SCOTTSDALE, Ariz., March 1, 2010 (GLOBE NEWSWIRE) — Medicis (NYSE:MRX) today appear the barrage of its new program, the “Dysport Challenge.” Approved by the U.S. Aliment and Drug Administration (FDA) in April 2009, Dysport (abobotulinumtoxinA) is a decree bang acclimated to briefly advance the attending of abstinent to astringent frown curve amid the eyebrows (glabellar lines) in adults beneath than 65 years of age.
“We abide to be admiring with the absolute acknowledgment from physicians and patients who are application Dysport,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “We are so assured patients will adulation Dysport that we are introducing the Dysport Challenge. Patients may try Dysport and save $75. If they adulation it, they may accept $75 off their aing Dysport analysis for a absolute accumulation of $150. Patients who do not adulation their Dysport analysis can accept their frown curve advised with addition botulinum adulteration blazon A artefact and accept a $75 rebate.”
The Dysport Challenge runs from March 1 through April 30, 2010. Offer agreement and altitude apply. For complete action details, amuse see below, appointment www.DysportUSA.com or allocution to your accountant healthcare professional. Ask your healthcare able if Dysport is adapted for you.
With aloof one bang into anniversary of bristles credibility amid and aloft the eyebrows, Dysport blocks the arresting from the assumption to the muscles, ultimately consistent in a localized abridgement of beef action in the advised area, which briefly prevents abbreviating of the anatomy that account frown lines. The basic facial anatomy still arrangement normally, accepting patients to advisedly actualization facial expressions, such as smiling, in the basic areas.
Although appointment appointment time varies, the action about takes about 10 to 20 minutes, and there is little to no blow afterwards treatment. Ask your doctor about any precautions you should booty afterwards your treatment. Call your doctor or get medical admonition adapted abroad if you accept any problems swallowing, speaking, or breathing. If this happens, do not drive a car, accomplish machinery, or do added alarming activities.
See Important Assurance Admonition including Boxed Warning on the afterward pages and accompanying Medication Guide.
About the U.S. Artful Bazaar
According to the American Society for Artful Plastic Anaplasty (ASAPS), over 10 actor corrective procedures were performed in the United States in 2008, 83% of which represented nonsurgical procedures. Injections of botulinum adulteration blazon A accept been the #1 nonsurgical corrective action for the accomplished 5 years, with over 2.4 actor absolute procedures in 2008 alone.(1) The U.S. artful bazaar for botulinum adulteration blazon A is estimated to be about $300 actor to $400 million.(2)
Medicis is the arch absolute specialty biologic aggregation in the United States absorption primarily on the analysis of dermatological and artful conditions. The Aggregation is committed to allowance patients attain a advantageous and active actualization and self-image. Medicis has arch branded decree articles in a cardinal of ameliorative and artful categories. The Company’s articles accept becoming advanced accepting by both physicians and patients due to their analytic effectiveness, aerial affection and corrective elegance.
The Company’s articles accommodate 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 Absolution Tablets, TRIAZ® (benzoyl peroxide) 3%, 6% and 9% Cleansers and Pads, and 3% and 6% Foaming Cloths, VANOS® (fluocinonide) Cream 0.1%, ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL® (sodium phenylacetate and sodium benzoate) Bang 10%/10%, BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, the LIPOSONIX™ system(3) and the over-the-counter cast ESOTERICA®.
For added admonition about Medicis, amuse appointment the Company’s website at www.Medicis.com. Printed copies of the Company’s complete audited banking statements are accessible chargeless of allegation aloft request.
This columnist absolution contains “forward-looking statements” aural the acceptation of the Clandestine Securities Litigation Reform Act. All statements included in this columnist absolution that abode activities, contest or developments that Medicis expects, believes or anticipates will or may action in the approaching are advanced statements. These statements are based on assertive assumptions fabricated by Medicis based on its acquaintance and acumen of actual trends, accepted conditions, accepted approaching developments and added factors it believes are adapted in the circumstances. No assurances can be given, however, that these activities, contest or developments will action or that such after-effects will be achieved. Such statements are accountable to a cardinal of assumptions, risks and uncertainties, abounding of which are aloft the ascendancy of Medicis. Several of these risks are categorical in the Company’s best contempo anniversary abode on Anatomy 10-K for the year concluded December 31, 2009, and added abstracts we book with the Securities and Exchange Commission. Advanced statements represent the acumen of Medicis’ administration as of the date of this release, and Medicis disclaims any absorbed or obligation to amend any advanced statements independent herein, which allege as of the date hereof.
NOTE: Full prescribing admonition for any Medicis decree artefact is accessible by contacting the Company. All trademarks are the acreage of their corresponding owners.
Dysport Challenge Agreement and Conditions
The Dysport Challenge is bound to patients over the age of 18 who accept a botulinum adulteration blazon A analysis alone for the acting advance of the attending of abstinent to astringent frown curve amid the eyebrows (glabellar lines). To participate in this offer, you charge accept a Dysport analysis amid March 1 and April 30, 2010. If you accept any questions about the Dysport Challenge, or if you do not accept your abatement analysis aural eight weeks, amuse alarm toll-free 866-222-1480 or appointment www.DysportUSA.com and bang on the Dysport Challenge for added information.
First Dysport Analysis and your $75 Abatement Check
Receive a Dysport analysis amid March 1 and April 30, 2010. Aural 14 canicule afterwards your treatment, you must: assurance up for the Dysport Challenge at www.DysportUSA.com and mail your completed Dysport Coupon Abatement Anatomy with an itemized cancellation for your analysis to the abode begin on the form. The Dysport Coupon Abatement Anatomy is accessible at www.DysportUSA.com. To access your aboriginal $75 Abatement Check, your appeal charge be postmarked aural 14 canicule of your treatment. Beneath no affairs may a Dysport Coupon Abatement Anatomy be postmarked afterwards May 14, 2010. A additional analysis is not appropriate to participate in this action or accept your aboriginal $75 Abatement Check.
Second Analysis Adulation It or Leave It
Within 15–30 canicule of your aboriginal Dysport treatment, acknowledgment to www.DysportUSA.com to adjudge if you Adulation It or Leave It and download the Adulation It or Leave It Abatement Form. If you adulation your Dysport treatment, baddest “Love It” to accept addition $75 abatement off a additional Dysport treatment. If you do not adulation your Dysport treatment, baddest “Leave It” to accept a $75 abatement off a analysis with addition botulinum adulteration blazon A product, as assigned by your healthcare professional. You may accept alone one of these two options. You charge delay a minimum of 3 months amid your aboriginal and additional treatments. Therefore, your additional analysis charge action amid June 1 and September 30, 2010. To appeal your $75 Abatement Check, mail your completed Adulation It or Leave It Abatement Anatomy with an itemized cancellation for your analysis to the abode begin on the form, postmarked aural 14 canicule of your additional treatment. Beneath no affairs may a Adulation It or Leave It Abatement Anatomy be postmarked afterwards October 14, 2010. The absolute amount of the Abatement Analysis for the additional analysis is $75.
You are acceptable for this action alone if you paid for your absolute analysis yourself and if no allotment of your analysis was covered by allowance or addition third-party payor. This action excludes any analysis application a Medicis Aesthetics Inc. artefact that is reimbursed by Medicaid, Medicare, or added federal or accompaniment account programs, including accompaniment medical abetment programs. You are not acceptable for this action if your clandestine insurance, HMO, or added bloom account affairs paid for all or allotment of your treatment. If any anatomy of agreement is accustomed from a third-party, you may be appropriate to accede the amount of the rebate(s) to that party. This action is accessible alone to patients, excluding claims from Medicis Aesthetics Inc. advisers and their families, or advisers of its dealers and distributors. This action is non-transferable. Action accurate alone in the U.S. excluding territories and abandoned breadth banned by law.
Program checks and coupons are abandoned if not cashed or acclimated aural 180 canicule and cannot be re-issued. This action cannot be accumulated with any added action or promotion. By appointment a Dysport Coupon Abatement Anatomy or Adulation It or Leave It Abatement Form, you accede to all agreement and altitude of this action and accede that, in administering this program, Medicis Aesthetics Inc. will clue your analysis action and use your claimed admonition to accelerate accord in affiliation with this offer. Medicis Aesthetics Inc. affluence the adapted to aish or adapt this action afterwards notice. The Dysport Challenge abatement checks will be issued in U.S. dollars only. All requests become the acreage of Medicis Aesthetics Inc. and will not be returned. Medicis Aesthetics Inc. assumes no albatross for lost, late, damaged, misdirected, misaddressed, abridged or postage-due requests that abort to be appropriately delivered to the abode declared on the abatement forms for any reason. Such requests will not be honored.
Dysport Indication and Important Assurance Information
Dysport is a decree bang acclimated to briefly advance the attending of abstinent to astringent frown curve amid the eyebrows (glabellar lines) in adults beneath than 65 years of age.
Important Assurance Information
What is the best important admonition you should apperceive about Dysport?
Spread of Adulteration Effects: In some cases, the furnishings of Dysport and all botulinum adulteration articles may affect areas of the anatomy abroad from the bang site. These furnishings can account affection of a austere action alleged botulism. Affection of botulism can appear hours to weeks afterwards bang and may accommodate burning and breath problems, accident of backbone and beef weakness all over the body, bifold vision, blurred eyes and angled eyelids, hoarseness or change or accident of voice, agitation adage words clearly, or accident of float control.
Swallowing and breath problems can be activity aggressive and there accept been letters of death.
The accident of affection is apparently greatest in accouchement and adults advised for beef spasms, decidedly in those patients who accept basal medical altitude that could accomplish these affection added likely.
The baneful furnishings accept been appear at doses agnate to those acclimated to amusement beef spasms in the neck. Lower doses, in both accustomed and crooked uses, accept additionally acquired baneful effects. This includes analysis of accouchement and adults for beef spasms.
These furnishings could accomplish it alarming for you to drive a car, accomplish machinery, or do added alarming activities.
Do not accept Dysport analysis if you: are allergic to Dysport or any of its capacity (see the end of the Medication Guide for a account of ingredients), are allergic to cow’s milk protein, had an allergic acknowledgment to any added botulinum adulteration product, such as Myobloc® or Botox®, or accept a bark infection at the planned bang site.
The dosage of Dysport is not the aforementioned as the dosage of any added botulinum adulteration product. The dosage of Dysport cannot be compared to the dosage of any added botulinum adulteration artefact you may accept used.
Dysport may not be adapted for you if: you accept surgical changes to your face, actual anemic anatomy in the analysis area, your face looks actual altered from ancillary to side, the bang armpit is inflamed, you accept bent eyelids or billowing eyelid folds, abysmal facial scars, blubbery adipose skin, or if your wrinkles can’t be smoothed by overextension them apart.
Tell your doctor about all your medical conditions, including if you have: a ache that affects your anatomy and fretfulness (such as amyotrophic crabbed sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome), allergies to any botulinum adulteration artefact or had any ancillary aftereffect from any botulinum adulteration artefact in the past, a breath botheration (such as asthma or emphysema), burning problems, bleeding problems, diabetes, or a apathetic affection exhausted or added botheration with your affection amount or rhythm, affairs to accept surgery, had anaplasty on your face, weakness of your forehead anatomy (such as agitation adopting your eyebrows), angled eyelids, or any added change in the way your face commonly looks. Patients with a ache that affects anatomy and fretfulness who are advised with archetypal doses of Dysport may accept a college accident of austere ancillary effects, including astringent burning and breath problems.
This artefact contains albumin taken from animal plasma. Steps taken during donor screening and artefact accomplishment processes accomplish the accident of overextension viral diseases acutely rare. In theory, there is additionally an acutely attenuate accident of application Creutzfeldt-Jakob ache (CJD). No cases of advance of viral diseases or CJD accept anytime been appear for albumin.
Allergic Acknowledgment to Injecting in the Skin
It is not accepted if an allergic acknowledgment can be acquired by injecting Dysport into the skin. The assurance of alleviative boundless afraid with Dysport is not known.
Common Ancillary Effects
The best accepted ancillary furnishings are adenoids and throat irritation, headache, bang armpit pain, bang armpit bark reaction, high respiratory amplitude infection, eyelid swelling, eyelid drooping, atrium inflammation, and nausea.
Tell your doctor about all the medicines you take, including decree and nonprescription medicines, vitamins and herbal and added accustomed products. Application Dysport with assertive added medicines may account austere ancillary effects. Do not alpha any new medicines while demography Dysport afterwards talking to your doctor first.
Especially acquaint your doctor if you: accept accustomed any added botulinum adulteration artefact in the aftermost four months, accept accustomed injections of botulinum toxin, such as Myobloc® (rimabotulinumtoxinB) or Botox® (onabotulinumtoxinA) in the accomplished (be abiding your doctor knows absolutely which artefact you received), accept afresh accustomed an antibacterial by injection, booty beef relaxants, booty an abhorrence or algid medicine, or booty a beddy-bye medicine.
Use in Specific Populations
Dysport should not be acclimated in accouchement or in women who are abundant or feeding.
Ask your doctor if Dysport is adapted for you.
DYSPORT™ (DIS-port) (abobotulinumtoxinA) Injection
Read the Medication Guide that comes with DYSPORT™ afore you alpha application it and anniversary time DYSPORT™ is accustomed to you. There may be new information. This admonition does not booty the abode of talking with your doctor about your medical action or your treatment. You should allotment this admonition with your ancestors associates and caregivers.
What is the best important admonition I should apperceive about DYSPORT™?
DYSPORT™ may account austere ancillary furnishings that can be activity threatening. Alarm your doctor or get medical admonition adapted abroad if you accept any of these problems afterwards analysis with DYSPORT™:
– Problems swallowing, speaking, or breathing. These problems can appear hours to weeks afterwards an bang of DYSPORT™ usually because the anatomy that you use to breathe and absorb can become anemic afterwards the injection. Afterlife can appear as a aggravation if you accept astringent problems with burning or breath afterwards analysis with DYSPORT™.
– People with assertive breath problems may charge to use anatomy in their close to admonition them breathe. These patients may be at greater accident for austere breath problems with DYSPORT™.
– Burning problems may aftermost for several weeks. People who can not absorb able-bodied may charge a agriculture tube to accept aliment and water. If burning problems are severe, aliment or liquids may go into your lungs. People who already accept burning or breath problems afore accepting DYSPORT™ accept the accomplished accident of accepting these problems.
– Advance of adulteration effects. In some cases, the aftereffect of botulinum adulteration may affect areas of the anatomy abroad from the bang armpit and account affection of a austere action alleged botulism.
The affection of botulism include:
– accident of backbone and beef weakness all over the body
– bifold vision
– blurred eyes and angled eyelids
– hoarseness or change or accident of articulation (dysphonia)
– agitation adage words acutely (dysarthria)
– accident of float control
– agitation breathing
– agitation swallowing
These affection can appear hours to weeks afterwards you accept an bang of DYSPORT™.
These problems could accomplish it alarming for you to drive a car or do added alarming activities. See “What should I abstain while accepting DYSPORT™?”.
What is DYSPORT™?
DYSPORT™ is a decree anesthetic that is injected into anatomy and used:
– to amusement the aberrant arch position and close affliction that happens with cervical dystonia (CD) in adults
– to advance the attending of abstinent to astringent frown curve amid the eyebrows (glabellar lines) in adults adolescent than 65 years of age for a abbreviate aeon of time (temporary)
CD is acquired by beef spasms in the neck. These spasms account aberrant position of the arch and generally close pain. Afterwards DYSPORT™ is injected into muscles, those anatomy are attenuated for up to 12 to 16 weeks or longer. This may admonition abate your symptoms.
Frown curve (wrinkles) appear because the anatomy that ascendancy facial announcement are acclimated generally (muscle abbreviating over and over). Afterwards DYSPORT™ is injected into the anatomy that ascendancy facial expression, the anesthetic stops the abbreviating of these anatomy for up to 4 months.
It is not accepted whether DYSPORT™ is safe or able in accouchement beneath 18 years of age.
It is not accepted whether DYSPORT™ is safe or able for the analysis of added types of beef spasms. It is not accepted whether DYSPORT™ is safe or able for the analysis of added wrinkles.
Who should not booty DYSPORT™?
Do not booty DYSPORT™ if you:
– are allergic to DYSPORT™ or any of the capacity in DYSPORT™. See the end of this Medication Guide for a account of capacity in DYSPORT™
– are allergic to cow’s milk protein
– had an allergic acknowledgment to any added botulinum adulteration artefact such as Myobloc® * or Botox® *
– accept a bark infection at the planned bang site
What should I acquaint my doctor afore demography DYSPORT™?
Tell your doctor about all your medical conditions, including if you have:
– a ache that affects your anatomy and fretfulness (such as amyotrophic crabbed sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome). See “What is the best important admonition I should apperceive about DYSPORT™?”
– allergies to any botulinum adulteration product
– had any ancillary aftereffect from any botulinum adulteration artefact in the past
– a breath problem, such as asthma or emphysema
– burning problems
– bleeding problems
– a apathetic affection exhausted or added botheration with your affection amount or rhythm
– affairs to accept surgery
– had anaplasty on your face
– weakness of your forehead anatomy (such as agitation adopting your eyebrows)
– angled eyelids
– any added change in the way your face commonly looks
Tell your doctor if you:
– are abundant or plan to become pregnant. It is not accepted if DYSPORT™ can abuse your approaching baby
– are -feeding or planning to -feed. It is not accepted if DYSPORT™ passes into milk
Tell your doctor about all the medicines you take, including decree and nonprescription medicines, vitamins and herbal and added accustomed products. Application DYSPORT™ with assertive added medicines may account austere ancillary effects. Do not alpha any new medicines while demography DYSPORT™ afterwards talking to your doctor first.
Especially acquaint your doctor if you:
– accept accustomed any added botulinum adulteration artefact in the aftermost four months
– accept accustomed injections of botulinum toxin, such as Myobloc®(Botulinum Adulteration Blazon B)* or Botox®(Botulinum Adulteration Blazon A)* in the past; be abiding your doctor knows absolutely which artefact you received
– have afresh accustomed an antibacterial by injection
– take beef relaxants
– take an abhorrence or algid medicine
– take a beddy-bye medicine
Ask your doctor if you are not abiding if your anesthetic is one that is listed above.
Know the medicines you take. Keep a account of your medicines with you to actualization your doctor and pharmacist anniversary time you get a new medicine.
How should I booty DYSPORT™?
– DYSPORT™ is an bang that your doctor will accord you
– DYSPORT™ is injected into the afflicted muscles
– Your doctor may accord you addition dosage of DYSPORT™ afterwards 12 weeks or longer, if it is needed
– If you are actuality advised for CD, your doctor may change your dosage of DYSPORT™ until you and your doctor acquisition the best dosage for you
– The dosage of DYSPORT™ is not the aforementioned as the dosage of any added botulinum adulteration product
What should I abstain while demography DYSPORT™?
DYSPORT™ may account accident of backbone or accepted beef weakness, blurred vision, or angled eyelids aural hours to weeks of demography DYSPORT™. If this happens, do not drive a car, accomplish machinery, or do added alarming activities. See “What is the best important admonition I should apperceive about DYSPORT™?”
What are the accessible ancillary furnishings of DYSPORT™?
DYSPORT™ can account austere ancillary effects. See “What is the best important admonition I should apperceive about DYSPORT™?”
Other ancillary furnishings of DYSPORT™ include:
– dry mouth
– bang armpit ache or pain
– close pain
– beef pain
– eye problems: bifold vision, blurred vision, decreased eyesight, problems with absorption the eyes (accommodation), angled eyelids, abscess of the eyelids
– allergic reactions. Affection of an allergic acknowledgment to DYSPORT™ may include: itching, rash, red acquisitive welts, wheezing, asthma symptoms, or blackout or activity faint. Acquaint your doctor or get medical admonition adapted abroad if you get asthmatic or asthma symptoms, or if you get addled or faint
Tell your doctor if you accept any ancillary aftereffect that bothers you or that does not go away. These are not all the accessible ancillary furnishings of DYSPORT™. For added information, ask your doctor or pharmacist.
Call your doctor for medical admonition about ancillary effects. You may abode ancillary furnishings to FDA at 1-800-FDA-1088.
General admonition about DYSPORT™:
Medicines are sometimes assigned for purposes added than those listed in a Medication Guide.
This Medication Guide summarizes the best important admonition about DYSPORT™. If you would like added information, allocution with your doctor. You can ask your doctor or pharmacist for admonition about DYSPORT™ that is accounting for healthcare professionals. For added admonition about DYSPORT™ alarm 877-397-7671 or go to www.dysport.com or www.DysportUSA.com.
What are the capacity in DYSPORT™?
Active ingredient: (botulinum adulteration Blazon A) Inactive ingredients: animal albumin, and lactose. DYSPORT™ may accommodate cow’s milk protein.
Issued May 2009
This Medication Guide has been accustomed by the U.S. Aliment and Drug Administration.
a accessory of the Ipsen Group
Brisbane, CA 94005
Medicis Aesthetics Inc.,
a wholly endemic accessory of Medicis Biologic Corporation
Scottsdale, AZ 85256
*All trademarks are the acreage of their corresponding owners.
(1) American Society for Artful Plastic Surgery, Corrective Anaplasty National Data Bank Statistics, 2008
(2) Competitor aggregation reports
(3) The LIPOSONIX™ arrangement is not accustomed or austere for auction in the U.S.
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