PERNIX Signs Agreement to Acquire TREXIMET® Tablets for Migraine From GSK

  PERNIX Signs Agreement to Acquire TREXIMET® Tablets for Migraine From GSK

Business Wire

MORRISTOWN, N.J. -- May 14, 2014

Pernix Therapeutics Holdings, Inc. (NASDAQ GM: PTX) (“Pernix” or the
“Company”), a specialty pharmaceutical company, today announced that it has
signed an agreement with GlaxoSmithKline (NYSE: GSK) to acquire the U.S rights
to Treximet^® (sumatriptan / naproxen sodium) for the acute treatment of
migraine attacks with or without aura in adults. Pernix’s team of
approximately 90 specialty sales professionals will support the sales and
marketing of Treximet^®.

Doug Drysdale, Chairman, President and CEO of Pernix noted, “The acquisition
of Treximet^®  further accelerates the transformation of Pernix into a
specialty pharmaceutical company and expands our portfolio of CNS brands,
Silenor^® and Khedezla^TM. With the strong presence Pernix is establishing in
the adjacent psychiatric market, this acquisition provides Pernix an
opportunity to expand the company’s reach and penetration into the very
important neurology space.”

Transaction Benefits

  *Adds immediate revenues and earnings, FY2013 Treximet^® net sales $78.7
    million
  *Leverages Pernix’s existing sales presence and experience across
    psychiatry and neurology customers
  *Expected to nearly double Pernix revenues and provide EBITDA margins in
    excess of 30% on a FY2014 pro forma basis
  *Pernix estimates pro forma FY2015 total company revenues will exceed $230
    million with an EBITDA margin of over 40%

Transaction Details

  *Pernix will make an upfront payment to GSK of $250 million for the U.S
    rights to Treximet^®
  *GSK will assign to Pernix the Product Development and Commercialization
    Agreement (“PDC Agreement”) between GSK and POZEN, Inc. (NASDAQ: POZN)
  *POZEN and Pernix will amend the PDC Agreement to facilitate further
    development of Treximet^®
  *The Company will purchase existing inventory from GSK and GSK will
    continue to manufacture Treximet^® in the near future under a long-term
    Supply Agreement with Pernix
  *The Company expects the transaction to close and to transfer Treximet^® no
    later than August 1, 2014 following Hart Scott Rodino approval and closing
    of financing by Pernix
  *The Company will continue to make royalty payments on net sales of the
    product
  *The transaction will be financed through a combination of cash, debt and
    equity-linked or other securities

Operational Plan

  *Pernix expects to begin sales of Treximet^® immediately following the
    closing of the transaction with its approximately 90 sales professionals
    to specific targets in the Neurology, Psychiatry and the Primary Care
    audiences.
  *Pernix is ready to take advantage of minimal branded competition in a
    promotionally sensitive market with a staged re-launch of Treximet^® with
    increased promotion, including a revised campaign for Healthcare
    professionals and consumers, as well as specific tactics addressing
    managed care and pharmacy programs.
  *Treximet^®  is currently the lowest priced branded migraine treatment
    available, yet provides superior pain relief compared to placebo and to
    both of the single mechanism of action components.
  *Pernix also plans to seek an extension of the exclusivity of Treximet^®
    with the first ever pediatric indication (age 12 to 17) for any
    sumatriptan treatment, expected to file by the end of 2014, as well as
    additional life-cycle opportunities that are currently being explored.
    Pernix will pay GSK additional consideration of $17 million upon receipt
    of updated FDA Written Request for pediatric exclusivity.

Under the amended PDC Agreement, Pernix will complete the filing for a
pediatric indication for Treximet^® and undertake certain new activities to
extend the product’s life. In addition, Pernix will release restrictions on
POZEN’s right to develop and commercialize additional dosage forms of
sumatriptan/naproxen combinations outside of the United States.

In connection with the assignment of the PDC Agreement, Pernix shall make a
payment of $3 million to CPPIB Credit Investments Inc. and 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
will be exercisable from the closing date of the transaction until February
2018.

The amended PDC Agreement provides for royalties of 18% of net sales with
quarterly minimum royalty amounts of $4 million for the calendar quarters
commencing on January 1, 2015 and ending on March 31, 2018.

Treximet^® was first 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™. Treximet^® has been shown to provide
superior sustained pain relief compared to placebo and to both of the single
mechanism of action components.

In clinical trials, Treximet^® provided a significantly greater percentage of
patients migraine pain relief at two hours compared to sumatriptan 85mg or
naproxen sodium 500 mg alone. In addition, Treximet^®  provided more patients
sustained migraine pain relief from two to 24 hours compared to the individual
components.

Important safety information about Treximet^®

Prescription Treximet^® is indicated for the acute treatment of migraine
attacks, with or without aura, in adults. Carefully consider the potential
benefits and risks of Treximet^® and other treatment options when deciding to
use Treximet^®. Treximet^® is not intended for the prophylactic therapy of
migraine or for use in the management of hemiplegic or basilar migraine (see
CONTRAINDICATIONS). Safety and effectiveness of Treximet^® have not been
established for cluster headache. Treximet^® should only be used where a clear
diagnosis of migraine headache has been established. Treximet^® may cause an
increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with
duration of use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk. Treximet^® contains a
non-steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause
an increased risk of serious gastrointestinal adverse events including
bleeding, ulceration, and perforation of the stomach or intestines, which can
be fatal. These events can occur at any time during use and without warning
symptoms. Elderly patients are at greater risk for serious gastrointestinal
events. Treximet^® is contraindicated in patients with history, symptoms, or
signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes
and in patients with other significant underlying cardiovascular diseases.
Treximet^® should not be given to patients in whom unrecognized coronary
artery disease is predicted by the presence of risk factors without a prior
cardiovascular evaluation. Treximet^® should not be given to patients with
uncontrolled hypertension because the components have been shown to increase
blood pressure. Concurrent administration of MAO-A inhibitors or use of
Treximet^® within two weeks of discontinuation of MAO-A inhibitor therapy is
contraindicated. Treximet^® and any ergotamine-containing or ergot-type
medication (like dihydroergotamine and mthysergide) should not be used within
24 hours of each other. Since Treximet^® contains sumatriptan, it should not
be administered with another 5-HT1 agonist.

Treximet^® is contraindicated in patients with hepatic impairment. Treximet^®
is contraindicated in patients who have had allergic reactions to products
containing naproxen. It is also contraindicated in patients in whom aspirin or
other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and
nasal polyps. Both types of reactions have the potential of being fatal.
Treximet^® is contraindicated in patients with hypersensitivity to
sumatriptan, naproxen, or any other component of the product. Cerebrovascular
events have been reported in patients treated with sumatriptan. In a number of
cases, it appears possible that the cerebrovascular events were primary. It is
important to advise patients not to administer Treximet^® if a headache being
experienced is atypical. The development of a potentially life-threatening
serotonin syndrome may occur with triptans, including treatment with
Treximet^®, particularly during combined use with selective serotonin reuptake
inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs).
NSAID-containing products, including Treximet^®, should be prescribed with
extreme caution in those with a prior history of ulcer disease or
gastrointestinal bleeding. Treximet should not be used in late pregnancy
because NSAID-containing products have been shown to cause premature closure
of the ductus arteriosus. Treximet^® should not be used during early pregnancy
unless the potential benefit justifies the potential risk to the fetus.

Conference Call Information

Management will host a conference call today at 10:00 a.m. EDT during which
Douglas Drysdale, President and Chief Executive Officer will review the
Company’s acquisition of TREXIMET^®. The slides of Mr. Drysdale’s presentation
will be available on our website at www.pernixtx.com at 8:30 a.m. EDT this
morning. To participate in the live conference call, please dial (877)
312-8783 (domestic) or (408) 940-3874 (international), and provide conference
ID code 47132477. A live webcast of the call will also be available on the
investor relations section of the Company’s website, www.pernixtx.com. Please
allow extra time prior to the webcast to register and download and install any
necessary audio software.

A replay of the call will be available through May 21, 2014. To access the
replay, please dial (855) 859-2056 (domestic) and (404) 537-3406
(international), and provide conference ID code 47132477. An online archive of
the webcast will be available on the Company's website for 30 days following
the call.

About Pernix Therapeutics Holdings, Inc.

Pernix Therapeutics is a specialty pharmaceutical company primarily focused on
the sales, marketing, and development of branded pharmaceutical products. The
Company markets a portfolio of branded products, including: SILENOR^®, a
non-narcotic product for the treatment of insomnia, and KHEDEZLA^™, as well as
CEDAX^®, an antibiotic for middle ear infections and a number of treatments
for cough and cold conditions including ZUTRIPRO^®, REZIRA^® and VITUZ^®. The
Company promotes its branded products to physicians through its Pernix sales
force and markets its generic portfolio through its wholly owned subsidiaries,
Cypress Pharmaceuticals and Macoven Pharmaceuticals. Additional information
about Pernix is available on the Company’s website located at
www.pernixtx.com.

About Glaxo SmithKline (LSE & NYSE: GSK)

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For detailed company
information, see GlaxoSmithKline's website: www.gsk.com.

About POZEN

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.

Cautionary Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Statements including
words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,”
“anticipate,” “believe,” “seek,” “target” or similar expressions are
forward-looking statements. Because these statements reflect the Company’s
current views, expectations and beliefs concerning future events, these
forward-looking statements involve risks and uncertainties. Investors should
note that many factors, as more fully described under the caption “Risk
Factors” in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities
and Exchange Commission and as otherwise enumerated herein or therein, could
affect the Company’s future financial results and could cause actual results
to differ materially from those expressed in forward-looking statements
contained in the Company’s Annual Report on Form 10-K. The forward-looking
statements in this press release are qualified by these risk factors. These
are factors that, individually or in the aggregate, could cause our actual
results to differ materially from expected and historical results. The Company
assumes no obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or otherwise.

Contact:

Pernix Therapeutics Holdings, Inc.
Doug Drysdale, 800-793-2145 ext. 7407
President and CEO
ddrysdale@pernixtx.com
 
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