Merck & Co.
Merck & Co., Inc.（Merck & Co., Inc.）は、アメリカのニュージャージー州ラーウェイに本社を置く多国籍製薬企業であり、1668年にドイツで設立されたMerck Groupに由来する。米国とカナダ以外ではMerck Sharp & DohmeまたはMSDとして事業を展開している。世界最大の製薬会社のひとつであり、売上高では世界トップ5に入る。
  1992年にChermayeff & GeismarのSteff Geissbuhlerがデザインした現在のメルク・アンド・カンパニーのロゴ。米国とカナダでは "MERCK"の商号が使用され（上）、これらの国以外では "MSD"が使用されている（下）。 | |
 アッパー・グウィネッド・タウンシップ, ペンシルバニア州にあるMerck's branch office campus | |
| Sector | Public |
|---|---|
| Industry | Pharmaceutical industry |
Area served | Worldwide |
Key people | Robert M. Davis (chairman, president and CEO) |
| Products | |
 US$1.889 billion (2023) | |
| US$365 million (2023) | |
| Total assets | US$106.7 billion (2023) |
| Total equity | US$37.58 billion (2023) |
Number of employees | c. 72,000 (2023) |
| Website | |
Merck & Co.は1891年にMerckグループのアメリカ法人として設立された。Merckは医薬品、ワクチン、生物学的製剤、動物用医薬品を開発・製造している。がん免疫療法、抗糖尿病医薬品、HPVおよび水疱瘡ワクチンなど、2020年の売上高を誇る複数のブロックバスター薬物や製品を有している。
2022年のFortune500では71位、2022年のForbesGlobal 2000では87位であり、いずれも2021年の売上に基づいている。2023年のForbes Global 2000における同社の座は73位だった。
Products
同社は医薬品、ワクチン、生物学的療法、アニマルヘルス製品を開発している。2020年には6つのブロックバスター医薬品または製品があり、それぞれの売上高は10億ドルを超えている。キイトルーダ（ペムブロリズマブ）はがん免疫療法に使用されるヒト化抗体で、2020年の売上高は143億ドル。 2020年の売上は13億ドル、2型糖尿病の治療に使われる抗糖尿病薬のジャヌビア（シタグリプチン）は53億ドル、HPVワクチンのガーダシルは39億ドルである。 2020年の売上は39億ドル、水痘の予防に使われる水痘ワクチンのバリバックスは19億ドル、神経筋遮断薬のブリディオン（スガマデクス）は12億ドル、肺炎球菌多糖体ワクチンのニューモバックス23は11億ドルである。同社の他の主要製品には、2020年の売上高が8億5700万ドルであったHIV/AIDSの治療に用いられる抗レトロウイルス薬であるIsentress（ラルテグラビル）、免疫抑制薬として使用されるヒトのモノクローナル抗体であるSimponi（ゴリムマブ）が2020年の売上は7億9700万ドル、成人のBRCA変異進行卵巣がんの維持治療薬のLynparza(オラパリブ)で2020年の売上は7億2500万ドルとなっている。
Merckの主要製品の詳細は以下の通りである：
- ジャヌビア（シタグリプチン）は、2型糖尿病治療薬のジペプチジルペプチダーゼIV阻害薬である。2013年、ジャヌビアは世界で2番目に売れている糖尿病治療薬である。ジャヌビアは一般的にジェネリックの抗糖尿病薬メトホルミンと併用される。ジャヌビアは、他の多くの糖尿病治療薬と異なり、体重増加がほとんどなく、低血糖を伴わないこともあって人気を博している。メルク社は、ジャヌビアとメトホルミンの両方を含む1錠の配合剤もジャヌメットという商品名で販売している。ジャヌビアや他のDPP-IV阻害薬による治療では、膵炎のリスクがわずかに上昇することが懸念されている。
- ゼチーア（エゼチミブ）は、食事性コレステロールの吸収を阻害する作用を持つ高コレステロール血症治療薬である。ゼチーアは、当初は血清コレステロール値への影響に基づいて承認されたが、実際に心血管疾患の発生率に影響を与えるという確証がなかったため、議論の的となっていた。しかし、2014年の米国心臓学会学術集会で発表されたIMPROVE-IT試験の結果では、高リスクの急性冠症候群後の患者に対して、シンバスタチンにゼチアを追加することで、緩やかではあるが統計学的に有意なベネフィットが示された。
- レミケード（一般名：インフリキシマブ）は、サイトカインTNFαを標的とするモノクローナル抗体であり、関節リウマチ、クローン病、強直性脊椎炎、尋常性乾癬などの広範な自己免疫疾患の治療に用いられる。レミケードおよび他のTNFα阻害薬は、メトトレキサートと相加的な治療効果を示し、QOLを改善する。副作用には、感染症や特定の癌のリスク増加が含まれる。Merckは特定の領域で、Janssen Biotechは他の領域でこの薬の権利を有していた。2017年、Merckはレミケードのバイオシミラーであるレンフレクシスを発表した。
- ガーダシル（遺伝子組換えヒト乳頭腫ウイルスワクチン）は、ヒト乳頭腫ウイルス（HPV）の複数の血清型に対するワクチンである。
- イセントレス（ラルテグラビル）は、HIV感染症治療用のヒト免疫不全ウイルスインテグラーゼ阻害薬である。この作用機序を持つ最初の抗HIV薬である。米国保健社会福祉省が推奨するいくつかの第一選択治療レジメンの一つである。
- キイトルーダ（ペムブロリズマブ）はがん治療用の免疫調節薬である。2014年9月4日、米国食品医薬品局（FDA）はペムブロリズマブ（MK-3475）をメラノーマ治療の画期的治療薬として承認した。臨床試験において、ペムブロリズマブは患者の約4分の1で腫瘍の部分的な退縮をもたらし、その多くは6カ月以上の追跡調査でもそれ以上の病状の進行が見られていない。
- インバンツ（エルタペネム）は注射用抗生物質で、Merckは1999年からその権利を所有している。Merckは台湾のSavior Lifetec社と、米国におけるジェネリック医薬品の販売権獲得をめぐって法的紛争を起こしていた。その後、Savior社はジェネリック医薬品であるエルタペネムの販売承認を取得した。
- メクサナは防腐剤入りの薬用パウダーである。
- メクチザン（イベルメクチン）は、伝統的に河川失明症の治療に用いられてきた抗寄生虫薬である。Merckのメクチザン・ドネーション・プログラムの中心的存在で、イエメンやアフリカ諸国などの何百万人もの人々の治療のために、Merckはこの薬の投与量を寄付している。
- モルヌピラビルはCOVID-19を治療するための抗ウイルス薬で、Ridgeback Biotherapeutics社と共同で開発された。
Merck & Co.は、医師、看護師、技術者、獣医師向けの医学参考書のシリーズであるThe Merck Manualsを出版している。これには、世界で最も売れている医学参考書であるMerck Manual of Diagnosis and Therapyが含まれる。2012年に英国王立化学会に買収されるまで、化合物の大要であるThe Merck IndexはMerck & Co.によって出版されていた。
History
Roots and early history
Merck & Co.の起源は、1668年にFriedrich Jacob MerckがDarmstadtの薬局を購入したときにMerck familyによって設立された旧ドイツの親会社Merck Groupに遡る。1827年、Merck Groupはモルヒネの商業的製造によって薬局から製薬会社へと発展した。Merckはアヘンからモルヒネを得る化学的プロセスを完成させ、後にコカインを導入した。
1887年、ドイツ生まれで長年Merck に勤務していたTheodore Weickerが、Merck Groupの代表として渡米した。1891年、WeickerはE.Merckから受け取った20万ドルを元手に、マンハッタン区に本社を置くMerck & Co.を設立した。この年、当時のE.Merckの社長の息子（創業者の孫）で23歳のGeorge MerckがニューヨークでWeickerに加わった。Merck & Co.は1891年から1917年まで、Merck Groupの米国子会社として運営された。
Nationalization
アメリカが第一次世界大戦に参戦した後、ドイツとのつながりがあったため、Merck & Co.は1917年敵国取引法に基づく収用の対象となった。政府はドイツの親会社が所有する株式の80％を差し押さえ、売却した。1919年、George F. Merck（Merck familyのアメリカ支社長）は、Goldman SachsおよびLehman Brothersと共同で、アメリカ政府の競売で350万ドルで会社を買い戻したが、Merck & Co.は元のドイツの親会社とは別会社のままであった。Merck & Co.は、米国とカナダにおける「Merck」の名称の商標権を保有し、それ以外の地域では旧親会社が権利を保有している。Merckの名称を使用する権利は、2016年に両社間で訴訟の対象となった。
1925年、George W. Merckが父George F. Merckの後を継いで社長に就任した。1927年、フィラデルフィアのキニーネ製造会社PowersWeightman-Rosengarten Companyと合併。George Merckが社長に留まり、Frederic Rosengartenが会長となった。1929年、H. K. Mulford CompanyはSharp and Dohmeと合併し、第一次世界大戦における騎兵馬の予防接種やジフテリア抗毒素のMerck & Co.への納入など、ワクチン技術をもたらした。
1943年、ラトガース大学のSelman Waksmanの研究室で、Merckが資金を提供した研究プログラムの中でストレプトマイシンが発見された。それは結核に対する最初の有効な治療薬となった。発見当時、結核感染者を隔離するための療養所は先進国の都市のいたるところにあり、50％が入所後5年以内に死亡していた。Merckとラトガース大学との契約では、ストレプトマイシンの独占権が与えられていたが、Waksmanの要請により、同社は契約を再交渉し、ロイヤリティと引き換えに権利を大学に返還した。大学はその後、抗生物質の安定供給を確保するため、7社と非独占的ライセンスを結んだ。
1950–2000
1950年代、チアジド系利尿薬がMerckの科学者Karl H. Beyer, James M. Sprague, John E. Baer, Frederick C. Novelloによって開発され、1958年にこのクラスの最初の薬剤であるクロロチアジドがデュイリルという商品名で販売されるに至った。クロロチアジドの発見につながる研究は、「数え切れないほどの何千人もの命を救い、何百万人もの高血圧患者の苦しみを和らげる」ことにつながり、1975年にラスカー財団から公衆衛生特別賞を授与された。
1953年、Merck & Co.はフィラデルフィアに本社を置くSharp & Dohme, Inc.と合併し、米国最大の医薬品メーカーとなった。Sharp & Dohme, Inc.は1929年にH. K. Mulford Companyを買収し、天然痘ワクチンをポートフォリオに加えた。統合された会社は、米国とカナダではMerckの商号を維持し、北米以外ではMerck Sharp & Dohme（MSD）となった。
1965年、Merck & Co.はCharles Frosst Ltd.を買収した。モントリオール（1899年設立）を買収し、カナダの子会社および製薬研究施設としてMerck-Frosst Canada, Inc.を設立した。Merckは2010年7月にこの施設を閉鎖したが、2011年にMerck Canadaとして再出発した。
Merckの科学者であったMaurice Hillemanは、1967年に最初のおたふくかぜワクチン、1969年に最初の風疹ワクチン、1971年に最初の3価の麻疹・おたふくかぜ・風疹（MMRワクチン）を開発した。風疹ワクチン開発の余波で、風疹に関連した先天性異常の発生率は、アメリカでは年間10,000人にも上っていたものがゼロになった。Hillemanはまた、最初のB型肝炎ワクチンと、水疱瘡のための最初の水痘ワクチンを開発した。
1970年にニュージャージー州で法人化された。1976年にJohn J. HoranがCEO兼会長に就任し、1985年まで務めた。彼のリーダーシップの下、研究開発への投資は3倍に増加し、Merckは世界最大の製薬会社となった。
1979年、Merckの科学者はロバスタチン（「メバコール」）を開発した。スタチンクラスの最初の薬である。
Merckの科学者であるウィリアム・C・キャンベルと大村智は1981年に獣医学用としてイベルメクチンを開発し、その後1987年から88年にかけてオンコセルカ症に対してメクチザンの名でヒトに使用されるようになり、今日では河川盲目症、リンパ系フィラリア症、疥癬などの寄生虫感染症に対して使用されている。
1982年にはAstraZenecaと合弁会社KBI Inc.を設立した。1980年代後半から1990年代にかけては、研究開発の専門知識を利用するためにDuPontと、市販の消費者向け医薬品を販売するためにJohnson & Johnsonとも合弁会社を設立した。
1985年、Merckはカルバペネムクラスの抗生物質の最初のメンバーであるイミペネムの承認を得た。カルバペネムクラスの抗生物質は、特定の院内感染や多剤耐性感染症の治療ガイドラインにおいて重要な役割を果たしている。同年、P. Roy VagelosがHoranの後任としてCEO兼会長に就任した。
1991年、Merckの子会社Kelcoはサンディエゴ地域の揮発性有機化合物（VOC）排出公害の責任を負った。1996年、Merckは大気汚染に対して180万ドルを支払った。年間680,000 lb (310,000 kg)のスモッグ排出量を削減するために新しい機械が設置された。
1993年11月、Merck & Co.はMedco Containment Servicesを60億ドルで買収した。Merckは10年後にMedcoを分離独立させた。
2001–2019
In May 2002, The Bill & Melinda Gates Foundation purchased stock in Merck.
From 2002 through 2005, the Australian affiliate of Merck paid publishing house Elsevier an undisclosed amount to produce eight issues of a medical journal, the Australasian Journal of Bone and Joint Medicine. Although it gave the appearance of being an independent peer-reviewed journal, without any indication that Merck had paid for it, the journal actually reprinted articles that originally appeared in other publications and that were favorable to Merck. The misleading publication came to light in 2009 during a personal injury lawsuit filed over Vioxx; 9 of 29 articles in the journal's second issue referred positively to Vioxx. The CEO of Elsevier's Health Sciences Division, Michael Hansen, admitted that the practice was "unacceptable".
In 2005, CEO Raymond Gilmartin retired following Merck's voluntary worldwide withdrawal of Vioxx. Former president of manufacturing Richard Clark was named CEO and company president.
In November 2009, Merck & Co. completed a merger with Schering-Plough in a US$41 billion deal. Although Merck & Co. was in reality acquiring Schering-Plough, the purchase was declared a "reverse merger", in which "Old" Merck & Co. was renamed Merck Sharp & Dohme, and Schering-Plough renamed as "Merck & Co., Inc. The maneuver was an attempt avoid a "change-of-control" in order to preserve Schering-Plough's rights to market Remicade. A settlement with Johnson & Johnson was reached in 2011, in which Merck agreed to pay $500 million. Merck Sharp & Dohme remains a subsidiary of the Merck & Co. parent.
Richard Clark retired as CEO and company president in October 2011 and Kenneth Frazier became CEO.
In October 2013, Merck announced it would cut 8,500 jobs in an attempt to cut $2.5 billion from its costs by 2015. Combined with 7,500 job cuts announced in 2011 and 2012, the layoffs amounted to 20% of its workforce.
By 2014, research performed at Merck has led to U.S. FDA approval of 63 new molecular entities.
In August 2014, Merck acquired Idenix Pharmaceuticals for $3.85 billion.
In December 2014, the company acquired Swiss biotechnology company OncoEthix for up to $375 million.
Between 2010 and 2015, the company cut around 36,450 jobs. During that time, the company sold its consumer health business to Bayer and narrowed the company's focus to immunology, vaccines, diabetes, emerging markets and medicines used in hospitals, like certain antibiotics.
In January 2015, Merck acquired Cubist Pharmaceuticals.
In July 2015, Merck and Ablynx expanded their 18-month-old immuno-oncology collaboration by four years, generating a potential $4.4 billion in milestone payments for the Abylnx. The company also announced it would spend $95 million up front collaborating with cCAM Biotherapeutics and its early-stage treatment similar to Keytruda. Merck & Co. will bring in CM-24, an antibody designed to block the immune checkpoint CEACAM1.
In January 2016, Merck announced two new partnerships; the first with Quartet Medicine and its small molecule pain treatments, the second with Complix investigating intracellular cancer targets, with both collaborations potentially generating up to $595 million and $280 million respectively. Days later the company announced it would acquire IOmet Pharma, with IOmet becoming a wholly owned subsidiary of Merck & Co. The acquisition includes IOmets indoleamine-2,3-dioxygenase 1 (IDO), tryptophan 2,3-dioxygenase (TDO), and dual-acting inhibitors.
In July 2016, the company acquired Afferent Pharmaceuticals, developer of a candidate used to block P2RX3 receptors, for approximately $1 billion, plus up to $750 million in milestone payments.
In 2017, Merck bought the PARP inhibitor Lynparza from AstraZeneca.
In April 2017, Merck Animal Health acquired Vallée S.A., a Brazilian animal health product manufacturer.
In September 2017, the company announced it would acquire Rigontec, developer of a candidate to target the retinoic acid-inducible gene I pathway, for $554 million.
In October 2017, the company granted the inaugural Merck-AGITG Clinical Research Fellowship in Gastro-Intestinal (GI) Cancer to David Lau, a professional in Melbourne, Australia.
In June 2018, Merck acquired Viralytics, an Australian viral cancer drug company, for AUD$502 million.
In 2018, Merck began the submission process for a Biologics License Application to the Food and Drug Administration under the Breakthrough Therapy Designation for an investigational vaccine, called V920, to fight the Zaire strain of the Ebola virus.
In April 2019, the company acquired Immune Design for approximately $300 million, gaining access to its immunotherapy programs. It also acquired Antelliq Group for $2.4 billion, or $3.7 billion including debt.
In May 2019, Merck announced it would acquire Peloton Therapeutics, developer of a HIF-2alpha inhibitor for Von Hippel–Lindau disease-associated renal cell carcinoma, for up to $2.2 billion.
In June 2019, Merck announced it would acquire Tilos Therapeutics for up to $773 million.
In November 2019, the company acquired Calporta, which focused on Parkinsons and Alzheimers treatments.
In December 2019, Merck Animal Health acquired Vaki, an aquaculture company, from Pentair.
2020–present
In January 2020, Merck acquired ArQule, developer of ARQ 531, an oral Bruton's tyrosine kinase (BTK) inhibitor, for $2.7 billion.
In March 2020, Merck was one of ten companies recognised at the inaugural Manufacturing Awards by New Jersey Business magazine and the New Jersey Business and Industry Association.
In June 2020, Merck acquired Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases including COVID-19 and cancer.
Also in June 2020, Merck Animal Health acquired Quantified Ag, a data and analytics company that monitors cattle body temperature and movement in order to detect illness early.
In August 2020, Merck Animal Health acquired IdentiGEN, engaged in DNA-based animal traceability.
In September 2020, Merck acquired $1 billion of Seattle Genetics common stock, and agreed to co-develop ladiratuzumab vedotin.
In November 2020, Merck announced it would acquire VelosBio for $2.75 billion, developer of VLS-101, an antibody-drug conjugate designed to target Tyrosine kinase-like orphan receptor 1 (ROR1) in both hematological and solid tumors. VLS-101 is currently Phase I and Phase II clinical trials. The company also announced it would acquire OncoImmune for $425 million and its phase 3 candidate, CD24Fc, used in the treatment of patients with severe and critical COVID-19.
In February 2021, Merck Animal Health acquired PrognostiX Poultry.
In March 2021, Merck Head of Corporate Affairs Petra Wicklandt represented the company at the Munich Security Conference, where she participated in a tabletop exercise simulating the public health response to the release of a weaponized strain of monkeypox.
In April 2021, Merck acquired Pandion Therapeutics for $1.85 billion, expanding its offering in treating autoimmune diseases.
In June 2021, the U.S. government agreed to spend $1.2 billion to purchase 1.7 million doses of Molnupiravir, a Merck product, if it were to be approved by regulators to treat COVID-19. In October 2021, the company said that the drug reduces the risk of hospitalization or death by around 50% for patients with mild or moderate cases of COVID-19 and that it would seek Emergency Use Authorization for the drug.
In July 2021, Robert M. Davis became CEO, succeeding Kenneth Frazier, who became executive chairman.
In July 2021, Merck completed the corporate spin-off of Organon & Co.
In September 2021, Merck announced it would acquire Acceleron Pharma for $11.5 billion, gaining control over Sotatercept, used in the treatment of pulmonary hypertension, and luspatercept-aamt.
In September 2022, the company announced it would acquire Vence, a livestock management company for an undisclosed sum, incorporating it within Merck Animal Health.
In December 2022, the company announced a licensing deal with Kelun-Biotech of China whereby it would expand its early cancer pipeline with a set of antibody-drug conjugates; this follows an earlier agreement between the two companies to co-develop such drugs.
In April 2023, Merck announced it would acquire Prometheus Biosciences Inc for $10.8 billion.
In January 2024, the company announced it would acquire Harpoon Therapeutics for $680 million. With this purchase, Merck expands its portfolio of oncological drugs. The main positions are HPN328, an activator of T-cells that is being researched to treat advanced cancer patients associated with DLL3 expression (delta-like ligand 3), an inherent small cell lung cancer (SCLC), neuroendocrine tumors, and several other species. Merck’s portfolio will also be complemented by T-cell attractions using the patented Harpoon Tri-specific design for T cell activation (TriTAC). According to engineering protein technology, tumor cells are destroyed by the patient’s own immune cells, and the ProTriTAC platform works with the TriTAC platform to develop a therapeutic agent that attracts T-cells, but is inactive until it reaches the tumor.
Acquisition history
- Merck & Co (Founded in 1891 as the US subsidiary of Merck of Darmstadt, later Nationalised by the US government in 1917 during the first World War)
- Merck & Co
- Merck & Co
- H. K. Mulford Company (Acq 1929)
- Sharp & Dohme, Inc (Acq 1953)
- Charles E. Frosst Ltd (Acq 1965, restructured into Merck-Frosst Canada, Inc, restructured into Merck Canada in 2011)
- Medco Containment Services Inc (Acq 1993, Spun off 2003)
- Schering‑Plough
- Schering-Plough (Merged 1971)
- Schering Corporation (Founded 1851)
- Plough, Inc (Founded 1908)
- Organon International
- Alydia Health (Acq 2021)
- Intervet
- Diosynth
- Nobilon
- Schering-Plough (Merged 1971)
- Merck & Co
- Imperial Blue Corporation
- Idenix Pharmaceuticals (Acq 2014)
- Maven Corporation
- Cubist Pharmaceuticals
- Trius Therapeutics (Acq 2013)
- Optimer Pharmaceuticals (Acq 2013)
- Cubist Pharmaceuticals
- OncoEthix (Acq 2015)
- IOmet Pharma (Acq 2016)
- Afferent Pharmaceuticals (Acq 2016)
- Merck Animal Health
- Vallée S.A. (Acq 2017)
- Vaki (Acq 2019)
- Quantified Ag (Acq 2020)
- IdentiGEN (Acq 2020)
- PrognostiX Poultry Ltd (Acq 2021)
- Vence (Acq 2022)
- Rigontec (Acq 2017)
- Viralytics (Acq 2018)
- Antelliq Group (Acq 2018)
- Cascade Merger Sub, Inc.
- Immune Design Corp (Acq 2019)
- Peloton Therapeutics (Acq 2019)
- Tilos Therapeutics (Acq 2019)
- Calporta (Acq 2019)
- Argon Merger Sub, Inc.
- ArQule, Inc. (Acq 2019)
- Themis Bioscience (Acq 2020)
- VelosBio (Acq 2020)
- OncoImmune (Acq 2020)
- Astros Merger Sub, Inc.
- Acceleron Pharma (Acq 2021)
- Prometheus Biosciences (Acq 2023)
- Caraway Therapeutics (Acq 2023)
- Harpoon Therapeutics (Pending)
- Merck & Co
Philanthropy
Merck Company Foundation
Since it was founded in 1957, the Merck Company Foundation has distributed $740 million in overall charitable distributions including more than $480 million to educational and non-profit organizations.
On December 7, 2012, the foundation announced that it was ending its donations to the Boy Scouts of America citing its discrimination against gay people.
Patient assistance programs
Merck & Co. was one of the first American pharmaceutical companies to offer assistance to those unable to afford its medications, beginning a program in the 1950s. Merck & Co. offers seven patient assistance programs, each with specific eligibility requirements.
Hilleman Laboratories
Merck and the Wellcome trust jointly fund the Hilleman Laboratories, an India-based non-profit research organization dedicated to the development of low-cost vaccines for use in developing countries. Current projects include the development of low cost, thermostable vaccines for the prevention of cholera, rotavirus, and meningitis.
Merck for Mothers
Merck for Mothers is Merck's global initiative to help create a world where no woman has to die while giving life.
Mectizan donation program
In 1987, Merck began a program with UNICEF to donate its new drug Mectizan to "all that need it for as long as needed" in an effort to combat onchocerciasis, also known as river blindness, primarily in Africa. Up to that point, the World Health Organization had fought the disease through the use of insecticides to lower the population of its primary vector, the Black Fly. However, when studies in the 1980s showed how effective the drug was at treating and preventing the disease, the WHO agreed to use it instead of its previous strategies. Merck's involvement is considered a key factor in the success against the disease all over the world, and the decision to donate the entirety of the drug to all those in need of it is used as part of the Mectizan Donation Program that covers countries such as Yemen and African countries. More than 700 million people have been treated since the inception of the program with 80 million people still undergoing treatment in Africa, Latin America, and Yemen. Blindness caused by onchocerciasis is decreasing, and there are regions of Latin America and Africa that have been shown to have eliminated the disease altogether.
Lawsuits and controversies
Vioxx
In 1999, the U.S. Food and Drug Administration (FDA) approved Vioxx (known generically as rofecoxib), a Merck product for treating arthritis. Vioxx was designed as a selective inhibitor of the enzyme cyclooxygenase-2. Such compounds were expected to cause less gastrointestinal bleeding than older anti-inflammatory drugs such as naproxen, which were associated with 20,000 hospitalizations and 2000 deaths each year. Vioxx became one of the most prescribed drugs in history.
Thereafter, studies by Merck and by others found an increased risk of heart attack associated with Vioxx use when compared with naproxen. Merck adjusted the labeling of Vioxx to reflect possible cardiovascular risks in 2002.
On September 23, 2004, Merck received information about results from a clinical trial it was conducting that included findings of increased risk of heart attacks among Vioxx users who had been using the medication for over eighteen months. On September 28, 2004, Merck notified the FDA that it was voluntarily withdrawing Vioxx from the market, and it publicly announced the withdrawal on September 30. An analysis for the period 1999–2004, based on U.S. Medical Expenditure Survey data, reported that Vioxx was associated with 46,783 heart attacks, and along with the other popular COX-2 inhibitor Celebrex, an estimated 26,603 deaths from both.
About 50,000 people sued Merck, claiming they or their family members had suffered medical problems such as heart attacks or strokes after taking Vioxx. In November 2007, Merck agreed to pay $4.85 billion to settle most of the pending Vioxx lawsuits. The settlement required that claimants provide medical and pharmacy records confirming the occurrence of a heart attack, ischemic stroke, or sudden cardiac death; the receipt of at least 30 Vioxx pills within 60 days prior to the injury or death; and confirmation of Vioxx being used within 14 days of the Vioxx-related event. The settlement was generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck's liability reached between $10 billion and $25 billion. As of mid-2008, when the plaintiff class had reached the threshold percentage required by Merck to go through with the settlement, plaintiffs had prevailed in only three of the twenty cases that had reached juries, all with relatively small awards.
Merck has refused to consider compensation for Vioxx victims and their families outside the US. This is particularly true in the UK where there are at least 400 victims and the legal protection afforded to the victims and their families is particularly weak.
According to internal e-mail traffic released at a later lawsuit, Merck had a list of doctors critical of Vioxx to be "neutralized" or "discredited". "We may need to seek them out and destroy them where they live," wrote an employee. A Stanford Medical School professor said that Merck was engaged in intimidation of researchers and infringement upon academic freedom.
On May 20, 2008, Merck settled for $58 million with 30 states alleging that Merck engaged in deceptive marketing tactics to promote Vioxx. All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.
Fosamax
Fosamax (alendronate) is a bisphosphonate used for the treatment of post-menopausal osteoporosis and for the prevention of skeletal problems in certain cancers. The American College of Clinical Endocrinology, the American College of Obstetricians and Gynecologists, the North American Menopause Society and the UK National Osteoporosis Guideline Group recommend alendronate and certain other bisphosphonates as first line treatments for post-menopausal osteopotosis. Long-term treatment with bisphosponates produces anti-fracture and bone mineral density effects that persist for 3–5 years after an initial 3–5 years of treatment. Alendronate reduces the risk of hip, vertebral, and wrist fractures by 35-39%.
In December 2013, Merck agreed to pay a total of $27.7 million to 1,200 plaintiffs in a class action lawsuit alleging that the company's osteoporosis drug had caused them to develop osteonecrosis of the jaw. Prior to the settlement, Merck had prevailed in 3 of 5 so-called bellwether trials. Approximately 4000 cases still await adjudication or settlement as of August 2014.
Medicaid overbilling
A fraud investigation by the United States Department of Justice began in 2000 when allegations were brought in two separate lawsuits filed by whistleblowers under the False Claims Act. They alleged that Merck failed to pay proper rebates to Medicaid and other health care programs and paid illegal remuneration to health care providers. On February 7, 2008, Merck agreed to pay more than $650 million to settle charges that it routinely overbilled Medicaid for its most popular medicines. The settlement was one of the largest pharmaceutical settlements in history. The federal government received more than $360 million, plus 49 states and Washington, DC, received over $290 million. One whistleblower received a $68 million reward. Merck made the settlement without an admission of liability or wrongdoing.
"Merck" name legal dispute
In 191 of 193 countries, the original Merck company, the Merck Group of Darmstadt, owns the rights to the "Merck" name. In the United States and Canada, the company trades under the name EMD (an abbreviation of Emanuel Merck, Darmstadt), its legal name here says Merck KGaA, Darmstadt, Germany, and instead of "Merck Group", the "EMD Group" name is used. In the United States and Canada, Merck & Co. holds the rights to the trademark "Merck", while in the rest of the world the company trades under the name MSD (an abbreviation of Merck, Sharp & Dohme) and its legal name says here Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. Kenilworth, NJ, USA.
In 2015 the Merck Group adopted a new logo and said it will be "much more aggressive" about protecting the brand of "the real Merck". Merck of Darmstadt has initiated litigation against its former subsidiary, Merck & Co. (MSD) of Kenilworth, in several countries over infringing use of the Merck name. In 2016, the High Court of Justice in the United Kingdom ruled that MSD had breached an agreement with its former parent company and that only Merck of Darmstadt is entitled to use the Merck name in the United Kingdom. The judge also held that MSD's use of "Merck" as part of branding on its global websites were directed to the UK and infringed Merck's trade mark rights in the UK.
In response to the ruling, MSD initiated counter-litigation in the United States in January 2016 by filing a federal lawsuit which accused its former parent company of "infringing on its trademark" through actions that included the increased usage of "Merck KGaA" and "MERCK" in branding in the US as well as on its social media presence. Further Merck & Co. has also accused the Merck Group of federal trademark dilution, unfair competition, false advertising, deceptive trade practices, breach of contract, and cybersquatting. The case came to a head when a research scientist believed he was communicating with Merck & Co regarding a research grant in oncology, when in fact he was talking with the Merck Group. As a result, Merck & Co. asked the federal court to stop the Merck Group from using "Merck" on any products or marketing materials in the United States. As a direct result, Merck & Co is seeking "all monetary gains, profits, and advantages" made by the Merck Group and three-times the damage, plus additional punitive damages.
In April 2020, in the course of litigation of Merck against MSD in Switzerland, the Federal Supreme Court of Switzerland ruled that MSD's use of the "Merck" brand in its global websites could, absent geotargeting mechanisms, have "commercial effect" in Switzerland and could therefore violate Merck's rights (if any) to the "Merck" brand in Switzerland.
Tax fraud
In 2007, Merck paid $2.3 billion to settle allegations of offshore tax fraud between 1993 and 2001.
Propecia
In 2021, an investigation by Reuters revealed that Merck's baldness drug Propecia caused persistent sexual dysfunction in men. The drug has been linked to over 700 incidences of suicidal thoughts and 110 deaths. Merck has been receiving reports since 1998, but never included the risks on the label. In 2015, Merck was sued by consumer-rights law firm Hagens Berman over a wrongful death linked to Propecia.
Environmental violations
Merck & Co. once used methylene chloride, an animal carcinogen on the United States Environmental Protection Agency's list of pollutants, as a solvent in some of its manufacturing processes. Merck chemists and engineers subsequently replaced the compound with others having fewer negative environmental effects. Merck has also modified its equipment to protect the environment, installing a distributed control system that coordinates chemical reactions more efficiently and expedites manufacturing by 50 percent, eliminating the need for the disposal and storage of harmful waste. Biological oxygen demand has also been reduced. In 2011, Merck paid a $1.5 million civil penalty to settle alleged violations of federal environmental laws at its pharmaceutical manufacturing facilities in Riverside, Pennsylvania and West Point, Pennsylvania.
Public-private engagement
Conferences
Merckは2020年9月に開催されるバーチャルISPORのカンファレンス・サポーターを務めた
Political lobbying
Merckは、政府機関、大学、製薬会社、ロビー団体を含む健康研究アドボカシー・ネットワークのAcademyHealthの貢献メンバーである。
External links
Media related to Merck & Co. at Wikimedia Commons
- Official website
- Business data for Merck & Co.:
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