no negative side
 effects except some roughness in patients' throats.
    In addition, medical experts said the aerosol form of
 pentamidine would enable AIDS victims to use the drug in
 combination with the antiviral drug AZT, which prolongs life
 for AIDS patients.  Patients receiving intravenous pentamidine
 couldn't receive both drugs at once because of adverse side
 effects.
    AIDS activists, who have picketed the FDA seeking
 clearance of the aerosol version of the drug, hailed the
 FDA's impending approval of aerosol pentamidine yesterday.
 Jeffrey Levi, executive director of the National Gay &
 Lesbian Task Force in Washington, D. C., called the pending
 clearance "a major breakthrough medically," and said that it
 showed federal regulators could act on human trials rather
 than waiting for results of long-term animal results.
 "They're moving it through with the kind of data that
 wouldn't have worked a year or two ago," Mr. Levi said.
    Industry analysts said that the FDA is likely to grant
 LyphoMed's aerosol drug Investigational New Drug for
 Treatment status.  IND status would allow the company to sell
 its pentamidine aerosol at a price covering manufacturing and
 other development costs.  Analysts predicted LyphoMed's sales
 of pentamidine in both intravenous and aerosol form could
 reach $50 million in 1989.  LyphoMed is expected to post 1988
 sales of about $125 million.
    Moreover, the FDA's clearance is likely to raise
 LyphoMed's battered public image.  FDA investigators shut down
 two of LyphoMed's three U. S. production facilities last year,
 citing quality control problems.  "This establishes that
 LyphoMed and the FDA are back on good terms again," said John
 Boettiger of Rotan Mosle, a Houston brokerage concern.
    LyphoMed officials declined to say how much the aerosol
 version of pentamidine would cost users.  The company's
 intravenous version of the drug costs about $100 a dose.
 Normal doseage is three times a day for 21 days.
    Last week, John Hancock Mutual Life Insurance Co., one of
 the nation's largest private health insurers, said it planned
 to offer coverage for aerosol pentamidine, a move that should
 broaden the drug's use.  The insurer said it would pay for
 treatments with the aerosol if a doctor certifies that a
 patient is infected with the AIDS virus and has signs of
 immune-system deterioration.  Previously, Hancock refused to
 cover the cost of the aerosol drug in its experimental form.

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