臺灣博碩士論文加值系統

本文以事件研究法，討論美國食品暨藥物管理局在核准新藥上市的宣告效果。結果顯示在宣告日當天，各藥廠的異常報酬沒有顯著改變，但在宣告日的前五十天交易日可以觀察到顯著的累計異常報酬，根據美國食品暨藥物管理局的審核新藥流程以及學術性期刊對於新藥的臨床實驗數據探討，亦或是新聞對於新藥療效的提前揭露，推測皆會影響事件日之前的股價反應。進一步根據會計資料的觀察，新藥的核准上市，對於藥廠的營收雖沒有顯著改變，仍可以看出有增加的趨勢。最後，諸多新聞指出分析師對於新藥的審核過程中可以取得此藥物是否會通過美國食品暨藥物管理局的內線消息，結果顯示約有41％的分析師可以準確預測藥物是否可以通過，或許跟製藥業不同於其他產業的流程導致內線消息流出有關。

In this paper, we use event-study to estimate the stock price changes of Food and Drug Administration (FDA) decisions on new products for pharmaceutical companies. We find that FDA decisions have insignificant effects in all countries on the drug approval date. The insignificant price changes accompanying FDA announcements approval suggest that drug results have leaked to the market. It is quite possible that the results of advisory are open to public and advisory committee are held before FDA approval, advisory committee can be viewed as important news source of drug approval. After the drug approved by the FDA, the new drugs may bring additional income to the companies. Although the accounting data are insignificant at five percent significant level, we still can peek that the companies with new approval drug have their EPS increase. Besides, 41% of analyst rates the performance of next quarter better than actual EPS at that time. The reason can be the access of undisclosed information about successful approval of new drugs.

Contents
I.Introduction…………………………………………………………… 1
II.Literature Review…………………………………………………… 4
A. Characteristics of Bio-Pharmaceutical industry…4
B. FDA approve drug………………………………………………7
C. Drug news release before FDA approval date… 11
D. Analysts and insider-trading in Bio-Pharmaceutical industry…………………………………………………14
III.Data and Methodology……………………………………… 17
A .Data………………………………………………………… 17
B. Event-study for stock returns……………………… 18
C. Analysts’ Earnings Forecasts……………………… 20
IV.Results…………………………………………………………………… 22
V.Conclusions……………………………………………………………… 28
VI.References……………………………………………………………… 30

Abrams S., 1994, The Publication of Clinical Facts: A Natural-Science View, International Journal of Psycho-Analysis, 75, 1201-1210
Acronym Required (http://www.acronymrequired.com/), 2005, Hedging Their Bets: Doctors, Pharmas and Investors
Adams C, Brantner V., 2006, Estimating the cost of new drug development: is it really 802 million dollars? Health Affairs, 25(2), 420–8
Anand, Geeta and Smith, Randall, 2002, Trial Heat: Biotech Analysts Strive to Peek Inside Clinical Tests of Drugs-One Impersonated a Patient, One a Doctor; Firms Pay Physicians as Consultants- `Creativity Knows No Bounds', The Wall Street Journal
Arnst, Catherine, 2002, How Drug News Leaks to Investors, Business Week, 3781, 32-33
Baird, P., 2008, Clinical Trials and Industry, Science, 297, 2211
Barnett, Antony, 2003, Revealed: how drug firms 'hoodwink' medical journals, from website: guardian.co.uk︱The Observer
Bosch, Jean-Claude and Lee Insup, 1994, Wealth effects of Food and Drug Administration (FDA) Decisions, Managerial and Decision Economics, 15(6), 589-599
Brown, S.J. and Warner, J.B., Using Daily Stock Returns: the Case of Event Studies, Journal of Financial Economics, 14, 3-31
Church, Robert F., 2008, Pharmaceutical and Biotechnology Update, Pharmaceutical and Biotechnology Update, 1-3
Danzon, Patricia M., Epstein, Andrew and Nicholson, Sean, 2004, Mergers and Acquisitions in the Pharmaceutical and Biotech Industries, The Wharton School of University of Pennsylvania
De Bondt, W. F. M. and Forbes, W. P., 1999, Herding in Analyst Earnings Forecasts: Evidence from the United Kingdom, European Financial Management 5, 143-163
DiMasi J, Hansen R and Grabowski H, 2003, The price of innovation: new estimates of drug development costs, Journal of Health Economics, 22(2), 151–85.
Ferguson, James R., 1997, Biomedical Research and Insider Trading, The New England Journal of Medicine, 337, 631-634
Frank, Richard G., 2003, New estimates of drug development costs, Journal of Health Economics, 22(2), 325-330
Gad, Shayne Cox, 2005, Drug Discovery Handbook, Wiley-Interscience
Hadzovic, 1997, Pharmacy and the great contribution of Arab-Islamic science to its development, Medicines Archive, 51 (1-2), 47-50
Huberman, Gur and T. Regev, 2001, Contagious Speculation and a Cure for Cancer: A non-event made stock prices soar, Journal of Finance, 56, 387-396
Kraljevic, Sandra, Stambrook, Peter J. and Pavelic, Kresimir, 2004, Accelerating drug discovery, EMBO Reports, 5(9), 837-842
Lenzer, Jeanne, 2005, What Can We Learn from Medical Whistleblowers? PLoS Medicine, 2(7), 583-586
Liu, Qiao, 2006, How Good is Good News? Technology Depth, Book-to-Market Ratios, and Innovative Events, Journal of Accounting Auditing and Finance, 21 (3), 293-321
Loomis, Carol J, 2008, Buffett’s biggest bets, Fortune
McGuire, John L., Hasskarl, Horst, Bode, Gerd, Klingmann, Ingrid and Zahn, Manuel, 2007, Pharmaceuticals: General Survey, Ullmann's Encyclopedia of Chemical Technology
Moynihan R., 2008, Who pays for the pizza? Redefining the relationships between doctors and drug companies, British Medical Journal, 326(7400), 1193–1196
Pollack, Andrew, 2002, ImClone Stock Sales Disclosed, The New York Times
Skolnick AA., 1998, SEC Going After Insider Trading Based on Medical Research Results, JAMA, 280(1), 10-11
Stewart, James B., 2007, Investors Should Heed Warren Buffett's Free Advice, Smart money
Stout, Hilary and Newman, Anne, 19 June 1991, FDA looks to stop leaks on drug stock, The Wall Street Journal
Timmerman, Luke and Heath, David, 2005, Drug researchers leak secrets to Wall St., The Seattle Times
Tufts Center for the Study of Drug Development
Unknown, 2003, Rising Nicely, Economist, 367(8327), 55-56
Unknown, Drug Discovery & Development, 2005, industry trends
Wold, Kirsten, Schneider, Chad, Shields, Brandon and Kerwin, Ricky, 2002, Prescription Drug Market, Economics 333