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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. -
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, -
2020 Annual Report Products
Products 2020 Annual Report From the CEO Dear Fellow Shareholders, Perrigo’s transformation to a pure-play Consumer Self-Care Company has come a long way LQMXVWWZRVKRUW\HDUV:HKDYHUHVWRUHGVXVWDLQDEOHWRSOLQHJURZWKGHOLYHUHGRQRXU¿QDQFLDO SURPLVHVUHFRQ¿JXUHGRXUSRUWIROLRRIEXVLQHVVHVXSGDWHGWKH,7LQIUDVWUXFWXUHDQGSURFHVVHV of the Company, expanded capacity, upgraded leadership talent, installed business intelligence capabilities, built a new product pipeline of over $500 million and re-instilled a sense of pride and energy among our 11,000 team members. Making this even more remarkable, is that we kept the WUDQVIRUPDWLRQRQWUDFNLQWKHIDFHRIWKHJOREDO&29,'SDQGHPLF,KRSH\RXDUHDVSURXGRI3HUULJR¶VJOREDOWHDP DV,DPIRUKRZWKH\ZRUNHGWRNHHSHDFKRWKHUVDIHNHSWRXUHVVHQWLDOSURGXFWVÀRZLQJDQGNHSWRXUWUDQVIRUPDWLRQ to a consumer self-care company on track through all of the personal and professional uncertainty that came their way LQ7KH\DUHKHURHV As a result of their efforts, Perrigo delivered strong net sales growth for the second year in a row in 2020 and World-wide Consumer sales reached a new record high. Equally important, the team stabilized adjusted operating income after a few years of decline even as we invested over $50 million in our business and overcame $35 million RIXQSODQQHGKHDGZLQGVGXHSULPDULO\WR&29,'UHODWHGVDIHW\FRVWVDQGEXVLQHVVLPSDFWIURPWKHZHDNFROG FRXJKDQGÀXVHDVRQUHODWHGWR&29,'¶VLPSDFWRQSXEOLFOLIH$OOLQDOOZHKDGDYHU\VWURQJ\HDU Our transformation efforts reached an essential milestone after the year closed when we announced the sale of RXU3UHVFULSWLRQ3KDUPDFHXWLFDOVEXVLQHVVWR$OWDULV&DSLWDO3DUWQHUV//&7KHWUDQVDFWLRQUHLQIRUFHVRXUDELOLW\ -
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’. -
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 -
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). -
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. -
FDA Listing of Authorized Generics As of July 1, 2021
FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc. -
Annual Report
ANNUAL REPORT 2019 MARCH 2020 To Our Shareholders Alex Gorsky Chairman and Chief Executive Officer By just about every measure, Johnson & These are some of the many financial and Johnson’s 133rd year was extraordinary. strategic achievements that were made possible by the commitment of our more than • We delivered strong operational revenue and 132,000 Johnson & Johnson colleagues, who adjusted operational earnings growth* that passionately lead the way in improving the health exceeded the financial performance goals we and well-being of people around the world. set for the Company at the start of 2019. • We again made record investments in research and development (R&D)—more than $11 billion across our Pharmaceutical, Medical Devices Propelled by our people, products, and and Consumer businesses—as we maintained a purpose, we look forward to the future relentless pursuit of innovation to develop vital with great confidence and optimism scientific breakthroughs. as we remain committed to leading • We proudly launched new transformational across the spectrum of healthcare. medicines for untreated and treatment-resistant diseases, while gaining approvals for new uses of many of our medicines already in the market. Through proactive leadership across our enterprise, we navigated a constant surge • We deployed approximately $7 billion, of unique and complex challenges, spanning primarily in transactions that fortify our dynamic global issues, shifting political commitment to digital surgery for a more climates, industry and competitive headwinds, personalized and elevated standard of and an ongoing litigious environment. healthcare, and that enhance our position in consumer skin health. As we have experienced for 133 years, we • And our teams around the world continued can be sure that 2020 will present a new set of working to address pressing public health opportunities and challenges. -
Gilead-V-Abbvie.Pdf
Case 1:15-cv-00399-GMS Document 1 Filed 05/19/15 Page 1 of 12 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE GILEAD SCIENCES, INC. and GILEAD SCIENCES IRELAND UNLIMITED COMPANY, C.A. No. _______________ Plaintiffs, JURY TRIAL DEMANDED v. ABBVIE, INC., Defendant. COMPLAINT FOR DECLARATORY JUDGMENT Douglas E. McCann (#3852) Gregory R. Booker (#4784) Susan Morrison Coletti (#4690) 222 Delaware Avenue, 17th Floor P.O. Box 1114 Wilmington, DE 19899 Telephone: (302) 652-5070 Facsimile: (302) 652-0607 [email protected]; [email protected]; [email protected] Attorneys for Plaintiffs Gilead Sciences, Inc. and Gilead Sciences Ireland Unlimited Company Case 1:15-cv-00399-GMS Document 1 Filed 05/19/15 Page 2 of 12 PageID #: 2 Gilead Sciences, Inc. and Gilead Sciences Ireland Unlimited Company (collectively, “Gilead”) file this complaint for declaratory judgment against AbbVie, Inc. (“AbbVie”) and allege as follows: NATURE OF THE ACTION 1. This is an action for a declaratory judgment of invalidity of United States Patent No. 9,034,832 (“the ’832 patent”) under 35 U.S.C. § 1 et seq. and 28 U.S.C. §§ 2201 and 2202. Defendant AbbVie continues to obtain patents that do not protect its inventions, but rather attempt to cover the products of its more successful competitors. See e.g., Gilead Sciences, Inc., et al v. AbbVie, Inc., C.A. No. 13-2034 (D. Del.). In this instance, AbbVie obtained a patent on formulations for tablets containing Gilead’s Ledipasvir molecule, which is part of Gilead’s revolutionary Hepatitis C treatment, HARVONI®. -
Case 3:15-Cv-06075-PGS-DEA Document 124 Filed 03/24/17 Page
Case 3:15-cv-06075-PGS-DEA Document 124 Filed 03/24/17 Page 1 of 9 PageID: <pageID> UNITEDD STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY MERCK SHARP & DOHME CORP. ) ) ) Civil Action No: Plaintiff, ) 15-cv-6075 (PGS)(DEA) ) v. ) ) MEMORANDUM ACTAVIS LABORATORIES FL, INC., ) & et al. ) ORDER ) ) Defendants. SHERIDAN, U.S.D.J. This matter comes before the Court on defendant Actavis, Inc. n/k/a Allergan Finance LLC’s (“Allergan Finance”) motion to dismiss plaintiff Merck Sharp & Dohme Corp.’s (“Merck”) complaint for lack of subject matter jurisdiction under Fed. R. Civ. P. 12(b)(1) (“Rule 12(b)(1)”). Defendants Actavis Laboratories FL, Inc., Andrx Corporation, & Actavis Pharma, Inc. (collectively, “Teva Defendants”), consent to this motion. (See Defs.’ Br. at 1; Dkt. No. 114-1). Allergan Finance argues that Merck’s complaint lacks subject matter jurisdiction against Allergan Finance because it divested its interests in an Abbreviated New Drug Application (“ANDA”) upon acquiring of its business by Teva Pharmaceuticals USA. The ANDA application is directed to posaconazole drug, which is protected by U.S. Pat. 5,661,151 (the “’151 patent”). Because of its divestiture of the ANDA application, Allergan Finance argues that it lacks the involvement in the marketing, distribution, or sale of Teva Defendants’ ANDA products. As a result, extinguishing this Court’s jurisdiction conferred by 35 U.S.C. § 271(e)(2). In opposition, Merck argues that the subject matter jurisdiction under Rule 12(b)(1) was satisfied at the time of filing of the complaint. In the complaint, Merck alleged that Allergan Case 3:15-cv-06075-PGS-DEA Document 124 Filed 03/24/17 Page 2 of 9 PageID: <pageID> Finance submitted the ANDA application for purposes of engaging in commercial manufacture, use, or sale of the posaconazole (i.e., the ANDA product) prior to the expiration of the ’151 patent. -
The Abbvie Experience • Business Overview • Talent Practices Welcome to • Our Culture Abbvie! • Company Resources • Rewards & Benefits
The AbbVie Experience • Business Overview • Talent Practices Welcome to • Our Culture AbbVie! • Company Resources • Rewards & Benefits ©2020 | Confidential | Do not distribute 2 AbbVie has as long history in healthcare dating back to 1888 with Abbott 130+ years of patient care Launched as AbbVie in 2013 Millions of lives touched ©2020 | Confidential | Do not distribute 3 The AbbVie Way ©2020 | Confidential | Do not distribute 4 Vision To be recognized as a biopharmaceutical company delivering a consistent stream of innovative medicines that solve serious health issues and have a remarkable impact on people’s lives. ©2020 | Confidential | Do not distribute 5 Our Principles Transforming Lives Acting with Integrity Driving Innovation Embracing Diversity & Inclusion Serving the Community ©2020 | Confidential | Do not distribute 6 A compelling growth story 2013 2014 2015 2016 2017 2018 On January 2, 2013, we AbbVie brands surpass We brought We expanded our We closed the year We exemplified our marked our first official 30 million patients Pharmacyclics into the neuroscience research with the #2 spot on culture of giving back, day as a new impacted around the AbbVie family and – including Alzheimer’s Barron’s 500. donating $350 million biopharmaceutical world and our first expanded our disease – with the to support U.S. company AbbVie-created commitment to opening of our 43,000- nonprofits. medicine is approved. identifying novel square-foot Cambridge treatments for cancer. Research Center in Massachusetts. ©2020 | Confidential | Do not distribute