POZEN to Receive Pernix Warrants and ROW Rights to Treximet
CHAPEL HILL, N.C.--(BUSINESS WIRE)--May 14, 2014--
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company
committed to transforming medicine that transforms lives, today
announced that GlaxoSmithKline (GSK) will divest all of its rights to Treximet®
(sumatriptan / naproxen sodium) to Pernix Therapeutics Holdings, Inc.
(Pernix). As part of the Divestiture, GSK will assign the Product
Development and Commercialization Agreement between POZEN and GSK to
Pernix, and POZEN and Pernix will amend the agreement to address rights
of the parties and future development.
“We are very pleased that Pernix will take over the sales and marketing
of Treximet in the United States,” said Dennis L. McNamara, Sr.
Vice President and Chief Business Officer. “We look forward to working
with Pernix to assist them in growing and expanding the brand and
appreciate their collaborative approach.”
Under the amended agreement, Pernix will continue certain of GSK’s
ongoing development activities and undertake certain new activities, for
which POZEN will provide reasonable assistance. In addition, any
restrictions on POZEN’s right to develop and commercialize additional
certain dosage forms of sumatriptan / naproxen combinations outside of
the United States will be eliminated, and POZEN may seek approval for
these combinations on the basis of the approved U.S. New Drug
Pernix has also granted POZEN a warrant to purchase 500,000 shares of
Pernix common stock at an exercise price equal to the closing market
price on May 13, 2014. The warrants, which will be registered by Pernix
with the Securities and Exchange Commission, will be exercisable from
the closing date of the Divestiture until February 28, 2018.
The amended Agreement provides for a guaranteed quarterly minimum
royalty amount of $4 million for the calendar quarters commencing on
January 1, 2015 and ending on March 31, 2018. In November 2011, POZEN
entered into a Purchase and Sale Agreement with CPPIB Credit Investments
Inc. (CII), pursuant to which it sold its right to receive future
royalty payments arising from U.S. sales of MT 400, including Treximet
to CII. Under the Purchase and Sale Agreement, POZEN will receive a
twenty percent (20%) interest in any royalties received by CII relating
to the period commencing on April 1, 2018.
The transaction will become effective only upon approval of the
transaction by the U.S. Federal Trade Commission under the Hart Scott
Rodino notification program, and closing of financing by Pernix.
POZEN will host a webcast on Wednesday, May 14, 2014 at 11:00 a.m. (ET).
The webcast can be accessed live and will be available for replay at www.pozen.com.
POZEN Inc. is a small pharmaceutical company that specializes in
developing novel therapeutics for unmet medical needs and licensing
those products to other pharmaceutical companies for commercialization.
By utilizing a unique in-source model and focusing on integrated
therapies, POZEN has successfully developed and obtained FDA approval of
two self-invented products. Funded by these milestones/royalty streams,
POZEN has created a portfolio of cost-effective, evidence-based
integrated aspirin therapies designed to enable the full power of
aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the
opportunities for its portfolio assets.
The Company's common stock is traded under the symbol “POZN” on The
NASDAQ Global Market. For more detailed company information, including
copies of this and other press releases, please visit www.pozen.com.
Treximet was approved by the U.S. Food and Drug Administration
(FDA) in April 2008 for the acute treatment of migraine attacks, with or
without aura, in adults. The product is formulated with POZEN’s patented
technology of combining a triptan with a non-steroidal anti-inflammatory
drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™. This migraine
medication contains sumatriptan, a 5-HT1 receptor agonist that mediates
vasoconstriction of the human basilar artery and vasculature of human
dura mater, which correlates with the relief of migraine headache. It
also contains naproxen, an NSAID that inhibits the synthesis of
inflammatory mediators. Therefore, sumatriptan and naproxen contribute
to the relief of migraine through pharmacologically different mechanisms
of action. As a result of this dual mechanism of action, Treximet
has been shown to provide superior sustained pain relief compared to
placebo and to both of the single mechanism of action components.
For Full Prescribing Information see www.treximet.com.
Statements included in this press release that are not historical in
nature are “forward-looking statements” within the meaning of the “safe
harbor” provisions of the Private Securities Litigation Reform Act of
1995. You should be aware that our actual results, our ability to return
value to our stockholders, including any cash distributions, and our
future prospects could differ materially from those contained in the
forward-looking statements, which are based on current market data and
research (including third party and POZEN sponsored market studies and
reports), management’s current expectations and are subject to a number
of risks and uncertainties, including, but not limited to, our inability
to further license our PA product candidates on terms and timing
acceptable to us, our failure to successfully commercialize our product
candidates; costs and delays in the development and/or FDA approval of
our product candidates, including as a result of the need to conduct
additional studies or due to issues with third-party manufacturers, or
the failure to obtain such approval of our product candidates for all
expected indications, including as a result of changes in regulatory
standards or the regulatory environment during the development period of
any of our product candidates; uncertainties in clinical trial results
or the timing of such trials, resulting in, among other things, an
extension in the period over which we recognize deferred revenue or our
failure to achieve milestones that would have provided us with revenue;
our inability to maintain or enter into, and the risks resulting from
our dependence upon, collaboration or contractual arrangements necessary
for the development, manufacture, commercialization, marketing, sales
and distribution of any products, including our dependence on
AstraZeneca and Horizon for the sales and marketing of VIMOVO®,
our dependence on Sanofi US for the sales and marketing of
PA8140/PA32540 in the United States, if approved, and our dependence on
Patheon for the manufacture of PA8140/PA32540; competitive factors; our
inability to protect our patents or proprietary rights and obtain
necessary rights to third party patents and intellectual property to
operate our business; our inability to operate our business without
infringing the patents and proprietary rights of others; general
economic conditions; the failure of any products to gain market
acceptance; our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry
practice; and one-time events, including those discussed herein and in
our Quarterly Report on Form 10-Q for the period ended March 31, 2014.
We do not intend to update any of these factors or to publicly announce
the results of any revisions to these forward-looking statements.
Source: POZEN Inc.
Bill Hodges, Chief Financial Officer
Bonestell Manager, Investor Relations & Public Relations