Allergan Outlines Open Science Model And Highlights Key Development Programs At R&D Day

DUBLIN, Nov. 4, 2015 /PRNewswire/ -- Allergan plc AGN, a leading global pharmaceutical company, today hosted its R&D day where the Company outlined its "Open Science" R&D model that is helping to build therapy area leadership and drive the Company's long-term growth. The meeting also featured highlights and upcoming milestones for game-changing late-stage pipeline development programs from across Allergan's leading therapeutic categories.

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"Over the past 15 years, the pharmaceutical innovation ecosystem has shifted. Where global pharma companies had previously driven the lion's share of new product revenue, now the driving source of innovation is coming from smaller biotechnology and specialty pharma companies, as well as academia. Open Science defines our position in this new ecosystem – as a magnet for game-changing ideas and innovation. We bring these programs into our best-in-class product development and commercialization platform to build a sustainable R&D portfolio that enables Allergan to continue to be a leader in Growth Pharma," said Brent Saunders, President and CEO of Allergan. "Through our Open Science model, we seek to continue to drive strong R&D productivity by delivering innovative therapies that create long-term shared value for Allergan, for customers and for patients."

The Company's R&D pipeline has delivered strong productivity within the last year, with 58 significant pharma and device submissions and approvals in the U.S. and internationally.  Through its Open Science strategy, the Company has also added multiple late-stage product opportunities from the innovation ecosystem, including from the recent acquisitions of Kythera, Naurex, Oculeve and AqueSys and a licensing agreement with Merck to acquire the rights to its oral CGRP compounds.

Allergan R&D Pipeline Highlights

At its R&D Day in Irvine, California Allergan provided an overview of the Company's overall pipeline and highlighted key late-stage development programs across each of its seven therapeutic categories.

Gastroenterology: Building on IBS Leadership and Addressing Unmet Needs

• 5 mid-to-late stage Gastroenterology (GI) development programs
• VIBERZI™ receives Drug Enforcement Agency (DEA) schedule IV recommendation
• Phase 2b study of Relamorelin for diabetic gastroparesis currently enrolling; top-line data expected Q2 2016

CNS: Focused Development in Undertreated Areas of Mental Health

• 9 mid-to-late stage CNS development programs
• Ubrogepant Phase 2 study showed achievement of acute pain relief and migraine freedom at two hours, and a favorable adverse event profile; Phase 3 study planned.
• Rapastinel demonstrated rapid response and sustained effect after a single-dose in Phase 2a study in Major Depressive Disorder; Phase 3 ready compound
• VRAYLAR™ (cariprazine) being investigated for treatment of bipolar depression and as adjunctive MDD therapy in adults.

Women's Health & Urology: Expanding Therapeutic Area Scope

• 8 mid-to-late stage Women's Health, Urology development programs
• Two pivotal studies for Esmya in uterine fibroids ongoing in U.S.; Allergan expects NDA submission in 2017
• SER-120 Phase 3 studies for nocturia completed; Allergan expects NDA  submission in 2016

Anti-Infectives: Meeting the Critical Need for Innovation in Antibiotic Resistance

• 5 mid-to-late stage Anti-Infective development programs
• AVYCAZ® Phase 3 studies completed; Allergan expects to file sNDA for complicated intra-abdominal infections (cIAI) by end of 2015; sNDA for complicated urinary tract infections (cUTI)TI in Q3 2016
• DALVANCE® Phase 3 study shows safety and efficacy of single-dose regimen compared to two-dose regimen in adults with acute bacterial skin and skin structure infections (ABSSSI); Data submitted to FDA and EMA to support single-dose indication for ABSSSI.

Medical Aesthetics & Dermatology: Leveraging Industry Leading Aesthetic Position to Drive Innovation

• 21 mid-to-late stage Medical Aesthetics and Dermatology development programs
• Allergan studying KYBELLA® as a potential treatment for additional medical and aesthetic conditions, including the reduction of discrete, localized subcutaneous fat, and potential extension into therapeutic applications.
• KYTH-105 for hair growth IND filed with FDA earlier this year; Allergan planning Phase 2 proof of concept study
• Bimatoprost for hair growth shows favorable safety profile in proof-of-concept study; Allergan planning Phase 1 pharmacokinetic and Phase 2b studies planned for Q1 2016
• AGN-199201 (Oxymetazoline) Phase 3 study in rosacea completed; NDA submission expected in Q1 2016  
• Sarecycline currently in Phase 3 study; potential treatment for acne vulgaris
• Aczone® 7.5% NDA submitted in 2015; approval anticipated in 2016

Neuromodulators: Building on a World-Class Pipeline in a Product

• 12 new Botox® indications in development; an additional 6 potential indications under consideration
• 3 new Neuromodulator toxins in development
• Botox® Cosmetic indications in development include forehead lines (FHL), Glabellar Lines (GL), Crow's Feet Lines (CFL)
• Therapeutic indications for Botox in development includes Juvenile Cerebral Palsy
• Potential indications include atrial fibrillation, platysma

Eye Care: Owning the Eye Through Continued Innovation

• 17 mid-to-late stage eye care development programs
• Restasis® Multi-Dose Preservative-Free (MDPF) U.S. Prior Approval Supplement submitted in 2015; awaiting approval and launch
• Oculeve, first dry eye ophthalmic electroceutical; pivotal trials on track
• Bimatoprost SR Phase 2 study for glaucoma completed; results to be presented at American Academy of Opthalmology (AAO) Meeting November 15, 2015
• Ozurdex® Protocol I study in diabetic macular edema (DME) to be presented at AAO
• DARPin® initial topline results from 50998-004 PALM study supports 12 weeks duration of treatment with safety comparable to AMD studies, two Phase 3 studies in AMD initiated in Q2 2015, with recruitment in progress.

Allergan Builds on Open Science with Acquisition of Earfold, License Agreement for Mimetogen's Tavilermide

Earlier today, Allergan announced two business development deals that continue to build on its leadership in key therapeutic areas, and underscores its Open Science model.

In aesthetics, Allergan announced that it has entered into an agreement under which the Company will acquire Northwood Medical Innovation Ltd, developer of innovative implant technology, earFold™. earFold™ is a medical device for the correction of prominent ears, with or without asymmetry, in patients aged 7 years and older. earFold™ received a CE mark in April 2015, and has been made available by Northwood Medical Innovation Ltd to trained and accredited plastic surgeons, otolaryngologists (Ear, Nose and Throat) and maxillo-facial surgeons, primarily in the UK.

In eye care, the Company also announced a licensing agreement with  Mimetogen, a clinical stage biotechnology company, to develop and commercialize tavilermide (MIM-D3), a topical formulation of a novel small molecule TrkA agonist for the treatment of dry eye disease. Tavilermide is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye responsible for the maintenance of corneal nerves and epithelium. Tavilermide is differentiated from other investigational therapies in dry eye disease because it induces the production of mucin, a naturally occurring component of the tear film, and works upstream prior to inflammation.

Allergan R&D Day Webcast Details
Allergan plc will host its R&D Day today in Irvine to provide an overview of the Company's research and development strategy and updates on its key pipeline programs. The meeting will begin today at 11:00 a.m. EST and will be webcast simultaneously.

In-person attendance at the meeting is by invitation only. The webcast will be available live to investors and the media on Allergan's Web site or at the following link: https://www.webcaster4.com/Webcast/Page/618/10953/. To access the webcast replay, go to Allergan's Investor Relations Web site at http://ir.allergan.com.

Additional information about Allergan's Open Science Model and R&D pipeline can be found via the following link: http://www.multivu.com/players/English/7671931-allergan-r-d-day/

About Allergan
Allergan plc AGN, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

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.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; risks associated with acquisitions, divestitures, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

 

 

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SOURCE Allergan plc