Merz Pharmaceuticals Joins Patient Advocates to Raise Awareness of Cervical Dystonia and Blepharospasm

GREENSBORO, N.C., April 14, 2011 /PRNewswire/ -- Merz Pharmaceuticals, LLC, maker of XEOMIN® (incobotulinumtoxinA), a botulinum toxin type A free from accessory proteins, today announced the launch of the "Make Your Mark" campaign. With the help of patient advocates, "Make Your Mark" celebrates the inspirational stories of people living with blepharospasm or cervical dystonia (CD), also known as spasmodic torticollis, and aims to raise awareness of these often debilitating conditions.

XEOMIN is approved in the U.S. to treat the abnormal head position and neck pain that happens in adults with cervical dystonia, as well as the abnormal spasms of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox®).

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"For those who suffer with chronic conditions like cervical dystonia or blepharospasm, self-expression and creativity play a part in how we feel," said Hallie Neill, an accomplished opera singer, actress and writer who was diagnosed with cervical dystonia in 2007. "When we express ourselves creatively through writing stories, making music, painting, cooking and dancing, we inspire ourselves and others, and make a positive mark on the world around us."

Cervical dystonia and blepharospasm are thought to be rare conditions but are possibly undiagnosed or misdiagnosed due to the lack of specific clinical criteria. According to a recent online survey conducted by Harris Interactive on behalf of Merz Pharmaceuticals, LLC, an average of 55 percent of cervical dystonia and blepharospasm patients surveyed reported that they experienced symptoms for one year or more before their conditions were diagnosed. In fact, 66 percent of surveyed patients on average say they were not diagnosed sooner because there is a lack of knowledge about these conditions or they were misdiagnosed with another condition first.

"I have cervical dystonia but it doesn't have me," said Dawn Brinkley, 2010 Mrs. North Carolina and an active volunteer who was diagnosed with cervical dystonia in 2004. "People may not know what cervical dystonia and blepharospasm are, and they may underestimate the impact of these conditions on a person's life. I make my Mark by helping others understand they don't have to just live with these conditions; there are treatments and resources available."

Alfred J. (A.J.) Deguio, a blepharospasm patient and support group leader in New Mexico, said, "I was diagnosed with blepharospasm 17 years ago, and I've made my Mark as a support group coordinator for over 16 years. The condition impacts me in many ways, but I've learned to adapt to it. It's important to me that others living with blepharospasm know they're not alone."

"The commitment that Merz is making to the cervical dystonia and blepharospasm communities is a great complement to the support and resources provided by advocacy organizations," states William Ondo, M.D., Professor of Neurology at Baylor College of Medicine in Houston, Texas, and an expert on medical uses of botulinum toxin. "With the availability of XEOMIN in the U.S., we have another therapeutic option for the treatment of these conditions in appropriate patients."

Botulinum toxin is the only FDA-approved medication for cervical dystonia orblepharospasm. Speak with your doctor to see if XEOMIN may be right for you.

Survey Methodology
The "Make Your Mark" Survey was recently conducted online by Harris Interactive on behalf of Merz Pharmaceuticals, LLC, between February 17 and March 7, 2011. The survey targeted 500 U.S. adults ages 18+ who have been diagnosed with cervical dystonia (250 respondents) or blepharospasm (250 respondents). Respondents for this survey are members of the Benign Essential Blepharospasm Research Foundation (BEBRF) and/or the National Spasmodic Torticollis Association (NSTA). Survey data are unweighted and therefore representative only of the individuals surveyed.

Other Recent XEOMIN News
Reimbursement Support
Merz also recently introduced two comprehensive programs to provide patients with financial assistance for XEOMIN. The XEOMIN Patient Co-payment Program is easy-to-use and offers eligible patients, who are appropriate for treatment with XEOMIN as determined by their physician, assistance for their actual out-of-pocket costs for therapeutic treatment with XEOMIN. Eligible treatment-related costs may include the cost of XEOMIN, associated guidance therapy and related administration fees.

The XEOMIN Patient Assistance Program provides XEOMIN at no cost to eligible patients who are experiencing financial hardship, do not have third-party drug coverage, and who are not eligible for government-funded drug programs.

For more information about reimbursement support and financial assistance programs for XEOMIN, visit www.Xeomin.com, or call 1-888-4-XEOMIN (1-888-493-6646). Dedicated support representatives are available from 8 a.m. until 8 p.m. (EDT), Monday through Friday.

About Cervical Dystonia and Blepharospasm
Dystonias are movement disorders characterized by abnormal, sustained muscle contractions that cause twisting, repetitive movements or abnormal postures in the face, neck, torso and extremities.

Focal dystonias, like cervical dystonia or blepharospasm, affect muscles in a single part of the body. Cervical dystonia causes contractions or spasms of the neck muscles which keep the head from its normal, upright position. It may also cause neck pain. While cervical dystonia may occur at any time, most individuals first experience symptoms near middle age.

Blepharospasm affects the muscles around the eye that you use to blink. It can result in involuntary contractions in the eyelids which can vary from an increased blink rate and intermittent eyelid spasm to eye closing for most of the day. Blepharospasm usually begins in the fifth to sixth decade of life and is more common in women than in men.

According to an epidemiology study conducted in Rochester, Minn., focal dystonia (which includes cervical dystonia and blepharospasm) is estimated to affect 295 per million people in the U.S.

About XEOMIN® (incobotulinumtoxinA)
XEOMIN is a prescription medicine that is used to treat adults with cervical dystonia to decrease the severity of abnormal head position and neck pain, as well as the abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox®). XEOMIN has been used around the world since 2005 and was introduced to the U.S. market in 2010 by Merz Pharmaceuticals, LLC.

Botulinum toxin is a naturally occurring protein produced by the bacteria Clostridium botulinum. Botulinum toxin type A—the active ingredient in XEOMIN—is produced commercially from C. botulinum serotype A.

XEOMIN is injected into muscles to decrease their activity. XEOMIN blocks the release of a chemical messenger—acetylcholine—that conveys the signal from nerve terminals and causes muscle fibers to contract. Not all terminals are affected by botulinum toxin, so the muscles can still contract, just less forcefully. This allows the muscles to contract more normally.

IMPORTANT SAFETY INFORMATION

XEOMIN® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after treatment with XEOMIN:

• Problems with swallowing, speaking, or breathing can happen after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. If these problems are severe, you could die.  People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
• Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
• Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN; had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport™); have a skin infection at the planned injection site.

Before you take XEOMIN, tell your doctor about all your muscle or nerve conditions, including if you have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome), as you may be at increased risk of serious side effects including difficulty swallowing or breathing.  

Before you take XEOMIN, tell your doctor about all your medical conditions, including if you have: breathing problems such as asthma or emphysema; a history of swallowing problems or inhaling food or fluid into your lungs (aspiration); bleeding problems; drooping eyelids; plans to have surgery; had surgery on your face.  Also tell your doctor if you are pregnant or plan to become pregnant (it is not known if XEOMIN can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not know if XEOMIN passes into breast milk).  

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. Using XEOMIN with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past.

Especially tell your doctor if you have received any other botulinum toxin product in the last four months or in the past.  Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.

XEOMIN may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

XEOMIN may cause other serious side effects including allergic reactions.  Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint.

Other side effects of XEOMIN include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, muscle weakness, and eye problems, including double vision, blurred vision, drooping eyelids, swelling of your eyelids, and dry eyes. Reduced blinking can also occur. Tell your doctor or get medical help right away if you have eye pain or irritation following treatment.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XEOMIN. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see XEOMIN full Prescribing Information and Medication Guide, available at www.MakeYourMarkCampaign.com.

About Merz
Merz Pharmaceuticals, LLC is a part of the Merz Group of companies and was established in 1995 to develop and commercialize products for the Merz Group. Areas of therapeutic focus include Neurology, Dermatology, and Podiatry.

With a 102 year heritage, the Merz Group is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic medicine. Global research is concentrated in fields that have a strong need for therapeutic innovation such as Alzheimer's disease, Parkinson's disease, tinnitus, chronic pain conditions, addictions, and neuromuscular disturbances.

XEOMIN is a registered trademark of Merz Pharma GmbH & Co KGaA. Patent pending.

Dysport™ is a trademark and Botox® and Myobloc® are registered trademarks of their respective owners.

SOURCE Merz Pharmaceuticals, LLC

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