AVANIR Licenses Docosanol 10% Cream in Japan
January 11 2006 - 7:35AM
Business Wire
AVANIR Pharmaceuticals (AMEX:AVN) announced today that it has
signed an exclusive agreement with a leading importer and
distributor of pharmaceuticals in Japan to develop and market
AVANIR's docosanol 10% cream (docosanol) as a treatment for cold
sores in Japan. "Under the terms of the agreement, our Japanese
partner will be responsible for all expenses incurred obtaining
marketing approval, as well as the manufacture, distribution and
promotion of the product in the territory. The agreement provides
for AVANIR to receive a license fee, development and sales
milestones, and a royalty on all product gross sales," said Marty
Emanuele, Ph.D., Vice President of Business Development and
Licensing at AVANIR. "We look forward to a long and productive
partnership." Docosanol is sold in North America under the brand
name Abreva(R) by AVANIR's licensee, GlaxoSmithKline Consumer
Healthcare, and is the only cold sore product approved by the U.S.
Food and Drug Administration (FDA) available without a
prescription. AVANIR Pharmaceuticals is focused on developing and
commercializing novel therapeutic products for the treatment of
chronic diseases. AVANIR's product candidates address therapeutic
markets that include central nervous system and cardiovascular
disorders, inflammation, and infectious diseases. AVANIR previously
announced positive results in the second of two required Phase III
clinical trials of Neurodex(TM), an investigational new drug for
the treatment of pseudobulbar affect. Additionally, AVANIR has
initiated a Phase III clinical trial for Neurodex as a potential
treatment for diabetic neuropathic pain, a second indication for
Neurodex. AVANIR has active collaborations with two international
pharmaceutical companies: Novartis International Pharmaceutical
Ltd. for the treatment of inflammatory disease and AstraZeneca for
the treatment of cardiovascular disease. The Company's first
commercialized product, Abreva(R), 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. Except for
the historical information presented in this press release, matters
discussed herein contain forward-looking statements that are
subject to certain risks and uncertainties that could cause actual
results to differ materially from any future results, performance
or achievements expressed or implied by such statements. Statements
that are not historical facts, including statements that are
preceded by, followed by, or that include such words as "estimate,"
"anticipate," "believe," "plan" or "expect" or similar statements
are forward-looking statements. There can be no assurance that
regulatory approval efforts will succeed, that docosanol 10% cream
will receive required regulatory clearance, or that even if such
regulatory clearance is received, that such products would
ultimately achieve commercial success. Risks and uncertainties for
AVANIR Pharmaceuticals also include the risks set forth in AVANIR's
most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q and from time-to-time in other publicly available information
regarding the Company. Copies of such information are available
from AVANIR upon request. The company disclaims any intent or
obligations to update these forward-looking statements.
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