DOCSLIB.ORG

Pharma Pricing, Non-Profit Ties Get Increasing Scrutiny from Prosecutors

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

REGULATORY UPDATE REGULATORY UPDATE CONSUMER DRUGS Pediatric Rare Disease Voucher Japan Wants EMA To Stay In Digital Marketing: Health Care Brands’ Program Faces Expiration, p. 12 UK Post-Brexit, p. 15 Window Into Consumers’ Lives, p. 20 Pharma intelligence Pinkpink.pharmamedtechbi.comSheetVol. 78 / No. 38 September 19, 2016 informa Mylan NV was subpoenaed for material Pharma Pricing, Non-Profit Ties Get about the pricing of its generic doxycycline and communications with competitors. And Valeant Pharmaceuticals International Inc. is Increasing Scrutiny From Prosecutors facing several probes about its pricing and BRENDA SANDBURG [email protected] patient assistance programs (see chart, p. 5). Mylan’s doxycycline price increases were called out by Sen. Bernie Sanders, I-Vt., and Rep. Elijah Cummings, D-Md., in October 2014 when they sent letters to 14 generic drug makers about the pricing of their prod- ucts. They noted that from October 2013 to April 2014, the average price charged for a 500-count bottle of 100 mg tablets had risen from $20 to $1,829, an 8,281% increase. Mylan is now under fire for repeatedly rais- ing the price of its severe allergy treatment EpiPen (epinephrine), which has increased from about $100 for a two-pack in 2008 to more than $600. Members of Congress sent a flurry of letters to the company requesting an explanation for the price hikes. And on Sept. 6, New York Attorney Gen- Shutterstock: blvdone Shutterstock: eral Eric Schneiderman announced that his office has begun an investigation into rug makers have been unable to programs, contractual agreements with Mylan with regard to EpiPen, saying a pre- shake free of government inves- pharmacy benefit managers, support of liminary review revealed that Mylan may Dtigations of their marketing and non-profit organizations, and calculation have inserted potentially anticompetitive sales practices. But the focus of the probes of average manufacturer and best prices. terms into its EpiPen sales contracts with has shifted in the last few years and one A look at recent Securities and Exchange numerous local school systems. word now routinely pops up – pricing. Commission filings of more than a dozen That has been the hot button issue roil- pharma companies shows the practices GOING BEYOND ing industry the past year as several com- that have drawn government attention. MISBRANDING CASES panies have been excoriated by Congress At least four companies – Biogen Inc., The government has subpoenaed several and the media for their steep price hikes. Celgene Corp., Gilead Sciences Inc. and other generic companies about their pric- The Department of Justice has also honed Jazz Pharmaceuticals PLC – have received ing. Most recently, Sun Pharmaceutical In- in on the issue. It is investigating firms subpoenas for information about their re- dustries Ltd. reported that it had received for details about their patient assistance lationships with charitable organizations. CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF SCRIP REGULATORY AFFAIRS, THE RPM REPORT, TAN SHEET, GOLD SHEET, PINK SHEET DAILY AND PINK SHEET Maximize Your Reimbursement Potential The balance of power behind the prescribing decision is changing: payers are ever more in charge. That means that insight into how payers make decisions – how they evaluate drugs, one against another – will be crucial to any successful drug launch. RxScorecard objectively, authoritatively, and systematically assesses marketed and pipeline drugs in a therapeutic indication from the payer’s point of view. Developed by senior medical and pharmacy leaders from major payers and pharmacy benefit managers, RxScorecard delivers practical and powerful insight into your drug’s reimbursement potential and how you can maximize it. Transparent, objective, and grounded in payer data, RxScorecard helps you refine your development path, future-proof your market access strategy, and achieve payer acceptance. Discover RxScorecard today. Visit https://goo.gl/mIof2t to review the selection of RxScorecards today. Interact with the data. Compare drugs on clinical, safety, and economic metrics. See the payer perspective. cover 12 15 exclusive online content inside: COVER Pharma Pricing, Non-Profit Ties Get Increasing Scrutiny Global Pharma Guidance Tracker – August 2016 From Prosecutors http://bit.ly/2d0h09o BIOSIMILARS Stay up to date on regulatory guidelines from around the world, with the Pink Sheet’s new monthly Guidance Tracker. 8 Biosimilar Launch Notification May Head Back To Court 9 Biosimilar Interchangeability May Be Losing Luster As Approval Goal Spectrum’s Apaziquone Pooled Analysis Can’t Make Up For Negative Studies LITIGATION http://bit.ly/2cCv7zB 10 EU Pay-For-Delay Ruling Against Lundbeck Sends Signal Faced with two unsuccessful pivotal trials, FDA advisory To Others, Including UK committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been FDA demonstrated. 24 FDA Neurology Clinical Team Leader Departure May Be Mountain Disguised As Molehill Removing Pfizer’s Chantix Boxed Warning A One-Off, REGULATORY UPDATE Committee Says 12 Pediatric Rare Disease Voucher Program Faces Expiration http://bit.ly/2cCvIl1 15 Japan Wants EMA To Stay In UK Post-Brexit Advisory committee says data supports dialing back safety label for the smoking cessation product, but shouldn’t be 18 Korean Health Tech Blueprint Highlights Precision, precedent setting. Regenerative Medicine INTELLECTUAL PROPERTY Paying For Cures Requires Bigger Budgets, 13 Pressure On Pharma: UN Report Backs Compulsory Not Lower Drug Prices – Execs Licensing http://bit.ly/2cC6rpg CLINICAL TRIALS Payers need to adopt a longer-term focus on coverage policies for prescription drugs and biologics that recognizes the benefits 16 India Moves To Replace Animal-Based Tests In Eye, of covering high-priced, but often curative, treatments like Skin Studies those for hepatitis C, panelists argue at AEI-sponsored event. 17 China Proposes Many New GLP Provisions For Pharma CONSUMER DRUGS 20 Digital Marketing: Health Care Brands’ Window Into ONLINE ONLY! Consumers’ Lives 22 Teva Seeds OTC Growth Synergies With Former FDA performance Allergan Business tracker GENERIC DRUGS 25 FDA’s ANDA Approvals Regularly updated information about new submissions, pending applications and FDA actions, online-only NEW PRODUCTS interactive content at your fingertips 24/7 at 25 FDA’s NDA And BLA Approvals pink.pharmamedtechbi.com/product-reviews- AdviSORY COMMITTEES and-approvals/fda-performance-tracker 26 Recent And Upcoming FDA Advisory Committees pink.pharmamedtechbi.com September 19, 2016 | Pink Sheet | 3 LITIGATION a subpoena for information pertaining to at DOJ, said that there is a big difference moted the sleep disorder drugs Nuvigil the pricing of its generic drugs. between issuing policy and standing (armodafinil) and Provigil (modafinil) off- In previous years, the DOJ has concen- in front of a judge and trying to prove label. The whistleblowers in these cases are trated on claims of off-label marketing and culpability. As a prosecutor, there is a «big pursuing the actions on their own. payment of kickbacks. These investigations distance between what you wish in the Several other investigations have resulted resulted in a slew of settlements, many top- case and what can be proven in the case,» in DOJ settlements. Among the most recent, ping $1bn. he said. “If you get enough bad outcomes Pfizer Inc. agreed to pay $784.6m to resolve Hogan Lovells partner Meredith Manning it will make you gun shy.” allegations that its Wyeth subsidiary paid said she thinks the government is trying to As for the focus of government investi- hospitals steep discounts if they purchased avoid cases alleging misbranding under the gations, both emphasized that the growth both oral and IV formulations of the acid- federal Food, Drug, and Cosmetic Act and is in federal regulation has meant and suppressant Protonix (pantoprazole). And looking for other theories of liability. will continue to mean growth in federal Roche and OSI Pharmaceuticals LLC reached “They run into First Amendment issues enforcement. Pauzé, a former assistant a $67m settlement to resolve claims they when they go down the misbranding route, US attorney, said that because there is so misrepresented the effectiveness of the and juries don’t want to convict individuals,” much talk about pricing it can lead to gov- non-small cell lung cancer drug Tarceva (er- Manning, a former attorney in FDA’s Office ernment scrutiny. Richter added that de- lotinib) (see story p. 6 for list of settlements). of Chief Counsel and a former assistant US spite the significant setbacks the govern- In addition to US healthcare fraud que- attorney, said. ment has faced in off-label cases recently ries, the government is also stepping up in- Indeed, in the last six months the gov- that area of inquiry is not dead. vestigations of foreign bribery. This year the ernment has struck out in two trials against DOJ increased the number of prosecutors individuals and got a limited conviction in a GOVERNMENT CLOSES looking into potential violations under the third. In March, a Texas jury found Vascular NOVARTIS, TEVA INQUIRIES Foreign Corrupt Practices Act and initiated a Solutions Inc. and its CEO Howard Root not Many government investigations evolve pilot program to give companies credit and guilty of off-label marketing of its Vari-Lase from False Claims Act complaints in which a reduction in fines for their cooperation. At vein ablation
Recommended publications
  • Understanding the FTC's Monetary Equitable Remedies Under Section

    Understanding the FTC's Monetary Equitable Remedies Under Section

    Understanding the FTC’s monetary equitable remedies under Section 13(b) for antitrust violations By Gerald A. Stein, American Bar Association — Fall 2019 Until recently the Federal Trade Commission’s ability to seek monetary equitable remedies (particularly disgorgement and restitution) for alleged antitrust violations— whether ongoing, impending, or stale— went virtually unchallenged. After it first gained statutory authority under Section 13(b)1 of the FTC Act to bring suit in federal district court to preliminarily enjoin conduct that “is violating, or is about to violate” the antitrust laws, the FTC successfully convinced many federal courts that Section 13(b) also impliedly allowed the FTC to seek standalone permanent injunctions and monetary equitable remedies regardless of whether a defendant’s alleged anticompetitive conduct was ongoing or completed long ago.2 The FTC brought few antitrust cases in the years following the enactment for alleged antitrust violations pursuant to Section 13(b) where the alleged of Section 13(b) in 1973, and the agency formalized its conservative anticompetitive conduct was neither ongoing nor imminent. Next, in approach in its unanimously approved 2003 Policy Statement on Monetary FTC v. Credit Bureau Center LLC,5 the Seventh Circuit vacated an award for Equitable Remedies in Competition Cases. In 2012, however, the FTC restitution in a consumer protection case based on its determination that abruptly, and without providing an opportunity for public comment, Section 13(b) authorizes only restraining orders and injunctions. And, in a withdrew its 2003 Policy Statement, asserting that it created “an overly third case that is still pending, FTC v.
  • Responding to Mylan's Inadequate Tender Offer

    Responding to Mylan's Inadequate Tender Offer

    Responding To Mylan’s Inadequate Tender Offer: Perrigo’s Board Recommends That You Reject the Offer and Do Not Tender September 2015 Important Information Forward Looking Statements Certain statements in this presentation are forward-looking statements. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, including future actions that may be taken by Mylan in furtherance of its unsolicited offer. These and other important factors, including those discussed under “Risk Factors” in the Perrigo Company’s Form 10-K for the year ended June 27, 2015, as well as the Company’s subsequent filings with the Securities and Exchange
  • Glaxosmithkline Bangladesh Limited (GSK)

    Glaxosmithkline Bangladesh Limited (GSK)

    GlaxoSmithKline Bangladesh Limited (GSK) Recruitment and Selection Process of GlaxoSmithKline Bangladesh Limited: An Evaluation nd Date of Submission: 2 September, 2014 ©Daffodil International University DAFFODIL INTERNATIONAL UNIVERSITY Internship Report On Recruitment and Selection Process of GlaxoSmithKline Bangladesh Limited: An Evaluation Submitted To Dr. Zakir Hossain Dean& Professor Faculty of Business & Economics Daffodil International University Submitted By Ishrat Jahan ID: 131-14-1019 Masters of Business Administration Daffodil International University Date of Submission: 2nd September, 2014 ©Daffodil International University Letter of Transmittal September 2, 2014 To Dr. Zakir Hossain Dean & Professor Faculty of Business and Economics Daffodil International University Dhaka-1205 Subject: Submission of internship report on recruitment and selection process: An evaluation of GlaxoSmithKline Bangladesh Limited Sir, I am highly satisfied to submit my report on recruitment and selection process: an evaluation of GSK. For preparing this report I tried my best to accumulate relevant and upgraded information from available sources. In preparing this report, I tried my level best to make it a complete one and sincerely look forward to any possible correction. I am very glad because you also given the opportunity to prepare this report .I hope that this report will meet the standards of your judgments. Your Sincerely ---------------- Ishrat Jahan ©Daffodil International University i Certificate of the Supervisor This is to certify that the internship report titled ―Recruitment and Selection Process of GlaxoSmithKline Bangladesh Limited: An Evaluation‖, has been prepared by Ms. Ishrat Jahan bearing ID: 131-14-1019 under my supervision, a practical study on GlaxoSmithKline Bangladesh Limited. I think on the basic of declaration Ms.
  • Gilead and Glaxo's HIV Battle Intensifies

    Gilead and Glaxo's HIV Battle Intensifies

    February 14, 2017 Gilead and Glaxo’s HIV battle intensifies Madeleine Armstrong The first phase II data with Gilead’s HIV integrase inhibitor bictegravir have set up a showdown with Glaxosmithkline/Viiv Healthcare’s marketed product dolutegravir. But Glaxo is already one step ahead with data from a two-drug combo that could reduce the side-effect burden for HIV patients. Glaxo believes that this doublet could “reshape the whole game”, the group's chief executive, Andrew Witty, said on its fourth-quarter earnings call. HIV has been one of the group’s main drivers in recent quarters as it has taken market share from Gilead, which is becoming increasingly reliant on HIV as its hepatitis C franchise slows (see tables below). Bictegravir vs dolutegravir The phase II study, presented today at the Conference on Retroviruses and Opportunistic Infections in Seattle, compared bictegravir plus emtricitabine and tenofovir alafenamide – known as FTC/TAF – with dolutegravir plus FTC/TAF in 98 treatment-naive, HIV-infected adults. Both are the latest iterations of the integrase inhibitor class, and unlike older products with the same mechanism do not require boosting – taking another drug to raise circulating levels – so have a lower risk of adverse events and drug-drug interactions. The phase II trial found similar response rates with a bictegravir-containing regimen versus a dolutegravir- containing therapy, which should boost confidence in Gilead’s compound ahead of phase III readouts expected mid-year. It found a 97% response in the bictegravir arm at 24 and 48 weeks, versus 94% at week 24 and 91% at week 48 in the dolutegravir arm, but the difference was not statistically significant.
  • 2020 Annual Report Products

    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\
  • General Assembly Distr

    General Assembly Distr

    UNITED NATIONS A General Assembly Distr. GENERAL A/HRC/11/12/Add.2 5 May 2009 Original: ENGLISH HUMAN RIGHTS COUNCIL Eleventh session Agenda item 3 PROMOTION AND PROTECTION OF ALL HUMAN RIGHTS, CIVIL, POLITICAL, ECONOMIC, SOCIAL AND CULTURAL RIGHTS, INCLUDING THE RIGHT TO DEVELOPMENT Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of health, Paul Hunt* Annex MISSION TO GLAXOSMITHKLINE** * The present report was submitted late in order to incorporate the most recent information. Paul Hunt ended his mandate as Special Rapporteur on 31 July 2008. His report is circulated as an addendum to the report of his successor, Anand Grover, who took up the mandate on 1 August 2008. ** The summary of the present report is circulated in all official languages. The report itself, annexed to the summary, is circulated as received, in the language of submission only. GE.09-13131 (E) 130509 A/HRC/11/12/Add.2 page 2 Summary The Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health visited the headquarters of GlaxoSmithKline, one of the world’s leading research-based pharmaceutical companies, in June 2008 for substantive interviews with the company’s senior management. In the Special Rapporteur’s previous reports, he examined States’ responsibilities in relation to access to medicines. However, enhancing access to medicines is a shared responsibility. The Millennium Development Goals recognize that pharmaceutical companies have a responsibility to improve access to medicines. In the present report, the Special Rapporteur outlines the responsibilities of pharmaceutical companies, including innovator, generic and biotechnology companies, with regard to the right to health in relation to access to medicines.
  • In This Section

    In This Section

    Strategic report In this section Chairman’s statement 2 CEO’s review 4 Business overview 6 The global context 8 Our business model 12 Our strategic priorities 14 How we performed 16 Risk management 18 Grow 20 Deliver 32 Simplify 44 Our financial architecture 48 Responsible business 50 Financial review 58 Strategic report Chairman’s statement Chairman’s statement To shareholders The value of the significant changes that have been made in recent years is evidenced in our performance this year “ Since Sir Andrew became It is clear from the following pages that Through the Audit & Risk Committee, we the Group made good progress against oversee the issues and challenges faced by CEO, the company has its strategy in 2013. management, and encourage the creation of an environment in which GSK can achieve The Board believes the business is seeing returned £30 billion its strategic ambitions in a responsible and the benefits of the significant changes the sustainable manner. to shareholders.” management team has driven over recent years to deliver sustainable growth, reduce risk and I have no doubt that commercial success is enhance returns to shareholders. directly linked to operating in a responsible way and which meets the changing expectations of The notably strong performance from the society. In this respect, the company continues R&D organisation in 2013 – with six major to adopt industry-leading positions on a range new product approvals in areas including of issues. respiratory disease, HIV and cancer – is critical to the longer-term prospects of the The announcement of plans during 2013 to Group.
  • Plaintiff Federal Trade Commission's Post-Trial Brief

    Plaintiff Federal Trade Commission's Post-Trial Brief

    Case 2:14-cv-05151-HB Document 403 Filed 03/23/18 Page 1 of 46 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA FEDERAL TRADE COMMISSION, Plaintiff, Case Number: 2:14-CV-5151-HB v. ABBVIE INC., et al., Defendants. PLAINTIFF FEDERAL TRADE COMMISSION’S POST-TRIAL BRIEF Armine Black Daniel S. Bradley Rebecca L. Egeland Jordy J. Hur Garth W. Huston Hannah Lamb Heather M. Johnson Thomas D. Mays Patricia M. McDermott Markus H. Meier Kara L. Monahan Lauren Peay Peter J. Taylor Matthew B. Weprin James Weingarten Attorneys for Plaintiff FEDERAL TRADE COMMISSION 600 Pennsylvania Avenue, N.W. Washington, D.C. 20580 (202) 326-2569 [email protected] Case 2:14-cv-05151-HB Document 403 Filed 03/23/18 Page 2 of 46 TABLE OF CONTENTS TABLE OF AUTHORITIES ........................................................................................................ ii KEY PERSONNEL ...................................................................................................................... vi I. Defendants’ objectively baseless lawsuits used the governmental process as an anticompetitive weapon .................................................................................................... 2 A. Defendants enjoyed substantial benefits from the collateral injuries their baseless lawsuits inflicted on Teva and Perrigo ...................................................... 3 B. The evidence at trial supports liability even under Defendants’ erroneous view that PRE requires proof that Defendants knew their lawsuits were baseless .........
  • Perrigo Board of Directors

    Perrigo Board of Directors

    Perrigo Company plc Board of Directors and Their Compensation (as of August 7, 2019) Bradley A. Alford, 62, has been a director of Perrigo since February 2017. Mr. Alford joined Advent International Corporation, a global private equity firm, in 2014 as an Industry Advisor and moved to Operating Partner in March of 2016. From 2006 to 2013, Mr. Alford was Chairman and Chief Executive Officer of Nestlé USA. Mr. Alford also served as CEO and President of Nestlé Brands Company. He currently serves as a director of Avery Dennison Corporation since April 2010 and previously served as a director of Conagra Brands, Inc. from July 2015 to September 2018. Throughout his career, Mr. Alford has been focused on developing brands, initiatives to improve processes and facilitate best practices across an organization. Rolf A. Classon, 73, has been a director of Perrigo since May 2017. Mr. Classon served as Interim President and Chief Executive Officer of Hillenbrand Industries, a global diversified industrial company, from May 2005 until March 2006. From 2002 until June 2004, Mr. Classon served as Chairman of the Executive Committee of Bayer Healthcare AG, a subsidiary of Bayer AG. Mr. Classon served as President of Bayer Diagnostics from 1995 to 2002 and as Executive Vice President from 1991 to 1995. Prior to 1991, Mr. Classon held various management positions with Pharmacia Corporation. Mr. Classon serves as a director of Fresenius Medical Care AG and Co. since May 2012, and Catalent, Inc. since July 2014. Mr. Classon also served as a director of Hill-Rom Holdings, Inc., from July 2001 to March 2018, Aerocrine AB, Stockholm from May 2013 to July 2015 and Auxilium Pharmaceuticals from July 2005 to January 2015 and served as a director of Tecan Group, Ltd.
  • Cusip No. G8807B106 13 D/A2 Page 2 of 7

    Cusip No. G8807B106 13 D/A2 Page 2 of 7

    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 2)* THERAVANCE BIOPHARMA, INC. (Name of Issuer) Ordinary Shares (Title of Class of Securities) G8807B106 (CUSIP Number) Victoria A. Whyte GlaxoSmithKline plc 980 Great West Road Brentford, Middlesex TW8 9GS England Telephone: +44 (0)208 047 5000 (Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications) December 31, 2016 (Date of Event which Requires Filing of this Statement) If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box. ☐ Note: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See §240.13d-7 for other parties to whom copies are to be sent. * The remainder of this cover page shall be filled out for a reporting person's initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page. The information required on the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act.
  • Annual Report 2008 Find out More About GSK Online…

    Annual Report 2008 Find out More About GSK Online…

    Do more, feel better, live longer Grow Deliver Simplify Annual Report 2008 Find out more about GSK online… www.gsk.com Website GlaxoSmithKline’s website www.gsk.com gives additional information on the Group. Information made available on the website does not constitute part of this Annual Report. Notice regarding limitations on Director liability under English Law Under the UK Companies Act 2006, a safe harbour limits the liability of Directors in respect of statements in and omissions from the Report of the Directors contained on pages 12 to 98. Under English law the Directors would be liable to the company (but not to any third party) if the Report of the Directors contains errors as a result of recklessness or knowing misstatement or dishonest concealment of a material fact, but would not otherwise be liable. Report of the Directors Pages 12 to 98 inclusive consist of a Report of the Directors that has been drawn up and presented in accordance with and in reliance upon English company law and the liabilities of the Directors in connection with that report shall be subject to the limitations and restrictions provided by such law. Cautionary statement regarding forward-looking statements The Group’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document and written information released, or oral statements made, to the public in the future by or on behalf of the Group, may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. A shareholder can identify these statements by the fact that they do not relate strictly to historical or current facts.
  • GCE a Level 1083/01 BUSINESS STUDIES –

    GCE a Level 1083/01 BUSINESS STUDIES –

    GCE A level 1083/01 S15-1083-01 BUSINESS STUDIES – BS3 A.M. WEDNESDAY, 10 June 2015 2 hours 1083 010001 ADDITIONAL MATERIALS In addition to this examination paper, you will need: • a calculator; • a 12 page answer book. INSTRUCTIONS TO CANDIDATES Use black ink or black ball-point pen. Answer all the questions. Write your answers in the separate answer book provided. INFORMATION FOR CANDIDATES The number of marks is given in brackets at the end of each question. You are reminded that assessment will take into account the quality of written communication used in answers that involve extended writing in questions 4 and 5. You are reminded that questions 4 and 5 are synoptic and so will test understanding of the connections between different elements of the subject. © WJEC CBAC Ltd. AM*(S15-1083-01) 2 Study the information provided about GlaxoSmithKline plc and answer the questions that follow. BACKGROUND GlaxoSmithKline plc (GSK) is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. It has three primary areas of business: pharmaceuticals, vaccines and consumer healthcare. Its consumer products include 5 Ribena, Macleans toothpaste, Panadol headache pills, Lucozade and Horlicks. The company can trace its history back to 1715 when Sylvanus Bevan established his pharmacy in Plough Court in London. In 1880, his descendants founded Burroughs Wellcome and Company which, eventually in 1995, merged with the Australian company Glaxo to form Glaxo Wellcome. The American branch of the business can trace its history back to 1830 when John K Smith 10 opened his first drugstore.