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Abbvie Allergan Acquisition
Creating a New Diversified Biopharmaceutical Company The Combination of AbbVie and Allergan Investor Presentation June 25, 2019 NO OFFER OR SOLICITATION This presentation is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this presentation is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. Any securities issued in the acquisition are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act of 1933, as amended. The acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer document), which will contain the full terms and conditions of the acquisition, including details with respect to the AbbVie shareholder vote in respect of the acquisition. Any decision in respect of, or other response to, the acquisition, should be made only on the basis of the information contained in the Scheme Document. IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC In connection with the proposed Acquisition, Allergan will file with the Securities Exchange Commission (the “SEC”) a Proxy Statement, which will include the Scheme Document. -
J. SCOTT MCBRIDE PARTNER ━ 54 West Hubbard Street, Chicago, IL 60654 | 312.494.4436 | [email protected]
J. SCOTT MCBRIDE PARTNER ━ 54 West Hubbard Street, Chicago, IL 60654 | 312.494.4436 | [email protected] EDUCATION & HONORS The University of Chicago Law School, 2002, J.D., with High Honors Order of the Coif 1st Place, Hinton Moot Court The University of Chicago Law Review Northwestern University, 1994, M.S. Ed., Earned Illinois Secondary Teaching Certificate for Chemistry, Physics and German Dartmouth College, 1992, A.B., summa cum laude, High Honors in Chemistry Phi Beta Kappa Rufus Choate Scholar German Academic Exchange Service Scholarship Chandler T. White Chemistry Research Prize CLERKSHIPS Honorable Richard D. Cudahy, United States Court of Appeals for the Seventh Circuit, 2002-2003 ADMISSIONS Illinois INTELLECTUAL PROPERTY LITIGATION ViiV Healthcare v. Gilead Sciences (D. Del.) Lead trial counsel for Gilead in patent infringement case related to Gilead's Biktarvy® HIV treatment. Case pending. www.bartlit-beck.com CHICAGO 312.494.4400 DENVER 303.592.3100 J. SCOTT MCBRIDE Adverio Pharma GmbH v. Alembic Pharmaceuticals, Ltd. et al. (D. Del.) Lead trial counsel for Adverio and Bayer in Hatch-Waxman litigation relating to Bayer's Adempas® (riociguat) treatment for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Gilead Sciences v. Mylan Pharmaceuticals (D. Del.) Lead trial counsel for Gilead in Hatch-Waxman litigation relating to Gilead's Tybost® (cobicistat) product. Case settled favorably. UroPep v. Eli Lilly (E.D. Tex.) Lead trial counsel (with my partners John Hughes) for UroPep in patent infringement action related to Lilly's Cialis product. Trial verdict for UroPep with damages of $20 million; affirmed on appeal. Regents of the Univ. -
Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials
02-DIJ42(4) 2348.qxd 6/9/08 1:46 PM Page 303 STATISTICS 303 Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials Craig H. Mallinckrodt, PhD Research Advisor, Lilly This position paper summarizes relevant theo- simple methods in favor of joint analysis of Research Laboratories, Eli ry and current practice regarding the analysis data from all time points based on a multivari- Lilly and Company, of longitudinal clinical trials intended to sup- ate model (eg, of a mixed-effects type). One Indianapolis, Indiana port regulatory approval of medicinal prod- such newer method, a likelihood-based mixed- Peter W. Lane, MA, CStat ucts, and it reviews published research regard- effects model repeated measures (MMRM) ap- Director of Consultancy and Training, Research Statistics ing methods for handling missing data. It is proach, has received considerable attention in Unit, GlaxoSmithKline, one strand of the PhRMA initiative to improve the clinical trials literature. We discuss specif- Harlow, United Kingdom efficiency of late-stage clinical research and ic concerns raised by regulatory agencies with Dan Schnell, PhD gives recommendations from a cross-industry regard to MMRM and review published evi- Section Head, Pharmaceutical Statistics, team. We concentrate specifically on continu- dence comparing LOCF and MMRM in terms Procter & Gamble ous response measures analyzed using a linear of validity, bias, power, and type I error. Our Pharmaceuticals, model, when the goal is to estimate and test main conclusion is that the mixed model ap- Mason, Ohio treatment differences at a given time point. proach is more efficient and reliable as a Yahong Peng, PhD Traditionally, the primary analysis of such tri- method of primary analysis, and should be Senior Biometrician, Clinical Biostatistics, Merck als handled missing data by simple imputation preferred to the inherently biased and statisti- Research Lab, Upper using the last, or baseline, observation carried cally invalid simple imputation approaches. -
Faculty Disclosure
Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences, -
Manufacturers and Wholesalers Street
Nevada AB128 Code of Conduct Compliant Companies Manufacturers and Wholesalers Street City ST Zip 10 Edison Street LLC 13 Edison Street LLC Abbott Diabetes Care Division Abbott Diagnostic Division Abbott Electrophysiology (including Kalila Medical 2- 2016)) Abbott Laboratories 100 Abbott Park Road, Dept. EC10, Bldg. APGA-2 Abbott Park IL 60064 Abbott Medical Optics Abbott Molecular Division Abbott Nutrition Products Division Abbott Vascular Division (includes Tendyne 9-2015) AbbVie, Inc. 1 N. Waukegan Road North Chicago IL 60064 Acadia Phamaceuticals 3611 Valley Centre Drive, Suite 300 San Diego CA 92130 Accelero Health Partners, LLC Acclarent, Inc. 1525-B O'Brien Dr. Menlo Park CA 94025 Accuri Cyometers, Inc. Ace Surgical Supply, Inc. 1034 Pearl St. Brockton MA 02301 Acorda Therapeutics, Inc. 420 Sawmill River Road Ardsley NY 10532 AcriVet, Inc. Actavis W.C. Holding, Inc. Morris Corporate Center III, 400 Interpace Parkway Parsippany NJ 07054 Actavis , Inc. Actelion Pharmaceuticals US, Inc. 5000 Shoreline Court, Suite 200 S. San Francisco CA 94080 Activis 400 Interpace parkway Parsippany NJ 07054 A-Dec, Inc. 2601 Crestview Dr. Newberg OR 97132 Advanced Respiratory, Inc. Advanced Sterilization Products 33 Technology Drive Irvine CA 92618 Advanced Vision Research, Inc., dba Akorn Consumer Health Aegerion Pharmaceuticals, Inc. 101 Main Street, Suite 1850 Cambridge MA 02142 Aesculap Implant Systems, Inc. Aesculap, Inc. 3773 Corporate Parkway Center Valley PA 18034 Aesthera Corporation Afaxys, Inc. PO Box 20158 Charleston SC 29413 AGMS, Inc. Akorn (New Jersey) Inc. Page 1 of 23 Pages 2/15/2017 Nevada AB128 Code of Conduct Compliant Companies Akorn AG (formerly Excelvision AG) Akorn Animal Health, Inc. -
Endo Pharmaceuticals Inc. V. Actavis
United States Court of Appeals for the Federal Circuit ______________________ ENDO PHARMACEUTICALS INC., MALLINCKRODT LLC, Plaintiffs-Appellees v. ACTAVIS LLC, FKA ACTAVIS INC., ACTAVIS SOUTH ATLANTIC LLC, TEVA PHARMACEUTICALS USA, INC., Defendants-Appellants ______________________ 2018-1054 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:14-cv-01381-RGA, Judge Richard G. Andrews. ______________________ Decided: May 3, 2019 ______________________ MARTIN JAY BLACK, Dechert LLP, Philadelphia, PA, ar- gued for plaintiffs-appellees. Also represented by SHARON K. GAGLIARDI; BLAKE GREENE, Austin, TX; JONATHAN LOEB, Mountain View, CA; ROBERT RHOAD, Princeton, NJ. JEFFREY J. TONEY, Kasowitz, Benson, Torres & Fried- man LLP, Atlanta, GA, for plaintiff-appellee Mallinckrodt LLC. Also represented by RODNEY R. MILLER, PAUL GUNTER WILLIAMS. 2 ENDO PHARM. INC. v. ACTAVIS LLC JOHN C. O'QUINN, Kirkland & Ellis LLP, Washington, DC, argued for defendants-appellants. Also represented by WILLIAM H. BURGESS; CHARLES A. WEISS, ERIC H. YECIES, Holland & Knight, LLP, New York, NY. ______________________ Before WALLACH, CLEVENGER, and STOLL, Circuit Judges. Opinion for the court filed by Circuit Judge WALLACH. Dissenting opinion filed by Circuit Judge STOLL. WALLACH, Circuit Judge. Appellees Endo Pharmaceuticals Inc. (“Endo Pharma- ceuticals”) and Mallinckrodt LLC (“Mallinckrodt”) (collec- tively, “Endo”) sued Appellants Actavis LLC, Actavis South Atlantic LLC, and Teva Pharmaceuticals USA, Inc. (collec- tively, “Actavis”) in the U.S. District Court for the District of Delaware (“District Court”), alleging that two Abbrevi- ated New Drug Applications filed by Actavis infringed claims 1–6 (“the Asserted Claims”) of Mallinckrodt’s U.S. Patent No. 8,871,779 (“the ’779 patent”), which Endo Phar- maceuticals licenses. -
The Covid–19 Pandemic and Haemoglobin Disorders
THE COVID–19 PANDEMIC AND HAEMOGLOBIN DISORDERS VACCINATIONS & THERAPEUTIC DRUGS An Informational Guide from the Thalassaemia International Federation (TIF) Prepared by: Dr Androulla Eleftheriou, Executive Director, TIF Last Updated: 12 May 2020 VACCINATIONS & THERAPEUTIC DRUGS Introduction It is important to note that there are currently no FDA1 or EMA2-approved or even recommended agents for the treatment of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) declared as pandemic on Wednesday 11th of March 2020. Any agent being used at this time is being administered in an experimental setting under controlled conditions. Thalassaemia International Federation (TIF) has made an effort to compile a list of studies/clinical trials for treatment and vaccines, which is by no means exhaustive as this situation is extremely labile and research in this area is dramatically intensified. New information is anticipated to be added to this guide which is prepared exclusively for TIF’s global thalassemia community. The viral genome was mapped very soon as rom early January 2020 and shared globally. In February 2020, the WHO published an overview of the potential therapeutic candidates for the treatment of COVID-19. The document outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of patients infected with the virus. Thirty-eight of these candidates are in the preclinical state with minimal information available on their proposed mechanism, uses, doses routes, or planned trials. Sixteen of the remaining regimens contain an interferon-based product. The rest include a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics. The Director-General of the WHO, Mr Tedros Adhanom, stated on the 10th of April 2020, that more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and 20 Institutions and companies ‘are racing to develop a vaccine’. -
1976 3M Medical Solutions Division 2019 Electrocore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc
CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2019 electroCore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc. 2010 Endo Pharmaceuticals 2018 Organogenesis 2013 AbbVie Inc. 2017 Exelixis 2004 Otsuka America Pharmaceutical, Inc. 2021 Adaptive Biotechnologies 2016 Express Scripts Federal Pharmacy 2018 Pacira BioSciences, Inc. 2017 ACADIA Pharmaceuticals, Inc. 2010 Federal Practitioner 2018 Paratek Pharmaceuticals 2020 AcelRx Pharmaceuticals, Inc. 2018 Foundation Medicine, Inc. 1990 Pfizer Pharmaceuticals 2020 Acorda Therapeutics 2021 Frontier Technology Inc. (FTI) 2017 Pharmacyclics, LLC 2019 Aimmune 2020 Fresenius Medical Care North America 2020 RedHill BioPharma 2003 Alcon Laboratories, Inc. 1989 Genentech Inc. 2019 Red One Medical 2019 Alexion Pharmaceuticals, Inc. 2006 Gilead Sciences 2020 Regeneron 2017 Alkermes, Inc. 1983 GLAXOSMITHKLINE 2009 Regenesis Biomedical, Inc. 2019 Alnylam Pharmaceuticals 2013 Golden State Medical Supply, Inc. 2011 Remund Group, LLC 2019 Altarum Institute 2020 GRAIL 2018 Rigel Pharmaceuticals 2020 Amarin Corporation 2019 Greenwich Biosciences 2000 Sanofi 1994 AmerisourceBergen 2013 Gulf Coast Pharmaceuticals Plus, LLC 2020 Seattle Genetics 1992 Amgen 2008 Heritage Health Solutions, Inc. 2004 Siemens Medical Solutions 2020 Amneal Pharmaceutical 2017 Hill-Rom Company 2019 SK Life Science, Inc. 2019 Aptive Resources LLC 2020 Immunomedics 2002 Smith & Nephew, Inc. 2020 The Arbinger Institute 2019 ImmunoVation, LLC 2019 Sobi Inc. 2011 Arbor Pharmaceuticals, LLC 2019 Incyte Corporation 2013 Stryker Orthopaedics 2010 Argentum Medical, LLC 2019 Indivior 2018 Sun Pharmaceutical 2019 ASM Research, LLC 2015 Intercept Pharmaceuticals 1999 Sunovion Pharmaceuticals, Inc. 1986 Astellas Pharma US, Inc. 2019 Ipsen Biopharmaceuticals, Inc. 2016 Taiho Oncology, Inc. 1995 AstraZeneca 2018 IT Cadre 2015 Takeda Oncology 2020 Baudax Bio, Inc. -
COVID-19 Pharmacotherapy MATTHEW F
COVID-19 Pharmacotherapy MATTHEW F. DERAEDT, PHARM.D., B.C.P.S. ANMC EMERGENCY DEPARTMENT PHARMACIST LT, USPHS Disclosure •No conflicts of interest to disclose •Recommendations to follow primarily from Alaska Native Medical Center’s Policy and Procedures •Clinical questions regarding specific patients should be deferred to ANMC Infectious Disease Department •Rapidly evolving FDA EUA and approved indications Objectives •Understanding inclusion and exclusion criteria for COVID-19 pharmacotherapies •Mechanism of action (MOA), pharmacokinetics, and pharmacodynamics for various therapies •Monitoring parameters for pharmacotherapies •Regulatory requirements for emergency use authorization therapies Remdesivir (Veklury®) •Adenosine nucleotide analog prodrug that is metabolized intracellularly to a nucleoside monophosphate intermediate •The nucleoside monophosphate is phosphorylated to active compound nucleoside triphosphate metabolite •The remdesivir- triphosphate (RDV TP) competes with ATP for incorporation into nascent RNA chains by SARS-CoV-2 RNA Dependent RNA Polymerase (RdRp) •Inhibits RNA chain termination Adamsick ML, et al. JASN. 2020:31(7):1384 - 1386 Remdesivir [package insert]. Foster City, CA. Gilead Sciences Inc. 2020. Road To Approval •FDA released on Emergency Use Authorization (EUA) May 1, 2020 •FDA approval on October 22, 2020 for adult patients and pediatric patients 12 years of age or older weighing at least 88 lbs (40kg) for the treatment of hospitalized COVID-19 patients •No longer need to follow EUA requirements for the approved patient population •Three Clinical Trials 1. NIAID ACTT-1: Mild/moderate and Severe COVID-19 2. GS-US-540-5774: Moderate COVID-19 3. GS-US-540-5773: Severe COVID-19 Remdesivir [package insert]. Foster City, CA. Gilead Sciences Inc. 2020. Spinner CD, et al. -
Amgen Inc. V. Sanofi, No
No. IN THE Supreme Court of the United States ———— AMGEN INC., AMGEN MANUFACTURING LIMITED, AND AMGEN USA, INC., Petitioners, v. SANOFI, AVENTISUB LLC, REGENERON PHARMACEUTICALS INC., AND SANOFI-AVENTIS U.S., LLC, Respondents. ———— On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit ———— PETITION FOR A WRIT OF CERTIORARI ———— STUART L. WATT JEFFREY A. LAMKEN WENDY A. WHITEFORD Counsel of Record ERICA S. OLSON MICHAEL G. PATTILLO, JR. EMILY C. JOHNSON SARAH J. NEWMAN AMGEN INC. MOLOLAMKEN LLP One Amgen Center Drive The Watergate, Suite 660 Thousand Oaks, CA 91320 600 New Hampshire Ave., NW (805) 447-1000 Washington, D.C. 20037 (202) 556-2000 [email protected] Counsel for Petitioners :,/621(3(635,17,1*&2,1&± ±:$6+,1*721'& QUESTION PRESENTED The 1952 Patent Act requires patents to “contain a written description of the invention, and of the manner and process of making and using it.” 35 U.S.C. §112(a). The “written description” must be “in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” Ibid. “The object of the statute is to require the patentee to describe his invention so that others may construct and use it after the expiration of the patent.” Schriber-Schroth Co. v. Cleveland Tr. Co., 305 U.S. 47, 57 (1938). The Federal Circuit has construed §112(a) as impos- ing separate “written description” and “enablement” re- quirements subject to different standards. -
Sample of Current Attendees
SAMPLE OF CURRENT ATTENDEES TITLE COMPANY Sr Mgr Global Meetings Mgmt Amgen Prin Tradeshow Spec Boston Scientific Events Mgr PR Medical Events Sr Buyer Pharma Ops ITA Group Travel Services Supv Grifols Asia Pacific Pte Ltd Compliance Specialist GCO Spend Jouney Lead Global Mtgs Travel Events UCB Category Project Specialist Roche Events & Travel Mgr Teva Brasil Mgr Event Mgmt Bayer Congress Mgr MediCongress Services Global Events Mgmt Sr Assoc Amgen Assoc Dir Congresses & Events MSD Internal Event Mgr Gilead Sourcing Mgr BMS Dir Sourcing Meeting Alliance Custoerm Srvs Meetings Mgr Eli Lilly & Company Sr Congress Mgr Novartis Pharmaceuticals Sourcing Mgr BCD Meetings & Events Sr Buyer Meetings & Incentives Worldwide Sourcing Mgr American Express GBT Acct Mgr Venue Sourcing Ashfield Meetings & Events Mtg Planner AbbVie Sr Sourcing Mgr CWT Dir Sourcing Planning Partners International Meetings Mgr ACOG Meeting Mgr Pfizer Canada Global Event Lead Astellas Meeting & Events Sanofi Events Specialist Cook Medical Meetings & Events Mgr Pfizer Spain Pfizer Spain Sr Mgr Hotel Procurement Meetings & Incentives WorldWide Inc Event Planner SFU BCcampus Mgr Global Strategic Mtg Mgmt Teva Pharmaceuticals Global Mtgs & Events Virtual Mtgs Specialist AstraZeneca Global Congress Strategy Lead MSD Assoc Dir Congresses & Events Alnylam Pharmaceuticals Event Planner AbbVie Institutional & Scientific Events Coordr Almirall Congress Mgr AO Spine Sr Meeting Planner Medtronic Mgr Global Mtgs Mgmt Alnylam Pharmaceuticals Meeting Planner AbbVie Global Audit Meetings -
View State-Of-The-Art Clinical Symposium Disclosures
Planning Committee Members The following Planning Committee members have no relevant financial relationship(s) with ineligible companies to disclose. Mastering E/M Changes for 2021 • Antanya Chung-Gardiner, BSc • Melesia Tillman 2021 Access in Rheumatology Planning Committee • Marcus Snow, MD 2021 Fellow-in-Training Educational Session Planning Committee • Nadia Elias, MD • Tate Johnson, MD • Justin Levinson, MD, MBA • Jean Lin, MD, PhD • Megan Lockwood, MD • Tyler Reese, MD • Zahra Rehman, MD • Didem Saygin, MD • Rachel Wallwork, MD 2021 State-of-the-Art Clinical Symposium Planning Committee • Sobia Hassan, MD • Aman Kugasia, MD • Jeanie Lee, MD • Manjari Malkani, MD • Rebecca Manno, MD, MHS The following Planning Committee members have relevant financial relationship(s) with ineligible companies to disclose. 2021 Access in Rheumatology Planning Committee • Christopher Phillips, MD - Pfizer (Self): 5 2021 Fellow-in-Training Educational Session Planning Committee • Mary Mamut, DO - Bendcare (Self): 8 2021 State-of-the-Art Clinical Symposium Planning Committee • Rohit Aggarwal, MD, MS - AbbVie, Amgen, , Genzyme, , Novartis, Roche, Sandoz, UCB (Self): 1, 5, 2; AdMIRx, Inc. / Now Q-32 (Self): 5, 2; Alexion (Self): 5; Argenx (Self): 5; AstraZeneca (Self): 5; Boehringer Ingelheim (BI) (Self): 5; Bristol-Myers Squibb(BMS) (Self): 5, 2; Corbus (Self): 5; CSL Behring (Self): 1, 5; EMD Serono (Self): 5, 2; Genentech (Self): 2; Janssen (Self): 5; Kezar (Self): 5; Kyverna (Self): 5; Mallinckrodt (Self): 1, 2; Octapharma (Self): 1, 5; Orphazyme (Self): 1; Pfizer (Self): 5, 2; Scipher Medicine: 5 • Narender Annapureddy, MD, MS - Medpage (Self): 1, Expert Reviewers for the ACR Reading Room section of MedPage Today. • Lianne Gensler, MD - AbbVie (Self): 1, 5; Eli Lilly (Self): 5; Gilead: 5; GSK (Self): 5; Janssen (Self): 5; Novartis (Self): 5; Pfizer (Self): 5, 2; UCB: 5 Faculty The following Faculty members have no relevant financial relationship(s) with ineligible companies to disclose.