DOCSLIB.ORG

2019 Annual Report on Form 10-K

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2019 Annual Report on Form 10-K 2 0 1 9 A n n u a l R e p o r t o n AbbVie F o r m 1 0 - K 2 0 2 0 . N Here Now o t i c e o f A n n u a l M e e t i n g & P r o x y S t a t e m e n t 2019 Annual Report on Form 10-K 2020 Notice of AbbVie 1 North Waukegan Road, North Chicago, IL 60064 U.S.A. Annual Meeting Copyright© 2020 AbbVie. All rights reserved. abbvie.com & Proxy Statement 3033_Cover.indd 1 3/18/20 6:36 PM AbbVie’s Commitment to Corporate Responsibility Stockholder Information We strive to make a remarkable impact on patients and drive sustainable growth by discovering and AbbVie Inc. Corporate Headquarters delivering a consistent stream of innovative medicines that address serious health problems. 1 North Waukegan Road North Chicago, IL 60064 IIn accordance wiitth our Priinciiplles:: 847.932.7900 abbvie.com Transforming lives Embracing diversity and inclusion Acting with integrity Serving the community Investor Relations Driving innovation Dept. ZZ05, AP34 Our Corporate Responsibility priorities are: Corporate Secretary Dept. V364, AP34 Using our expertise to Stewarding our ethical and Supporting long-term Stock Listing improve health sustainable business community strength The ticker for AbbVie’s common stock Creating real health improvement is We recognize that health is of The health of our business is is ABBV. The principal market for our mission and the premise of our fundamental importance to all people. intertwined with that of our communities. AbbVie common stock is the NYSE. business. To be a leading health care To participate over the long term in the We can use our unique resources to AbbVie common stock is also listed on innovator, we must attract, retain and provision of health care, we must earn and support well-being, resilience and the Chicago Stock Exchange. support a diverse workforce and invest maintain the trust of patients, growth in the communities where we do in their efforts to develop medicines health care providers, regulators, business and help lay the foundation for Annual Meeting that bring value to patients. policymakers, and the public. broader community vitality. The Annual Meeting will be held on Friday, May 8, 2020, at 9 a.m. CT. Please see the proxy statement for information about how to attend the virtual Annual Meeting. 2019 Highlights Dividend Reinvestment Plan Using our expertise to improve health: Advancing our The AbbVie Dividend Reinvestment environmental Plan offers registered stockholders an ABBV-4083 sustainability priorities: opportunity to purchase additional shares, + commission-free, through automatic had a successful end of phase 89,000 dividend reinvestment and/or optional 1 meeting with the U.S. FDA. A U.S. patients received AbbVie cash investments. Interested persons may phase 2 study in patients with river medicines at no cost through the –16 % contact the transfer agent. blindness will be conducted by myAbbVie Assist patient assistance change in absolute carbon emissions our partner, Drugs for Neglected program, up from nearly 81,000 in (scopes 1 and 2) since 2015, more than Transfer Agent Diseases initiative, with drug 2018. This program is just one of the halfway to our 2025 target of 25%. EQ Shareowner Services product and pro bono technical ways AbbVie helps to expand access P.O. Box 64874 support from AbbVie. to our medicines. St Paul, MN 55164-0874 www.shareowneronline.com % 877.881.5970 24 651.450.4064 Attracting and retaining a diverse and inclusive workforce: of our purchased electricity came from renewable sources, up from 9% in 2016 % Ability at AbbVie and almost halfway to our 2025 target 48 We introduced a new Employee Resource of 50%. of management positions are Group (ERG) focused on people with held by women globally. disabilities and their caregivers. 1 0 Supporting long-term community strength: new environmental sustainability projects were approved through About AbbVie our SPARK innovation accelerator, AbbVie is a global, research and development-based 40,000 hours an incubator for employee-driven biopharmaceutical company committed to developing $13 MM sustainability proposals. spent by AbbVie volunteers in 50 raised, including AbbVie Foundation innovative advanced therapies for some of the world’s countries contributing to communities matching donations, for community most complex and critical conditions. The company’s during Week of Possibilities, our annual mission is to use its expertise, dedicated people and organizations during the 2019 U.S. / employee volunteer event. unique approach to innovation to markedly improve Puerto Rico Employee Giving Campaign. treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are For more on how we support the United Nations Sustainable Development Goals, working every day to advance health solutions for visit globalhealthprogress.org. people around the world. For more information about AbbVie, please visit us at www.abbvie.com. For more on our corporate responsibility efforts, visit abbvie.com/responsibility. Printed on recycled paper 3033_Cover.indd 2 3/18/20 6:36 PM 13NOV201221365766 Dear AbbVie Shareholder, As we start a new decade, AbbVie embarks on our eighth year as an independent company. What an amazing journey it has been—and a tremendously successful one. For patients, for our employees and for you—our investors. Record-setting performance and execution In 2019, we delivered our fifth consecutive year of double-digit earnings per share growth—the only company in our peer group to achieve that level of sustained performance. Adjusted earnings per share grew 13 percent to $8.94. That growth was driven by operating margin profile improvement while we continued to invest in our future. Operational revenue grew 2.7 percent to $33.3 billion—despite the entry of biosimilars to Humira in most international markets—and nearly 30 percent of our 2019 global sales were generated from products launched since our inception in 2013. A growing dividend is an enduring hallmark of AbbVie’s investment identity and in 2019, we increased our quarterly cash dividend 10 percent to $1.18 per share. Since our inception, we have increased our dividend by 195 percent and have been a member of the S&P Dividend Aristocrat Index since 2013. A robust pipeline Science and innovation have always been the cornerstones of our business. That’s why we’ve increased our annual R&D investment by roughly 80 percent since inception—our pipeline is truly the lifeblood of our business. Last year, we launched two new immunology therapies—SKYRIZI for psoriasis and RINVOQ for rheumatoid arthritis—to bring new and differentiated therapeutic options for patients and strengthen our leadership position in immunology. We’re very pleased with the reception these medicines have received from physicians and patients and believe they will be important long-term contributors to our growth. Our pipeline is robust—with more than 60 active clinical development programs. In 2020, we expect a number of late-stage data readouts and regulatory submissions for additional indications in immunology and oncology. Our early- and mid-stage pipeline continues to advance rapidly. We will also continue to augment with external innovation to develop next-generation therapies in critical areas of need. A new, more diversified AbbVie In June, we took a transformative step with the announcement to acquire Allergan. A leader in medical aesthetics, women’s health and eye care, Allergan enhances the scale and profitability of AbbVie’s growth platform and diversifies our revenue base with nearly $50 billion in global sales between the two companies. The combined organization will produce significant cashflow that will immediately enable AbbVie to simultaneously support continued dividend growth, long-term investment across our pipeline and debt reduction. This is an exciting step that positions our company extremely well for the long-term. A committed partner for patients and communities At AbbVie, we are focused on doing all that we can to have a remarkable impact on people’s lives. We are committed to helping patients in many ways to access and benefit from their therapies. In 2019, we enhanced our patient assistance program, My AbbVie Assist, which provides AbbVie medicines free of charge to ensure that patients can access our medicines. We did this by lowering the eligibility criteria, so more patients experiencing financial hardships can qualify for assistance and expanding the number of medications covered by our program. As a result, approximately 89,000 patients received AbbVie medicines at no cost. We also have a number of other ways to financially assist patients, such as our co-pay assistance program. This program provides co-pay support for AbbVie medicines to more than 97 percent of patients covered by commercial insurance programs, with 98 percent of those patients paying less than $5 a month for their medicine. Additionally, our company, our employees and our community partners spend hours and millions of dollars to support communities, strengthen K-12 education, help families thrive and much more. Last year, AbbVie volunteers contributed more than 68,000 hours making an impact across their local communities. A sustainable business As a global biopharmaceutical company, we are thoughtful about how our business decisions affect our patients, employees, contractors, the public and the environment. As we pursue long-term sustainable growth, our corporate responsibility framework guides our priorities, decisions and behaviors. We are committed to using our deep expertise to improve health, operate an ethical and sustainable business, and help build stronger communities. We care deeply about the environment and safety of our people. We have reduced our absolute carbon dioxide emissions by more than 16 percent, which is more than halfway toward our target of a 25 percent reduction and we have made great progress against our 2025 environmental goals.
Load more

Recommended publications
  • 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.
    [Show full text]
  • 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,
    [Show full text]
  • Health Advisory
    Health Advisory July 2, 2021 • Information for Pierce County Healthcare Providers Communicable Disease Control Communicable Disease Control • (253) 649-1412 3629 S. D St. • Tacoma, WA 98418 (253) 649-1412 • (253) 649-1358 (fax) COVID-19 Updates for Providers Requested actions • Be aware Washington State Department of Health (DOH) issued a behavioral health provider alert about Fourth of July celebrations and other summertime gatherings. The alert asks providers to give patients information about safe social behaviors and the potential negative effects of impulsive behaviors following the state’s full reopening and the misperception that the COVID-19 pandemic has ended. • Be aware the U.S. Food and Drug Administration (FDA) updated the following Emergency Use Authorization (EUA) fact sheets to include the possible risk of pericarditis and myocarditis following vaccination: o Pfizer fact sheet for healthcare providers. o Pfizer fact sheet for patients. o Moderna fact sheet for healthcare providers. o Moderna fact sheet for patients. • Continue to report any case of myocarditis and pericarditis among people who received COVID-19 mRNA vaccine within the last 2 weeks. o Promptly report cases to the U.S. Vaccine Adverse Events Reporting System (VAERS). o Report cases to the Health Department’s 24-hour reporting line at (253) 649-1413. Include vaccine manufacturer, vaccine lot number, vaccination date, dose number, patient gender, age and history of prior SARS-CoV-2 infection. • Be aware the FDA extended the shelf life of Janssen (Johnson & Johnson) COVID-19 vaccine from 3 months to 4½ months. Visit Janssen’s lot expiry checker to determine the updated expiration of your vaccine.
    [Show full text]
  • 1 UNITED STATES DISTRICT COURT DISTRICT of MINNESOTA Shirley
    CASE 0:10-cv-01821-JNE-JJK Document 65 Filed 04/05/11 Page 1 of 5 UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA Shirley Venus Shannon, Plaintiff, v. Civil No. 10-1821 (JNE/JJK) ORDER Baxter Healthcare Corporation, Hospira, Inc., and Abbott Laboratories, Inc., Defendants. In April 2010, Shirley Venus Shannon brought this action against Eli Lilly & Company and several unidentified entities. In October 2010, she filed an Amended Complaint against Baxter Healthcare Corporation, Hospira, Inc., and Abbott Laboratories, Inc. Abbott Laboratories and Hospira moved to dismiss the case for improper venue, see Fed. R. Civ. P. 12(b)(3); moved to dismiss the case for failure to state a claim upon which relief can be granted, see Fed. R. Civ. P. 12(b)(6); and moved to transfer the case to the United States District Court for the Northern District of Illinois, Eastern Division, see 28 U.S.C. § 1404(a) (2006). After answering, Baxter Healthcare joined the motions of Abbott Laboratories and Hospira. Baxter Healthcare did not separately submit memoranda of law. Shannon opposed the motions, but she asserted that the case should be transferred to the United States District Court for the Western District of Tennessee, Western Division. For the reasons set forth below, the Court transfers this action to the Western District of Tennessee. The Court first considers whether this case should be dismissed for improper venue. See Fed. R. Civ. P. 12(b)(3). The defendant bears the burden of establishing improper venue. United States v. Orshek, 164 F.2d 741, 742 (8th Cir.
    [Show full text]
  • Abbott-Abbvie Multiple Employer Pension Plan
    Abbott-AbbVie Multiple Employer Pension Plan Summary Plan Description Effective January 1, 2013 This summary plan description (SPD) describes the key features of the Abbott-AbbVie Multiple Employer Pension Plan effective January 1, 2013. This booklet describes only the highlights of the plan and does not attempt to cover all administrative details. Every attempt has been made to communicate this information clearly and in easily understandable terms. Benefits and services described here apply only to those former employees and retirees eligible for benefits under the plan. The boards of directors of the companies, or when applicable, the Abbott-AbbVie Pension Plan Administrative Committee, reserve the right to modify, suspend or terminate these benefits at any time to the extent permitted by law. This SPD does not constitute a contract of employment or guarantee any particular benefit. The terms of the Abbott-AbbVie Multiple Employer Pension Plan are governed by the plan and trust documents. In case of a conflict between this SPD and those documents, the plan and trust documents will control. Table of Contents Introduction................................................................................................................................................. 1 Eligibility ..................................................................................................................................................... 1 Eligible Employees ................................................................................................................................
    [Show full text]
  • 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’.
    [Show full text]
  • Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines
    Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S.
    [Show full text]
  • Companies in Attendance
    COMPANIES IN ATTENDANCE Abbott Diabetes Care Archbow Consulting LLC Business One Technologies Abbott Laboratories ARKRAY USA BusinessOneTech AbbVie Armory Hill Advocates, LLC CastiaRX ACADIA Artia Solutions Catalyst Acaria Health Asembia Celgene Accredo Assertio Therapeutics Celltrion Acer Therapeutics AssistRx Center for Creative Leadership Acorda Therapeutics Astellas Pharma US Inc. Cigna Actelion AstraZeneca Cigna Specialty Pharmacy AdhereTech Athenex Oncology Circassia Advantage Point Solutions Avanir Coeus Consulting Group Aerie Pharmaceuticals Avella Coherus Biosciences AGIOS AveXis Collaborative Associates LLC Aimmune Theraputics Bank of America Collegium Akcea Therapeutics Bausch Health Corsica Life Sciences Akebia Therapeutics Bayer U.S. CoverMyMeds Alder BioPharmaceuticals Becton Dickinson Creehan & Company, Inc., an Inovalon Company Alexion Biofrontera CSL Behring Alkermes Biogen Curant Health Allergan Biohaven CVS Health Almirall BioMarin D2 Consulting Alnylam BioMatrix Specialty Pharmacy Daiichi Sankyo Amarin BioPlus Specialty Pharmacy DBV Technologies Amber Pharmacy Bioventus Deloitte Consulting LLP AmerisourceBergen Blue Cross Blue Shield Association Dendreon Amgen Blue Fin Group Dermira Amicus Therapeutics bluebird bio Dexcom Amneal Boehringer Ingelheim Diplomat Pharmacy Anthem Boston Biomedical Dova Applied Policy Bowler and Company Decision Resources Group Aquestive Therapeutics Braeburn Eisai Arbor Pharmaceuticals Bristol-Myers Squibb 1 electroCore Indivior Merz Pharmaceuticals EMD Serono Inside Rx Milliman Encore Dermatology,
    [Show full text]
  • Johnson & Johnson / Abbott Medical Optics Regulation
    EUROPEAN COMMISSION DG Competition Case M.8237 - JOHNSON & JOHNSON / ABBOTT MEDICAL OPTICS Only the English text is available and authentic. REGULATION (EC) No 139/2004 MERGER PROCEDURE Article 6(1)(b) NON-OPPOSITION Date: 21/02/2017 In electronic form on the EUR-Lex website under document number 32017M8237 EUROPEAN COMMISSION Brussels,21.2.2017 C(2017) 1336 final In the published version of this decision, some PUBLIC VERSION information has been omitted pursuant to Article 17(2) of Council Regulation (EC) No 139/2004 concerning non-disclosure of business secrets and other confidential information. The omissions are shown thus […]. Where possible the information omitted has been replaced by ranges of figures or a general description. To the notyfing party: Subject: Case M.8237 – Johnson & Johnson / Abbott Medical Optics Commission decision pursuant to Article 6(1)(b) of Council Regulation No 139/20041 and Article 57 of the Agreement on the European Economic Area2 Dear Sir or Madam, (1) On 17 January 2017, the European Commission received notification of a proposed concentration pursuant to Article 4 of the Merger Regulation by which Johnson & Johnson ("J&J", US) acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of Abbott Medical Optics Inc. ("AMO", US) by way of purchase of shares3. J&J and AMO are collectively referred to as "the Parties". I. THE PARTIES AND THE OPERATION (2) J&J, headquartered in the US, is the parent company of a global group of companies which are active in the provision of pharmaceutical products, medical devices and consumer healthcare products.
    [Show full text]
  • UNITED STATES SECURITIES and EXCHANGE COMMISSION Form
    Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Form 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☒ 1934 For the fiscal year ended December 31, 2008 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ☐ OF 1934 Commission file number 000-12477 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Amgen Center Drive, 91320-1799 Thousand Oaks, California (Zip Code) (Address of principal executive offices) (805) 447-1000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(g) of the Act: Common stock, $0.0001 par value; preferred share purchase rights (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
    [Show full text]
  • 1:19-Cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 Pageid #:1
    Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 PageID #:1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS WELFARE PLAN OF THE INTERNATIONAL UNION OF OPERATING ENGINEERS LOCALS 137, 137A, 137B, 137C, 137R, on behalf of itself Civil Action No.______________ and all others similarly situated, CLASS ACTION Plaintiff, v. JURY TRIAL DEMANDED ABBVIE INC., ABBVIE BIOTECHNOLOGY LTD, and AMGEN INC., Defendants. CLASS ACTION COMPLAINT Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 2 of 74 PageID #:2 TABLE OF CONTENTS I. INTRODCUTION ...............................................................................................................1 II. PARTIES .............................................................................................................................3 III. JURISDICTION AND VENUE ..........................................................................................5 IV. THE REGULATORY FRAMEWORK OF BIOLOGICS ..................................................6 A. Cost Concerns Prompt Congress to Enact the Biologics Price Competition and Innovation Act ..............................................................................6 1. New biologic drug approval under the BPCIA ............................................7 2. Biosimilar drug approval under the BPCIA .................................................8 3. Biosimilar entrants’ effect on marketplace ..................................................9 B. Patent Challenges Under the BPCIA .....................................................................11
    [Show full text]
  • Effectiveness of Pfizer-Biontech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021
    Morbidity and Mortality Weekly Report Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021 Mark W. Tenforde, MD, PhD1; Samantha M. Olson, MPH1; Wesley H. Self, MD2; H. Keipp Talbot, MD2; Christopher J. Lindsell, PhD2; Jay S. Steingrub, MD3; Nathan I. Shapiro, MD4; Adit A. Ginde, MD5; David J. Douin, MD5; Matthew E. Prekker, MD6; Samuel M. Brown, MD7; Ithan D. Peltan, MD7; Michelle N. Gong, MD8; Amira Mohamed, MD8; Akram Khan, MD9; Matthew C. Exline, MD10; D. Clark Files, MD11; Kevin W. Gibbs, MD11; William B. Stubblefield, MD2; Jonathan D. Casey, MD2; Todd W. Rice, MD2; Carlos G. Grijalva, MD2; David N. Hager, MD, PhD12; Arber Shehu, MD12; Nida Qadir, MD13; Steven Y. Chang, MD, PhD13; Jennifer G. Wilson, MD14; Manjusha Gaglani, MBBS15,16; Kempapura Murthy, MPH15; Nicole Calhoun, LMSW, MPA15; Arnold S. Monto, MD17; Emily T. Martin, PhD17; Anurag Malani, MD18; Richard K. Zimmerman, MD19; Fernanda P. Silveira, MD19; Donald B. Middleton, MD19; Yuwei Zhu, MD2; Dayna Wyatt2; Meagan Stephenson, MPH1; Adrienne Baughman2; Kelsey N. Womack, PhD2; Kimberly W. Hart2; Miwako Kobayashi, MD1; Jennifer R. Verani, MD1; Manish M. Patel, MD1; IVY Network; HAIVEN Investigators On April 28, 2021, this report was posted as an MMWR Early ≥65 years. Vaccination is a critical tool for reducing severe Release on the MMWR website (https://www.cdc.gov/mmwr). COVID-19 in groups at high risk. Adults aged ≥65 years are at increased risk for severe outcomes Randomized clinical trials of vaccines that have received an from COVID-19 and were identified as a priority group to EUA in the United States showed efficacy of 94%–95% in receive the first COVID-19 vaccines approved for use under preventing COVID-19–associated illness (4,5).§ However, an Emergency Use Authorization (EUA) in the United States hospitalization is a rare outcome among patients with (1–3).
    [Show full text]