Merck – Schering-Plough

About

– Schering-Plough = Merger of Schering Corporation and Plough Inc. in 1971.
– 2009: Merger of Merck & Co. Inc. (68%) and Schering-Plough (32%). 41.1 billion dollar deal by 56% stock and 44% cash financed with $9.8 billion from existing cash balances and $8.5 billion from committed financing provided by J.P. Morgan.
– Following the entry of the United States into World War II in 1941, U.S. President Franklin Delano Roosevelt ordered Schering AG‘s U.S. assets be seized, becoming the Schering Corporation. Placed under a government administratorship until 1952, when it was released and its assets sold to the private sector.
– Business operations: More than 140 countries.
– Net Sales: $20.8 billion in 2008 ; $15.2 billion in 2007 ; $12.5 billion in 2006 ; $10.7 billion in 2005.

Business

Key Products
– ASMANEX (mometasone furoate), AVELOX (moxifloxacin), CAELYX (pegylated liposomal doxorubicin HCI), CLARINEX (desloratadine), CLARITIN (loratadine), FOLLISTIM (follitropin beta), INTEGRILIN (eptifibatide), INTRON A (interferon alfa-2b), NASONEX (mometasone furoate monohydrate), NOXAFIL (posaconazole), PEGINTRON (peginterferon alfa-2b), REMICADE (infliximab), TEMODAR (temozolomide), ZEMURON (rocuronium bromide).
– VYTORIN (ezetemibe/simvastatin) and ZETIA (ezetimibe) by joint venture with Merck.

2009
– License agreement between Nobilon, Schering-Plough’s human vaccine business unit, and the World Health Organization to provide access to pandemic influenza vaccine manufacturing technology for the WHO Global Vaccine Action Plan. Nobilon is developing a cell culture-based LAIV for seasonal influenza and is currently preparing for the “first-in-human” study with LAIV for seasonal influenza.
– Changes to global collaboration with Novartis for exclusive worldwide rights to develop and commercialize a fixed-dose combination of inhaled corticosteroid ASMANEX (mometasone furoate inhalation powder), and Novartis‘ long-acting beta2-adrenergic receptor agonist, FORADIL (formoterol fumarate). Novartis assumes exclusive worldwide rights to develop and commercialize a fixed-dose combination of Schering-Plough’s inhaled corticosteroid mometasone furoate with its investigational beta2-agonist QAB149 (indacaterol).

2008
– Approval of ASMANEX TWISTHALER 110 mcg (mometasone furoate inhalation powder) in the U.S. for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age.
– Agreement with OraSure Technologies Inc. to collaborate on the development and promotion of a rapid oral hepatitis C virus test utilizing OraSure Technologies‘ OraQuick technology platform on a worldwide basis outside the United States.
– European launch of BRIDION (sugammadex) injection.
– Approval of PEGINTRON (peginterferon alfa-2b) and REBETOL (ribavirin, USP) combination therapy in the U.S. for use in previously untreated patients 3 years of age and older with chronic hepatitis C.

2007
– Strategic alliance with ALK-Abello to develop and commercialize ALK-Abello’s tablet-based allergy immunotherapies in the United States, Canada and Mexico.
– Collaboration with OraSure Technologies Inc. on the development and promotion of a rapid oral test for the detection of antibodies to the hepatitis C virus utilizing OraSure Technologies‘ OraQuick technology platform in the United States.
– Exclusive worldwide agreement for the development and commercialization of AN2690, a topical antifungal therapy, with Anacor Pharmaceuticals.
– Acquisition of Organon BioSciences N.V., human and animal health care businesses of Akzo Nobel N.V., for approximately €11 billion in cash.
– The European Commission approves a new indication for REMICADE (infliximab) allowing for the treatment of severe, active Crohn’s disease in pediatric patients aged 6 to 17 years.
– Schering-Plough Corporation and Bayer HealthCare announce ZETIA marketing approval in Japan.
Kurve Technology Inc., a leading developer of nasal drug delivery devices, and Schering-Plough Corporation in a new agreement that expands Schering-Plough’s evaluation of, and option for exclusivity rights to, Kurve Technology‘s Controlled Particle Dispersion platform from a single field to multiple fields of use.
– Approval of PEGINTRON and REBETOL combination therapy in the E.U. for HCV/HIV coinfection.
– Worldwide licensing of Acadesine, an investigational, potentially first-in-class adenosine regulating agent, from PeriCor Therapeutics Inc.
– Approval of CLARITIN Dry Syrup 1% (loratadine drug syrup), in Japan, a once-a-day nonsedating antihistamine for treatment of allergic rhinitis, urticaria and itching associated with skin diseases in patients ages 3 years and older, and CLARITIN (loratadine) Tablets and CLARITIN (loratadine) Reditab Tablets in patients over age 7 years. In Japan, Schering-Plough co-markets the CLARITIN line of medications with Shionogi & Co. Ltd.
Centocor Inc. and Schering-Plough Corporation revise their 1998 distribution agreement regarding the development, commercialization and distribution of both REMICADE (infliximab), an anti-tumor necrosis factor alpha therapy for chronic inflammatory disorders. Centocor Inc. is a wholly owned subsidiary of Johnson & Johnson.

2006
– Approval of CLARINEX-D 12 HOUR Extended Release Tablets in the U.S. for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older.
– Approval of TEMODAL (temozolomide) Capsules in Japan for the treatment of malignant glioma, and in Canada for use in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme, a form of malignant brain cancer.
– The European Commission approves REMICADE (infliximab) for the treatment of moderately to severely active ulcerative colitis.
– Exclusive collaboration and licensing agreement with PTC Therapeutics Inc. for the development of PTC’s preclinical compounds for the oral treatment of hepatitis C virus infection and other viral diseases.
– Approval of REMICADE (infliximab) in Australia to include the treatment of early rheumatoid arthritis and for a new indication for psoriatic arthritis, and in the E.U. as monotherapy in the treatment of active and progressive psoriatic arthritis.
– Global collaboration with Novartis AG to develop and commercialize a new combination therapy using a new molecular entity to treat asthma and chronic obstructive pulmonary disease.
– Approval of NOXAFIL (posaconazole) Oral Suspension in the U.S. for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients 13 years of age and older.
Schering-Plough HealthCare Products Inc. enters into an agreement with Santarus Inc., granting certain exclusive rights to commercialize an over-the-counter version of ZEGERID (omeprazole/sodium bicarbonate) products for heartburn in the U.S. and Canada.
– Exclusive licensing agreement with Braintree Laboratories Inc. to market MiraLAX (polyethylene glycol 3350), as a non-prescription treatment for occasional constipation.
– Licensing agreements with Valeant Pharmaceuticals International and Metabasis Therapeutics Inc. for exclusive worldwide development and commercial rights to pradefovir, an investigational oral antiviral compound for treatment of chronic hepatitis B.
– Approval of REMICADE in the U.S. for pediatric patients with moderately to severely active Crohn’s disease.

2005
– Acquisition of NeoGenesis Pharmaceuticals Inc.
– Approval of CLARINEX-D 24 HOUR (desloratadine 5mg and pseudoephedrine sulfate USP 240 mg) Extended Release Tablets in the U.S. for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older.
– Approval of ASMANEX 220 mcg in U.S. for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.
– Approval of TEMODAL in the E.U. for the treatment of patients with newly diagnosed glioblastoma multiforme.
– Schering-Plough acquires exclusive development and commercialization rights from Millennium Pharmaceuticals Inc. to cardiovascular drug INTEGRILIN in the U.S.
– License agreement with Sankyo Company Ltd. for olmesartan for the treatment of hypertension. Exclusive rights to market olmesartan in Bolivia, Peru, Chile, Argentina, Paraguay and Uruguay, and co-market the product in Mexico, Venezuela, Panama, Costa Rica, Honduras, El Salvador, Guatemala, Nicaragua and the Dominican Republic.
– The European Commission approves REMICADE (infliximab) for the treatment of moderate to severe plaque psoriasis.
– Approval of NOXAFIL (posaconazole) Oral Suspension in the E.U. for the treatment of certain serious invasive fungal infections in adult patients.
– Approval of REMICADE in the U.S. for adult ulcerative colitis.
– Approval of TEMODAR in the U.S.
– HOMEAGAIN and the HOMEAGAIN Pet Recovery Service, national pet identification microchip database, begin offering new scanners used to detect microchips in companion animals throughout the U.S. The HOMEAGAIN microchip is marketed by Schering-Plough Animal Health Corporation, wholly-owned subsidiary of Schering-Plough Corp, and manufactured by Digital Angel Corporation.
– Collaboration and license agreement to utilize assay technology from ONCOMETHYLOME Sciences that measures the methylation status of the MGMT gene in patients with glioblastoma multiforme, a form of malignant brain cancer, treated with Temodar (temozolomide).
– Approval of once-daily broad-spectrum antibiotic AVELOX (moxifloxacin HCl) in the U.S. for treatment of complicated intra-abdominal infections in adults.
– Approval of PEG-INTRON and REBETOL in Japan for expanded use in treating chronic hepatitis C.

2004
Nobilon acquires the majority of rights to develop, commercialize and manufacture the Live Attenuated Influenza Vaccines, both egg and cell culture-based, from Australian company BioDiem, which had acquired these rights from the Institute of Experimental Medicine in St. Petersburg, Russian Federation.
– Approval of VYTORIN in the U.S. for the treatment of high cholesterol.
– Approval of REMICADE in the E.U. for psoriatic arthritis, and in the U.S. for reducing signs and symptoms in patients with active ankylosing spondylitis.

2003
– Agreement with Novartis for the joint worldwide development and marketing of a new combination treatment of the active ingredients in Schering-Plough’s ASMANEX and Novartis‘ FORADIL.
– Approval of REMICADE in the U.S. for maintenance therapy of fistulising Crohn’s disease, and in the E.U. for the treatment of ankylosing spondylitis.

2002
– Agreement with Novartis for exclusive U.S. distribution and marketing rights to Novartis‘ FORADIL AEROLIZER.
– In collaboration with Merck, obtains FDA approval for ZETIA, cholesterol-lowering medication. Then, approved in 90 countries worldwide.
– Co-promotion of cardiovascular drug INTEGRILIN and sharing of profits in the U.S. with Millennium Pharmaceuticals Inc.
– Approval of the over-the-counter sale of the original prescription strength of CLARITIN Tablets in the U.S.
– Approval of CLARITIN tablets in Japan for patients 15 years of age and older.
– Approval of REMICADE in the U.S. for maintenance therapy in patients with moderate to severe Crohn’s disease.

Before 2002
– 2001: Approval of PEGINTRON/REBETOL combination therapy in the E.U. for chronic hepatitis C and REMICADE in Japan for the treatment of moderate-to-severe Crohn’s disease.
– 2000: Schering- Plough Corporation and Merck & Co. Inc. form Schering-Plough/Merck Pharmaceuticals to develop and market a fixed-combination product that would combine loratadine and montelukast.
– 1999: Approval of REMICADE in the E.U. for the short-term treatment of severe, active Crohn’s disease and fistulizing, active Crohn’s disease and TEMODAL for the treatment of patients with malignant glioma.
– 1998: Approval of REMICADE in the U.S. for adult Crohn’s disease and CLARITIN in Belgium for treatment of symptoms of allergic rhinitis and CIU.
– 1997: Approval of NASONEX, a nasal inhaled steroid related to cortisol, in the U.S.
– 1993: Approval of CLARITIN in the U.S.

Corporate Governance (2009)

Fred Hassan
– Chairman of the Board and Chief Executive Officer since April 2003.
– Chairman and Chief Executive Officer of Pharmacia Corporation (1997-2003).
– Executive Vice President of Wyeth.
– U.S. pharmaceuticals business at Sandoz Pharmaceuticals (Novartis).
– Board Member of Avon Products Inc.
– President of International Federation of Pharmaceutical Manufacturers Associations.
– Past Chairman of Board of Directors at Pharmaceutical Research and Manufacturers of America (PhRMA).
– Past Chairman of HealthCare Institute of New Jersey.
– Chairman of Board of Pharmacia (2001).
– Board Member of Pharmacia & Upjohn (1997).
– Board Member of Wyeth (1995).
– B.S. Chemical Engineering from Imperial College of Science and Technology at University of London.
– M.B.A. from Harvard Business School.

Robert J. Bertolini
– Executive Vice President and Chief Financial Officer since 2003.
PricewaterhouseCoopers.
Coopers & Lybrand (1983).
– B.A. Economics from Rutgers University.
– Certified Public Accountant.

Richard S. Bowles III, Ph.D.
– Senior vice president, global quality operations since March 2001.
– Employee (1974-2000); Vice president for quality, manufacturing division (1992-1997); Vice president for Latin American and Puerto Rican manufacturing operations (1997-2000) at Merck.
– B.S. and M.S. degrees in chemical engineering from Columbia University and Ph.D. in chemical engineering from Princeton University.

C. Ron Cheeley
– Senior vice president, Global Human Resources since August 2003.
– Group vice president, global compensation and benefits, for Pharmacia Corporation.
– Director, global compensation and benefits, for The Coca-Cola Company. Director of human resources for Coca-Cola India.
– Member of the Schering-Plough Foundation Board of Trustees.
– Chairman of the board of directors and member of the executive committee of WorldatWork (1999-2000).
– Past member and chairman of the Conference Board Research Council on Employee Benefits. Also served on the Conference Board Executive Compensation Council and currently serves as a member of the American Benefits Council and the National Academy of Chief Human Resources Officers.
– Board of directors of the Susan G. Komen Breast Cancer Foundation.
– Certificate in strategic human resources management from Duke University Fuqua School of Business.
– B.B.A. degree in accounting from the University of Georgia and Master of Insurance degree from Georgia State University with a concentration in property and casualty risk management and employee benefits.

Carrie S. Cox
– Executive vice president and president Global Pharmaceuticals since May 2003.
– Executive vice president and president of the Global Prescription Business at Pharmacia Corporation, prior to its merger with Pfizer.
– Senior vice president and head of Global Business Management (1997); Executive vice president (1999) of Pharmacia & Upjohn.
– Vice president of Women’s Health Care at Wyeth for 7 years.
– Positions in market research, sales and product management for 10 years in Sandoz Pharmaceuticals (Novartis).
– Member of the Harvard School of Public Health‘s Health Policy and Management Executive Council.
– Member of the Board of Directors of Texas Instruments and member of that board’s audit committee.
– Member of the Board of Overseers of the University of Pennsylvania Museum of Archaeology and Anthropology.
– Graduate of the Massachusetts College of Pharmacy.

Thomas P. Koestler, Ph.D.
– Executive vice president and president of Schering-Plough Research Institute. Joined in August 2003
– Senior vice president and head of global regulatory affairs for Pharmacia Corporation.
– Senior vice president and global head, drug regulatory affairs, compliance assurance, clinical safety and epidemiology for Novartis.
– Senior director, drug regulatory affairs, at Ortho McNeil.
– Director of regulatory affairs at Bristol-Myers Squibb.
– Ph.D. degree from the State University of New York at Buffalo, Roswell Park Memorial Institute and B.S. degree in biology from Daeman College, Amherst, N.Y.
– Vice chairman and officer of the Children’s Specialized Hospital Foundation in Mountainside.

Ian McInnes, Ph.D.
– Senior vice president and president, Global Supply Chain since May 2004.
– Executive vice president, Supply Chain of Watson Pharmaceuticals Inc.
– Senior vice president, Global Supply of Pharmacia Corporation.
– Positions of increasing responsibility at GlaxoSmithKline, Baxter Healthcare and AstraZeneca.
– B.S. degree in manufacturing technology and manufacturing management and Ph.D. degree in manufacturing engineering and systems from the University of Strathclyde in Glasgow, Scotland.

Lori Queisser
– Senior vice president, Global Compliance and Business Practices since February 2007.
– Vice president, Chief Compliance Officer of Eli Lilly and Company.
– Auditor in Ernst & Young.
– Co-chair of the Pharmaceutical Compliance Forum.
– B.S. degree from the Indiana University School of Business.

Thomas J. Sabatino Jr.
– Executive vice president and general counsel since April 2004.
– Senior vice president and general counsel for Baxter International Inc. in Deerfield, III.
– Corporate counsel at Baxter‘s former Systems and Medical Specialty Device divisions (joined in 1986).
– Heads Baxter‘s legal team in the establishment of the IBAX joint venture in 1989.
– President and chief executive officer of Secure Medical Inc. (joined in 1990).
– Associate general counsel for American Medical International Inc. in 1992 and vice president and general counsel in 1993. American Medical International later merged with National Medical Enterprises to become Tenet Healthcare Corporation.
– Associate general counsel (1995); General counsel (1997); Senior vice president (2001) of Baxter.
– B.A. degree, cum laude, from Wesleyan University and a J.D. degree from the University of Pennsylvania Law School.

Operations Management
– Stanley F. Barshay: Chairman, Consumer Health Care since July 2003. Senior vice president of American Home Products Corporation (Wyeth) since 1987 to 1997 and president of several of the company’s subsidiaries, including Boyle-Midway Household Products Corporation and Whitehall Laboratories. On the Council of Overseers for the Arnold & Marie Schwartz College of Pharmacy and Health Sciences. On the board of directors of Bed, Bath & Beyond Inc.
– Margriet Gabriel-Regis: Senior vice president, Specialty Care Customer Group, for the Global Pharmaceutical Business since September 2003. Group vice president, hospital and specialty for Pharmacia Corporation since 2000. Various leadership roles in strategic planning and marketing in Rhone-Poulenc Rorer. Increasingly responsible positions in finance, sales, marketing and regional and country management in Lederle International (merged with Wyeth).
– Maria Teresa Hilado: Vice president and treasurer since May 2008. Assistant treasurer for General Motors Corporation, responsible for global funding, cash management, securitizations, foreign exchange and commodities management and other strategic financial initiatives (joined in 1990).
– Alex Kelly, R.Ph.: Group vice president, Global Communications and Investor Relations since October 2007 (joined in April 2004). Executive director of Investor Relations for Novartis Corporation. Senior director of Investor Relations at Pharmacia Corporation.
– Steven H. Koehler: Vice president and controller since March 2006. Senior vice president, chief financial officer and treasurer of The Medicines Company. Vice president and chief financial officer at Vion Pharmaceuticals. Vice president, Finance Americas, for the Knoll Pharmaceuticals Company, the U.S. pharmaceutical unit of BASF. Vice president, global finance and controller of BASF Germany.
– Ellen Geisel: Senior vice president, Primary Care Customer Group since July 2003. Senior vice president of customer communications for Pharmacia Corporation. Management positions at Wyeth Pharmaceuticals, Earle Palmer Brown and SmithKline Consumer Products, a division of GlaxoSmithKline.

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