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ALLERGANS BELKYRA® (DEOXICHOLSYRA) GODKÄNT I SVERIGE FÖR BEHANDLING AV MÅTTLIG TILL SVÅR UTBUKTNING UNDER HAKAN (S.K. DUBBELHAKA)

Pressmeddelanden   •   Maj 30, 2017 09:00 CEST

Deoxicholsyra har i fyra fas 3 randomiserade, multicenter, dubbelblinda, placebokontrollerade studier innefattande 1 503 patienter i Europa och Nordamerika visat att deoxicholsyra som injiceras i fettcellerna under hakan förstör den fettcellerna hos vuxna människor med måttlig till svår utbuktning under hakan.1 Studierna visade att vid injicering av deoxicholsyra nåddes en 1 gradig förbättring av utbuktningen under hakan 12 veckor efter sista behandling hos 63,8 % av patienterna i de europeiska studierna och 78,5% av patienterna i de nordamerikanska studierna enligt läkarbaserad skattning (att jämföra med 28,6% och 35,3% i placebogrupperna). 44,6% av de människor som behandlats med deoxicholsyra i de europeiska studierna och 48,6% av de som behandlats i de nordamerikanska studierna rapporterade under samma tidsperiod en förbättring av den psykologiska inverkan av utbuktningen under hakan (att jämföra med 18 % och 17,3 % i placebogrupperna). Av de patienter som fick minskad SMF-volym (submentalt fett dvs dubbelhaka), fick 68,9% av patienterna i EU, samt 70,5% av patienterna i USA/Kanada, ingen förändring eller en förbättring (21,6 % och 22,9 %) i skattningen av förslappad hud vid 12 veckor efter den sista behandlingen jämfört med innan första behandlingen.1

I de kliniska studierna visade sig de mest förekommande biverkningarna (>1/10) vara vid injektionsstället, i form av smärta, ödem, svullnad, anestesi, knutor, hematom, parestesi, induration, erytem och klåda. Andra vanliga biverkningar (>1/100, <1/10) var huvudvärk, dysfagi, illamående och stramande hud samt blödning, obehag, värmekänsla, missfärgning och nervskada vid injektionsstället.1

Behandling med deoxicholsyra genomförs på klinik av vårdpersonal med lämpliga kvalifikationer, expertis och kunskaper om den submentala anatomin. Maximalt sex behandlingar får ges. Den behandlande läkaren genomför en komplett bedömning av ansiktet för att avgöra hur många behandlingssessioner som kan behövas, baserat på mängden och fördelningen av fett under hakan och patientens personliga behandlingsmål.1

Deoxicholsyra utvärderades i en decentraliserad procedur, med svenska Läkemedelsverket som referensmyndighet, och inkluderade 20 andra länder i EU samt Island och Norge.

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com.

Det globala läkemedelsföretaget Allergan meddelar att Sverige har fått marknadsföringstillstånd för BELKYRA®(deoxicholsyra) efter godkännande av Läkemedelsverket. Deoxicholsyra är en receptbelagd behandling mot måttlig till svår utbuktning eller utfyllnad kopplad till submentalt fett (s.k. dubbelhaka) hos vuxna när förekomsten av submentalt fett har en psykologisk inverkan på patienten.1

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Allergan lanserar Juvéderm® VOLITE – en innovativ behandling utformad för att förbättra hudens kvalitet

Pressmeddelanden   •   Maj 29, 2017 15:23 CEST

Allergan, ett av världens ledande läkemedelsföretag, lanserar i slutet av mars sin senaste innovation Juvéderm® VOLITE – en unik injektionsbehandling som är framtagen för att förbättra hudens kvalitet som fukt, elasticitet och en jämnare hudstruktur.

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Allergan Reports First Quarter 2011 Operating Results

Pressmeddelanden   •   Maj 04, 2011 15:29 CEST

Board of Directors Declares First Quarter Dividend

IRVINE, Calif.--(BUSINESS WIRE)-- Allergan, Inc. (NYSE:AGN) today announced operating results for the quarter ended March 31, 2011. Allergan also announced that its Board of Directors has declared a first quarter dividend of $0.05 per share, payable on June 10, 2011 to stockholders of record on May 20, 2011.

Click here for release.

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Allergan and Serenity Pharmaceuticals Enter into Global Agreement for the Treatment of Nocturia

Pressmeddelanden   •   Apr 01, 2010 15:29 CEST

IRVINE, Calif. & MILFORD, Pa., Apr 01, 2010 (BUSINESS WIRE) -- Allergan, Inc. (NYSE: AGN) and Serenity Pharmaceuticals, LLC today announced a global agreement for the development and commercialization of Ser-120, a Phase III investigational drug currently in clinical development for the treatment of nocturia, a common yet often under-diagnosed urological disorder in adults characterized by frequent urination at night time.

Under the terms of the agreement, Allergan receives exclusive worldwide rights to develop, manufacture and commercialize Ser-120. The agreement encompasses all potential indications except Primary Nocturnal Enuresis (pediatric bedwetting). Allergan will make an upfront payment to Serenity of $43 million, potential development and regulatory milestone payments of up to $122 million, future potential sales milestones, and royalty payments on worldwide sales.

"There is a significant unmet medical need for the treatment of nocturia, which often affects patients who suffer from urologic conditions such as overactive bladder, benign prostatic hyperplasia and general primary nocturia. With Allergan's strategic focus on establishing a strong urology franchise and its proven track record in pharmaceutical development and commercialization, we are convinced that this will be a successful partnership," said Samuel Herschkowitz, M.D., Chief Executive Officer of Serenity Pharmaceuticals.

"We are pleased to be partnering with Serenity to further explore the potential of Ser-120 as a possible treatment for nocturia, a condition that can negatively impact a patient's quality of life. If successful, Ser-120 would complement our emerging urology portfolio of treatments for a variety of urinary disorders," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research & Development and Chief Scientific Officer.

About SER-120

Ser-120 is a novel, nasally administered clinical drug candidate in Phase III clinical trials being investigated for its safety and efficacy in relieving the symptoms of nocturia and mitigating excessive urinary frequency at night.

About Serenity Pharmaceuticals, LLC

Founded in 2006 and headquartered in Milford, Pa., Serenity develops patented pharmaceuticals using unique delivery mechanisms combined with low threshold efficacious formulations. This dual approach allows Serenity to engineer safer drugs with minimal side effects in targeted populations.

About Allergan, Inc.

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,300 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

Serenity Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will move from early stage development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Nor is there any guarantee that the transaction described in this release will receive the necessary regulatory approvals to close. Forward-looking statements in the press release should be evaluated together with the many uncertainties that can effect the full development of this pharmaceutical. Serenity undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Contact us at akodsi@serenitypharma.com or 917-548-8181.

Allergan Forward-Looking Statement

This press release contains "forward-looking statements," including statements by Dr. Herschkowitz and Dr. Whitcup, and other statements regarding the safety, effectiveness, development timing and market potential associated with Ser-120. If the underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products; inconsistency of treatment results among patients; the potential for product failures; potential difficulties in manufacturing new products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.

Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2009 Form 10-K. Copies of Allergan's press releases and additional information about Allergan are available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 714-246-4636.

SOURCE: Allergan, Inc.

Serenity Pharmaceuticals, LLC
Media
Dia Onizawa, 718-797-1691
donizawa@serenitypharma.com
or
Allergan, Inc.
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Caroline Van Hove, 714-246-5134
vanhove_caroline@allergan.com
or
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Jim Hindman, 714-246-4636
hindman_jim@allergan.com
Joann Bradley, 714-246-4766
bradley_joann@allergan.com
Emil Schultz, 714-246-4474
schultz_emil@allergan.com

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Allergan Receives FDA Approval for OZURDEX(TM) Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease

Pressmeddelanden   •   Jun 18, 2009 16:25 CEST

First and Only Drug Therapy Indicated for Macular Edema Associated with Retinal Vein Occlusion (RVO)

IRVINE, Calif., Jun 18, 2009 (BUSINESS WIRE) -- Allergan, Inc. (NYSE: AGN) today announced that the United States Food and Drug Administration (FDA) has approved OZURDEX(TM) (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Retinal vein occlusion (RVO), including BRVO and CRVO, is the second most common retinal vascular disease after diabetic retinopathy1 and is a significant cause of vision loss.

OZURDEX(TM) is a first-of-its kind therapy administered via intravitreal injection delivering dexamethasone, a highly potent corticosteroid, via Allergan's proprietary and innovative NOVADUR(TM) solid polymer delivery system. Via the NOVADUR(TM) delivery system, OZURDEX(TM), a biodegradable implant which enables the extended release and effect of dexamethasone, is placed in the vitreous cavity in the back of the eye treating the macular edema associated with RVO, thereby improving a patient's visual acuity.

With OZURDEX(TM), patients can achieve high concentrations of dexamethasone to reduce macular edema associated with RVO, while relying on the delivery of a consistent low level of dexamethasone to maintain edema control and enhance safety.

"OZURDEX(TM) represents the first injectable, sustained-release, potent steroid implant that provides prolonged efficacy and a favorable safety profile. In the clinical studies, 20 to 30 percent of patients suffering from this severe retinal condition experienced a 3-line improvement in best-corrected visual acuity with an onset of effect within the first two months following therapy2," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. "With our nearly 60-year leadership and research investment in eye care, we are pleased to enter the retina market and provide physicians and their patients with the first FDA-approved drug treatment for macular edema following retinal vein occlusion."

The efficacy of OZURDEX(TM) was assessed in two multi-center, double-masked, randomized parallel studies involving approximately 1,300 patients. In each individual study and in a pooled analysis, time to achieve a â%¥ 15 letter (3-line) improvement in best-corrected visual acuity (BCVA) cumulative response rate curves were significantly faster with the OZURDEX(TM) implant compared to sham (p < 0.01) with OZURDEX(TM) treated patients achieving a 3-line improvement in BCVA earlier than sham-treated patients.2

The onset of effect with OZURDEX(TM), defined as a â%¥ 15 letter (3-line) improvement in BCVA, occurred within the first two months after implantation in approximately 20 to 30 percent of subjects. The duration of effect persisted approximately one to three months after onset.2

"RVO is a common condition in patients 40 years of age and older and if left untreated can lead to vision loss. In the United States alone, more than 150,000 new cases of RVO are diagnosed each year3," said Mark S. Blumenkranz, M.D., professor and chairman, department of ophthalmology, Stanford University, Palo Alto, California. "This new therapy provides physicians with a meaningful advancement in treating RVO, offering a convenient option to patients through its unique extended delivery profile."

OZURDEX(TM) will be administered as an in-office procedure. The treatment is expected to be available to physicians and patients in the United States in the third quarter of 2009.

About Macular Edema Caused by Retina Vein Occlusion (RVO)

Macular edema is an eye disease where the macula swells and thickens due to fluid accumulating or leaking from retinal veins into the macula, located at the back of the eye. When the macula thickens, vision may become impaired. If swelling is caused by retinal vein leakage over a prolonged period of time, permanent visual loss may result. Macular edema may be caused by chronic diabetic retinopathy or more acute events such as RVO.

Clinical signs of RVO include hemorrhages in the retina, retinal edema or swelling, retinal vein tortuosity (twisting) and dilation, and the appearance of "cotton-wool spots" or white patches in the retina.

Systemic risk factors associated with RVO include hypertension, diabetes mellitus, cerebrovascular disease, cardiovascular disease, increased body mass index, reduced high-density lipoprotein cholesterol levels, smoking, thyroid disorder and peptic ulcer.4 Ocular risk factors associated with RVO include glaucoma or ocular hypertension, shorter axial length, and focal arteriolar narrowing and arteriovenous (AV) nicking.4

INDICATIONS AND USAGE

OZURDEX(TM) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

DOSAGE AND ADMINISTRATION

For ophthalmic intravitreal injection only.

The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

IMPORTANT SAFETY INFORMATION

Contraindications

OZURDEX(TM) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitits), vaccinia, varicella, mycobacterial infections and fungal diseases. It is also contraindicated in patients with advanced glaucoma and in patients with known hypersensitivity to any components of this product or to other corticosteroids.

Warnings and Precautions

Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corticosteroids should not be used in active ocular herpes simplex.

Adverse Reactions

The most common ocular adverse reactions reported by greater then 2% of the patients in the first six months included increased intraocular pressure (25%), conjunctival hemorrhage (20%), eye pain (7%), conjunctival hyperemia (7%), ocular hypertension (4%), cataract (4%), and vitreous detachment (3%), and headache (3%).

Full prescribing information is available at www.allergan.com.

About Allergan, Inc.

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

Forward-Looking Statements

This press release contains "forward-looking statements", including the statements by Dr. Whitcup and Dr. Blumenkranz and other statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding the OZURDEX(TM) implant. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2008 Form 10-K and Allergan's Form 10-Q for the quarter ended March 31, 2009. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.

© 2009 Allergan, Inc. Irvine, CA 92612. (TM) marks owned by Allergan, Inc.

1 Héron E., Marzac C., Feldman-Billard S., Girmens J., Paques M. , Delarue R. , Piette J., Casadevall N., Hermine, O. (2007). Endogenous Erythroid Colony Formation in Patients with Retinal Vein Occlusion. Ophthalmology, 114, Issue 12, 2155 - 2161.

2 Data on File, Allergan, Inc.

3 Data on File, Allergan, Inc.

4 Cugati, S., Wang, J. J., Rochtchina, E., & Mitchell, P. (2006). Ten-year incidence of retinal vein occlusion in an older population: the Blue Mountains Eye Study. Arch. Ophthalmol., 124, 726-732.

 

SOURCE: Allergan, Inc.

Allergan Contacts
Caroline Van Hove, (714) 246-5134 (media)
Crystal Muilenburg, (714) 246-5842 (media)
Jim Hindman, (714) 246-4636 (investors)
Joann Bradley, (714) 246-4766 (investors)
Emil Schultz, (714) 246-4474 (investors)

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ALLERGAN RECEIVES COMPLETE RESPONSE LETTER FOR BOTOX® (Botulinum Toxin Type A) FOR TREATMENT OF UPPER LIMB SPASTICITY IN ADULTS

Pressmeddelanden   •   Maj 27, 2009 09:22 CEST

(IRVINE, Calif., May 26, 2009) - Allergan, Inc. (NYSE: AGN) today announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's Supplemental Biologics License Application (sBLA) for BOTOX® (Botulinum Toxin Type A) to treat upper limb spasticity in post-stroke adults. Allergan submitted its sBLA for this indication in the third quarter of 2008.

The FDA has not requested additional pre-approval clinical studies. However, the FDA has identified items that must be completed before the sBLA can be considered for approval, including the following:

  • Risk Evaluation and Mitigation Strategy (REMS) and Safety Update:

    • On April 29, 2009, the FDA approved DYSPORTTM (abobotulinumtoxinA) for the treatment of cervical dystonia in adults and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age and imposed a REMS for that product. Concurrently, the FDA requested that Allergan adopt a substantially similar REMS for BOTOX®. Allergan has submitted its proposed REMS for the FDA's review. The FDA indicated that it had not yet reviewed Allergan's submission and that an approved REMS will be necessary prior to approving BOTOX® to treat upper limb spasticity. Also, the FDA requested that in its reply to the complete response letter, Allergan provide a product safety update from clinical and non-clinical studies across indications.

  • Source Data Documentation:

    • While the FDA's complete response letter acknowledges that the sBLA supports the efficacy and safety of BOTOX® for the treatment of upper limb spasticity, the FDA has requested that Allergan independently verify underlying patient source documentation at study sites relating to one of the pivotal clinical studies conducted in 1999 and upon completion of the verification, provide an updated analysis. In the sBLA, Allergan submitted data from 16 studies including an integrated analysis of 7 double-blind, placebo-controlled trials.

      Allergan estimates that the re-verification can be completed and the analysis submitted to the FDA in approximately 60 to 90 days.

  • Product Labeling:

    • In its complete response letter, the FDA proposed revisions to Allergan's proposed labeling, including enhanced safety information and other clarifications. Among other revisions, the FDA proposed a revised spasticity indication. In its sBLA, Allergan proposed the use of BOTOX® for the treatment of upper limb spasticity associated with stroke. In its complete response letter, the FDA noted the focal nature of BOTOX® treatments and the similarities of spasticity across conditions and thus proposed revised labeling that would broaden the indication of use to upper limb spasticity regardless of underlying cause. Also, noting the number of pediatric patients such as those with juvenile cerebral palsy who suffer from upper limb spasticity, the FDA requested that Allergan conduct a post-approval study for BOTOX® to treat upper limb spasticity in pediatric patients 2-17 years of age. This request is consistent with Allergan's proposal in connection with the submission of its proposed REMS and Allergan hopes to discuss with the FDA a protocol that, if successful, would support an approval for the treatment of children suffering from spasticity.

      Allergan will diligently respond to the FDA's proposed label revisions and will develop a pediatric plan to further study BOTOX® in children.

    "A significant unmet medical need for those suffering from upper limb spasticity exists in the United States. It is estimated that nearly 500,000 Americans each year develop stroke-related spasticity, the majority of which includes upper limb spasticity1,2. And yet about half of those patients receive no treatment for their spasticity," said Scott Whitcup, M.D., Executive Vice President, Research & Development, Chief Scientific Officer, Allergan, Inc. "We have already submitted our REMS for BOTOX® as we anticipated this requirement as a condition to an approved spasticity indication. We will work expeditiously to provide the FDA with all other information requested in the complete response letter to support a rapid final review of our application for BOTOX® as a treatment for upper limb spasticity."

    About BOTOX®

    BOTOX® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. When injected at approved and labeled doses into a specific muscle or gland, BOTOX® is expected to diffuse locally and expected to produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting between 3 and 6.7 months depending on the individual patient and indication.

    BOTOX® was first approved by the FDA nearly twenty years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval, BOTOX® has been recognized by regulatory authorities worldwide as an effective treatment for 21 different indications in approximately 80 countries, benefiting millions of patients worldwide. In the United States, BOTOX® is also approved for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with the disorder, and for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating) that is inadequately managed with topical agents. In addition to its therapeutic uses, the same formulation of BOTOX® with dosing specific to glabellar lines was approved by the FDA in 2002 under the trade name BOTOX® Cosmetic.

    In addition to nearly 20 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 50 randomized, placebo-controlled clinical trials and in approximately 11,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan's clinical trials3.

    Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Information

    BOTOX® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

    BOTOX® is also indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

    The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.

    And BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

    BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18-65.

    Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Safety Information

    BOTOX® and BOTOX® Cosmetic treatment should not be injected in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.

    Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately. Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX® or BOTOX® Cosmetic with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic side effects with BOTOX® or BOTOX® Cosmetic.

    BOTOX® for Blepharospasm in Patients > 12 Years of Age: Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal perforation. The most frequently reported treatment-related adverse reactions in these patients are ptosis (20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%).

    BOTOX® for Strabismus in Patients > 12 Years of Age: Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing. The most commonly reported adverse effects are ptosis (16%) and vertical deviation (17%).

    BOTOX® for Cervical Dystonia in Adults: There have been rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube. The most frequently reported adverse reactions in patients with cervical dystonia are dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

    BOTOX® for Severe Primary Axillary Hyperhidrosis Inadequately Managed with Topical Agents: The most frequently reported adverse events (3 - 10%) are injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.

    BOTOX® Cosmetic for Temporary Improvement in the Appearance of Moderate to Severe Frown Lines Between the Brows in Adults 18-65: The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness and/or bleeding/bruising may be associated with the injection.

    Additional Important Safety Information

    The FDA on April 30, 2009, in its update to the early communication sent in 2008, gave the following recommendations:

    • Understand that dosage strength (potency) expressed in "Units" or "U" are different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one botulinum toxin product to another.
    • Be alert to and educate patients and caregivers about potential adverse events due to distant spread of botulinum toxin effects following local injections including: unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
    • Understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment.
    • Advise patients to seek immediate medical attention if they develop any of these symptoms.

    For full prescribing information, please visit www.BotoxMedical.com and www.BotoxCosmetic.com

    Forward-Looking Statement

    This press release contains "forward-looking statements," including the statements by Dr. Whitcup and other statements regarding the safety, effectiveness, adverse events, approval and market potential associated with BOTOX®. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2008 Form 10-K and Allergan's Form 10-Q for the quarter ended March 31, 2009. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.

    About Allergan, Inc.

    Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

    SOURCE: Allergan

    Allergan Contacts

    Caroline Van Hove 714-246-5134 (media)

    Crystal Muilenburg714-246-5842 (media)

    Jim Hindman 714-246-4636 (investors)

    Joann Bradley 714-246-4766 (investors)

    Emil Schultz714-246-4474 (investors) © 2009 Allergan, Inc. Irvine, CA 92612.® marks owned by Allergan, Inc.

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    VIDEO: Allergan, Inc. Announces the 'BOTOX(R) Cosmetic: Express Success' Charitable Education Campaign, Committing $250,000 to the Not-For-Profit Dress for Success

    Pressmeddelanden   •   Maj 15, 2009 15:08 CEST

    --Actress and singer Vanessa Williams serves as campaign ambassador

    IRVINE, Calif., May 15, 2009 /PRNewswire via COMTEX News Network/ -- In honor of working women who have helped make BOTOX(R) Cosmetic (Botulinum Toxin Type A) the most popular physician-administered aesthetic treatment for the last seven years, Allergan, Inc. (NYSE: AGN) has announced the "BOTOX(R) Cosmetic: Express Success" charitable education campaign. Spearheaded by actress and singer Vanessa Williams, the campaign will benefit the not-for-profit Dress for Success, an organization that helps disadvantaged women succeed in the workforce, through a $250,000 donation from Allergan. The donation will support the organization in its efforts to promote the economic independence of disadvantaged women by providing professional attire, a network of support and the career development tools to help women thrive in work and in life.

    To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/allergan/37902/

    "Dress for Success is about more than providing business attire to women in need. Our mission is to change women's lives by enabling them to express success and confidence in their professional endeavors," said Joi Gordon, CEO of Dress for Success. "We're excited to partner with Allergan and Vanessa Williams to raise awareness of Dress for Success."

    As part of the donation to Dress for Success, up to $50,000 of the total $250,000 donation will be generated through an online drive, with Allergan donating $2 to the organization on behalf of each of the first 25,000 people who visit and register on the campaign Web site, ExpressSuccessCampaign.com. When pledging support on the Web site, people also can enter to win a trip for two to New York City to have lunch with Vanessa Williams, read Vanessa's personal blog as well as get interview and workplace tips.

    In addition to the donation, the "BOTOX(R) Cosmetic: Express Success" campaign includes a series of educational events featuring campaign ambassador, Vanessa Williams, Dress for Success CEO Joi Gordon and an aesthetic-specialty physician. The events will take place in select markets across the country where consumers will be able to support Dress for Success by donating nearly new professional attire as a cost of entry, while learning about fast and simple tips for working women, including treatment with BOTOX(R) Cosmetic.

    "As a working woman and actress, I know how important it is to 'look the part' when interviewing for a new position or in any professional setting. It's no secret that I receive BOTOX(R) Cosmetic treatments, which is a quick procedure that reduces the two frown lines in between my brows that look like an '11' and give me a tired or stressed appearance," said Ms. Williams. "For me, putting my best face forward means finding ways to help other women express their own success, personally and professionally. That's why I'm so excited to be involved with the 'BOTOX(R) Cosmetic: Express Success' campaign benefiting Dress for Success, which has helped more than 500,000 women prepare for, find and keep the job that ultimately leads to financial independence. There is truly no better time to get involved than now, so I ask all women to join our efforts by pledging their support online, joining us at our local events and participating in our New York City launch event."

    Vanessa Williams will host the "BOTOX(R) Cosmetic: Express Success" campaign launch event with Allergan and Dress for Success on June 30 in New York City's Union Square. The event includes a celebrity "Rack Relay Race" and clothing drive. The public is invited to join Vanessa in the race by donating nearly new professional clothing and registering to race on ExpressSuccessCampaign.com. The first 100 people to pre-register online and participate in the "Rack Relay Race" will receive a certificate for a physician consultation and, if appropriate, a complimentary BOTOX(R) Cosmetic treatment from a licensed and trained aesthetic-specialty physician. The winning "Rack Relay Race" team also will win an opportunity to have lunch with Vanessa Williams in New York City.

    Additional information about the launch and local events is available on the campaign Web site which also features an inspiring animated video featuring Vanessa Williams and three Dress for Success graduates directed by Dex Deboree, a highly acclaimed Grammy(R)-award nominee.

    "We are pleased to launch the 'BOTOX(R) Cosmetic: Express Success' campaign on behalf of the women who have helped make BOTOX(R) Cosmetic the most popular physician administered treatment over the past seven years," said Robert Grant, president of Allergan Medical, a division of Allergan, Inc. "During this time, Allergan has developed many programs to educate women about the product, especially the importance of seeing a licensed and trained physician. Through this campaign, Allergan also will be realizing the important philanthropic goal of helping disadvantaged women around the country fulfill their professional potential and express their success. It's a first of its kind campaign for BOTOX(R) Cosmetic and we are proud to be partnering with both Dress for Success and Vanessa Williams on this important mission."

    For more information about BOTOX(R) Cosmetic and the "BOTOX(R) Cosmetic: Express Success" campaign, please visit www.ExpressSuccessCampaign.com.

    About BOTOX(R) Cosmetic

    BOTOX(R) Cosmetic (Botulinum Toxin Type A) was approved by the U.S. Food and Drug Administration (FDA) in 2002 for the temporary improvement in the appearance of moderate to severe glabellar lines (the vertical "frown lines" between the eyebrows) in adult women and men ages 18 to 65. The glabellar lines, which often look like the number "11," can have a negative effect on one's overall facial appearance by creating a sad, angry, or tired impression.

    BOTOX(R) Cosmetic has been ranked as the number one physician-administered, aesthetic injectable treatment(2) and 11.8 million treatment sessions with BOTOX(R) Cosmetic have been recorded in the United States alone.(3) High patient satisfaction rates following treatment with BOTOX(R) Cosmetic have been well established with 97 percent of patients indicating satisfaction with the product, according to a survey of approximately 1,000 patients conducted by the research arm of the American Society for Aesthetic Plastic Surgery (ASAPS).(4)

    Important BOTOX(R) Cosmetic (Botulinum Toxin Type A) Information

    BOTOX(R) Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 to 65.

    Important Safety Information

    BOTOX(R) Cosmetic injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in BOTOX(R) Cosmetic.

    Serious heart problems and serious allergic reactions have been reported rarely. If you think you are having an allergic reaction or other reactions, such as difficulty swallowing, speaking, or breathing, call your doctor immediately. The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising may be associated with the injection. Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.

    The FDA on April 30, 2009, in its update to the early communication sent in 2008, gave the following recommendations:

    -- Understand that dosage strength (potency) expressed in "Units"
    or "U" are different among the botulinum toxin products;
    clinical doses expressed in units are not interchangeable from one
    botulinum toxin product to another.
    -- Be alert to and educate patients and caregivers about potential adverse
    events due to distant spread of botulinum toxin effects following local
    injections including: unexpected loss of strength or muscle weakness,
    hoarseness or trouble talking (dysphonia), trouble saying words clearly
    (dysarthria), loss of bladder control, trouble breathing, trouble
    swallowing, double vision, blurred vision and drooping eyelids.
    -- Understand that these adverse events have been reported as early as
    several hours and as late as several weeks after treatment.
    -- Advise patients to seek immediate medical attention if they develop any
    of these symptoms.

    Please click here for BOTOX(R) Cosmetic full product information.

    About Dress for Success

    Dress for Success is an international not-for-profit organization that promotes the economic independence of disadvantaged women by providing professional attire, a network of support and the career development tools to help women thrive in work and in life. Since starting operations in 1997, Dress for Success has expanded to more than 90 cities in the U.S., Canada, Mexico, the Netherlands, New Zealand, Poland, the UK and the West Indies. To date, Dress for Success has helped more than 500,000 women work towards self-sufficiency. Visit http://www.dressforsuccess.org to learn more.

    About Vanessa Williams:

    Vanessa Williams has achieved success in every area of entertainment, including the worlds of music, theatre, film and television. She has sold millions of albums, earning multiple Grammy(R) Award nominations and countless other awards and honors. She has starred in numerous films, television and Broadway productions and has won or been nominated for the Emmy(R), Golden Globe(R) and Screen Actors Guild(R) awards and has won two NAACP Image Awards for her role as the deliciously wicked Wilhelmina Slater on the hit ABC series, "Ugly Betty." Concord Records will release her 13th album, "The Real Thing" in June and she recently appeared in the box-office hit, "Hannah Montana: The Movie."

    About Allergan, Inc.

    Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

    Forward-Looking Statements

    This press release contains "forward-looking statements", including the statements by Ms. Gordon, Ms. Williams and Mr. Grant and other statements regarding the "BOTOX(R) Cosmetic: Express Success" charitable education campaign. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients and the potential for product failures; unknown risks associated with the investigational devices that are the subject of clinical trials; potential difficulties in manufacturing new products; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.

    Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2008 Form 10-K and Allergan's Form 10-Q for the quarter ended March 31, 2009. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling (714) 246-4636.

    (C) 2009 Allergan, Inc. Irvine, CA 92612. (R) marks owned by Allergan, Inc. Grammy(R) is a registered trademark of The Recording Academy Screen Actors Guild(R) is a registered trademark of the Screen Actors Guild Emmy(R) is a registered trademark of the Academy of Television Arts & Sciences and the National Academy of Television Arts & Sciences (ATAS/NATAS) Golden Globe(R) is a registered trademark of the Hollywood Foreign Press Association APC53TZ09

    (1) American Society of Plastic Surgeons; "Top Five Minimally-Invasive Cosmetic Procedures" 2002, 2003, 2004, 2005, 2006, 2007, 2008.

    (2) American Society of Plastic Surgeons; "Top Five Minimally-Invasive Cosmetic Procedures" 2002, 2003, 2004, 2005, 2006, 2007, 2008.

    (3) Allergan data on file; Global Regulatory Affairs

    (4) Aesthetic Surgery Education & Research Foundation press release "First-of-its-kind Survey Finds That BOTOX(R) Cosmetic has Gone Mainstream" Released 04/28/06

    SOURCE Allergan, Inc.

    http://www.allergan.com

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    Video: Allergan, Inc. Marks 20 Years Since the First Approved Indications by the U.S. Food and Drug Administration for BOTOX(R) (Botulinum Toxin Type A)

    Pressmeddelanden   •   Apr 15, 2009 15:29 CEST

    --New Patient Video Vignettes and Mechanism of Action 3-D Video Illustrate the Versatility and Application of BOTOX(R) Across Several Approved Indications

    IRVINE, Calif., April 15, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- As part of the nearly 20-year milestone since the first approved indications by the U.S. Food and Drug Administration (FDA) for BOTOX(R) (Botulinum Toxin Type A), Allergan, Inc. (NYSE: AGN), the maker of BOTOX(R) and BOTOX(R) Cosmetic, conducted a Web-based media briefing that provided an in-depth review of the evolution and science of BOTOX(R) therapy, its risk/benefit profile and how to evaluate the differences between botulinum toxin therapies. Perspectives on these topics were provided by leading researchers and Allergan scientists, and by patients who discussed their treatment with BOTOX(R) and BOTOX(R) Cosmetic.

    To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/allergan/37769/

    It has been nearly 20 years since BOTOX(R) was first approved by the FDA to treat two specific eye muscle disorders. Since 1989, the FDA has approved two additional therapeutic indications for BOTOX(R) and one aesthetic indication, using the same formulation and under the name BOTOX(R) Cosmetic (Botulinum Toxin Type A), with dosing specific to temporarily treat moderate to severe glabellar lines in people ages 18 to 65. To date, BOTOX(R) is approved for 20 different therapeutic indications in approximately 80 countries worldwide. BOTOX(R) Cosmetic is authorized for aesthetic treatment in approximately 60 countries.

    The Webinar also featured a new video demonstrating in detail how BOTOX(R) therapy works by blocking overactive nerve impulses that trigger excessive muscle contractions or glandular activity.

    "One of the advantages of BOTOX(R) therapy is its highly selective mechanism of action and targeted mode of administration, via injection directly into the affected muscle or gland, which in large part explains the product's clinical performance and predictable patient outcomes," explained Mitchell F. Brin, M.D., Allergan's Senior Vice President of Global Development and Chief Scientific Officer for BOTOX(R).

    No Two Botulinum Toxins Are Alike

    With additional botulinum toxin products awaiting FDA approval, Dr. Brin reviewed the scientific differences among botulinum toxin therapies and the factors that physicians and patients should weigh when considering treatment options.

    "The well-established risk/benefit profile of BOTOX(R) is unique to the product, because no two botulinum toxins are alike," said Dr. Brin. He pointed out that botulinum toxin products are biologics - i.e., derived from living substances, in this case, from the Clostridium botulinum bacteria. This bacteria produces seven different subtypes of botulinum toxin, with type A being the most potent. Differences among subtypes may influence therapeutic effects and how long they last, or the occurrence of adverse events following treatment. Even among botulinum toxin products of the same subtype, variations in manufacturing processes can result in differences in the product's characteristics, including formulation (e.g., molecular uniformity and weights of toxin complexes), pharmacokinetics, and clinical parameters such as efficacy, duration of effect, risk/benefit profile and immunogenicity(1).

    "Because of these differences, each botulinum toxin also has distinct dosing requirements," said Dr. Brin. "Importantly for physicians and patients, this means that BOTOX(R) is not interchangeable with other botulinum toxins and a physician cannot simply use a fixed-dose ratio and expect the same precise and predictable results."

    The Patient and Physician Experience

    While practicing in the 1980s at Columbia-Presbyterian Medical Center in New York City, Dr. Brin, a neurologist, co-led one of the first clinical trials of BOTOX(R) (Botulinum Toxin Type A) as a treatment for cervical dystonia supported by the Food and Drug Administration's Office of Orphan Product Development, when a young man named Tom Stampe was referred to him.

    "I was 23 years old, and I started getting this very bad neck pain," said Mr. Stampe. "One day the neck pain started making me go into a twitch and my head started pulling to one side to the point that it stayed stuck on my right shoulder. For three years I couldn't move it, couldn't turn it, couldn't do anything. After years of misdiagnosis and disability, I was finally referred to Dr. Brin who diagnosed my condition as cervical dystonia. At that time they were trying out a new investigational drug, and he thought I'd be a very good candidate for it. It was BOTOX(R). Shortly after those first injections my head and neck began to move freely, and it's a feeling I'll never forget." Today, Mr. Stampe is an advocate for cervical dystonia patients and currently serves as President of the New York chapter of the Dystonia Medical Research Foundation.

    "The clinical development of BOTOX(R) (Botulinum Toxin Type A) has improved the management of a number of disabling conditions characterized by excessive muscle or glandular activity, and just as importantly for patients like Mr. Stampe, it has expanded interest in their diagnosis and treatment," said Joseph Jankovic, M.D., Professor of Neurology, Distinguished Chair in Movement Disorders, and Director of the Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine in Houston, Texas. Dr. Jankovic, a leader in the field of neurotoxin research, led the first studies of BOTOX(R) for the treatment of cervical dystonia and blepharospasm in the 1980s.

    "Now it is decades later, and we have a wealth of clinical data on BOTOX(R), as well as expertise in its administration and a thorough scientific understanding of the product, and we know that optimal results with BOTOX(R) depend on several critical factors," explained Dr. Jankovic. "Unlike oral drugs, there are many technical aspects involved in administering BOTOX(R), including dosing, dilution and injection placement and technique. Therefore, the injecting physician should have extensive knowledge of these treatment factors, along with a thorough understanding of the disease and its symptoms to ensure the product can deliver a targeted and precise effect." Dr. Jankovic emphasized the importance to patients, whether they are considering medical treatment with BOTOX(R) or aesthetic treatment with BOTOX(R) Cosmetic (Botulinum Toxin Type A), of seeking a well-trained physician with the qualifications necessary to evaluate and determine the best injection plan for each patient.

    BOTOX(R) Research and Development

    In concluding the Webinar, Scott Whitcup, M.D., Allergan's Executive Vice President for Research and Development, noted that Allergan is building upon its two decades of research and clinical experience with BOTOX(R) to investigate new medical uses for the product, with research focused on areas where safe and effective new treatment options will make a meaningful difference to large numbers of patients. Allergan also is exploring novel next generation neurotoxins with the potential for even more specific modes of action.

    About BOTOX(R)

    BOTOX(R) was first approved by the FDA in 1989 for the blepharospasm (excessive eye blinking) and strabismus (misalignment of the eye). Since then BOTOX(R) also has been approved by the FDA for the treatment of cervical dystonia (a painful twisting of the neck) and severe primary axillary hyperhidrosis (excessive underarm sweating that is inadequately managed by topical agents). The same product, with dosing specific to treat glabellar lines (vertical frown lines between the brows), received FDA approval in 2002 under the name BOTOX(R) Cosmetic (to differentiate between its therapeutic and aesthetic applications). With that approval, BOTOX(R) Cosmetic has been the most popular physician-administered, aesthetic injectable treatment for the past seven years(2).

    Nearly 17 million treatment sessions with BOTOX(R) and BOTOX(R) Cosmetic have been recorded in the United States alone over the past 14 years(3), with approximately 22 million vials of BOTOX(R) and BOTOX(R) Cosmetic distributed worldwide to date(4). In addition to this extensive clinical experience with the product, the safety and efficacy of BOTOX(R) has been studied in approximately 50 randomized, placebo-controlled clinical trials(5). Additionally, approximately 11,000 patients have been treated with BOTOX(R) and BOTOX(R) Cosmetic in Allergan-sponsored trials(6). With approximately 2,000 articles on BOTOX(R) and BOTOX(R) Cosmetic in peer-reviewed publications, BOTOX(R) is the most widely researched neurotoxin, and one of the most widely researched medicines in the world.

    Important BOTOX(R) (Botulinum Toxin Type A) and BOTOX(R) Cosmetic (Botulinum Toxin Type A) Information

    BOTOX(R) is approved for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

    BOTOX(R) is approved for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

    The efficacy of BOTOX(R) treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX(R) is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.

    And BOTOX(R) is approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

    BOTOX(R) Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 - 65.

    Important Safety Information

    Who should not be treated with BOTOX(R)

    BOTOX(R) injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in the BOTOX(R) product.

    Warnings

    Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other reactions, such as difficulty swallowing, speaking, or breathing, call your doctor immediately.

    Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.

    Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia (difficulty swallowing) and respiratory compromise from typical doses of BOTOX(R).

    Dysphagia (difficulty swallowing) is a commonly reported adverse event following treatment of cervical dystonia patients with all botulinum toxins. In these patients, there are reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube.

    Precautions

    Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory disorders arise.

    Side Effects

    Localized pain, infection, inflammation, tenderness, swelling, redness and/or bruising may be associated with the injection.

    In cervical dystonia, the most common side effects following injection include difficulty swallowing (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

    In blepharospasm, the most common side effects following injection include ptosis (20.8%), inflammation of the cornea (6.3%), and eye dryness (6.3%).

    In strabismus, the most common side effects following injection include ptosis (15.7%) and vertical deviation (16.9%).

    In severe primary axillary hyperhidrosis, the most common side effects (3-10% of patients) following injection include injection-site pain and bleeding, non-underarm sweating, infection, sore throat, flu, headache, fever, neck or back pain, itching and anxiety.

    The most common side effects following BOTOX(R) Cosmetic injections include temporary eyelid droop and nausea.

    Please see accompanying full product information for BOTOX(R) and BOTOX(R) Cosmetic, also available at www.botox.com and www.botoxcosmetic.com.

    About Allergan, Inc.

    Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,500 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

    Forward-Looking Statements

    This press release contains "forward-looking statements", including the statements by Drs. Brin, Jankovic and Whitcup and Mr. Stampe and statements regarding the safety, effectiveness, market potential and adverse events associated with BOTOX(R) and BOTOX(R) Cosmetic.

    These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry, biologic and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing new products; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.

    Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2008 Form 10-K. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling (714) 246-4636.

    (C) 2009 Allergan, Inc. Irvine, CA 92612. (R) and (TM)marks owned by Allergan, Inc.

    APC99IJ09

    (1)Sampaio C, Costa J, Ferreira JJ. Clinical comparability of marketed formulations of botulinum toxin. Mov Disord. 2004;19(suppl 8):S129-136

    (2)American Society of Plastic Surgeons; "Top Five Minimally-Invasive Cosmetic Procedures" 2002, 2003, 2004, 2005, 2006, 2007, 2008

    (3)Allergan data on file; Global Regulatory Affairs

    (4)Allergan data on file; Global Regulatory Affairs

    (5)Allergan data on file; Medical Affairs

    (6)Allergan data on file; Medical Affairs

    SOURCE Allergan, Inc.

    http://www.allergan.com

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    Allergan Announces Quarterly Conference Call

    Pressmeddelanden   •   Apr 06, 2009 09:05 CEST

    IRVINE, Calif., Apr 03, 2009 (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) invites you to listen to David Pyott, Chairman of the Board and Chief Executive Officer, and Jeff Edwards, Executive Vice President, Finance and Business Development, Chief Financial Officer, discuss the Company's first quarter 2009 results on Friday, May 1, 2009. The live Webcast can be accessed through the Allergan Web site, www.allergan.com, beginning at 8:00 a.m. Pacific Time. A replay of the discussion will be available shortly after the call and can be accessed through www.allergan.com, or by dialing 1-866-463-4105 for domestic locations or 1-203-369-1381 for international locations. A passcode will not be required. The replay will be available for one week following the live call.

    It is Allergan's policy to comply fully with Regulation FD. Therefore, Allergan intends to utilize this Webcast event to discuss financially oriented goals and objectives and to disclose material Company and industry-based topics in an open manner. Allergan does not plan to report or comment on its progress during the current fiscal quarter. Any statement made by others with respect to progress mid-quarter cannot be attributed to Allergan. During a quarter, Allergan's commentary will be limited to discussions of public information, such as historic financial performance, and matters that are deemed to be immaterial. Allergan will make no comments with respect to market rumors or speculation.

     

    SOURCE: Allergan, Inc.

    Jim Hindman
    Joann Bradley
    Emil Schultz
    (714) 246-4636

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    ALLERGAN REPORTS FOURTH QUARTER 2008 OPERATING RESULTS AND ANNOUNCES RESTRUCTURING

    Pressmeddelanden   •   Feb 04, 2009 15:47 CET

    §         Board of Directors Declares Fourth Quarter Dividend

    (IRVINE, Calif., February 04, 2009) -- Allergan, Inc. (NYSE: AGN) today announced operating results for the quarter ended December 31, 2008. Allergan also announced that its Board of Directors has declared a fourth quarter dividend of $0.05 per share, payable on March 13, 2009 to stockholders of record on February 20, 2009.

     

    Operating Results

    For the quarter ended December 31, 2008:

    • Allergan reported $0.50 diluted earnings per share from continuing operations compared to $0.52 diluted earnings per share reported for the fourth quarter of 2007.
    • Allergan's adjusted diluted earnings per share from continuing operations were $0.76 in the fourth quarter of 2008, compared to adjusted diluted earnings per share of $0.60 in the fourth quarter of 2007, a 26.7 percent year-over-year increase.

    Product Sales

    For the quarter ended December 31, 2008:

    • Allergan's total product net sales were $1,041.0 million. Total product net sales decreased 3.2 percent as compared to total product net sales in the fourth quarter of 2007. On a constant currency basis, total product net sales increased 1.6 percent compared to total product net sales in the fourth quarter of 2007.
      • Total specialty pharmaceuticals net sales decreased 1.4 percent as compared to total specialty pharmaceuticals net sales in the fourth quarter of 2007. On a constant currency basis, total specialty pharmaceuticals net sales increased 3.3 percent compared to total specialty pharmaceuticals net sales in the fourth quarter of 2007.
      • Core medical devices net sales decreased 9.6 percent, or 4.8 percent at constant currency, compared to core medical devices net sales in the fourth quarter of 2007.

     

    "Allergan continued to demonstrate an ability to apply discipline and execution in our core specialty businesses despite the challenging economic environment observed in the fourth quarter of 2008," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "Our goal is to continue to focus on enhancing efficiencies and strengthening our position within our core specialty markets throughout 2009, as we look forward to the anticipated approvals and launches of new growth drivers from our rich R&D pipeline, including the recently approved LATISSETM for enhanced eyelash prominence."

    Based on internal information and assumptions, full year 2008 therapeutic sales accounted for approximately

    50% of total BOTOX® (botulinum toxin type A) sales and grew at a rate of approximately 8% compared to

    2007. Full year 2008 cosmetic sales accounted for approximately 50% of total BOTOX® sales and grew at a rate of approximately 8% compared to 2007.

     

    Restructuring

    In order to concentrate Allergan's resources during this recessionary period on customer-facing activities and on building the strength of its R&D pipeline, while continuing to deliver on its earnings goals, Allergan conducted a worldwide review of its operations to improve efficiency.  Furthermore, Allergan will focus its spending on programs and businesses that produce the highest returns.  Consequently, Allergan will lay off approximately 460 employees, or approximately 5 percent of its global headcount, primarily in the United States and Europe.

     

    The majority of the employees affected by the restructuring are in two areas: (1) U.S. urology sales and marketing personnel as a result of the Company's decision to focus on the urology specialty and to seek a partner to promote SANCTURA XR® to general practitioners, and (2) marketing personnel in the United States and Europe as Allergan adjusts its back-office structures to the reduced short-term sales outlook for some businesses.  With the exception of the U.S. urology sales force and some low productivity sales territories in Europe, no other sales force positions are affected.  Modest reductions are being made in other functions as Allergan re-engineers its processes and increases productivity.

     

    Further, Allergan has reviewed its stock option-related cost structure.  Allergan's 2008 full-round employee stock option grant took place in February 2008 with a strike price of $64.47 versus a current stock price of approximately $40.  While Allergan does not intend to institute a stock option exchange or repricing program, the Company's Board of Directors has decided to accelerate the vesting and remove certain stock option expiration features for all employees holding the 2008 full-round employee stock options and to modify certain stock option expiration features for other stock options held by employees impacted by the restructuring.   Allergan will incur a one-time charge in the first quarter of 2009 associated with these stock option grant modifications.

    Allergan currently estimates that it will incur total non-recurring pre-tax charges of between $110 million and $117 million in connection with the restructuring, of which only $40 million to $45 million will be a cash charge.  The remainder will be a non-cash accounting-related charge associated with the acceleration of previously unrecognized share-based compensation costs and any additional estimated costs associated with the modification of stock option grants as discussed above and certain other non-cash accounting adjustments.

    These charges will be incurred beginning in the first quarter of 2009 and are expected to continue up through and including the fourth quarter of 2009.  The realized expense savings from the restructuring are expected to exceed the cash charges in less than one year.

     

    Product and Pipeline Update

    During the fourth quarter of 2008:

    • On October 15, 2008, Allergan and Clinique, the #1 prestige cosmetics brand in the United States, announced the nationwide availability of CLINIQUE MEDICAL. This new skin care line is scientifically designed and clinically proven to complement select in-office cosmetic procedures and is available only through skin care physicians' offices.
    • Allergan completed the initial analysis of data from its Phase III studies of POSURDEX® for macular edema associated with retinal vein occlusion (RVO).The data demonstrated that patients receiving either the 350 microgram or the 700 microgram dose of POSURDEX® had a statistically significant increase in vision based on a 3-line or better improvement in visual acuity compared to a sham treatment.In addition, both doses of POSURDEX® were well tolerated in the studies. Less than 7% of patients receiving 700 or 350 micrograms of POSURDEX® experienced an elevation of intraocular pressure (IOP) greater than 35 mm Hg at any time during the 6 month study, and at 6 months less than 1% of patients had an IOP above 25 mm Hg. In the fourth quarter, Allergan completed filing the last module of its new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for the approval of POSURDEX® to treat macular edema associated with RVO. POSURDEX® is a novel formulation of dexamethasone in Allergan's proprietary, sustained-release drug delivery system that can be used to locally administer medications to the retina. Brimonidine in this drug delivery system is also currently being investigated as a treatment for retinal disease in Phase II clinical trials.
    • Allergan invested in BAROnova, Inc.'s Series B financing to further advance the development of BAROnova's new technology designed to meet an unmet need in obesity intervention. BAROnova's non-surgical, non-pharmacologic TransPyloric Shuttle (TPS) weight-loss technology uses a revolutionary mechanical approach that helps the patient's stomach to fill up more quickly and to stay full longer, triggering the body's natural intake-reduction processes.
    • Allergan entered into an exclusive discovery and license agreement with Polyphor Ltd whereby Allergan obtained the rights to discover, develop and commercialize compounds for the treatment of eye diseases.
    • On October 29, 2008, Allergan announced that Allergan and Spectrum Pharmaceuticals, Inc. signed an exclusive collaboration for the development and commercialization of apaziquone, an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder cancer.
    • On December 26, 2008, Allergan announced FDA approval of LATISSETM (bimatoprost ophthalmic solution) 0.03%, a novel treatment for eyelash hypotrichosis or inadequate eyelashes. LATISSETM is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes.

     

    Following the end of the fourth quarter of 2008:

    • GlaxoSmithKline received approval of BOTOX® (botulinum toxin type A) for the treatment of glabellar lines in Japan. They plan to launch in the first quarter of 2009.

    Outlook

    For the full year of 2009, Allergan estimates:

    • Total product net sales between $4,100 million and $4,300 million.
      • Total specialty pharmaceuticals net sales between $3,395 million and $3,510 million.
      • Total medical devices net sales between $705 million and $790 million.
      • ALPHAGAN®Franchise product net sales between $350 million and $370 million.
      • LUMIGAN®Franchise product net sales between $410 million and $430 million.

    o       RESTASIS® product net sales between $490 million and $510 million.

    o       SANCTURA® Franchise product net sales at approximately $70 million.

    o       BOTOX® product net sales between $1,150 million and $1,190 million.

    o       LATISSETM product net sales between $30 million and $50 million.

    o       Breast aesthetics product net sales between $265 million and $290 million.

    o       Obesity intervention product net sales between $255 million and $285 million.

    o       Facial aesthetics product net sales between $185 million and $215 million.

    • Adjusted cost of sales to product net sales ratio between 17.0% and 17.5%.
    • Other revenue between $60 million and $70 million.
    • Adjusted selling, general and administrative expenses to product net sales ratio at approximately 39%.
    • Adjusted research and development expenses to product net sales ratio at approximately 17%.
    • Amortization of acquired intangible assets at approximately $20 million. This guidance excludes the amortization of acquired intangible assets associated with the Inamed, Cornéal, EndoArt and Esprit acquisitions.
    • Adjusted diluted earnings per share guidance between $2.69 and $2.75.
    • Diluted shares outstanding between approximately 304 million and 306 million.
    • Effective tax rate on adjusted earnings at approximately 29%.

     

    For the first quarter of 2009, Allergan estimates:

    • Total product net sales between $960 million and $1,000 million.
    • Adjusted diluted earnings per share guidance between $0.50 and $0.52.

     

    Historical adjusted diluted earnings per share and guidance amounts for adjusted diluted earnings per share, adjusted cost of sales, adjusted selling, general and administrative expenses, adjusted research and development expenses, and effective tax rate on adjusted earnings as well as net sales reported in constant currency are presented as non-GAAP financial measures.  A reconciliation of those measures to the most directly comparable GAAP financial measure is included in the financial tables of this press release. The reconciliation for the guidance amounts in the financial tables includes historical non-GAAP adjustments and an estimate of the future effect from amortization of acquired intangible assets and non-cash interest expense associated with amortization of convertible debt discount

     

    Forward-Looking Statements

    In this press release, the statements regarding product development, market potential, expected growth, anticipated product filings and approvals, the statements by Mr. Pyott as well as the outlook for the state of the economy, Allergan's earnings per share, product net sales, revenue forecasts, future investment allocations, restructuring benefits or outcomes and any other future performance, among other statements above, are forward-looking statements. Because forecasts are inherently estimates that cannot be made with precision, Allergan's performance at times differs materially from its estimates and targets, and Allergan often does not know what the actual results will be until after a quarter's end and year's end. Therefore, Allergan will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Allergan.

     

    Any other statements in this press release that refer to Allergan's expected, estimated or anticipated future results are forward-looking statements. All forward-looking statements in this press release reflect Allergan's current analysis of existing trends and information and represent Allergan's judgment only as of the date of this press release. Actual results may differ materially from current expectations based on a number of factors affecting Allergan's businesses, including, among other things, changing competitive, market and regulatory conditions; the timing and uncertainty of the results of both the research and development and regulatory processes; domestic and foreign health care and cost containment reforms, including government pricing and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of strategic initiatives; the results of any pending or future litigation, investigations or claims; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; and Allergan's ability to obtain and successfully maintain a sufficient supply of products to meet market

    demand in a timely manner. In addition, U.S. and international economic conditions, including higher unemployment, financial hardship, consumer confidence and debt levels, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions, as well as the general impact of the current economic crisis, can materially affect Allergan's results. Therefore, the reader is cautioned not to rely on these forward-looking statements. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.

    Additional information concerning the above-referenced risk factors and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2007 Form 10-K and Allergan's Form 10-Q for the quarter ended September 30, 2008. Copies of Allergan's press releases and additional information about Allergan is available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 714-246-4636.

    About Allergan, Inc.

    Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,500 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

    Allergan Contacts

    Jim Hindman (714) 246-4636 (investors)

    Joann Bradley (714) 246-4766 (investors)

    Emil Schultz (714) 246-4474 (investors)

    Caroline Van Hove (714) 246-5134 (media)

    ® and TM Marks owned by Allergan, Inc.

    Clinique is a registered trademark of Clinique Laboratories, LLC

     

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    Om Allergan Norden AB

    Global pharmaceutical company and leader in a new industry model - Growth Pharma

    Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

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