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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report: August 14, 1997
(Date of earliest event reported)
LIDAK PHARMACEUTICALS
(Exact name of registrant as specified in its charter)
CALIFORNIA
(State or other jurisdiction of incorporation)
0-18734 33-0314804
(Commission File Number) (IRS Employer Identification No.)
11077 North Torrey Pines Road, La Jolla, California 92037
(Address of principal executive offices) (Zip code)
(619) 558-0364
(Registrants telephone number, including area code)
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Item 5. OTHER EVENTS
The registrant incorporates by reference herein the press release dated
August 14, 1997, attached hereto as Exhibit 99.
Item 7. Financial Statements and Exhibits
(c) Exhibits
(i) Exhibit 99 -- Press Release dated August 14, 1997.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
LIDAK PHARMACEUTICALS
Date: August 18, 1997 By:\s\Susan Yeagley Sullivan
----------------------------
Susan Yeagley Sullivan
Vice President, Chief Financial Officer
and Secretary
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EXHIBIT 99
LIDAK PHARMACEUTICALS
NEWS RELEASE
DATE: AUGUST 14, 1997 CONTACT: Lisa Dawn Katz
Director, Corporate
RELEASE DATE: IMMEDIATE Communications &
Investor Relations
LIDAK Pharmaceuticals
(619) 558-0364, ext. 256
LIDAK PHARMACEUTICALS ACHIEVES POSITIVE RESULTS WITH LIDAKOL(R)
IN PHASE 3 HERPES CLINICAL TRIALS;
WILL APPLY TO FDA FOR MARKETING APPROVAL
LA JOLLA, CALIFORNIA -- August 14, 1997 -- LIDAK Pharmaceuticals (NASDAQ
NNM: LDAKA) announced that treatment of recurrent oral herpes outbreaks with its
topical anti-viral drug, LIDAKOL(R), resulted in a statistically significant (P=
0.035 or less) reduction of the healing times of acute herpes episodes versus
the placebo control. This data was established in just completed, large (743
patients) multi-center, double-blind Phase 3 clinical trials. Healing time is
the critical primary end-point efficacy parameter required by the U.S. Food and
Drug Administration (FDA) for new drug marketing approval of this drug.
In secondary end-points evaluated in these trials, treatment with LIDAKOL
also reduced, to a statistically significant degree versus placebo-treatment (P=
0.0027), the time until patients were free of herpes-associated symptoms, which
included pain, itching, tingling and burning. As observed in previous studies,
there was a higher incidence of aborted outbreaks in LIDAKOL-treated versus
placebo-treated patients. In one subset of patients, the difference in aborted
episodes between LIDAKOL and placebo treatments was statistically-significant
(P=0.048), but the difference was not statistically significant among all
patient subsets (P =0.109).
"The favorable outcome of these Phase 3 studies verifies and confirms our
long-standing confidence in the clinical importance of LIDAKOL as a topical
treatment for this serious infectious disease caused by herpes viruses," stated
David H. Katz, M.D., president and chief executive officer of LIDAK.
"Anticipating the possibility of these positive results, we continued efforts
during the past 12 months to prepare the required documentation to file a New
Drug Application (NDA) for marketing approval of LIDAKOL with the FDA. We are
prepared to complete and file this application by year end 1997," Katz
concluded.
Katz also noted that LIDAK plans to make detailed data from the trials
available in the future through published articles in peer reviewed journals and
presentations at scientific conferences.
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AUGUST 14, 1997
LIDAK PHARMACEUTICALS ACHIEVES POSITIVE RESULTS WITH LIDAKOL(R)
IN PHASE 3 HERPES CLINICAL TRIALS;
WILL APPLY TO FDA FOR MARKETING APPROVAL
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LIDAK Pharmaceuticals has licensed marketing and distribution rights to
LIDAKOL in most territorial regions, including Japan to Grelan Pharmaceuticals,
Co., Ltd.; all of Europe and certain African and Mid-East countries to
Yamanouchi Europe, B.V.; Israel to C.T.S. Chemical Industries; Korea to Boryung
Pharma; and the entire North American continent to Bristol-Myers Squibb Company.
In commenting on the results Arend Paasman, the president and chief
executive officer of Yamanouchi Europe said, "As the European partner of LIDAK
in the development of this drug we are encouraged by the results of these
combined Phase 3 studies. We believe that the new data, which we will analyze in
more detail in the coming weeks, considerably increases our chances for
obtaining marketing approval for LIDAKOL in Europe."
LIDAK Pharmaceuticals is developing therapeutic products against virally
caused diseases, inflammatory disorders, allergies and asthma, and cancer.
# # #
The information contained in this press release, including any forward
looking statements contained herein, should be reviewed in conjunction with the
Company's Annual Report on Form 10-K and other publicly available information
regarding the Company, copies of which are available from the Company upon
request. Such publicly available information sets forth many risks and
uncertainties related to the Company's business and such statements, including
risks and uncertainties related to drug development and clinical trials. Final
review decisions made by the FDA and other regulatory agencies concerning
clinical trial results are unpredictable and outside of the influence and/or
control of the Company.
