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US WorldMeds Announces Launch of ALSUMA(TM) (sumatriptan injection) 6 mg/0.5 mL Auto-Injector for Subcutaneous Use


February 2, 2011 - Louisville, KY

US WorldMeds, LLC, 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 Headaches
According 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 ALSUMA™
ALSUMA™ 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 for the full Prescribing Information and Patient Information.

Indication
ALSUMA™ 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 Information
ALSUMA™ 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

  • Mental changes (e.g., seeing things that are not there, unusual tension, and restlessness)
  • Fast heartbeat
  • Changes in Blood Pressure
  • High body temperature
  • Tight muscles
  • Trouble walking
  • Nausea, vomiting, or diarrhea

Do not take ALSUMA™ if you have

  • Taken any triptan or ergotamine medicine within the last 24 hours, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, ergotamine, or dihydroergotamine
  • Narrowing of blood vessels to the legs, arms, stomach, or kidneys (Peripheral Vascular Disease)
  • Heart disease or a history of heart disease
  • Uncontrolled high Blood Pressure
  • Migraines that cause temporary Paralysis on one side of your body
  • Basilar migraine
  • Had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • Are allergic to sumatriptan or any of the other ingredients in ALSUMA™

Before taking ALSUMA™, tell your healthcare professional about all of your medical conditions, including if you

  • Have high cholesterol
  • Have Diabetes
  • Smoke
  • Have gone through menopause
  • Have heart disease or a family history of heart disease or stroke
  • Have had epilepsy or seizures

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™

  • Take ALSUMA™ exactly as your healthcare professional tells you
  • Give the injection in the side of your thigh or upper arm, just below the skin (subcutaneous)
  • Do not inject ALSUMA™ into a vein or muscle
  • Take ALSUMA™ as soon as your symptoms of a migraine or cluster headache start, although it may be given at any time during an attack
  • You may take a second injection at least 1 hour after your first dose if your migraine or cluster headache symptoms come back
  • Do not take more than 2 doses of ALSUMA™ in 24 hours
  • If you do not feel better after the first injection, do not give a second injection for the same attack without talking with your healthcare professional

ALSUMA™ can cause serious side effects or even death. Serious side effects can include

  • heart attacks
  • Fast heartbeat
  • Increase in Blood Pressure
  • Stroke
  • Changes in mental status (agitation, hallucinations, or coma)
  • Changes in color or sensation in your fingers and toes (Raynaud syndrome)
  • Poor blood flow to the arms or legs
  • Poor blood flow to the gastrointestinal tract

Get medical help right away if you have

  • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • Shortness of breath or wheezing
  • Sudden or severe stomach pain
  • Hives
  • Swelling of your tongue, mouth, or throat
  • Problems seeing
  • Unusual weakness or numbness
  • Nausea or vomiting
  • Bloody diarrhea
  • High temperature
  • Unusual sweating

The most common side effects of ALSUMA™ include but are not limited to

  • Bleeding, swelling, redness, bruising, and pain at the injection site
  • Tingling or numbness in your fingers or toes
  • Dizziness
  • Warm, hot, or burning feeling to your face (flushing)
  • Feeling of heaviness or pressure
  • Discomfort or tightness in the chest, neck, throat, nose, or jaw
  • Feeling weak, drowsy, or tired
  • Feeling strange
  • Muscle pain

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.

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. 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 © 2011 US WorldMeds, LLC. All rights reserved. ALS7325 01/2011

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