Subject: Barr Laboratories Applies to the FDA For Approval to Make an AIDS Drug 
Date: Published: 4/19/91 (77 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    Barr Laboratories Applies to the FDA
    For Approval to Make an AIDS Drug
    ----
    By Lourdes Lee Valeriano
    Staff Reporter of The Wall Street Journal

    POMONA, N. Y. -- Barr Laboratories Inc. applied to the Food
 and Drug Administration for approval to make a generic
 equivalent of AZT, challenging the exclusive U. S. marketing
 rights held by Burroughs Wellcome Co. for the AIDS drug.
    A generic version of AZT, or zidovudine, the only drug
 approved to treat acquired immune deficiency syndrome, could
 broaden access to the drug by lowering its price.  Currently,
 a year's worth of AZT therapy costs about $2,200, according
 to Burroughs Wellcome, a unit of Britain's Wellcome PLC. 
    However, Barr faces a number of legal and regulatory
 hurdles before it could actually market such a drug, and even
 in the best of circumstances the drug wouldn't be available
 until 1992 at the earliest.  Further, Burroughs Wellcome
 intends to challenge any such efforts.
    Barr closed at $19, up $1.25, in American Stock Exchange
 composite trading.
    Burroughs Wellcome, which has held the U. S. patents to the
 drug since 1988, is the only company that can market AZT in
 the world.  Last year, world-wide sales of AZT totaled $286
 million, of which about $175 million was generated in the
 U. S., according to the company.
    Burroughs Wellcome "can lose at least half their business
 in the first year a copy drug reaches the market," resulting
 from loss of market share and a 30% to 50% discount in price,
 said Samuel D. Isaly of Mehta & Isaly, a New York-based
 pharmaceuticals consulting firm.
    Barr, in filing its generic drug application, "is hoping
 to ride on the coattails" of suits seeking to strip Burroughs
 Wellcome of its AZT patents, said Viren Mehta, Mr. Isaly's
 partner.  "They're trying to get in the front of the queue in
 case the patent is overturned," he said.
    The patent held by Burroughs Wellcome gives the company
 exclusive rights to market AZT for AIDS and AIDS-related
 complex for 17 years, or until Feb. 9, 2005.  But last month,
 the People With AIDS Health Group, based in New York, filed a
 civil suit seeking to strip Burroughs Wellcome of the patent
 on grounds that it allegedly neither invented the drug nor
 conceived of its use for treating the virus.
    "We continue to be confident in our patent position," said
 a spokeswoman for Burroughs Wellcome, based in Research
 Triangle Park, N. C.  "We will defend it against any
 challenge."
    Carol Rozek, Barr's corporate counsel, said Barr has
 notified Burroughs Wellcome of its application, and by so
 doing is challenging its patent.  She said Burroughs Wellcome
 now has 45 days to choose to sue Barr for patent
 infringement.  If it does so, the case would be decided in
 court.
    Even if the patent is overturned, Burroughs Wellcome is
 protected for five years after the drug was approved under
 the exclusivity provisions of the Waxman-Hatch Act of 1984,
 which regulates the approval process for copycat products.
 Since Burroughs got approval for its drug in 1987, that
 protection would cease in 1992.
    In addition, the drug has orphan drug status, which gives
 Burroughs Wellcome seven years' exclusivity from the receipt
 of approval, or until 1994.  But Ms. Rozek said that orphan
 drug protection only extends to the use of the drug by
 patients diagnosed with AIDS or AIDS-related complex.
 Therefore a generic drug can be marketed to patients who are
 infected with the virus but don't show any symptoms.

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