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新闻
AVANIR to Raise $40.0 Million to Fund Zenvia Through Clinical
Development and Regulatory Approval
Aliso Viejo,
CA - March 27, 2008 - AVANIR Pharmaceuticals (NASDAQ:AVNR) today
announced that it has obtained commitments from a select group of
institutional investors led by ProQuest Investments and joined by Clarus
Ventures, Vivo Ventures, and OrbiMed Advisors to raise gross proceeds of
$40.0 million in a registered direct offering. At closing, AVANIR will
issue an aggregate of approximately 35.0 million shares at a price of
$1.14 per share unit (the market closing bid price as of March 26, 2008
plus a nominal amount for warrants) with 35% warrant coverage. The
warrants, which represent the right to acquire up to approximately 12.2
million shares, are exercisable at 125% of the offering price and have a
5 year exercise term. Net offering proceeds are expected to be
approximately $37.9 million. The transaction is expected to close on or
about April 4, 2008, subject to customary closing conditions. Piper
Jaffray & Co. served as the sole placement agent. The proceeds from this
transaction will be used to complete the confirmatory Phase III STAR
trial of the investigational drug Zenvia (dextromethorphan/quinidine)
and submit a complete response to the U.S. Food and Drug Administration
(FDA) approvable letter for the pseudobulbar affect (PBA) indication.
Top-line PBA data from the STAR trial are expected in the second half of
calendar year 2009 with a complete response expected to be submitted to
the FDA in the first half of calendar year 2010. Proceeds will also be
used for general working capital. The shares are being offered pursuant
to the Company's registration statements on Form S-3 declared effective
by the U.S. Securities and Exchange Commission (SEC) on August 3, 2005
and February 8, 2008, respectively. The offering is being made by means
of a prospectus and prospectus supplement available from the AVANIR
website at http://www.avanir.com or
from the SEC at http://www.sec.gov.
Copies of the prospectus supplement for this offering are available by
writing to the Company at 101 Enterprise, Suite 300, Aliso Viejo,
California 92656 or by calling the Investor Relations department at
(949) 389-6700.
About AVANIR.
AVANIR Pharmaceuticals is focused on acquiring, developing, and
commercializing novel therapeutic products for the treatment of chronic
diseases. AVANIR's products and product candidates address therapeutic
markets that include the central nervous system, inflammation, and
infectious diseases. AVANIR's lead product candidate, Zenvia, is being
developed for the treatment of pseudobulbar affect (PBA) and is the
subject of an approvable letter from the U.S. Food and Drug
Administration (FDA) for that indication. The Company has initiated a
confirmatory Phase III study under a Special Protocol Assessment (SPA)
agreement with the FDA utilizing a new lower quinidine dose formulation
of Zenvia intended to address safety concerns raised in the Agency's
approvable letter for Zenvia in the treatment of PBA. Additionally, in
April 2007 AVANIR announced meeting all primary endpoints in a Phase III
clinical trial with Zenvia in patients with diabetic peripheral
neuropathic (DPN) pain. The Company is conducting a formal
pharmacokinetic (PK) study to assess alternative lower-dose quinidine
formulations of Zenvia for DPN pain that are intended to deliver similar
efficacy and improve safety/tolerability versus the formulations
previously tested for this indication. AVANIR has licensed the MIF
inhibitor program to Novartis International Pharmaceuticals Ltd and has
sold its anthrax monoclonal antibody program to Emergent BioSolutions.
The Company's first commercialized product, Abreva®, is marketed in
North America by GlaxoSmithKline Consumer Healthcare and is the leading
over-the-counter product for the treatment of cold sores. Further
information about AVANIR can be found at www.avanir.com.
Forward Looking Statements
Statements in this press release that are not historical facts,
including statements that are preceded by, followed by, or that include
such words as "estimate," "intend," "anticipate," "believe," "plan,"
"goal," "expect," or similar statements, are forward-looking statements
that are subject to certain risks and uncertainties that could cause
actual results to differ materially from the future results expressed or
implied by such statements. There can be no assurance that any
additional Phase III trial for Zenvia will be successful, that any new
doses of Zenvia will be safe and effective, or that the U.S. Food and
Drug Administration (FDA) will approve Zenvia for any indication. There
can also be no assurance that the proceeds from this offering will be
sufficient to fund our clinical trials to completion as expected. Risks
and uncertainties affecting the Company's financial condition and
operations also include the risks set forth in AVANIR's most recent
Annual Report on Form 10-K and subsequent Quarterly Reports on Form
10-Q, and from time-to-time in other publicly available information
regarding the Company. Copies of this information are available from
AVANIR upon request. AVANIR disclaims any intent to update these
forward-looking statements.
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