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 REDWOOD CITY, Calif., Jan. 10 /PRNewswire/ -- Cygnus Therapeutic Systems (NASDAQ: CYGN) announced the filing of one New Drug Application (NDA) and two investigational New Drug applications (INDs) for potential products for the $1.7 billion hormone replacement market. The NDA was filed by Cygnus' partner, Warner-Lambert, for an estrogen transdermal patch using Cygnus' proprietary 7-day drug delivery system. The two INDs were filed by Cygnus on behalf of its new partner Wyeth-Ayerst. One IND filing is a 7-day estrogen patch which is expected to begin phase I clinical trials during the first quarter of 1994. The second IND filing is a combination estrogen and progestin 3 1/2-day patch and is already in phase I clinical trials.
 "Our top priority is to move products to market as quickly as possible," according to Gregory Lawless, president and chief operating officer of Cygnus. "We made a commitment to complete these filings by the end of 1993 and we are very pleased to have achieved these milestones. We believe our proprietary 7-day delivery systems provide distinct advantages and offer significant sales potential."
 Cygnus now has partnership commitments for the development of six transdermal patches for the hormone replacement market. The company believes that these products have the potential to help it to achieve considerable market share in the growing patch segment of this market. The hormone replacement market is expected to reach $3 billion by the end of the decade.
 Cygnus' proprietary 7-day drug delivery systems have the potential to release hormones at a controlled, predetermined rate over 7 consecutive days. They offer improved therapy by providing the correct therapeutic blood levels for 7 straight days rather than the peaks and valleys associated with other dosage forms. Transdermal delivery can use lower doses of these hormones because it avoids initial metabolism in the liver. This can lead to a reduction in side-effects. The 7-day systems can also improve dosing compliance. A recent study indicated 57% of women undergoing hormone replacement therapy do not correctly follow their dosing regimen. A recent survey of obstetricians and gynecologists revealed that 77% believed 7-day patches would offer significant advantages over 3 1/2-day patches, primarily due to increasing dosing compliance.
 Cygnus Therapeutics Systems is a leader in the development of advanced drug delivery systems. The company is focusing on four key markets: hormone replacement, glucose monitoring, smoking cessation and consumer products. The company has more than a dozen products in various stages of development with one in the market, Nicotrol(TM), and one awaiting FDA approval.
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 /CONTACT: Craig Carlson of Cygnus, 415-369-4300/

CO: Cygnus Therapeutic Systems ST: California IN: MTC SU:

LW-RB -- SJ005 -- 0695 01/10/94 16:16 EST
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Publication:PR Newswire
Date:Jan 10, 1994

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