The nicotine patch wars have begun in earnest, with Ciba-GeigyCorp.'s confirmation on Tuesday that it is the second companyto receive Food and Drug Administration approval to market atransdermal nicotine patch.
But the sales battle for the U.S. smoking cessation market,estimated at $400 million to $500 million, has instead turnedinto a courtroom brawl over alleged patent infringement. Twosuits have been filed against Alza Corp. and its marketingpartner, Marion Merrell Dow Inc. They were the first to receivethe FDA nod on Nov. 8.
Ciba-Geigy is scheduled to formally announce on Thursday thatthe FDA approved its 24-hour patch on Nov. 27. The patch isdesigned to be used for three months at decreasing monthlydosages of 21 milligrams, 14 mgs, and 7 mgs. Alza's 10-weekNicoderm patch is designed to be used in gradually decreasingdosages in conjunction with behavior modification therapy.
MMD and Ciba-Geigy both said they intend to begin U.S.marketing this month. Ciba-Geigy's patch has been sold inseveral European countries since 1980.
On Monday, Ciba-Geigy sued Alza and MMD, seeking to blocksales of Nicoderm. The suit, filed in U.S. District Court in NewJersey, alleges infringement of U.S. patent No. 5,016,656. Thepatent, relating to a transdermal nicotine system, was assignedto the University of California, San Francisco, and exclusivelylicensed to Ciba-Geigy.
Although Alza had announced that a hearing would be heldTuesday to act on Ciga-Geigy's request for a temporaryrestraining order, the court on Tuesday said no date has yetbeen scheduled.
Alza and MMD were sued last month by Elan Corp. plc andAmerican Cyanamid Co. for allegedly infringing U.S. patent No.4,943,435, which was assigned to Elan of Athlone, Ireland. Ahearing on that suit has been scheduled for Friday in DistrictCourt in San Francisco. Elan's patch hasn't been approved bythe FDA.
Elan in May also sued Cygnus Therapeutic Systems Inc. ofRedwood City, Calif., the other nicotine patch developer. Cygnus(NASDAQ:CYGN) has licensed its patch, which isn't yetapproved, to Kabi Pharmacia. Kabi granted U.S. rights toWarner-Lambert.
Alza shares (AMEX:AZA) rose 88 cents, closing at $85.13.Cygnus jumped $1.75 to $22.25. -- Karen Bernstein
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