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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, 1998
(Date of earliest event reported)
AVANIR 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.)
9393 Towne Centre, Suite 200, San Diego, California 92121-3016
(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, 1998 attached hereto as Exhibit 99.
Item 7. Financial Statements and Exhibits
(c) Exhibits
(i) Exhibit 99 - Press Release dated December 23, 1998
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.
AVANIR PHARMACEUTICALS
Date: December 23, 1998 By:\s\Gregory P. Hanson
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Gregory P. Hanson
Vice President, Finance and Chief Financial Officer
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EXHIBIT 99
AVANIR PHARMACEUTICALS
NEWS RELEASE
FOR IMMEDIATE RELEASE
Contacts: Gregory Hanson, CFO
AVANIR Pharmaceuticals
619/410-2670
Bob Stone/Ken DiPaola
The Dilenschneider Group
212/922-0900
914/591-5534 Stone home
AVANIR PHARMACEUTICALS RECEIVES
ACTION LETTER FROM FDA REGARDING NDA APPLICATION FOR DOCOSANOL CREAM
SAN DIEGO, December 23, 1998 -- AVANIR Pharmaceuticals (NASDAQ: AVNR),
today announced receipt of a letter dated December 22, 1998, from the Food and
Drug Administration (FDA) stating that the New Drug Application (NDA) for
docosanol 10% cream for the treatment of oral-facial herpes infections is "not
approvable." The letter indicates that the FDA has completed its review and
states that additional evidence is needed to substantiate the drug's
effectiveness. The letter goes on to state that one additional clinical trial
may be sufficient to substantiate the efficacy findings of studies the Company
submitted with the NDA.
According to the FDA, the other sections of AVANIR's application,
including the chemistry, manufacturing and controls, the
pharmacology/toxicology, and the evidence for safety of docosanol for its
proposed human use, were not the basis for the "not approvable" action.
AVANIR's chief executive officer, Dr. Gerald J. Yakatan, stated, "We are
obviously disappointed at this initial FDA decision because we feel that the
efficacy data are strong enough for the drug to be approved. The fact that the
FDA agreed that one of our clinical trials showed evidence of effectiveness in
both the primary and certain secondary endpoints reinforces our belief in
docosanol's efficacy. We have already informed the FDA that we intend to respond
to their letter. Based on the resulting FDA discussions, the Company will
determine the best course of action."
(More)
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AVANIR Pharmaceuticals, based in San Diego, develops novel therapeutic
products for the treatment of chronic diseases. The Company is also seeking
in-licensing agreements with other pharmaceutical companies for late-stage
products to complete its drug pipeline.
The information contained in this press release, including any forward looking
statements contained herein, should be reviewed in conjunction with the
Company's risk factors contained in the Annual Report on Form 10K, which sets
forth many risks and uncertainties related to the Company's business, including
risks and uncertainties related to drug development and clinical trials. The
Company can give no assurance that it will be able to finance the additional
clinical trials that may be required by the FDA with respect to docosanol or
that the FDA will ultimately grant marketing approval. 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.
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