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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: December 23, 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
December 23, 1997, attached hereto as Exhibit 99.
Item 7. Financial Statements and Exhibits
(c) Exhibits
(i) Exhibit 99 -- Press Release dated December 23, 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: December 31, 1997 By:\s\Jeffery B. Weinress
--------------------------
Jeffery B. Weinress
Vice President and Chief Financial Officer
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EXHIBIT 99
DATE: DECEMBER 23, 1997 LIDAK PHARMACEUTICALS CONTACT:Lisa Dawn Katz
NEWS RELEASE Director, Corporate
RELEASE DATE: IMMEDIATE Communications &
Investor Relations
LIDAK Pharmaceuticals
(619) 558-0364, ext. 256
Steven Rouhandeh or
Jeffrey B. Davis
StartUp Solutions LLC
(212) 554-4158
LIDAK PHARMACEUTICALS SUBMITS NEW DRUG APPLICATION
TO MARKET NEW HERPES DRUG
LA JOLLA, CALIFORNIA -- December 23, 1997 -- LIDAK Pharmaceuticals
(NASDAQ NM:LDAKA) announced today that it has filed a New Drug Application
(NDA) for its herpes drug, LIDAKOL(R), with the U.S. Food and Drug
Administration (FDA).
With this NDA submission, LIDAK is seeking approval for marketing
LIDAKOL (n-docosanol 10% cream) as a topical treatment for recurrent oral
herpes (cold sores or fever blisters). LIDAKOL is a therapeutic compound,
developed by Company scientists,which has demonstrated a broad spectrum of
anti-viral activities and other therapeutic properties in promoting wound
healing and in reducing acute inflammatory reactions.
"All of us at LIDAK are proud to have achieved this major milestone,"
said David H. Katz, M.D., president and CEO of LIDAK. "In particular, I want to
express my profound appreciation to the LIDAK team which assembled this
application in apparently record time. This NDA is the culmination of an
intensive research and clinical development program of many years' duration.
We look forward to a positive completion of the FDA review process so that we
can make this product available to consumers," Dr. Katz concluded.
The NDA has been submitted four months after the successful completion
of LIDAK's pivotal Phase 3 clinical trials. Almost 750 patients were
evaluated in two double-blind, placebo-controlled studies which evaluated
LIDAKOL in the treatment of recurrent oral herpes. The primary endpoint of
the studies was overall time-to-healing. Secondary endpoints evaluated
percentage of aborted outbreaks and relief of pain symptoms.
The primary end-point evaluation of these trials showed that treatment
with LIDAKOL resulted in a statistically significant reduction of the healing
times of acute herpes episodes versus the placebo control. Contrasting with
the 8 to 10 days normal duration of untreated herpes episodes, LIDAKOL-
treated patients were healed in an average of 4.1 days from beginning-to-end
of their outbreaks.
In secondary end-point evaluations, LIDAKOL-treated patients were
completely relieved of their major herpes-associated symptoms, such as pain,
itching, tingling and burning, significantly faster than the placebo-treated
patients. Moreover, as observed in previous studies there was a higher
incidence of aborted outbreaks in LIDAKOL-treated versus placebo-treated
patients.
--more--
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DECEMBER 23, 1997
LIDAK PHARMACEUTICALS SUBMITS NEW DRUG APPLICATION
TO MARKET HERPES DRUG
PAGE 2
Finally, an additional endpoint demonstrated in earlier studies showed
that LIDAKOL substantially decreased the duration of viral shedding from
active lesions, thereby shortening the most contagious portion of the acute
episode when herpes could be transmitted to another person.
Herpes simplex virus is one of the most common and easily spread viral
infections in the world. In the U.S. alone, one in three adults suffers from
the herpes virus. Oral herpes is the more prevalent form, but over 50 million
Americans have the genital form of herpes, and there are 500,000 new cases
diagnosed each year. There is no currently-known cure for herpes once the
disease is contracted.
The market potential of a topical cream for the treatment of oral herpes
is substantial. Currently, only 18% (or less) of herpes infected patients are
treated because the relatively few drugs that have FDA approval are expensive,
are variable in effectiveness and no currently approved drug has shown the
ability to abort acute outbreaks. Worldwide sales of the most widely used
and approved therapy for the treatment of herpes simplex virus,
acyclovir/Zovirax(R) (in all of its forms), surpassed $1.3 billion dollars
in 1996.
LIDAK Pharmaceuticals is developing therapeutic products against virally
caused diseases, allergies and asthma, inflammatory disorders 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.
