Cygnus Therapeutic Systems Inc. said Monday that its Nicotrolnicotine transdermal patch has received FDA marketingapproval.
Nicotrol won't be on the market until early in the third quarter,after Cygnus has completed manufacturing validations andbuilt up stock, said Gregory Lawless, president and chiefexecutive.
"We're ramping up production as fast as we can," said Lawless."Parke-Davis doesn't want to end up with insufficient stock."Parke-Davis, a division of Warner-Lambert Co., is marketingthe patch in the United States.
Cygnus shares (NASDAQ:CYGN) gained $1.75 to $18.25. TheRedwood City, Calif., company co-developed the patch with KabiPharmacia AB of Sweden, which is funding a portion ofdevelopment costs in exchange for worldwide marketing rights.
Cygnus retained manufacturing rights and will receive aportion of Kabi's revenues and a portion of sublicensing feespaid to Kabi by Warner-Lambert for the U.S. rights.
Nicotrol, the fourth patch to gain FDA approval, is the only 16-hour product. The other patches are made to be worncontinuously.
Marion Merrell Dow, which markets Alza Corp.'s patch, posted$55 million in sales for the first quarter. Ciba-Geigy had salesof $116.5 million. American Cyanamid Co., which markets ElanCorp. plc's version, doesn't release figures. But analyst DavidSteinberg of Volpe, Welty & Co. put its sales at $10 million to$20 million.
Excess demand is running at about $100 million to $120million, said Steinberg, so the Cygnus patch should get decentmarket share unless the other companies have caught up withdemand by the third quarter.
"The key question," he said, "is can Cygnus get market sharefrom the two leaders. MMD and Ciba-Geigy are getting moreand more entrenched every day. The jury is still out onwhether the advantages of Cygnus' 16-hour patch will gainthem market share."
Cygnus' patch has a slightly lower irritation rate than the otherpatches and mimics the natural pattern of smoking duringwaking hours. However, it may not counter the craving thatsmokers often experience on waking.
-- Karen Bernstein BioWorld Staff
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