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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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):
June 3, 1996
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EPITOPE, INC.
(Exact name of Registrant as specified in charter)
Oregon
(State or other jurisdiction of incorporation)
1-10492
(Commission File No.)
93-0779127
(IRS Employer Identification No.)
8505 S.W. Creekside Place
Beaverton, Oregon 97008
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code:
(503) 641-6115
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Item 5. Other Events.
On June 3, 1996, Epitope, Inc. ("Epitope") issued a press release
and memorandum to the investment community announcing Food and Drug
Administration ("FDA") approval of Epitope's Western blot HIV-1 confirmatory
test for use with its oral specimen collection device. Copies of the press
release and memorandum are attached as exhibits to this report.
On June 5, 1996, Adolph J. Ferro, Ph.D., President and Chief
Executive Officer of Epitope, discussed the approval and related matters in a
conference call with members of the investment community. Dr. Ferro made
several forward-looking statements during the call, including:
1. Epitope does not anticipate problems with manufacturing its
oral specimen collection device or the Western blot confirmatory test.
Epitope believes manufacturing capacity will be adequate to meet projected
demand.
2. Both Epitope and its marketing partner, SmithKline Beecham plc
("SB"), plan to begin marketing oral specimen collection devices for use with
the Western blot confirmatory test within two to three months.
3. SB will market the oral specimen collection device in two
formats: a bundled format consisting of the oral specimen collection device
and a prepaid testing service, and an unbundled format consisting of only the
oral specimen collection device. The price of the bundled format is likely to
be $25 or more.
4. Epitope's target market in the insurance industry is testing of
applicants for policies of under $100,000. Epitope estimates that this target
market represents potential sales of $40 to $60 million annually.
5. Recent FDA approval of Johnson & Johnson's blood-based HIV home
testing kit may accelerate the need for testing in the insurance industry.
Insurance companies may find it necessary to test more applicants to
discourage individuals who find out that they are HIV positive from applying
for life insurance from an insurer known not to test all applicants.
6. Approval of the Western blot confirmatory test is expected to
eliminate restrictions imposed by several states on use of oral specimen
testing for HIV. Prior to approval, an initial positive result from an oral
specimen had to be confirmed with a blood test. Some states have not
permitted oral specimen testing on the theory that individuals who were asked
to return for a second, blood-based test would assume they were HIV positive,
before a confirmatory test had been conducted. Epitope expects that most
states will allow use of its oral specimen collection device by August 1996.
7. Epitope is considering the possibility of spinning off
Agritope, Inc., Epitope's agricultural biotechnology subsidiary, under
conditions that would be beneficial to shareholders.
Dr. Ferro noted that the forward-looking statements are subject to
factors described in Epitope's Annual Report on Form 10-K for the year ended
September 30, 1995, and other documents filed with the Securities and Exchange
Commission. These factors include unexpected interruption of supply or
manufacturing operations, changes in SB's marketing strategy or emphasis,
development of competing products, market acceptance of oral testing, changes
in insurance industry practices, unexpected delays in obtaining state
approvals, changes in federal or state law or regulations, and changes in
Epitope's business strategy.
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Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(a) Not applicable.
(b) Not applicable.
(c) Exhibits.
The exhibits filed herewith are listed in the exhibit index
following the signature page of this report.
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SIGNATURES
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 hereunto duly authorized.
EPITOPE, INC.
Dated: June 17, 1996 By:
Gilbert N. Miller
Executive Vice President and Chief
Financial Officer
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EXHIBIT INDEX
99.1 Press release of Epitope, Inc., dated June 3, 1996.
99.2 Memorandum to the investment community from Gus Allen/Mary Hagen,
dated June 3, 1996.
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Exhibit 99.1
Media Contact: Trina Chiara/Lori Agin
(212) 213-4211
ORASURE(R) HIV-1 WESTERN BLOT KIT
CLEARED FOR PROFESSIONAL MARKETING BY FDA
- -- The First Major Breakthrough With Potential to Expand HIV Antibody Testing
In More Than Ten Years; No Blood, No Needles Required --
Pittsburgh, Pa., June 3, 1996 - Today, the Food and Drug Administration (FDA)
cleared for professional marketing the OraSure HIV-1 Western Blot Kit, the
first oral HIV antibody confirmation test. The OraSure technology -- which
does not require blood or needles -- provides a simple, highly accurate HIV
testing option and represents the first major breakthrough with the potential
to expand HIV testing in more than ten years. OraSure was developed by
Epitope, Inc. (AMEX:EPT) and will be marketed to health professionals by
SmithKline Beecham Consumer Healthcare (NYSE:SBE).
"A person can have the virus for ten years or more before the symptoms of AIDS
appear, and as a result, more than half the people who are infected don't know
it," said Richard Sadovsky, MD, Associate Professor of Family Medicine, State
University of New York Health Science Center at Brooklyn, and Past President,
New York State Chapter, American Academy of Family Physicians. "HIV antibody
testing is one of the strongest weapons we have to wage war on the spread of
AIDS, and this painless new testing option is likely to have wide appeal."
OraSure technology is unique in that it does not test saliva, but rather an
oral sample called oral mucosal transudate (OMT), which contains high
concentrations of antibodies and is free of most of the contaminants found in
saliva.
"An OraSure sample is not saliva -- that's the key to the technology and to
its high level of accuracy," said John Fitchen, MD, Chief Operating
Officer/Medical Products, Epitope. "Like traditional blood tests, it tests
for HIV antibodies, not the virus. Unlike any other tests, it draws out HIV
antibodies from the tissues of the cheek and gum."
HIV Antibody Testing and OraSure Technology
A specially treated pad attached to a handle is placed by the patient between
the lower cheek and gum for two minutes. The pad is then placed in a vial
with a preservative and sent to a clinical laboratory for testing for the
presence of HIV antibodies, the same way blood samples are tested.
Analysis of the oral sample is done with an enzyme-linked immunosorbent assay
(ELISA), a highly sensitive screening test that detects HIV antibodies.
Reactive results (those that are positive in the initial screening test) are
automatically re-tested with a second OraSure ELISA. If the second ELISA
results are also reactive, the sample is tested with the OraSure Western Blot,
which confirms HIV infection. A single OraSure sample is adequate for the
entire testing procedure.
Individual samples are recorded by number to help ensure confidentiality;
results will be available to the healthcare provider within three days.
"We believe the partnership between Epitope's innovative technology and SBCH's
marketing expertise will result in broader access to HIV antibody testing,"
said Donna Sturgess, Director of Diagnostic Products, SmithKline Beecham
Consumer Healthcare (SBCH). "FDA approval of the OraSure Western Blot Kit for
professionals is a significant milestone in the effort to provide accurate,
non-invasive HIV antibody testing."
-- more--
-2-
OraSure Clinical Trials for Western Blot Approval
In a large, multi-center trial, matched OraSure and blood specimens were
collected from 3,570 subjects at 11 sites around the United States. Subjects
ranged in age from 13 to 80. Approximately 38% of study participants were
women.
Clinical trial results showed that OraSure is a highly accurate alternative to
blood testing. Overall, testing of OraSure samples gave the correct result or
triggered appropriate follow-up testing in 99.97% (3,569/3,570) of cases.
The Importance of HIV Testing
"It is important for everyone to discuss with a health professional the value
of knowing his/her HIV status because AIDS cuts across gender, ethnicity,
sexual orientation, age and socio-economic status," Dr. Sadovsky said.
"Confirming a negative HIV status can be a great relief and provides an
opportunity for people to adopt behaviors to protect themselves from the
virus. When a test is positive, there are treatments that can slow
progression of the disease and support systems that can improve quality of
life."
Dr. Sadovsky noted that testing, together with effective counseling, empowers
people to make better personal choices and lead healthier lives. Without
reinforcement, people may continue high risk behaviors or remain unaware of
treatment and counseling options that are available, he added.
OraSure Availability
OraSure will be available in physicians' offices, private testing sites,
public health departments, community-based health services, and AIDS service
organizations in approximately two to three months. The test will be priced
competitively with standard blood tests.
To help address product and general HIV testing questions, a toll-free number
and World Wide Web site for OraSure will be in place for consumers and health
professionals at the time of availability. SmithKline Beecham Consumer
Healthcare also plans to distribute consumer education materials on HIV
testing and transmission through community-based and AIDS service
organizations.
SmithKline Beecham Consumer Healthcare is a division of SmithKline Beecham,
one of the world's leading healthcare companies that discovers, develops,
manufactures and markets pharmaceuticals, vaccines, over-the-counter
medicines, health-related consumer products and healthcare services including
clinical laboratory testing, disease management and pharmaceutical benefit
management.
Epitope is a biotechnology company that develops and markets medical
diagnostic products and through its agricultural unit, superior plants and
related products.
# # #
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Exhibit 99.2
To: The Investment Community
From: Gus Allen/ Mary Hagen
Subject: FDA approval of OraSure Western blot HIV-1 confirmatory test
Date: June 3, 1996
Attached is a copy of today's joint announcement from Epitope, Inc. and
SmithKline Beecham (SB) disclosing that FDA has approved Epitope's OraSure
Western blot HIV-1 confirmatory test. The announcement has broad implications
for Epitope and its investors.
Approval of the OraSure Western blot confirmatory test completes the oral
specimen testing system for HIV-1 the virus that causes AIDS. Positive
screening results may now be confirmed by utilizing the OraSure Western blot
HIV confirmatory test on the original oral sample, thereby avoiding the need
to draw a blood sample to confirm the initial positive indication.
The previous requirement for a blood-based confirmation causes many insurance
companies to adopt a "wait and see" attitude towards adoption of Epitope's
oral specimen HIV screening system, despite the obvious advantages of a
noninvasive device. Availability of the OraSure Western blot confirmation
test is expected to change that attitude for many firms. In fact, twenty life
insurance companies have already advised our marketing representatives that
they plan to adopt oral specimen-based testing upon approval of the OraSure
Western blot confirmatory test.
As indicated in the attached release, OraSure will now be offered by SB to a
wide variety of additional markets, including physicians' offices, private
testing sites, community-based health services and AIDS service organizations
in approximately two to three months.
We are enthusiastic about the prospects for increased sales that this latest
FDA approval presents to Epitope and its investors. We appreciate the support
that shareholders have given in the past and look forward to a prosperous
future for all of us. Epitope management continues to be fully committed to
do our best to see that your support will be rewarded.
