Avanir Pharmaceuticals and OptiNose Announce Development and Commercialization Agreement for a New Fast-Acting Investigational

Avanir Pharmaceuticals and OptiNose Announce Development and Commercialization
 Agreement for a New Fast-Acting Investigational Product for the Treatment of
                                Acute Migraine

New Drug Application (NDA) Filing Expected by Early 2014

PR Newswire

ALISO VIEJO, Calif. and YARDLEY, Pa., July 2, 2013

ALISO VIEJO, Calif. and YARDLEY, Pa., July 2, 2013 /PRNewswire/ -- Avanir
Pharmaceuticals, Inc. (NASDAQ: AVNR) and OptiNose AS today announced that the
companies have entered into an exclusive North American license agreement for
the development and commercialization of OptiNose's novel Breath Powered™
intranasal delivery system containing low-dose sumatriptan powder to treat
acute migraine. If approved, this product would be the first and only
fast-acting, dry-powder nasal delivery form of sumatriptan.

Under the terms of the agreement, OptiNose received an upfront cash payment of
$20 million and is eligible to receive certain shared development costs and up
to an additional $90 million in total linked to the achievement of future
clinical, regulatory and commercial milestones. In addition, if approved,
Avanir will make tiered royalty payments based on net sales in North America.

"The large migraine market is characterized by a high level of
dissatisfaction. OptiNose has developed a unique device that has the potential
to transform the clinical profile of the leading migraine drug, resulting in a
new product candidate that we believe can significantly improve upon the
current treatment options," said Greg Flesher, senior vice president of
corporate development and chief business officer of Avanir Pharmaceuticals.
"In clinical trials, this innovative and easy-to-use device has demonstrated
rapid absorption and migraine relief using approximately 80% less drug than
the most commonly prescribed oral sumatriptan. This NDA-ready asset fits well
with our current commercial infrastructure and is strategically aligned with
strengthening our position as a leading CNS specialty company."

Under the terms of the agreement, Avanir will assume responsibility for
regulatory, manufacturing, supply-chain and commercialization activities for
the investigational product, now named AVP-825. Both parties will work
together on the remaining activities in support of the NDA submission. Avanir
will begin preparing the NDA immediately and expects to file the application
with the U.S. Food and Drug Administration by early calendar 2014.

"Avanir is an ideal partner given its proven track record of successfully
developing and commercializing neuroscience products," said Peter Miller,
chief executive officer of OptiNose. "The results from our phase III clinical
study were extremely encouraging and we believe we have a potential treatment
that provides pain relief quickly and with few adverse events. This new
delivery method offers significant benefits and we look forward to working
with the Avanir team to bring an important new treatment option to people who
continue to suffer from migraines."

Migraine represents an area of significant unmet medical need. According to
the Centers for Disease Control and Prevention, over 37 million Americans
suffer from migraine headaches.^1 The triptan class of medications is
generally considered the gold standard of care with over 13 million
prescriptions written annually. Sumatriptan is the class leader with a market
share of over 50% making it the most commonly prescribed migraine drug in the
U.S.^2 An online survey of over 2,500 frequent migraine sufferers revealed
that 66% were dissatisfied with their treatments.^3 As a result, many migraine
sufferers are seeking fast-acting, well tolerated treatment options.

About the Phase III TARGET study

In November 2012, Optinose reported results from its pivotal Phase III study
in 212 subjects. The TARGET study tested delivery of 16 mg of sumatriptan
using OptiNose's Breath Powered delivery technology. The study found that the
product provided headache relief for 68% of subjects with moderate to severe
migraines after two hours (p<0.01 compared to placebo). The trial found
subjects began to experience headache relief as quickly as 15 minutes after
administration, with nearly 42% reporting pain relief at 30 minutes
post-treatment (p<0.05 vs. placebo at 30 minutes).

In this multicenter, double-blind, placebo-controlled study, migraine
sufferers were randomized to self-administer either OptiNose sumatriptan
(AVP-825) or placebo using the Breath Powered device when they had moderate to
severe migraine pain. Pain scores were then assessed at various time points
after administration. Pain was evaluated using a four point scale with
headache relief defined as a reduction from moderate (grade 2) or severe
(grade 3) pain to mild (grade 1) or complete relief (grade 0). The data show
pain relief for some subjects began as early as 15 minutes after treatment,
and a statistically significant greater number of subjects receiving OptiNose
sumatriptan (AVP-825) experienced headache relief compared to placebo at all
times from 30 minutes through two hours. At two hours after taking the
medication, 70% of subjects taking OptiNose sumatriptan (AVP-825) reported
that they were experiencing meaningful relief from their headache pain.

There were no serious adverse events associated with OptiNose sumatriptan
(AVP-825) in the study. There were also no systemic adverse events reported in
more than a single subject, and local adverse events reported in the nose were
generally mild and transient.

Other Events

Additionally, Avanir plans to enter into a debt financing, subject to
syndication of the facility and customary closing conditions. The term loan
would include a total loan amount of $50 million. Funds from the loan would be
used to retire Avanir's current $30 million term loan and the remaining $20
million will be used to fund the upfront payment for the Optinose license
agreement.

About OptiNose Breath Powered Delivery Technology

OptiNose's Breath Powered delivery technology is unique in that it uses the
natural function of a user's breath to propel medications beyond the nasal
valve into the deep, targeted areas of the nasal cavity more effectively,
efficiently and consistently than current treatments. A user exhales into the
device, automatically closing the soft palate and sealing off the nasal cavity
completely. The exhaled breath carries medication from the device into one
side of the nose through a sealing nosepiece. Narrow nasal passages are gently
expanded and medication is transported well beyond the nasal valve to targeted
sites. After delivering medication to the targeted sites, air painlessly flows
around to the opposite side of the nasal cavity and exits through the other
side of the nose rather than into the throat or lungs. To view a multimedia
overview of the OptiNose technology, please visit this link.

Note to Investors: Avanir will hold a conference call to discuss this
transaction today, July 2, 2013, beginning at 3:00 p.m. Pacific Time. You can
listen to this call by dialing 1- 877 280 4960 for domestic callers or +1- 857
244 7317 for international callers, and entering passcode 96822585. Those
interested in listening to the conference call live via the internet may do so
by visiting http://ir.avanir.com.

About AVP-825

AVP-825 is an investigational drug-device combination product consisting of
low-dose sumatriptan powder delivered intranasally utilizing a novel breath
powered delivery technology. If approved, AVP-825 would be the first and only
fast-acting, dry-powder intranasal form of sumatriptan.

About Avanir Pharmaceuticals, Inc.

Avanir Pharmaceuticals, Inc.is a biopharmaceutical company focused on
bringing innovative medicines to patients with central nervous system
disorders of high unmet medical need. As part of our commitment, we have
extensively invested in our pipeline and are dedicated to advancing medicines
that can substantially improve the lives of patients and their loved ones. For
more information about Avanir, please visitwww.avanir.com.

About OptiNose

OptiNose is a drug delivery company developing a breakthrough Breath Powered
nasal technology set to transform the static nasal drug delivery market.
OptiNose devices are designed to reliably deliver nasal medication to target
regions of the nasal cavity, including the sinus and olfactory regions, while
preventing lung deposition. The simple devices are intended to unlock the
potential for significant new benefits, including better local activity,
better systemic bioavailability and pharmacodynamics and for "nose-to-brain"
delivery for treating neurologic and psychiatric disorders.

OptiNose has created single and multi-use nasal devices for delivering both
liquid and powder formulations. The patent-protected technology has been
successfully tested in a number of clinical trials evaluating the advantages
of the technology compared to traditional nasal sprays. OptiNose is actively
developing internal products using the new technology, which is also available
to license for delivery of proprietary medicines. Investors in OptiNose
include Avista Capital Partners in New York, WFD Ventures LLC located in New
York and Entrepreneurs Fund LP based in Jersey, Channel Islands. For more
information please visitwww.optinose.com.

AVANIR® is a trademark or registered trademark ofAvanir Pharmaceuticals,
Inc.inthe United States and other countries. All other trademarks are the
property of their respective owners.

^©2013 Avanir Pharmaceuticals, Inc. All Rights Reserved.

^1 Centers for Disease Control and Prevention, Summary Health Statistics for
U.S. Adults: National Health Interview Survey, 2010

^2 IMS NPA February 2013

^3 Migraine in America 2012, Health Union LLC

Forward Looking Statements

Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding Avanir's plans,
potential opportunities, financial or other expectations, projections, goals
objectives, milestones, strategies, market growth, timelines, legal matters,
product pipeline, clinical studies, product development and the potential
benefits of its commercialized products and products under development are
forward-looking statements within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995. These forward-looking
statements are subject to risks and uncertainties that may cause actual
results to differ materially, including the risks and uncertainties associated
with Avanir's operating performance and financial position, joint ventures,
collaborations and partnerships with third parties, market size, market share,
commercial viability, market demand for and acceptance of a new product in
the United States, Canada and/or Mexico, research, development, supply,
manufacturing and commercialization of a new product , obtaining additional
indications, obtaining and maintaining regulatory approvals in the United
States, Canada and/or Mexico, including, but not limited to potential
regulatory delays or rejections in the filing or acceptance of the New Drug
Application, and timing of market entry relative to potential competitors, and
other risks detailed from time to time in the Company's most recent Annual
Report on Form 10-K and other documents subsequently filed with or furnished
to theSecurities and Exchange Commission. These forward-looking statements
are based on current information that may change and you are cautioned not to
place undue reliance on these forward-looking statements, which speak only as
of the date of this press release. All forward-looking statements are
qualified in their entirety by this cautionary statement, and the Company
undertakes no obligation to revise or update any forward-looking statement to
reflect events or circumstances after the issuance of this press release.

SOURCE OptiNose US Inc.

Website: http://www.optinose.com
Contact: Ian Clements, PhD, Avanir Investor & Media Contact, ir@avanir.com, +1
(949) 389-6700; or David Barton, OptiNose Media Contact,
david.barton@hkstrategies.com, +1 (212) 885-0432
 
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