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The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

Merck wins Fast Track designation from FDA for experimental anticoagulant therapy

FDA has informed Merck (NYSE:MRK) that its investigational anticoagulant therapy MK-2060 has received Fast Track designation. The program accelerates the review of new drugs to treat serious conditions or unmet medical need.

The Fast Track designation covers the risk reduction of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

“We are encouraged by this Fast Track designation because additional anticoagulation medicines are urgently needed for patients with ESRD who are susceptible to high rates of life-threatening thrombotic events as well as high bleeding risk,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a news release. “Today, there is no anticoagulation standard of care for such patients.”

A Phase 2 Study of MK-2060 is now underway in people with end-stage renal disease who are undergoing hemodialysis.

The FXI…

Kallyope’s focus on the gut-brain axis yields a diverse portfolio

New York City-based Kallyope is one of the few biotechs focused solely on the gut-brain axis.

The privately-held company has built a cross-disciplinary team that weaves together advanced technologies in sequencing, bioinformatics, neural imaging, human genetics, and cellular and molecular biology.

The company has raised $479 million to date, including a $236 million Series D financing in February.

Jay Galeota

The president and CEO of the company is Jay Galeota, who worked at Merck & Co. (NYSE:MRK) for almost three decades.

“I was fortunate enough to lead the team that brought Merck into diabetes with Januvia (sitagliptin) and Janumet (sitagliptin/metformin),” Galeota said. Last year, the drugs generated $5.3 billion in revenue.

The discoverers of sitagliptin, Nancy Thornberry and Ann Weber, are both Merck alumni who are now senior executives at Kallyope. Thornb…

Senate Finance Committee chair says Abbott, Merck aren’t complying

Ron Wyden [Image from U.S. Senate Finance Committee]

Senate Finance Committee Chair Ron Wyden (D-Oregon) wrote a letter demanding compliance from Merck and Abbott.

The letter demands that Merck and Abbott complay with the Senate Finance Committee’s investigation into the tax practices of Big Pharma.

According to a news release from the Senate Finance Committee, the two companies have, to this point, “stonewalled” the committee, refusing to provide specific information related to where they book profits from U.S. drug sales. That includes the refusal to provide specific data on how much taxable income is reported by offshore subsidiaries — known as controlled foreign corporations — for tax purposes, the committee said.

The data would allow the committee to better understand the discrepancy between U.S. sales and where income is booked, the Senate Finance Committee noted, adding …

Merck halts Phase 3 Lynparza for futility

Merck (NYSE:MRK) has announced that it will stop the Phase 3 LYNK-003 trial focused on Lynparza (olaparib) with or without bevacizumab for patients with unresectable or metastatic colorectal cancer.

Two experimental arms in the trial, one focused on Lynparza as monotherapy or in combination with the immunotherapy drug bevacizumab, will be suspended.

The primary endpoint of the trial was progression-free survival.

The study focused on patients without progression after first-line therapy.

Merck made the decision after receiving feedback from an independent Data Monitoring Committee (DMC) following review from an interim analysis.

The PARP inhibitor Lynparza was first developed by KuDOS Pharmaceuticals and the University of Pennsylvania.

AstraZeneca acquired KuDOS Pharmaceuticals in 2005.

In 2021, the drug jointly earned AstraZeneca and Merck $3.7 billion.

The two companies continue to develop Lynparza for a variety of on…

Merck moves forward with Seagen acquisition plans

Executives from Merck & Co. (NYSE:MRK) and Seagen (Nasdaq:SGEN) are reportedly considering a $40 billion acquisition deal.

Readington, New Jersey–based Merck has offered to spend about $200 per share for Seagen, according to The Wall Street Journal.

Executives from the company aim to finalize the deal before Merck announces its Q2 earnings on July 28, according to WSJ.

Seagen shares were up about 2%, trading at $178.56 in afternoon trading.

Merck shares held steady, hovering around $92.90.

In a Q1 earnings call, Merck CEO Robert M. Davis said the company is working to diversify its business as it plans to lose exclusivity for its megablockbuster immunotherapy drug Keytruda. “In oncology, we remain committed to building on the foundational position that we have achieved with Keytruda, and we aim to expand our presence in this key therapeutic area and to establish an enduring leadership position,” Davis said.

The patent protections…

Illumina, Merck launch test for cancer development, progression insights

[Image from Illumina/Merck]Illumina (Nasdaq:ILMN) announced today that it launched a new research test, co-developed with Merck (NYSE:MRK).

The jointly developed test adds the assessment of a new genomic signature to the already distributed TruSight Oncology 500 assay, enabling researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous recombination deficiency (HRD). HRD, a genomic signature, describes when cells are unable to effectively repair double-stranded DNA breaks, an occurrence that can lead to genomic instability and eventually tumor formation.

According to a news release, the new test will be made available globally, excluding the U.S. and Japan. The two companies originally announced that they partnered in September 2021 to develop and commercialize tests that identify genetic mutations used in the assessment of HRD.

“HRD status has emerged as an important biomarker …

Merck reportedly mulling Seagen acquisition

Approximately one month after Seagen (Nasdaq:SGEN) CEO Clay Siegall resigned following a domestic abuse arrest, Merck & Co. (NYSE:MRK) is considering purchasing the company, according to WSJ.

One potential hurdle is the possibility of increased antitrust enforcement from the DOJ and FTC focused on the pharmaceutical sector.

To sidestep such risks, the two companies could enter a joint marketing arrangement instead, according to the WSJ article, which cited anonymous sources. The two companies have already had strategic collaborations in oncology.

Investors reacted to the news by sending SGEN shares up almost 13% to $165.45.

Merck shares were mostly flat, closing at $84.62.

Last year, Merck generated $48.7 billion in revenue. More than one-third of it, however, came from the immunotherapy drug Keytruda (pembrolizumab). Keytruda patent protections are set to expire in 2028.

Seagen had $1.6 billion in revenue in 2021.

In Apri…

Propecia label gets new warning related to possible suicidal risk

A number of patient advocates, including the Post-Finasteride Syndrome Foundation (PFSF), had petitioned the FDA to remove the anti-baldness drug Propecia (finasteride) from the market.

The FDA recently announced that the drug would remain on the market but agreed to revise the label for finasteride to include a notice about reports of suicidal behavior.

Merck & Co.’s Organon division is the manufacturer of Propecia, which

The agency had earlier agreed to add a warning to the label about the risk of persistent sexual depression and depression.

In September, the nonprofit watchdog group Public Citizen filed a lawsuit on behalf of PFSF, asking FDA to either halt sales of the drug or add new warnings to its label.

Merck won approval to market finasteride (1 mg) to treat male pattern hair loss. A 50-mg dose of the drug initially won FDA approval in 1992 to treat benign prostatic hyperplasia.

In 2001, FDA decided not to incl…

50 of 2021’s best-selling pharmaceuticals

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments.

Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the Pfizer-BioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. (Look out for more insights from our annual Pharma 50 report.)

The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue.

Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. T…

Lynparza cut death risk by one-third in adjuvant treatment of germline BRCA-mutated high-risk early breast cancer

Lynparza (olaparib) significantly reduced death risk when treating germline BRCA-mutated high-risk early breast cancer in the Phase 3 OlympiA study, according to AstraZeneca (LON: AZN).

Lynparza recently became the first FDA-approved medicine targeting BRCA mutations in the same type of cancer.

The drug is the first poly(ADP-ribose) polymerase (PARP) inhibitor to show an overall survival benefit in early breast cancer, according to AstraZeneca.

AstraZeneca developed the drug with Merck & Co. (NYSE:MRK), a company known as MSD outside of the U.S.

The OlympiA study showed that olaparib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Patients in the study had received earlier local treatment and standard neoadjuvan…

J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…