Allergan to Acquire Naurex

Similar documents
ARQULE AND DAIICHI-SANKYO ENTER INTO STRATEGIC R&D PARTNERSHIP TO PROGRESS NOVEL COMPOUNDS TO TARGET CANCER

Pfizer Completes Acquisition of Hospira

Sage Therapeutics, Inc. (Exact name of registrant as specified in its charter)

Momenta Pharmaceuticals Reports First Quarter 2017 Financial Results

Pfizer To Acquire Hospira

AVEO Oncology Reports Third Quarter 2016 Financial Results and Provides Business Update

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC FORM 8-K

-- Sarepta strengthens position as a leader in gene therapy; expands rare disease franchise --

Cortendo and Antisense Therapeutics Announce Licensing Agreement for ATL1103 for Acromegaly

10 November Evotec reports nine months results: Upside materialising

Agios Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Charter)

BioCryst Reports Fourth Quarter and Full Year 2017 Financial Results. Updates Investors Regarding Proposed Merger with Idera Pharmaceuticals, Inc.

ALLERGAN ENTERS STRATEGIC R&D ALLIANCE WITH EDITAS MEDICINE TO DISCOVER AND DEVELOP CRISPR GENE EDITING PROGRAMS FOR OCULAR DISEASES

BioXcel Therapeutics Reports Third Quarter 2018 Quarterly Results and Provides Business Update

Catabasis Pharmaceuticals Reports First Quarter 2018 Financial Results and Reviews Business Progress

PATHWAY TO VALUE CREATION NASDAQ: BNTC ASX: BLT

PATHWAY TO VALUE CREATION NASDAQ: BNTC ASX: BLT. For personal use only

Jefferies 2014 Global Healthcare Conference June 3, 2014 NYSE: Q

Vertex and Moderna Establish Exclusive Collaboration to Discover and Develop mrna Therapeutics for Cystic Fibrosis

14 May Evotec Q1 2013: Driving Innovation Efficiency

Melinta Therapeutics The Antibiotics Company

Mustang Bio Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights

Allergan, Inc. Product Pipeline Review 2015

ABLYNX ANNOUNCES Q BUSINESS UPDATE

A Next Generation Stem Cell Therapeutics Company. Investor Presentation: Cynata Therapeutics Limited

Nasdaq: MBRX. Moleculin Biotech, Inc. Reports Financial Results for the Third Quarter Ended September 30, 2017

Achillion Reports Third Quarter 2017 Financial Results and Provides Update on Clinical Programs

Media Release. Roche enters a broad strategic collaboration with Foundation Medicine in the field of molecular information in oncology

Fourth Quarter and Full Year Financial and Operational Results Conference Call March 21, 2018

Idorsia Company Profile

PARTNERING IN NEUROSCIENCE Sharing a Vision to Help Improve Patients Lives

Global Allied Pharmaceuticals, LLC. Innovation, Research, and Technology. Breaking the bounders, first in its class, thinking outside the box.

First Quarter 2018 Financial Results & Update

Teva Pharmaceutical Industries Ltd. J.P. Morgan Healthcare Conference. Kåre Schultz President and CEO January 7, 2019

March 13, Dear Shareholder:

Johan Christenson MD; PhD Partner Farmasidagene 2014 Oslo

Pain Therapeutics, Inc. Pain Therapeutics Announces Update on Drug Portfolio

KRISANI BIO SCIENCES PVT. LTD.

Sosei Business Update and Revised Financial Forecast Following Acquisition of Arakis

Swissmedic Accepts Santhera's Filing of SNT-MC17 in Friedreich's Ataxia

Moderna Therapeutics Announces Transition to a Clinical Stage Company, Provides Business Update and Outlines 2016 Strategic Priorities

Antisense Therapeutics Ltd ASX:ANP January 2017

First Quarter 2018 Financial Results. May 8, 2018

Second Quarter 2016 Financial Results. August 4, 2016

Loxo Oncology Announces Third Quarter 2016 Financial Results

LEVERAGING OUR BIOLOGICS EXPERTISE IN BIOSIMILARS SCOTT FORAKER VICE PRESIDENT AND GENERAL MANAGER, BIOSIMILARS

Prosensa announces commencement of redosing of drisapersen in North America in patients with Duchenne muscular dystrophy

Can-Fite Presentation January 2015

SYNTHETIC BIOLOGICS, INC.

Pfizer Supports The Global Fight Against Malaria And Commemorates World Malaria Day Counting Malaria Out

A full-service CRO with integrated early-stage capabilities

Acquisition of Vtesse Inc. Increased Focus on Orphan and Pediatric Diseases

uniqure Announces First Quarter 2018 Financial Results and Highlights Company Progress

(212) Cellectis Media Contact: Philippe Valachs +33(0)

Dealdoc. Marketing agreement for Recombinant Human Insulin, Glargine, Aspart and Lispro biosimilars (terminated) Pfizer Biocon.

Hill-Rom: Acquiring Mortara Instrument Complementary Combination Strengthens Clinical Focus on Diagnostic Cardiology and Patient Monitoring

ADVANCING SCIENTIFIC INNOVATION Together, the possibilities are endless.

Spark Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter)

Capital Raising Presentation January 2017

Good morning and thank you for joining us for our quarterly update.

Molecular Partners launches IPO on SIX Swiss Exchange

Oral NT-KO-003 for the Treatment of Multiple Sclerosis

Theranexus files its registration document as part of its planned Initial Public Offering (IPO) on the Euronext Growth market in Paris

J.P. Morgan Healthcare Conference. January 15, 2009

Aravive s Lead Drug Candidate - AVB-S6-500

About the Healthcare Strategic Analysis Team Geographic specific reports: Global issue reports: 1. About This Report Chapter structure Executive

Medivir Corporate Presentation December, A research-based pharmaceutical company focused on infectious diseases and oncology

Company Profile. German-Taiwan Biotech Seminar 6 November 2017

Chimerix Announces First Quarter 2017 Financial Results

J.P. Morgan Healthcare Conference

INITIATOR PHARMA: Q report

MEDICATION DELIVERY. David Ferguson GM, Medication Delivery. May 21, 2018

License Agreement of Tildrakizumab for Psoriasis in Europe

Move to significantly strengthen position in consumer care

ImmunoGen, Inc. Reports Fourth Quarter and Fiscal Year 2013 Financial Results and Provides Fiscal Year 2014 Financial Guidance and Corporate Update

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K

TOKYO, JAPAN AND SOUTH SAN FRANCISCO,

ProMetic Life Sciences Inc. Biotech Showcase San Francisco January, 2011

Genentech Contacts: Media: Tara Cooper (650) Investor: Kathee Littrell (650)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C FORM 8-K CURRENT REPORT

University of Connecticut Student Managed Fund 2018 Analyst Report. Jonathan Stryjek & Michael Pehota

CHINA S LIFE SCIENCE INDUSTRY 02-05/15

EXANE Conference. Jérôme Contamine, Executive Vice President, Chief Financial Officer. Paris June 13, 2017

CRO partner in Rx/CDx Co-Development

The Future of Consumer Health Care

ADDING VALUE TO A PRODUCT S LIFE CYCLE MANAGEMENT: Product Enhancement Through Drug Delivery Systems

Press Releases Boston Scientific to Acquire Vessix Vascular, Inc.

Intec. Pharma Unfolding drug delivery solutions. Investor Presentation. Nasdaq: NTEC. June 2017

Fresenius Investor News

UBS 2007 Global Life Sciences Conference. September 24, 2007

VISION & STRATEGY FIC LIC. Interview with the President

Discovery of a First-In-Class Topically Bioavailable Kit Inhibitor With Clinical Activity Using Computational Chemogenomics Technology

FORWARD LOOKING STATEMENTS

EVOTEC REPORTS FIRST QUARTER 2018 RESULTS AND PROVIDES CORPORATE UPDATE

Proof of Concept. Achieve your molecule s full potential

Corporate Presentation OCTOBER 2018

trial. Key trial data points:

company overview M A R C H

Trubion Investor Presentation BioCentury NewsMakers in the Biotech Industry Conference September 6, 2007

Agios Pharmaceuticals, Inc.

Transcription:

NEWS RELEASE CONTACTS: ALLERGAN: Investors: Lisa DeFrancesco (862) 261-7152 Media: Mark Marmur (862) 261-7558 NAUREX: Canale Communications Pam Lord pam@canalecomm.com 619-849-6003 Naurex Inc. Ashish Khanna VP, Corporate Development corporate@naurex.com (847) 871-0377 Allergan to Acquire Naurex Builds on Allergan s World-Class Position and Leadership Strategy in Mental Health Differentiated Therapies Utilizing Compelling New Mechanism Target Areas of Significant Unmet Medical Need in Major Depressive Disorder Two Lead Development Products Rapastinel (GLYX-13) and NRX-1074 Have Demonstrated Rapid and Robust Efficacy in Phase 2 Clinical Studies Naurex Preclinical Assets and Discovery Platform to Be Spun Out into New Company DUBLIN, IRELAND and EVANSTON, IL July 26, 2015 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Naurex Inc., a clinical-stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system, today announced that they have entered into a definitive agreement under which Allergan will acquire Naurex in an all-cash transaction. Under the terms of the agreement, Allergan will acquire Naurex for a $560 million upfront payment net of cash acquired, $460 million of which is payable upon the closing of the acquisition and $100 million of which is payable by January of 2016 (or upon the closing if the closing has not occurred by such time), as well as potential R&D success-based and sales-threshold milestone payments. The

Company remains committed to de-leveraging to below 3.5x debt-to-ebitda by the end of the first quarter of 2016. The acquisition will strengthen Allergan s long-term growth profile with the addition of Naurex s lead development product rapastinel (GLYX-13), a once-weekly intravenous Phase 3-ready molecule that has demonstrated rapid, robust and sustained efficacy in multiple Phase 2 clinical studies in depression. The acquisition will also add Naurex s development product NRX-1074, a next-generation drug candidate, the intravenous form of which has shown rapid and robust antidepressant efficacy in an initial single-dose Phase 2 study. NRX-1074 is also an orally bioavailable drug candidate which is in Phase 1 studies. Rapastinel and NRX-1074 are both targeted modulators of the N-methyl-D-aspartate (NMDA) receptor. Both therapies have been found to be well-tolerated in all studies to date, with no drug-related serious adverse events or any of the dissociative side effects typically seen with NMDA antagonists. The acquisition of Naurex is a great fit for Allergan and a compelling and exciting investment. We expect Naurex will build on our strategy to lead in this important therapeutic area, said Brent Saunders, CEO and President of Allergan. Naurex s unique pipeline comprises compounds that utilize a new mechanism to target areas of significant unmet medical need in Major Depressive Disorder (MDD), including severe and/or treatment-resistant depression. These highly differentiated compounds will immediately bolster our exceptional mental health pipeline. Our team at Naurex has been successful in bringing these two highly innovative treatments for depression through proof-of-concept clinical trials, said Norbert Riedel, Ph.D., President and CEO of Naurex. We recognized that Allergan s deep commitment and experience in mental health position them particularly well to progress these programs through further clinical development and into commercialization. This transaction also enables us to leverage our proven team and technology to continue innovating in this space through the spin-out of Naurex s platform and initiation of a research collaboration with Allergan, a credible and committed partner in the field. Naurex s Unique Drug Discovery Platform Naurex has built a platform for discovering drugs that enhance synaptic plasticity, or strengthen the network for neural cell communication. Molecules discovered by Naurex achieve this through a novel mechanism that modulates the NMDA receptor rather than shutting it down resulting in drugs that are both highly effective and well-tolerated. Naurex s discovery platform has yielded a rich pipeline of NMDA receptor modulators, including subtype-selective

molecules, with the potential to treat a broad set of psychiatric and neurologic disorders. Immediately prior to the closing of the acquisition, Naurex will spin-out this discovery platform into a new company. Allergan and this new company will enter into a research collaboration focused on the discovery and early development of innovative small molecule NMDA receptor modulators for the treatment of certain psychiatric and neurologic disorders. Allergan will receive first right to in-license a defined number of drug candidates resulting from the collaboration for certain indications. Further details on the new company will be shared at a later date. Rapastinel and NRX-1074 offer the potential for faster onset of action, equal or greater efficacy and a more favorable safety and tolerability profile than traditional anti-depressants, said David Nicholson, EVP and President of Global Brands Research and Development for Allergan. If approved, they will provide a significant and complementary addition to our worldclass CNS and mental health portfolio. Our ongoing research collaboration will also position us to continue to leverage Naurex s innovative drug discovery platform to drive further long-term value and provide patients with needed treatment options in this important therapeutic area. The transaction is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Pending approvals, Allergan anticipates closing the transaction by the end of 2015. Additional information about Naurex, rapastinel and NRX-1074, as well as the unmet medical need in the treatment of MDD is available as a slide presentation on the Allergan web site at http://ir.allergan.com. About Rapastinel (GLYX-13) Rapastinel (GLYX-13) is a novel NMDA receptor modulator being developed as an adjunctive treatment for difficult-to-treat major depressive disorder. Unlike most currently approved antidepressants, which act on serotonin and related neurotransmitter pathways in the brain, rapastinel works through an entirely different mechanism, mobilizing glutamate pathways to enhance synaptic plasticity and improve the communication between neuronal cells. In Phase 2b clinical trial results presented at the Annual Meeting of the American College of Neuropsychopharmacology last year, it was demonstrated that repeat-dose adjunctive treatment with rapastinel resulted in robust and sustained antidepressant effects in subjects with inadequate responses to their current antidepressants. Rapastinel was well-tolerated with no drug-related serious adverse events reported, including no sign of the psychotomimetic, or

psychosis-like, effects associated with NMDA receptor antagonists such as ketamine. These data confirmed the efficacy and safety results from an earlier Phase 2 single-dose study of rapastinel, which also documented the drug s rapid onset of antidepressant activity in as little as two hours. Naurex has completed an end-of-phase 2 meeting with the U.S. Food and Drug Administration and the Phase 3 program is expected to begin in 2016. About Major Depressive Disorder (MDD) MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7% of the adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a person's ability to function. Depression costs the U.S. an estimated $83 billion each year. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020. About Allergan Allergan plc (NYSE: 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, highquality 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. About Naurex Naurex is a clinical-stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system. The company has built a platform for discovering drugs that enhance synaptic plasticity, or strengthen the network for neural cell communication. Molecules discovered by Naurex achieve this through a novel mechanism that modulates the NMDA receptor rather than shutting it down resulting in drugs that are both highly effective and well-tolerated. Naurex s lead molecule, rapastinel (GLYX-13), is Phase 3- ready, having demonstrated rapid, robust and sustained efficacy in multiple Phase 2 clinical studies in depression, an area of high unmet need that has seen little innovation in decades. NRX-1074, a next-generation, intravenous drug candidate, has also shown rapid and robust antidepressant efficacy in Phase 2 studies. NRX-1074 is also an orally bioavailable drug

candidate in Phase 1 studies. Naurex s platform has yielded a rich pipeline of NMDA receptor modulators, including subtype-selective molecules, with the potential to treat a broad set of psychiatric and neurologic disorders. Major investors in Naurex include Adams Street Partners, LVP Life Science Ventures, Baxter Ventures and Baxalta Ventures, Savitr Capital, Genesys Capital, H. Lundbeck A/S, PathoCapital Group, Takeda Ventures, Druid BioVentures, Shire LLC, Longboat Ventures, Goudy Park Capital, EcoR1 Capital, Sabby Capital, Northwestern University, Cowen Investments and Portola Capital Partners. 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, whether clinical trials of rapastinel or NRX-1074 will be successful, 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, 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 March 31, 2015 (such periodic public filings having been filed under the Actavis plc name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.