Mallinckrodt and Zogenix Announce Exclusive Co-Promotion Arrangement on SUMAVEL® DosePro®

  Mallinckrodt and Zogenix Announce Exclusive Co-Promotion Arrangement on
  SUMAVEL® DosePro®

Collaboration agreement between Mallinckrodt and Zogenix on migraine treatment

Business Wire

HAZELWOOD, Mo. -- June 07, 2012

Mallinckrodt LLC, the Pharmaceuticals business of Covidien (NYSE: COV), today
announced that it has entered into a co-promotion agreement with Zogenix Inc.
(NASDAQ: ZGNX) for SUMAVEL^® DosePro^® (sumatriptan injection), a prescription
medicine given with a needle-free delivery system to treat adults who have
been diagnosed with acute migraine or cluster headaches.

Under terms of the agreement, Mallinckrodt’s U.S. sales force will sell
SUMAVEL DosePro to its customer base of prescribers. Zogenix will continue to
record all product revenues and Mallinckrodt will be compensated based on a
percentage of net sales from prescriptions generated by Mallinckrodt. The
agreement runs through June 30, 2014, and can be extended.

"This agreement represents a key component of our growing pharmaceuticals
business as we prepare to spin off from Covidien next year,” said Mark
Trudeau, President, Pharmaceuticals. "We believe that the combined resources
of these two companies will enable us to leverage our talented and successful
sales force where it can make the most difference for prescribers and

“We are leaders in pain management,” Mr. Trudeau said. “This opportunity
allows us to help patients who suffer from migraine manage its
often-debilitating impact, as well as to build out our existing pain
management franchise. We look forward to working with Zogenix and to providing
SUMAVEL DosePro to our customers.”

Covidien’s Pharmaceuticals business is the largest U.S. supplier of opioid
pain medications and among the top 10 generic pharmaceuticals manufacturers in
the U.S., based on prescriptions. Its branded portfolio includes EXALGO^®
(hydromorphone HCl) Extended-Release Tablets (CII) and PENNSAID^® (diclofenac
sodium topical solution) 1.5% w/w. Mallinckrodt is also one of the world’s
leading producers of bulk acetaminophen.

“Adding Mallinckrodt’s large sales force to the efforts of our 95 sales
representatives will double our reach into prescribers of migraine products
and significantly expand the sales coverage for SUMAVEL DosePro within the
primary care market,” said Roger Hawley, Chief Executive Officer, Zogenix.
“The Mallinckrodt team has a track record of commercial success in the pain
market, and is committed to educating its customers on the potential benefits
of SUMAVEL DosePro as an exciting treatment option. Our team will remain
engaged with neurologists, headache specialists and other key migraine
prescribers, while working closely with Mallinckrodt at the field level to
effectively drive sales.”

SUMAVEL DosePro is the first and only needle-free delivery system for
subcutaneous sumatriptan for the treatment of acute migraine and cluster
headache. In clinical studies^1, sumatriptan injection provided migraine
relief within 10 minutes for 16% of patients versus 4% for placebo. The
product was launched in January 2010, and sales have grown sequentially every
quarter since launch, reaching over 129,000 total prescriptions through March

Covidien announced last December that the Company planned to spin off its
pharmaceuticals business into a stand-alone company, a process that is
expected to be completed in mid-2013.

^1 Cady RK, Wendt JK, Kirchner JR, Sargent JD, Rothrock JF, Skaggs Jr., H.
Treatment of Acute Migraine with Subcutaneous Sumatriptan. JAMA 1991;

About SUMAVEL DosePro

SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment
of migraine attacks, with or without aura, and the acute treatment of cluster
headache episodes.

SUMAVEL DosePro should only be used where a clear diagnosis of migraine or
cluster headache has been established. SUMAVEL DosePro is not intended for the
prophylactic therapy of migraine or for use in the management of hemiplegic or
basilar migraine and should not be administered intravenously. For a given
attack, if a patient does not respond to the first dose of SUMAVEL DosePro,
the diagnosis of migraine or cluster headache should be reconsidered before
administration of a second dose.


SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension,
in patients with history, symptoms or signs of ischemic heart disease,
coronary artery vasospasm, cerebrovascular or peripheral vascular disease
including ischemic bowel disease and in patients with other significant
underlying cardiovascular diseases or known hypersensitivity to sumatriptan.
SUMAVEL DosePro 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.

Serious cardiovascular events, including death, have been reported when taking
sumatriptan, including patients with no findings of cardiovascular disease.
Considering the extent of use of sumatriptan in patients with migraine, the
incidence of these events is extremely low. Cerebrovascular events, some
fatal, have been reported in patients treated with sumatriptan. In a number of
cases, it appears possible that the cerebrovascular events were primary,
sumatriptan having been administered in the incorrect belief the symptoms
experienced were a consequence of migraine when they were not. It is important
to advise patients not to administer SUMAVEL DosePro if a headache being
experienced is atypical.

Do not use SUMAVEL DosePro and any ergotamine-containing or ergot-type
medication within 24 hours of each other; do not use SUMAVEL DosePro and
another 5-HT[1] agonist (e.g. triptan) within 24 hours of each other (with the
exception of a single dose of another sumatriptan product, provided the doses
are separated by at least 1 hour). SUMAVEL DosePro is not generally
recommended for use with MAO-A inhibitors. The development of a potentially
life-threatening serotonin syndrome may occur with triptans, including
treatment with SUMAVEL DosePro, particularly during combined use with
selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine
reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy
only if the potential benefit justifies the potential risk.

In controlled clinical trials with sumatriptan injection, the most common
adverse reactions were injection site reactions, tingling, warm/hot sensation,
burning sensation, feeling of heaviness, pressure sensation, feeling of
tightness, numbness, feeling strange, tight feeling in head, flushing,
tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort,
dizziness/vertigo, drowsiness/sedation and headache.

For full prescribing information, please click here:

For more information about SUMAVEL DosePro, please visit


Cardiovascular Risk

• Non-steroidal anti-inflammatory drugs (NSAIDs) 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.

• PENNSAID is contraindicated in the perioperative setting of coronary artery
bypass graft (CABG) surgery.

Gastrointestinal Risk

• NSAIDs 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.




Potential for Abuse

EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled
substance with an abuse liability similar to other opioid analgesics. EXALGO
can be abused in a manner similar to other opioid agonists, legal or illicit.
These risks should be considered when administering, prescribing, or
dispensing EXALGO in situations where the healthcare professional is concerned
about increased risk of misuse, abuse, or diversion. Schedule II opioid
substances which include hydromorphone, morphine, oxycodone, fentanyl,
oxymorphone and methadone have the highest potential for abuse and risk of
fatal overdose due to respiratory depression.

Proper Patient Selection

EXALGO is an extended-release formulation of hydromorphone hydrochloride
indicated for the management of moderate to severe pain in opioid tolerant
patients when a continuous around-the-clock opioid analgesic is needed for an
extended period of time. Patients considered opioid tolerant are those who are
taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour,
30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral
oxymorphone/day or an equianalgesic dose of another opioid, for a week or

EXALGO is for use in opioid tolerant patients only.

Fatal respiratory depression could occur in patients who are not opioid

Accidental consumption of EXALGO, especially in children, can result in a
fatal overdose of hydromorphone.

Limitations of Use

EXALGO is not indicated for the management of acute or postoperative pain.

EXALGO is not intended for use as an as-needed analgesic.

EXALGO tablets are to be swallowed whole and are not to be broken, chewed,
dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed
EXALGO or its contents leads to rapid release and absorption of a potentially
fatal dose of hydromorphone.

About Covidien

Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers value
through clinical leadership and excellence. Covidien manufactures, distributes
and services a diverse range of industry-leading product lines in three
segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011
revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than
65 countries, and its products are sold in over 140 countries. Mallinckrodt,
the Pharmaceuticals business of Covidien, manufactures active pharmaceutical
ingredients, including bulk acetaminophen, opioid pain medications, nuclear
and contrast media diagnostic agents. Sales in 2011 were $2.0 billion. Please
visit to learn more about our business.

EXALGO is a registered trademark of Mallinckrodt LLC. PENNSAID is a registered
trademark of Nuvo Research Inc.

SUMAVEL and DosePro are registered trademarks of Zogenix, Inc.


Lynn Phillips, 314-654-3263
Manager, Media Relations
Stephen Littlejohn, 314-654-6595
Vice President Communications
Coleman Lannum, CFA, 508-452-4343
Vice President
Investor Relations
Todd Carpenter, 508-452-4363
Investor Relations
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