Merck & Co.: Difference between revisions

In January 2020, Merck acquired ArQule, developer of [[Nemtabrutinib|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 [[ROR1|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 conjugate]]s; this follows an earlier agreement between the two companies to co-develop such drugs.

In April 2023, Merck announced it would acquire [https://www.prometheusbiosciences.com/ 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.

*'''Merck & Co''' {{small|(Founded in 1891 as the US subsidiary of [[Merck Group|Merck of Darmstadt]], later Nationalised by the US government in 1917 during the first World War)}}

****H. K. Mulford Company {{small|(Acq 1929)}}

****Sharp & Dohme, Inc {{small|(Acq 1953)}}

****Charles E. Frosst Ltd {{small|(Acq 1965, restructured into Merck-Frosst Canada, Inc, restructured into Merck Canada in 2011)}}

****Medco Containment Services Inc {{small|(Acq 1993, Spun off 2003)}}

****[[Schering-Plough]] {{small|(Merged 1971)}}

*****Schering Corporation {{small|(Founded 1851)}}

*****Plough, Inc {{small|(Founded 1908)}}

*****Alydia Health {{small|(Acq 2021)}}

***Idenix Pharmaceuticals {{small|(Acq 2014)}}

***[[Cubist Pharmaceuticals]]

****[[Trius Therapeutics]] {{small|(Acq 2013)}}

****Optimer Pharmaceuticals {{small|(Acq 2013)}}

**OncoEthix {{small|(Acq 2015)}}

**IOmet Pharma {{small|(Acq 2016)}}

**Afferent Pharmaceuticals {{small|(Acq 2016)}}

***Vallée S.A. {{small|(Acq 2017)}}

***Vaki {{small|(Acq 2019)}}

***Quantified Ag {{small|(Acq 2020)}}

***IdentiGEN {{small|(Acq 2020)}}

***PrognostiX Poultry Ltd {{small|(Acq 2021)}}

***Vence {{small|(Acq 2022)}}

**Rigontec {{small|(Acq 2017)}}

**[[Viralytics]] {{small|(Acq 2018)}}

**Antelliq Group {{small|(Acq 2018)}}

***Immune Design Corp {{small|(Acq 2019)}}

**Peloton Therapeutics {{small|(Acq 2019)}}

**Tilos Therapeutics {{small|(Acq 2019)}}

**Calporta {{small|(Acq 2019)}}

***ArQule, Inc. {{small|(Acq 2019)}}

**Themis Bioscience {{small|(Acq 2020)}}

**VelosBio {{small|(Acq 2020)}}

**OncoImmune {{small|(Acq 2020)}}

***[[Acceleron Pharma]] {{small|(Acq 2021)}}

**Prometheus Biosciences {{small|(Acq 2023)}}

**Caraway Therapeutics {{small|(Acq 2023)}}

**Harpoon Therapeutics {{small|(Pending)}}

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.

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.

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 is Merck's global initiative to help create a world where no woman has to die while giving life.

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.

In 1999, the [[Food and Drug Administration (United States)|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.

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 ([[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.

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 [[List of Largest Pharmaceutical Settlements|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.

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.

In 2021, an investigation by [[Reuters]] revealed that Merck's baldness drug [[Finasteride|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.

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]].