Merck – Business

About

Merial = Merger of Merck & Co. Inc. (MSD AgVet) and Sanofi-Aventis (Rhone Mérieux) in 1997. In 2009 Merck sells its 50% to Sanofi-Aventis for $4 billion in cash.
– 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.
– Merck supports the United Nations Global Compact.
– Member of The Corporate Council on Africa.
– Corporate member of the Council on Foreign Relations.

Business

Origins
– 1891: Established in the United States as subsidiary of German company Merck KGaA.
– 1917: Confiscated during World War I and set up as independent company.
– 1940: Max Tishler develops sulfaquinoxaline, first efficient anticoccidial for use in the poultry industry.
– 1960: Launch of first avian veterinary products, Nicrazin and Amprol.
– 1962: Launch of Thibenzole (thiabendazole), first broad-spectrum endoparasitic agent.
– 1974: Acquisition of Hubbard (acquired by Groupe Grimaud in 2005).
– 1978: Acquisition of British United Turkeys.
– 1979: Creation of Merck MSD AgVet, including all animal health and poultry breeding activities and all crop science activities.
– 1980: Development of 19 different forms of ivermectin for the treatment of more than 11 animal species against internal and external parasites.
– 1986: HIV research program begins.
– 1996: Merck AgVet ranks Nº2 on the world animal health market.

2006
– Merck acquires Sirna Therapeutics Inc., original Ribozyme Pharmaceutical, co-founded in 1993 by Thomas R. Cech, president of Howard Hughes Medical Institute, and elected for the board of directors of Merck in May 2009.

2007
– License and Research Collaboration Agreement with SurModics Inc. to pursue the joint development and commercialization of the I-vation sustained drug delivery system with TA (triamcinolone acetonide) and other products that combine Merck proprietary drug compounds with the I-vation system for the treatment of serious retinal diseases.
– Global collaboration with ARIAD Pharmaceuticals Inc. to jointly develop and commercialize AP23573, ARIAD‘s novel mTOR inhibitor, for use in cancer.
– Merck acquires NovaCardia Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular diseases. NovaCardia‘s investors include Domain Associates, Forward Ventures, Montreux Equity Partners, Versant Ventures, Skyline Ventures and InterWest Partners. NovaCardia will spin-out a new corporate entity to support clinical development of the company’s second compound, K201 (JTV-519) for atrial fibrillation.
– Partnership with GlaxoSmithKline for over-the-counter marketing rights for MEVACOR.
– ISENTRESS, Merck’s first-in-class HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, launched in the United States, the European Union, Canada and Mexico.
– Merck, the HIV Vaccine Trials Network and the National Institutes of Health announce that the HIV vaccine created by Merck Research Laboratories, which had been in development at Merck for more than a decade, is not effective.

2008
– IVEMEND approved in the European Union.
FDA approves use of EMEND for injection (IVEMEND in E.U.), an intravenous therapy for chemotherapy-induced nausea and vomiting, and ISENTRESS (raltegravir), Merck’s first-in-class HIV integrase inhibitor.
– TREDAPTIVE (nicotinic acid/laropiprant) 1 g/20 mg modified-release tablets, a new lipid-modifying therapy for patients with dyslipidemia and primary hypercholesterolemia, approved in the European Union, Iceland and Norway.
– The Merck Company Foundation, the philanthropic arm of Merck, creates the Merck Alliance to Reduce Disparities in Diabetes.
Merck BioVentures, new division which capitalizes on the manufacture of biologics, as well as proprietary technologies that streamline the production of protein-based therapies.
– More than $8 million in grants to more than 200 non-governmental organizations and community-based organizations to combat HIV and AIDS in the U.S. and worldwide.

2009
– Definitive agreement with Insmed Inc. to purchase Insmed‘s portfolio of follow-on biologic therapeutic candidates and its commercial manufacturing facilities located in Boulder, Colo.
– Licensing agreement with Medicines for Malaria Venture for an investigational drug candidate for the treatment of malaria in the developing world.
– Worldwide licensing agreement with Santen Pharmaceutical Co. Ltd. for Tafluprost, approved in several European and Nordic countries, Japan and Asia Pacific markets for the reduction of elevated intraocular pressure in open-angle glaucoma and ocular hypertension.
– Collaboration and license agreement with Cardiome Pharma Corp. for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation.
– Collaboration with AstraZeneca to investigate novel combination anticancer regimen.
– Worldwide license agreement with Portola Pharmaceuticals Inc. to develop and commercialize Betrixaban, a novel investigational oral anticoagulant for cardiovascular disease.
– Master agreement with Drugs for Neglected Diseases initiative to support discovery and development of improved treatments for neglected tropical diseases.
FDA approves expanded indication for ISENTRESS that includes use in the treatment of adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as in treatment-experienced adult patients.
– Exclusive agreement with CSL Biotherapies, subsidiary of CSL Limited, to market and distribute AFLURIA (Influenza Virus Vaccine).

Vioxx

History
– Merck knows Vioxx raises the risk of heart-related side effects by 35%.
– 1999: The FDA approves Vioxx (rofecoxib) to treat osteoarthritis, acute pain conditions, and dysmenorrhoea. Killed up to 140,000 people after being ‘proved safe’ in animals, including monkeys.
– 2000: Enero, llega al mercado español. Marzo, un ensayo clínico patrocinado por Merck (que compara Vioxx con un antiinflamatorio clásico en 8000 pacientes) desvela que quienes toman el primero tienen menos problemas gastrointestinales pero 4 veces más riesgo cardiovascular.
– 2001: Agosto, una extensa revisión en la revista “JAMA” pone en entredicho la seguridad cardiovascular de los COX-2. Septiembre, la FDA amonesta a Merck por no advertir en la publicidad dirigida a los médicos del riesgo coronario de Vioxx.
– 2002: Abril, la FDA ordena que se modifique el etiquetado de Vioxx, deberá incluir una advertencia sobre sus riesgos cardiovasculares. Julio, el Ministerio de Sanidad introduce la exigencia de visado para todas las recetas de inhibidores de la COX-2.
– 2004: Agosto, estudio realizado por la FDA dice que las personas que consumen la dosis más alta de rofecoxib triplican su riesgo cardiaco. September, the FDA‘s decision to approve Vioxx for children is reached at the same time that Merck decide to withdraw the drug because it causes cardiac arrest and kills people. Los reumatólogos estadounidenses advierten que se valoren los riesgos cardiacos de los COX-2 antes de recetarlos.
– 2005: Merck is found liable in the first case that went to trial and the plaintiff was awarded $253.4 million in damages; however, the judgement was subsequently reduced to $20 million and then, upon appeal, the verdict was reversed in 2008.
– 2007: November, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits. The settlement will require that claimants provide medical proof of having suffered a heart attack or a stroke and show they received at least 30 Vioxx pills. This proposed settlement is generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck’s liability reached as high as $50 billion. As of mid-2008, plaintiffs have prevailed in only three of the twenty cases that have reached juries, all with relatively small awards.
– 2008: May 20, Merck is found liable for using deceptive marketing tactics to promote Vioxx and 30 states split the $58 million settlement, the largest multi-state settlement against a pharmaceutical company. All its new television pain-advertisements must be vetted by the FDA and changed or delayed upon request until 2018.

Scott S. Reuben
– Professor of Anesthesiology and Pain Medicine at Baystate Medical Center in Springfield, Massachusetts. Educated at Columbia University. Graduated from medical school at the State University of New York at Buffalo in 1985 and anesthesiology residency at Mount Sinai Medical Center in New York.
– 5 research grants between 2002 and 2007 by Pfizer. Paid member of the company’s speakers bureau, giving talks about Pfizer drugs to colleagues.
– March 11, 2009: Admits that fabricated much of the data underlying his research and never conducted the clinical trials that wrote about in 21 journal articles dating from at least 1996, in some cases, even invented the patients. Reported favorable results from painkillers including Pfizer‘s Bextra, Celebrex and Lyrica, Merck’s Vioxx and Wyeth‘s antidepressant Effexor, and wrote to the FDA urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness.

Press
– Vioxx became one of the most prescribed drugs in history. Worldwide, over 80 million people were prescribed rofecoxib at some time. Sales revenue of US$2.5 billion in 2003.
– Entre 1999 y 2004 se dispensaron en EEUU más de 100 millones de recetas de Vioxx.
– Merck had a list of doctors critical of Vioxx to be “neutralised” or “discredited”. “We may need to seek them out and destroy them where they live”, wrote an employee. Also alleged were intimidation of researchers and impingement upon academic freedom.
– En los años 90 (Vioxx aún no comercializado) empleados de la empresa intercambiaron correos electrónicos manifestando su preocupación por los riesgos cardiovasculares del fármaco.
– La alternativa de Pfizer se beneficia de la retirada de Vioxx.
– David J. Graham, M.D., M.P.H., Associate Director of the FDA‘s Office of Drug Safety: “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless”, (November 18, 2004).

Gardasil

2009
– As of February, 40 million doses of Gardasil had been distributed worldwide.
– Federal report conclude that the human papillomavirus vaccine Gardasil has a 400% higher rate of adverse effects than another comparable vaccine, the Menactra anti-meningitis shot. Associated with twice as many emergency room visits, four times as many deaths, four times as many heart attacks, seven times as many “disabled” reports and 15 times as many strokes. All reported cases of blood clots and heart attacks associated with Gardasil occurred when the vaccine was given alone, not in conjunction with other drugs.
– Gardasil, first cervical cancer vaccine to receive WHO pre-qualification. Now eligible for procurement by the United Nations Children’s Fund and other United Nations agencies including the Pan American Health Organization, for use in national immunization programs.
FDA approves GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine Recombinant, for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus types 6 and 11.
U.S. Centers for Disease Control and Prevention‘s Advisory Committee on Immunization Practices supports the permissive use of GARDASIL for boys and young men ages 9 to 26. Also recommens vaccination with either the bivalent or the quadrivalent HPV vaccine for the prevention of HPV 16 and -18 related cervical cancers, precancers and dysplastic lesions, and recommended vaccination with the quadrivalent HPV vaccine, GARDASIL, for the prevention of cervical, vulvar and vaginal cancers, precancers and dysplastic lesions due to HPV types 16 or 18, and for prevention of genital warts due to HPV types 6 or 11.

2008
– The European Medicines Agency reports that 2 young women died shortly after receiving Gardasil.
– 3 young women, aged 12, 19 and 22, died in the United States within days after receiving a Gardasil shot. 1,700 cases reported of patients suffering non-lethal adverse reactions.
– 3 girls in Australia developed pancreatitis shortly after being given the Gardasil jab.
U.S. Citizenship and Immigration Services announces that people from other countries who want to become legal permanent residents of the US are required to have the HPV vaccination to protect against cervical cancer.

2007
– 3,461 complaints about Gardasil filed with FDA‘s Vaccine Adverse Event Report System since its approval in 2006, and 11 women died after exposure to the vaccine.
– Side-effects reported included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. And of 42 women who were vaccinated with Gardasil while pregnant, 18 experienced complications, ranging from miscarriages to fetal abnormalities, according to FDA data. One of the 18 women was diagnosed with an abnormal fetus, and a test conducted on another woman during her pregnancy showed an increased risk of fetal defect.
– Gardasil posted total sales of $1.5 billion.

2006
Gardasil approved for 9 to 26 year old girls and women.

Barbara Loe Fisher, Prevent Gardasil Vaccine Injuries & Deaths
Product Performance Highlights

2008
– JANUVIA (sitagliptin), first-in-class DPP-4 inhibitor for the treatment of type 2 diabetes, reached $1.4 billion in worldwide sales.
– JANUMET (sitagliptin/metformin hydrochloride), a single tablet that targets all three key defects of type 2 diabetes achieved $351 million in global sales.
– ISENTRESS (raltegravir) reported worldwide sales of $361 million.
– Worldwide sales of SINGULAIR (montelukast sodium), a once-a-day oral medicine indicated for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, were $4.3 billion.
– Global sales of antihypertensive medicines, COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide), were $3.6 billion.
– ZOSTAVAX, vaccine to help prevent shingles (herpes zoster), recorded sales of $312 million.
– Worldwide sales of ROTATEQ (rotavirus vaccine, live, oral, pentavalent), vaccine to help protect children against rotavirus gastroenteritis, were $665 million.
– Worldwide sales of other viral vaccines, including VARIVAX (varicella virus vaccine live), M-M-R II (measles, mumps and rubella virus vaccine live) and PROQUAD (measles, mumps, rubella and varicella virus vaccine live), were $1.3 billion.

2007
– Worldwide sales of SINGULAIR, a once-a-day oral medicine indicated for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, were $4.3 billion. Nº1 prescribed product in the U.S. respiratory market.
– Global sales of antihypertensive medicines, COZAAR and HYZAAR, were $3.4 billion.
– Worldwide sales of FOSAMAX and FOSAMAX PLUS D (FOSAVANCE throughout the E.U.) were $3.0 billion.
– ROTATEQ achieved worldwide sales of $525 million.
– Other pediatric vaccines, including VARIVAX, PROQUAD and M-M-R II, posted total sales of $1.3 billion.
– VARIVAX, a vaccine for the prevention of chickenpox, were $855 million.
– ZOSTAVAX recorded sales of $236 million.

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