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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: September 16, 1999
(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 Drive, Suite 200, San Diego, California 92121
(Address of principal executive offices) (Zip code)
(619) 558-0364
(Registrants telephone number, including area code)
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Item 5. OTHER EVENTS
1. On September 24, 1999, we received an action letter from the U.S.
Food and Drug Administration confirming a September 16, 1999
teleconference discussion that our submissions of additional
analyses for our new drug application for docosanol 10% cream were
not adequate to establish effectiveness for the treatment of
oral-facial herpes simplex infections, more commonly known as cold
sores or fever blisters. The FDA noted that it anticipated that one
additional adequate and well-controlled study may be sufficient to
confirm the effectiveness of the drug. The FDA did not provide any
details of its reviews of our additional statistical analyses,
interpretations and answers to FDA questions submitted between
December 1998 and August 1999, but indicated that it would explore
how it can best make that information available to us.
Following the teleconference, we have accelerated the pursuit of
several alternative strategies intended to maximize the value of our
development efforts completed to date for a cold sore product. The
primary strategies are to find a pharmaceutical development or
marketing partner that would either:
(i) perform the additional clinical trial and market the drug if
and when approved or
(ii) market a reformulated version of the product that can be taken
directly to the over-the-counter (OTC) marketplace.
If partnering for our cold sore product is unsuccessful, then we
will not be able to carry out our commercialization plans unless we
raise substantially dilutive capital or we are acquired by another
company.
2. On September 17, 1999 we were notified by The Nasdaq Stock Market
that our stock would be de-listed from the Nasdaq National Market
listing effective before the market would open on Monday, September
20, 1999, but that we would be eligible for trading on Nasdaq's
over-the-counter (OTC) Bulletin Board. On Monday, September 20,
1999, we began trading on the OTC Bulletin Board under the symbol
AVNR.OB. Nasdaq's decision came to us approximately 24 hours after
we received the FDA action letter.
Item 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits
99.1 Press release dated September 16, 1999 regarding FDA
teleconference
99.2 Press release dated September 17, 1999 regarding
delisting from Nasdaq National Market System
99.3 Press release dated September 28, 1999 regarding
alternative strategies being pursued after FDA action
letter
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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: October 4, 1999 By:/s/Gregory P. Hanson
------------------------------------
Gregory P. Hanson
Vice President, Finance and
Chief Financial Officer
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Exhibit 99.1
NEWS RELEASE
FOR IMMEDIATE RELEASE
Company Contacts:
Investor Relations: Financial Media Relations: Patrice Saxon, Investor Relations
Tom Redington Bob Stone 858/ 410-2660
Redington, Inc. The Dilenschneider Group Gregory Hanson, CFO
203/ 222-7399 212/ 922-0900 858/ 410-2670
FDA REQUESTS AVANIR PROVIDE ADDITIONAL DATA
FOR TOPICAL TREATMENT OF COLD SORES
San Diego, September 16, 1999 -- AVANIR Pharmaceuticals (NASDAQ: AVNR)
today announced that its application with the U.S. Food and Drug Administration
(FDA) for approval of docosanol cream for the treatment of oral-facial herpes
requires additional clinical data.
In a telephone conference, the FDA did not provide the company with the
basis for today's decision, other than to say it was a "judgment call" and that
there was not quite enough data for final approval. The FDA said that while the
company has provided good data, "a little more is needed."
Gerald J. Yakatan, Ph.D., AVANIR's chief executive officer and
president, said he was surprised that the FDA stated the decision was a
"judgment call" on their part. "We will await the letter outlining the basis for
their decision, which they stated will be sent within five days, before
determining our next steps and addressing their request for `a little more
data.'" Dr. Yakatan said.
AVANIR Pharmaceuticals, based in San Diego, California, is a specialty
pharmaceutical company that identifies, acquires and commercializes therapeutic
compounds through discovery and in-licensing.
###
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/A and other publicly available information
regarding the company, copies of which are available from the company upon
request. Readers are cautioned not to place undue reliance on these
forward-looking statements, which are only predictions and speak only as of the
date hereof. Forward-looking statements usually contain the words "anticipate,"
"intend," "believe" or similar expressions, and are subject to numerous known
and unknown risks and uncertainties. In evaluating such statements, prospective
investors should carefully review various risks and uncertainties identified in
Form 10-K/A. Even though the final terms of the FDA's action letter have not yet
been received, the company cannot provide any assurance that it will be able to
obtain the financial resources necessary to provide the additional clinical data
or continue to develop docosanol.
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Exhibit 99.2
NEWS RELEASE
FOR IMMEDIATE RELEASE
Company Contacts:
Investor Relations: Financial Media Relations: Patrice Saxon, Investor Relations
Tom Redington Bob Stone 858/ 410-2660
Redington, Inc. The Dilenschneider Group Gregory Hanson, CFO
203/ 222-7399 212/ 922-0900 858/ 410-2670
AVANIR PHARMACEUTICALS TO TRADE ON THE OTC BULLETIN BOARD
San Diego, September 17, 1999 -- AVANIR Pharmaceuticals (NASDAQ: AVNR)
today announced that it was determined by a Nasdaq Listing Qualifications Panel
that the company's stock is to be delisted from trading on the Nasdaq Stock
Market effective at close of business today. The Panel noted that the company
currently does not meet the requirements for continued listing.
Gerald J. Yakatan, Ph.D., AVANIR's chief executive officer and
president, said AVANIR will begin trading on the OTC Bulletin Board on Monday,
September 20, 1999. "Given the recent unfavorable decision by the Food and Drug
Administration on docosanol, the company's lead therapeutic product, the
decision by Nasdaq was not unexpected."
AVANIR Pharmaceuticals, based in San Diego, California, is a specialty
pharmaceutical company that identifies, acquires and commercializes therapeutic
compounds through discovery and in-licensing.
###
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/A and other publicly available information
regarding the company, copies of which are available from the company upon
request. Readers are cautioned not to place undue reliance on these
forward-looking statements, which are only predictions and speak only as of the
date hereof. Forward-looking statements usually contain the words "anticipate,"
"intend," "believe" or similar expressions, and are subject to numerous known
and unknown risks and uncertainties. In evaluating such statements, prospective
investors should carefully review various risks and uncertainties identified in
Form 10-K/A. Even though the final terms of the FDA's action letter have not yet
been received, the company cannot provide any assurance that it will be able to
obtain the financial resources necessary to provide the additional clinical data
or continue to develop docosanol.
<PAGE> 1
Exhibit 99.3
NEWS RELEASE
FOR IMMEDIATE RELEASE
Company Contacts:
Investor Relations: Financial Media Relations: Patrice Saxon, Investor Relations
Tom Redington Bob Stone 858/ 410-2660
Redington, Inc. The Dilenschneider Group Gregory Hanson, CFO
203/ 222-7399 212/ 922-0900 858/ 410-2670
AVANIR PURSUES PHARMACEUTICAL MARKETING AND DEVELOPMENT PARTNERS
FOR COLD SORE PRODUCT
COMPANY REVISES STRATEGY FOR DOCOSANOL FOLLOWING EXPECTED FDA ACTION LETTER
San Diego, September 28, 1999 -- AVANIR Pharmaceuticals (OTC Bulletin
Board: AVNR) today announced that the U.S. Food and Drug Administration (FDA)
issued an action letter confirming the September 16, 1999 teleconference
discussion that the company's submissions of additional analyses of docosanol
10% cream clinical data were not adequate to establish effectiveness for the
treatment of oral-facial herpes simplex infections, more commonly known as cold
sores or fever blisters. The FDA noted they anticipated that one additional
adequate and well-controlled study may be sufficient to confirm the
effectiveness of the drug. The FDA did not provide any details of its reviews of
AVANIR's additional statistical analyses, interpretations and answers to FDA
questions submitted between December 1998 and August 1999, but indicated it
would explore how it can best make that information available to the company.
Gerald J. Yakatan, Ph.D., AVANIR's chief executive officer and
president, stated, "We are extremely disappointed that, after the FDA reviewed
17 different analyses and presentations of data provided by the company over the
last nine months, they did not provide any scientific justification for why the
supplemental analyses and presentations failed to satisfy the FDA's concerns. We
intend to vigorously seek the scientific justification for the FDA's decision."
Dr. Yakatan went on to state, "We are accelerating the pursuit of
several alternative strategies intended to maximize the value of our development
efforts completed to date. Last week we held two meetings with potential
prospective pharmaceutical development and/or marketing partners for the
product, and we have scheduled two other meetings that will be held shortly.
Several pharmaceutical companies have expressed interest in conducting the
additional clinical trial if we continue to seek approval as a prescription
product, which is one of our alternatives. Simultaneously, we have accelerated
discussions with several experienced potential marketing partners that have
expressed interest in a reformulated version of the product that can be taken
directly to the over-the-counter (OTC) marketplace, which is another
alternative. If partnering for our product is unsuccessful, then we will not be
able to carry out our commercialization plans unless substantially dilutive
capital is raised or we are acquired by another company."
Earlier this year, AVANIR reported that it would consider alternative
strategies for commercialization of a cold sore product in the event of an
unfavorable decision by the FDA. Steps taken prior to receiving the FDA's
decision included holding preliminary discussions with several potential
development or marketing partners for docosanol or some modified version of the
company's cold sore product.
"The biggest concern that we expressed earlier this year was that an
extended delay by the FDA in reaching a decision would be very costly for us,"
Dr. Yakatan stated. "As a small company, we have limited financial resources.
The protracted discussions with the FDA in attempting to achieve marketing
approval have caused us to delay pursuing any commercialization plan until the
discussions were concluded. Given the difficulty in achieving a timely decision
by the FDA, we now face extreme financial difficulty in being able to complete
the commercialization of the product by ourselves."
AVANIR also reported that it recently took a number of additional
cost-cutting actions to save cash resources while the company pursues the
immediate objective to maximize the value of the development efforts for
docosanol. Cost-cutting actions included temporary across-the-board cuts in
employee salaries, reduced employee benefits, and a freeze on all purchase
commitments. Earlier this year, the company reduced its staff by 40 percent.
AVANIR Pharmaceuticals, based in San Diego, California, is a specialty
pharmaceutical company that develops therapeutic compounds found through
discovery and in-licensing.
###
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/A and other publicly available information
regarding the company, copies of which are available from the company upon
request. Readers are cautioned not to place undue reliance on these
forward-looking statements, which are only predictions and speak only as of the
date hereof. Forward-looking statements usually contain the words "anticipate,"
"intend," "believe" or similar expressions, and are subject to numerous known
and unknown risks and uncertainties. In evaluating such statements, prospective
investors should carefully review various risks and uncertainties identified in
Form 10-K/A. The company may not be able to obtain any partners or the financial
resources necessary to provide the additional clinical data or to continue to
develop docosanol or any other cold sore product.
