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Total Number of Pages: 3
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) January 29, 1999
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CYGNUS, INC.
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(Exact name of registrant as specified in charter)
DELAWARE 0-18962 94-2978092
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
400 PENOBSCOT DRIVE, REDWOOD CITY, CALIFORNIA 94063-4719
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (650) 369-4300
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NOT APPLICABLE
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(Former name or former address, if changed since last report.)
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Item 5. OTHER EVENTS.
On January 28, 1999, Cygnus, Inc. issued a press release, the text
of which is attached hereto as Exhibit 99.1, announcing the submission of the
first part of the pre-market approval application (PMA) for the GlucoWatch
(Registered Trademark) Automatic Glucose Biographer. The Company also
announced the completion of the first of two additional small clinical studies
agreed upon with the FDA for the GlucoWatch (Registered Trademark) Biographer.
Item 7. Financial Statements and Exhibits.
(c) Exhibits.
Exhibit Number
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99.1 Press Release by Cygnus, Inc. dated January 28, 1999
referred to in Item 5 above.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CYGNUS, INC.
DATE: January 29, 1999 By: /s/ Barbara G. McClung
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Name: Barbara G. McClung
Title: Vice President and General Counsel
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EXHIBIT INDEX
EXHIBIT
NUMBER DOCUMENT DESCRIPTION
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99.1 Press Release by Cygnus, Inc. dated January 28, 1999. Refer to Item
5 above.
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EXHIBIT 99.1
FOR ADDITIONAL INFORMATION:
Craig Carlson/CFO, Cygnus
(650) 369-4300 www.cygn.com
Burns McClelland (212) 213-0006
Jonathon M. Nugent -Investors
Justin Jackson - Media
FOR IMMEDIATE RELEASE
Cygnus Submits First Part of the Pre-Market Approval Application for the
GlucoWatch (Registered Trademark) Biographer Ahead of Schedule
First Additional Clinical Study for Remainder of Application Also Completed
January 28, 1999 - Redwood City, Ca - Cygnus Inc. (Nasdaq: CYGN)
announced today the submission of the first part of the pre-market
approval application (PMA) for the GlucoWatch (Registered Trademark)
Automatic Glucose Biographer. This submission includes a variety of
information, including manufacturing documentation. Previously, the
Company planned to submit the first part of the PMA by the end of
February.
In addition, the Company announced the completion of the first of two
additional small clinical studies agreed upon with the FDA for the GlucoWatch
Biographer. The second small clinical study is expected to be completed in
February. These studies are intended to address potential data requests which
could arise at a panel meeting. The clinical studies and other information
which constitute the remainder of the PMA are expected to be submitted to the
FDA no later than June 1999.
"We are delighted to announce that we submitted the first part of the
pre-market approval application to the FDA on January 25, one month
earlier than we expected," stated John C. Hodgman, President and Chief
Executive Officer of Cygnus, Inc. "With the submission of the first
part of the PMA, the completion of this first additional clinical study,
and plans to complete the second clinical study in February, we believe
we are on track for submitting the remainder of our pre-market approval
application to the FDA no later than the end of June," he added.
Cygnus has previously completed a series of clinical studies, with more
than 500 subjects, which will be part of the remaining PMA submission.
In December, Cygnus met with the FDA to discuss the appropriate
regulatory path for the GlucoWatch Biographer. At that meeting, Cygnus
and the FDA agreed that Cygnus would conduct two additional small
clinical studies in support of the PMA. Also at that meeting, it was
indicated that the FDA would waive the requirement for an approved
Investigational Device Exemption (IDE), thus speeding up the submission
process. In addition, the FDA indicated Cygnus' PMA submission would be
appropriate for expedited review.
Cygnus is currently in discussions with a number of companies regarding
a marketing and distribution agreement in the United States and Europe
for the GlucoWatch Biographer. The Company has a marketing and
distribution agreement with Yamanouchi Pharmaceuticals for Japan and
Korea.
The GlucoWatch Biographer is designed to take frequent measurements,
thus providing an abundance of glucose data to potentially better
control fluctuating glucose levels. The product uses reverse
iontophoresis to non-invasively extract and measure glucose levels.
After calibrating with a standard blood glucose monitor, which can occur
3 hours after putting on the GlucoWatch Biographer, the device will
automatically and non-invasively take up to three measurements an hour
for 12 hours. Each AutoSensor (the disposable component) will provide 12
hours of measurements. The GlucoWatch Biographer has features which
include the capability to sound an alert if glucose levels get too high
or too low, to store data for three months, and to download glucose data
into a PC.
Diabetes, which afflicts 16 million people in the U.S. and accounts for
approximately $100 billion in health care costs annually, is a chronic
disease characterized by the body's inability to produce or properly use
insulin. This disease is the fourth leading cause of death by disease in
this country. Effective diabetes management includes frequent and
consistent glucose monitoring. Due to the pain and inconvenience of
current monitoring methods, many people with diabetes test their blood
glucose levels less frequently than recommended to better control their
glucose levels.
Cygnus is engaged in the development and manufacture of diagnostic and
drug delivery systems utilizing its proprietary technologies to satisfy
unmet medical needs cost effectively. Cygnus' current efforts are
primarily focused on two core areas: an automatic and continuous glucose
monitoring device (the GlucoWatch Biographer) and transdermal drug
delivery systems.
This news release contains forward-looking statements regarding future
events and the future performance of the Company that involve risks and
uncertainties that may cause the Company's actual results to differ
materially. Such factors include the timely development, regulatory
submission, government approvals, commercial introduction and market
acceptance of the GlucoWatch Biographer. There can be no assurances that
the results achieved in the clinical studies would result in the FDA
clearing this device for market approval. There can also be no
assurances that the Company will be able to submit the remainder of the
PMA by June 1999. The Company refers you to the documents the Company
files from time to time with the Securities and Exchange Commission,
including the Company's Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K, which contain descriptions of
certain factors that could cause the Company's actual results to differ
from the Company's current expectations and any forward-looking
statements contained in this news release.
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