SCOTTSDALE, Ariz., April 27, 2010 -- Medicis (NYSE:MRX) today announced it has extended the "Dysport Challenge: Love It or Leave It" for Dysport (abobotulinumtoxinA) 300 Units for Injection through May 31, 2010, due to its popularity. Approved by the U.S. Food and Drug Administration (FDA) in April 2009, Dysport is a prescription injection used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
"We are so pleased with the overwhelming response in just two months from patients who have registered for the Dysport Challenge that we are extending the program through May 31," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "We were so confident patients would love Dysport that we introduced the Dysport Challenge on March 1, allowing patients to try Dysport and save $75. We went a step further to offer those patients who chose 'Love It' another $75 off their next Dysport treatment for a total savings of $150. Patients who do not love their Dysport treatment can have their frown lines treated with another botulinum toxin type A product as prescribed by their physician and receive a $75 rebate. To date, tens of thousands of patients have registered for the Dysport Challenge."
The Dysport Challenge was launched on March 1 and now runs through May 31, 2010. Offer terms and conditions apply. For complete offer details, please see below, visit www.DysportUSA.com or talk to your licensed healthcare professional. Ask your healthcare professional if Dysport is right for you.
With just one injection into each of five points between and above the eyebrows, Dysport blocks the signal from the nerve to the muscles, ultimately resulting in a localized reduction of muscle activity in the treated area, which temporarily prevents contraction of the muscles that cause frown lines. The untreated facial muscles still contract normally, allowing patients to freely show facial expressions, such as smiling, in the untreated areas.
Although office visit time varies, the procedure generally takes about 10 to 20 minutes, and there is little to no downtime after treatment. Ask your doctor about any precautions you should take after your treatment. Call your doctor or get medical help right away if you have any problems swallowing, speaking, or breathing. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
See Important Safety Information including Boxed Warning on the following pages and accompanying Medication Guide.
About the U.S. Aesthetic Market
According to the American Society for Aesthetic Plastic Surgery (ASAPS), almost 10 million cosmetic procedures were performed in the United States in 2009, 85% of which represented nonsurgical procedures. Injections of botulinum toxin type A have been the #1 nonsurgical cosmetic procedure for the past 6 years, with over 2.5 million total procedures in 2009 alone.1 The U.S. aesthetic market for botulinum toxin type A is estimated to be approximately $300 million to $400 million.2
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
The Company's products include the brands DYSPORT™ (abobotulinumtoxinA) 300 Units for Injection, PERLANE® Injectable Gel, PERLANE-L™ Injectable Gel with 0.3% Lidocaine, RESTYLANE® Injectable Gel, RESTYLANE-L™ Injectable Gel with 0.3% Lidocaine, DYNACIN® (minocycline HCl Tablets, USP), LOPROX® (ciclopirox) Gel 0.77% and Shampoo 1%, PLEXION® (sodium sulfacetamide 10% and sulfur 5%) Cleanser, Cleansing Cloths and Cream, SOLODYN® (minocycline HCl, USP) Extended Release Tablets, TRIAZ® (benzoyl peroxide) 3%, 6% and 9% Cleansers, Pads and Foaming Cloths, VANOS® (fluocinonide) Cream 0.1%, ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, the LIPOSONIX™ system3 and the over-the-counter brand ESOTERICA®.
For more information about Medicis, please visit the Company's website at www.Medicis.com. Printed copies of the Company's complete audited financial statements are available free of charge upon request.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Several of these risks are outlined in the Company's most recent annual report on Form 10-K for the year ended December 31, 2009, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis' management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.
NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. All trademarks are the property of their respective owners.
Dysport Challenge Terms and Conditions
The Dysport Challenge is limited to patients over the age of 18 who receive a botulinum toxin type A treatment only for the temporary improvement of the look of moderate to severe frown lines between the eyebrows (glabellar lines). To participate in this offer, you must receive a Dysport treatment between March 1 and May 31, 2010. The time to receive your first treatment in the Dysport Challenge has been extended until May 31, 2010. If you have already received your first treatment in the Dysport Challenge, this change does not affect you. Your second treatment must still occur at least three months after your first treatment and between June 1 and September 30, 2010. If you have any questions about the Dysport Challenge, or if you do not receive your rebate check within eight weeks, please call toll-free 866-222-1480 or visit www.DysportUSA.com and click on the Dysport Challenge for further information.
First Dysport Treatment and your $75 Rebate Check
Receive a Dysport treatment between March 1 and May 31, 2010. Within 14 days after your treatment, you must: sign up for the Dysport Challenge at www.DysportUSA.com and mail your completed Dysport Coupon Rebate Form with an itemized receipt for your treatment to the address found on the form. The Dysport Coupon Rebate Form is available at www.DysportUSA.com. To obtain your first $75 Rebate Check, your request must be postmarked within 14 days of your treatment. Under no circumstances may a Dysport Coupon Rebate Form be postmarked after June 14, 2010. A second treatment is not required to participate in this offer or receive your first $75 Rebate Check.
Second Treatment Love It or Leave It
Within 15–30 days of your first Dysport treatment, return to www.DysportUSA.com to decide if you Love It or Leave It and download the Love It or Leave It Rebate Form. If you love your Dysport treatment, select "Love It" to receive another $75 rebate off a second Dysport treatment. If you do not love your Dysport treatment, select "Leave It" to receive a $75 rebate off a treatment with another botulinum toxin type A product, as prescribed by your healthcare professional. You may choose only one of these two options. You must wait a minimum of 3 months between your first and second treatments. Therefore, your second treatment must occur between June 1 and September 30, 2010. To request your $75 Rebate Check, mail your completed Love It or Leave It Rebate Form with an itemized receipt for your treatment to the address found on the form, postmarked within 14 days of your second treatment. Under no circumstances may a Love It or Leave It Rebate Form be postmarked after October 14, 2010. The total value of the Rebate Check for the second treatment is $75.
You are eligible for this offer only if you paid for your entire treatment yourself and if no part of your treatment was covered by insurance or another third-party payor. This offer excludes any treatment using a Medicis Aesthetics Inc. product that is reimbursed by Medicaid, Medicare, or other federal or state benefit programs, including state medical assistance programs. You are not eligible for this offer if your private insurance, HMO, or other health benefit program paid for all or part of your treatment. If any form of reimbursement is sought from a third-party, you may be required to disclose the value of the rebate(s) to that party. This offer is available only to patients, excluding claims from Medicis Aesthetics Inc. employees and their families, or employees of its dealers and distributors. This offer is non-transferable. Offer valid only in the U.S. excluding territories and void where prohibited by law.
Program checks and coupons are void if not cashed or used within 180 days and cannot be re-issued. This offer cannot be combined with any other offer or promotion. By submitting a Dysport Coupon Rebate Form or Love It or Leave It Rebate Form, you agree to all terms and conditions of this offer and acknowledge that, in administering this program, Medicis Aesthetics Inc. will track your treatment activity and use your personal information to send correspondence in connection with this offer. Medicis Aesthetics Inc. reserves the right to cancel or modify this offer without notice. The Dysport Challenge rebate checks will be issued in U.S. dollars only. All requests become the property of Medicis Aesthetics Inc. and will not be returned. Medicis Aesthetics Inc. assumes no responsibility for lost, late, damaged, misdirected, misaddressed, incomplete or postage-due requests that fail to be properly delivered to the address stated on the rebate forms for any reason. Such requests will not be honored.
Dysport Indication and Important Safety Information
Dysport is a prescription injection used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
Important Safety Information
What is the most important information you should know about Dysport?
Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. These effects can cause symptoms of a serious condition called botulism. Symptoms of botulism can happen hours to weeks after injection and may include swallowing and breathing problems, 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, or loss of bladder control.
Swallowing and breathing problems can be life threatening and there have been reports of death.
The risk of symptoms is probably greatest in children and adults treated for muscle spasms, particularly in those patients who have underlying medical conditions that could make these symptoms more likely.
The toxic effects have been reported at doses similar to those used to treat muscle spasms in the neck. Lower doses, in both approved and unapproved uses, have also caused toxic effects. This includes treatment of children and adults for muscle spasms.
These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow's milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc® or Botox®, or have a skin infection at the planned injection site.
The dose of Dysport is not the same as the dose of any other botulinum toxin product. The dose of Dysport cannot be compared to the dose of any other botulinum toxin product you may have used.
Dysport may not be right for you if: you have surgical changes to your face, very weak muscles in the treatment area, your face looks very different from side to side, the injection site is inflamed, you have droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, or if your wrinkles can't be smoothed by spreading them apart.
Tell your doctor about all your medical 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), allergies to any botulinum toxin product or had any side effect from any botulinum toxin product in the past, a breathing problem (such as asthma or emphysema), swallowing problems, bleeding problems, diabetes, or a slow heart beat or other problem with your heart rate or rhythm, plans to have surgery, had surgery on your face, weakness of your forehead muscles (such as trouble raising your eyebrows), drooping eyelids, or any other change in the way your face normally looks. Patients with a disease that affects muscles and nerves who are treated with typical doses of Dysport may have a higher risk of serious side effects, including severe swallowing and breathing problems.
This product contains albumin taken from human plasma. Steps taken during donor screening and product manufacturing processes make the risk of spreading viral diseases extremely rare. In theory, there is also an extremely rare risk of contracting Creutzfeldt-Jakob disease (CJD). No cases of spread of viral diseases or CJD have ever been reported for albumin.
Allergic Reaction to Injecting in the Skin
It is not known if an allergic reaction can be caused by injecting Dysport into the skin.The safety of treating excessive sweating with Dysport is not known.
Common Side Effects
The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.
Especially tell your doctor if you: have received any other botulinum toxin product in the last four months, have received injections of botulinum toxin, such as Myobloc® (rimabotulinumtoxinB) or Botox® (onabotulinumtoxinA) in the past (be sure your doctor knows exactly which product you received), have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine.
Use in Specific Populations
Dysport should not be used in children or in women who are pregnant or breastfeeding.
Ask your doctor if Dysport is right for you.
DYSPORT™ (DIS-port) (abobotulinumtoxinA) Injection
Read the Medication Guide that comes with DYSPORT™ before you start using it and each time DYSPORT™ is given to you. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. You should share this information with your family members and caregivers.
What is the most important information I should know about DYSPORT™?
DYSPORT™ 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 after treatment with DYSPORT™:
-- Problems swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of DYSPORT™ usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with DYSPORT™.
-- People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with DYSPORT™.
-- Swallowing problems may last for several weeks. People who can not swallow well 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 DYSPORT™ 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 (dysphonia)
-- trouble saying words clearly (dysarthria)
-- loss of bladder control
-- trouble breathing
-- trouble swallowing
These symptoms can happen hours to weeks after you receive an injection of DYSPORT™.
These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving DYSPORT™?".
What is DYSPORT™?
DYSPORT™ is a prescription medicine that is injected into muscles and used:
-- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults
-- to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary)
CD is caused by muscle spasms in the neck. These spasms cause abnormal position of the head and often neck pain. After DYSPORT™ is injected into muscles, those muscles are weakened for up to 12 to 16 weeks or longer. This may help lessen your symptoms.
Frown lines (wrinkles) happen because the muscles that control facial expression are used often (muscle tightening over and over). After DYSPORT™ is injected into the muscles that control facial expression, the medicine stops the tightening of these muscles for up to 4 months.
It is not known whether DYSPORT™ is safe or effective in children under 18 years of age.
It is not known whether DYSPORT™ is safe or effective for the treatment of other types of muscle spasms. It is not known whether DYSPORT™ is safe or effective for the treatment of other wrinkles.
Who should not take DYSPORT™?
Do not take DYSPORT™ if you:
-- are allergic to DYSPORT™ or any of the ingredients in DYSPORT™. See the end of this Medication Guide for a list of ingredients in DYSPORT™
-- are allergic to cow's milk protein
-- had an allergic reaction to any other botulinum toxin product such as Myobloc®* or Botox® *
-- have a skin infection at the planned injection site
What should I tell my doctor before taking DYSPORT™?
Tell your doctor about all your medical 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). See "What is the most important information I should know about DYSPORT™?"
-- allergies to any botulinum toxin product
-- had any side effect from any botulinum toxin product in the past
-- a breathing problem, such as asthma or emphysema
-- swallowing problems
-- bleeding problems
-- a slow heart beat or other problem with your heart rate or rhythm
-- plans to have surgery
-- had surgery on your face
-- weakness of your forehead muscles (such as trouble raising your eyebrows)
-- drooping eyelids
-- any other change in the way your face normally looks
Tell your doctor if you:
-- are pregnant or plan to become pregnant. It is not known if DYSPORT™ can harm your unborn baby
-- are breast-feeding or planning to breast-feed. It is not known if DYSPORT™ passes into breast milk
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using DYSPORT™ with certain other medicines may cause serious side effects. Do not start any new medicines while taking DYSPORT™ without talking to your doctor first.
Especially tell your doctor if you:
-- have received any other botulinum toxin product in the last four months
-- have received injections of botulinum toxin, such as Myobloc®(Botulinum Toxin Type B)* or Botox®(Botulinum Toxin Type A)* in the past; be sure your doctor knows exactly which product you received
-- have recently received an antibiotic by injection
-- take muscle relaxants
-- take an allergy or cold medicine
-- take a sleep medicine
Ask your doctor if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take DYSPORT™?
-- DYSPORT™ is an injection that your doctor will give you
-- DYSPORT™ is injected into the affected muscles
-- Your doctor may give you another dose of DYSPORT™ after 12 weeks or longer, if it is needed
-- If you are being treated for CD, your doctor may change your dose of DYSPORT™ until you and your doctor find the best dose for you
-- The dose of DYSPORT™ is not the same as the dose of any other botulinum toxin product
What should I avoid while taking DYSPORT™?
DYSPORT™ may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking DYSPORT™. If this happens, do not drive a car, operate machinery, or do other dangerous activities. See "What is the most important information I should know about DYSPORT™?"
What are the possible side effects of DYSPORT™?
DYSPORT™ can cause serious side effects. See "What is the most important information I should know about DYSPORT™?"
Other side effects of DYSPORT™ include:
-- dry mouth
-- injection site discomfort or pain
-- neck pain
-- muscle pain
-- eye problems: double vision, blurred vision, decreased eyesight, problems with focusing the eyes (accommodation), drooping eyelids, swelling of the eyelids
-- allergic reactions. Symptoms of an allergic reaction to DYSPORT™ may include: itching, rash, red itchy welts, 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
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 DYSPORT™. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about DYSPORT™:
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about DYSPORT™. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DYSPORT™ that is written for healthcare professionals. For more information about DYSPORT™ call 877-397-7671 or go to www.dysport.com or www.DysportUSA.com.
What are the ingredients in DYSPORT™?
Active ingredient: (botulinum toxin Type A) Inactive ingredients: human albumin, and lactose. DYSPORT™ may contain cow's milk protein.
Issued May 2009
This Medication Guide has been approved by the U.S. Food and Drug Administration.
|a subsidiary of the Ipsen Group|
|Brisbane, CA 94005|
|Medicis Aesthetics Inc.,|
|a wholly owned subsidiary of Medicis Pharmaceutical Corporation|
|Scottsdale, AZ 85256|
*All trademarks are the property of their respective owners.
1 American Society for Aesthetic Plastic Surgery, Cosmetic Surgery National Data Bank Statistics, 2009
2 Competitor company reports
3 The LIPOSONIXTM system is not approved or cleared for sale in the U.S.
CONTACT: Medicis Investors Kara Stancell (480) 291-5854 LaForce + Stevens Media Vicki Crafton Ilisa Wirgin (212) 242-9353