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EXHIBIT 99.1
FOR MORE INFORMATION, CONTACT:
Corporate Communications, Cygnus, Inc.
(650) 369-4300 www.cygn.com
FOR IMMEDIATE RELEASE
CYGNUS DISCUSSES GLUCOWATCH-REGISTERED TRADEMARK- BIOGRAPHER INTERNATIONAL
EVENTS
REDWOOD CITY, CA - OCTOBER 16, 2000 - Cygnus, Inc. (Nasdaq: CYGN) announced
today that the first commercial GlucoWatch-Registered Trademark- systems have
been shipped to the United Kingdom. As part of the introduction of the
GlucoWatch Biographer in the UK, Cygnus has established a UK Medical Advisory
Board. The members of this esteemed group of physicians will provide the
GlucoWatch Biographer to select adults with diabetes in order to understand
patient and health care provider experiences with this first-of-its-kind
frequent, automatic, and non-invasive glucose monitor. Cygnus plans to launch
the GlucoWatch Biographer in the UK prior to the end of the year.
The introduction of the GlucoWatch Biographer in the UK will be managed as a
controlled launch. The purpose of the controlled launch is to work closely
with Cygnus' UK Medical Advisory Board members to assess patient usage
experiences, to evaluate training and education programs, and to fine-tune
logistics and technical services functions prior to a broader launch in the
UK. Cygnus established its UK subsidiary in July 2000 and has hired initial
management, training, and sales personnel to manage the launch. In addition,
Cygnus is finalizing an agreement with one company to provide
direct-to-consumer distribution/logistics functions and a second agreement
with another company to provide call center technical services for the UK.
Cygnus received CE certification in December 1999, permitting the GlucoWatch
Biographer to be sold in the European Union.
"Shipping the first commercial GlucoWatch systems is a momentous
accomplishment for Cygnus. But more importantly, we are anxious to provide
this revolutionary new technology to people with diabetes in the UK who may
benefit from making more informed choices about controlling their glucose
fluctuations. It will be exciting to see how patients and health care
providers can best use the additional information provided by the GlucoWatch
Biographer as part of a diabetes management program," stated John C Hodgman,
Chairman, Chief Executive Officer, and President of Cygnus, Inc.
In separate news, Cygnus announced that it has regained the marketing and
distribution rights for the GlucoWatch Biographer in Japan. Yamanouchi
Pharmaceutical Co., Ltd. informed Cygnus that, due to strategic reasons, the
collaboration between Cygnus and Yamanouchi for the marketing and
distribution of the GlucoWatch Biographer in Japan needed to be terminated.
Under terms of the agreement, Yamanouchi will continue to be responsible for
a potential milestone payment over the next nine months and Cygnus assumes
ownership of all the Japanese clinical trial data and regulatory submissions.
"We believe that the GlucoWatch non-invasive glucose monitoring system will
have considerable appeal to physicians and patients in Japan. Unfortunately,
for strategic reasons, our continued collaboration with Cygnus is not
possible," stated Mr. Takeshita, Director of Diagnostic Division, Yamanouchi
Pharmaceutical Co., Ltd.
"Regaining our rights in Japan is consistent with our overall objective to
maintain strategic flexibility as we begin to commercialize the GlucoWatch
Biographer in Europe. The Japanese clinical trials achieved excellent
results, though we do not anticipate product sales in Japan for a number of
years, due to the nature of the Japanese regulatory process. We understand
that Yamanouchi's strategic considerations require ending our collaboration
and we wish them well," concluded Mr. Hodgman.
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Cygnus plans to establish one or more alliances to provide commercialization
functions for the GlucoWatch system in North America, Europe, Japan, and
elsewhere in the world. Cygnus is continuing discussions for alliances with
companies ranging from international companies that would provide a broad
range of commercialization functions worldwide, to companies that would
provide specific commercialization functions, such as distribution, sales,
and customer service. Cygnus recently entered into an agreement with
Livingston Healthcare Services, Inc. to provide outsourced logistics services
in the US for the GlucoWatch system. The agreement covers receiving, storage,
customer service, technical support, and shipment. Livingston Healthcare
Services, Inc., a leading health care and logistics supply chain management
provider, develops logistics solutions and provides essential
logistics-related services to companies in the pharmaceutical and health care
industries. Cygnus is still solely responsible for the production, marketing,
and sales of the GlucoWatch system.
In the US, Cygnus is currently focusing on key activities in preparation for
commercializing the GlucoWatch Biographer. Assuming FDA approval of its
pre-market approval (PMA) application, Cygnus will conduct a marketing pilot
program, and plans to introduce the GlucoWatch Biographer initially on a
limited basis to a small number of patients selected by designated
physicians, to learn more about patients' and caregivers' firsthand
experiences with the product. To support that effort, comprehensive training
materials have been completed and will be introduced to physicians and health
care professionals. In addition, new clinical research trials will be started
to potentially expand the indications for the product, focusing on various
patient groups, including adolescents and gestational diabetes. The company
will also conduct outcome studies designed to demonstrate the clinical
benefits of the GlucoWatch Biographer, collecting information that can become
part of efforts to secure reimbursement from managed care organizations.
Assuming FDA approval of the PMA application and before the GlucoWatch
Biographer can be made broadly available in the US, Cygnus must qualify and
validate, then submit a PMA Supplement to the FDA for approval of, its
large-scale AutoSensor production equipment and facility.
On December 6, 1999, Cygnus received a unanimous recommendation for approval
of its PMA application for the GlucoWatch system from the FDA's Clinical
Chemistry and Clinical Toxicology Devises Panel of the Medical Devices
Advisory Committee, subject to certain conditions. In May 2000 Cygnus
received an approvable letter from the FDA for its GlucoWatch Biographer. An
approvable letter means that the FDA has reviewed Cygnus' PMA application, as
well as its own Advisory Committee's report and recommendation, and believes
it will approve the application, pending specific final conditions. The FDA's
conditions relate to manufacturing, final printed labeling materials, and
post-market evaluations of aspects of product performance.
The GlucoWatch Biographer is a frequent, automatic, and non-invasive glucose
monitoring device intended for detecting trends and tracking patterns of
glucose levels in adults, 18 years and older, who have diabetes. Cygnus'
GlucoWatch system, with its durable Biographer and consumable AutoSensor,
represents a potential advance in glucose monitoring technology, as compared
to the currently prevailing "finger stick" blood monitoring methods. The
GlucoWatch system is designed to automatically measure glucose through the
wearer's skin as frequently as every 20 minutes, for up to 12 hours, through
the ease and convenience of a device worn like a wristwatch. Every reading is
displayed to the wearer and stored in memory. Stored readings can be reviewed
at the touch of a button. The device is intended for use at home and in
health care facilities to supplement, not replace, information obtained from
standard blood glucose monitoring devices. The frequency of the automatic and
non-invasive readings gives patients and their caregivers more complete
information about glucose levels, potentially allowing them to make
better-informed decisions regarding diet, medication, and physical
activities. Diabetes is a chronic disease characterized by the body's
inability to produce or properly use insulin, a hormone that is needed to
convert sugar, starches, and other food into the energy needed for daily
life. People with diabetes can take measurements to reduce the likelihood of
serious complications and premature death associated with diabetes.
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Cygnus, Inc., headquartered in Redwood City, California, develops and
manufactures non-invasive diagnostic medical devices, utilizing proprietary
biosensor technologies to satisfy unmet medical needs cost-effectively. The
company's current efforts are focused on a frequent, automatic, and
non-invasive glucose monitoring device (the GlucoWatch Biographer) and
enhancements thereto.
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 GOVERNMENT APPROVALS, COMMERCIAL
INTRODUCTION, AND MARKET ACCEPTANCE OF THE GLUCOWATCH BIOGRAPHER. FURTHER,
THERE CAN BE NO ASSURANCE THAT THE APPROVABLE LETTER FROM THE FDA WILL RESULT
IN APPROVAL FROM THE FDA FOR THE GLUCOWATCH BIOGRAPHER. THERE CAN BE NO
ASSURANCE THAT THE COMPANY WILL BE ABLE TO ENTER INTO A COMMERCIALIZATION
ALLIANCE OR ALLIANCES OR THAT THE COMPANY WILL BE ABLE TO OUTSOURCE CERTAIN
COMMERCIALIZATION CAPABILITIES FOR LAUNCH WITHOUT A WORLDWIDE
COMMERCIALIZATION ALLIANCE IN PLACE. THERE ALSO CAN BE NO ASSURANCE THAT, IF
THE COMPANY RECEIVES MARKETING APPROVAL FROM THE FDA AND SIGNS
COMMERCIALIZATION AGREEMENTS, THE PRODUCT CAN BE SUCCESSFULLY MANUFACTURED OR
MARKETED EITHER IN THE US OR IN EUROPE. 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.
END
