http://www.usworldmeds.com () —
US WorldMeds, LLC (http://www.usworldmeds.com/) , announced today that
it has launched the recently Food and Drug Administration-approved
ALSUMA Auto-Injector, which is indicated for the acute treatment of
migraine attacks with or without aura, and cluster headache episodes.
ALSUMA is a prescription medication that delivers sumatriptan through
subcutaneous injection supplied by a single-use, pre-filled
auto-injector that requires minimal steps for use.(1)
King Pharmaceuticals@, Inc., has licensed the exclusive rights to
market and sell ALSUMA in the United States to US WorldMeds, LLC, a
specialty pharmaceutical company located in Louisville, KY.
"Migraine headaches continue to be a significant problem for more than
30 million Americans, nearly half of whom are undiagnosed," said
Dennis P. O'Brien, President of Meridian Medical Technologies, Inc., a
wholly owned subsidiary of King Pharmaceuticals@, Inc. "ALSUMA is a
natural extension of King's existing portfolio of acute drug delivery
products."
The total U.S. market for sumatriptan was approximately $203 million
for the twelve months ending March 2010, according to IMS health data,
of which the market for auto-injectors using pre-filled syringes and
cartridges approximated $186 million.
In two U.S. clinical trials involving 1,104 migraine patients with
moderate or severe migraine pain, a 6-mg subcutaneous dose of
sumatriptan injection resulted in a rapid onset of relief (less than
10 minutes). Headache relief, as evidenced by a reduction in pain from
severe or moderately severe to mild or no headache, was achieved in 70
percent of patients within 1 hour of a single 6-mg subcutaneous
injection of sumatriptan (compared with 18 percent study 1 and 26
percent study 2 receiving placebo).(1)
"US WorldMeds is dedicated to uncovering and commercializing
medications that fulfill unmet medical needs, solve healthcare
challenges and help improve the lives of patients," said P.
Breckinridge Jones, CEO of US WorldMeds. "ALSUMA is a great advance
in migraine therapy and an excellent addition to our line of products.
With its rapid onset of relief ALSUMA has significant potential to
help millions of people who suffer from migraine attacks and cluster
headache episodes in the United States. We are excited to work with
King Pharmaceuticals and are excited to be launching ALSUMA."
About Migraine HeadachesAccording to the American Migraine Foundation,
migraine is an inherited neurological disorder characterized by
hyperexcitable brain networks that may be triggered by a variety of
stimuli (e.g., alcohol, menstruation, fragrances, light glare), or
become active spontaneously, leading to attacks. In one-third of
sufferers, attacks may include an aura phase, during which sufferers
may see flashing lights, squiggly lines, or lose partial vision. The
headache phase of migraine is often moderate or severe in intensity,
and can be extremely disabling for sufferers.(2)
Thirty-six million Americans, about 12 percent of the U.S. population,
suffer from migraine headaches. Migraine is three times more common in
women than men, affecting 30 percent of women over a lifetime. There
is no cure for migraine.(2)
About ALSUMAALSUMA Auto-Injector is a prescription medicine
injection used to treat people who have been diagnosed with migraine,
with or without aura, or cluster headaches. ALSUMA is not used to
treat other types of headaches or used to prevent or lessen the number
of migraine or cluster headaches patients have. Please visit
www.alsuma.com (http://www.alsuma.com/) for the full Prescribing
Information and Patient Information.
IndicationALSUMA auto-injector is a prescription medicine that
contains sumatriptan and is used to treat adults who have been
diagnosed with migraine or cluster headaches.
ALSUMA is not used to treat other types of headaches or used to
prevent or lessen the number of migraine or cluster headaches you
have.
It is not known if ALSUMA is safe or effective in people younger than
18 years.
Important Safety InformationALSUMA may increase your chance of having
a heart attack or stroke that can lead to death. This chance is higher
in people who have heart disease.
ALSUMA is not for people with risk factors for heart disease unless a
heart examination is performed and shows no problems. The risk factors
for heart disease include
Serotonin syndrome is a serious and life-threatening problem that can
be caused by ALSUMA, especially if used with antidepressant medicines
called selective serotonin reuptake inhibitors (SSRIs) or serotonin
norepinephrine reuptake inhibitors (SNRIs).
Call your healthcare professional if you have symptoms of serotonin
syndrome, which include
Do not take ALSUMA if you have
Before taking ALSUMA, tell your healthcare professional about all of
your medical conditions, including if you
It is not known if ALSUMA will harm your unborn baby, so talk to your
healthcare professional if you are pregnant or plan to become
pregnant. ALSUMA passes into your breast milk and may harm your baby,
so talk to your healthcare professional if you are breast-feeding or
plan to breast-feed.
Tell your healthcare professional about all of the medicines (both
prescription and nonprescription), vitamins, and herbal supplements
that you take. Serotonin syndrome is a serious and life-threatening
problem that can be caused by ALSUMA, especially if used with
antidepressant medicines called selective serotonin reuptake
inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors
(SNRIs). Make sure to tell your healthcare professional if you take
SSRIs, SNRIs, or monoamine oxidase inhibitors (MAOIs).
Use of ALSUMA
ALSUMA can cause serious side effects or even death.Serious side
effects can include
Get medical help right away if you have
The most common side effects of ALSUMA include but are not limited to
Keep ALSUMA and all medicines out of the reach of children.
About US WorldMeds, LLC US WorldMeds is a specialty pharmaceutical
company that develops, licenses and commercializes unique medical
therapies that address unmet patient needs. US WorldMeds' products
include novel treatments for malignant hyperthermia and cervical
dystonia in adults. An additional product, Lofexidine, is well under
clinical development for relief of opiate detoxification withdrawal
symptoms. To learn more about US WorldMeds, please visit
www.usworldmeds.com (http://www.usworldmeds.com/) .
About King Pharmaceuticals@, Inc.King, headquartered in Bristol,
Tennessee, is a vertically integrated branded pharmaceutical company.
King, an S&P 500 Index company, seeks to capitalize on opportunities
in the pharmaceutical industry through the development, including
through in-licensing arrangements and acquisitions, of novel branded
prescription pharmaceutical products and technologies that complement
the Company's focus in specialty-driven markets, particularly
neuroscience and hospital. King's wholly owned subsidiary, Alpharma,
LLC, is also a leader in the development, registration, manufacture,
and marketing of pharmaceutical products for food-producing animals.
On October 11, 2010, King entered into an agreement and plan of merger
with Pfizer Inc. pursuant to which Pfizer agreed to commence a tender
offer to purchase all of the outstanding shares of common stock of
King for $14.25 per share net to the seller in cash. The tender offer
is ongoing.
References
1. Alsuma package insert. Columbia, MD: Meridian Medical Technologies,
Inc; 2010.
2. About Migraine. American Migraine Foundation Web site.
http://www.americanmigrainefoundation.org/whatismigraine.aspx (http://www.americanmigrainefoundation.org/whatismigraine.aspx) . Accessed
January 11, 2011.
Distributed by: US WorldMeds, LLC, Louisville, KY 40207 Manufactured
by: Meridian Medical Technologies, Inc., Columbia, MD 21046 ALSUMA
and the ALSUMA logo are trademarks of Meridian Medical Technologies,
Inc., a wholly owned subsidiary of King Pharmaceuticals@, Inc.
Copyright 5/8 2011 US WorldMeds, LLC. All rights reserved. ALS7325
01/2011