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FDA advisory panel to weigh in on molnupiravir

An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19.

Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations.

The benefit-risk calculation for molnupiravir has grown more complicated recently.

Over the Thanksgiving holiday, Merck announced that the drug offered a relative risk reduction of 50% against hospitalization or death. An earlier interim analysis of the Phase 2/3 MOVe-OUT clinical trial found it provided a relative risk reduction of 50%.

Developed in collaboration with Ridgeback Biotherapeutics, molnupiravir is an oral prodrug of the antiviral ribonucleoside analog N-hydroxycytidine (NHC). The drug’s mode of action is to contribute to errors in the viral genome during replication.

FDA has signaled it has questions about the drug’s safet…

Pfizer bolsters COVID-19 antiviral manufacturing capacity

Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame.

An interim analysis of the Phase 2/3 EPIC-HR study found the drug to be 89% effective at reducing hospitalization or death. Pfizer announced the launch of a Phase 1 study of PF-07321332 in March.

Pfizer has inked a $5.29 billion Paxlovid deal with the U.S. government.

One course of oral Paxlovid therapy would consist of two daily 150-mg doses for five days.

Meanwhile, molnupiravir, the antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has lost some of its luster. New data suggests the drug led to an absolute risk reduction against hospitalization or death of 3% compared to placebo. Furthermore, the drug led to a relative risk reduction of…

Pfizer to make COVID-19 pill available in low- and middle-income nations

In late October, Merck (NYSE:MRK) and its partner Ridgeback Biotherapeutics agreed to make the COVID-19 antiviral molnupiravir available in the developing world.

Now, Pfizer (NYSE:PFE) is taking a similar approach for its investigational antiviral cocktail Paxlovid, which contains PF-07321332 and ritonavir.

Pfizer, like Merck, struck an agreement with the Medicines Patent Pool (MPP) related to Paxlovid.

MPP’s mission is to expand low- and middle-income countries’ access to vital medicines. The United Nations supports the organization.

Pfizer announced earlier this month that Paxlovid was 89% effective in reducing the risk of hospitalization or death in an interim analysis of the Phase 2/3 EPIC-HR trial.

The collaboration with MPP will enable generic drug makers internationally with sub-licenses to produce Paxlovid for use in 95 countries, which comprise more than half of the world’s population.

“This license is so important because, …

U.S. to buy 1.4 million additional courses of molnupiravir

Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir.

One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion.

The U.S. has committed to buy approximately 3.1 million molnupiravir courses for $2.2 billion, which equates to about $710 per course.

For the sake of comparison, the U.S. pays about $40 per dose of COVID-19 vaccines.

Molnupiravir photo courtesy of Merck.

The U.S. has the option of buying an additional 2 million courses of molnupiravir.

Merck and Ridgeback are awaiting news from FDA regarding their submission for emergency use authorization of molnupiravir. The application would cover adults with mild-to-moderate COVID-19 who have …

UK approves Merck’s oral COVID-19 drug molnupiravir

The United Kingdom has become the first country to authorize molnupiravir, the oral antiviral drug from Merck (NYSE:MRK) and Ridgeback Biotherapeutics.

The Medicines and Healthcare products Regulatory Agency (MHRA) allowed conditional marketing authorization for the drug in Great Britain only. Furthermore, it has granted emergency use authorization of the drug for Northern Ireland.

MHRA recommends that the drug be used in people with mild-to-moderate COVID-19 who have at least one risk factor predisposing them to severe illness. MHRA further recommended that the drug be used as soon as possible after a positive COVID-19 test and “within five days of symptoms onset.”

Merck will market the drug as Lagevrio.

MHRA also noted that it does recommend the drug as an alternative to vaccination.

Merck has also vowed to make the drug available internationally, assuming it passes the requisite regulatory hurdles. Developing nations could pay approximat…

Merck projects at least $5B in 2022 sales for molnupiravir

Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected.

Sales of the drug could be higher, assuming it finds widespread use in wealthy countries.

Merck expects sales between $500 million and $1 billion for 2021.

Merck’s stock climbed more than 5% per share to $85.70 in mid-day trading.

Several other companies are also developing COVID-19 antivirals, including Pfizer and Novartis. Roche and Atea recently announced disappointing Phase 2 results involving their investigational antiviral AT-527.

Merck also announced that the molnupiravir, which it developed with Ridgeback Biotherapeutics, would be available in developing countries. To that end, Merck agreed to a royalty-free license for molnupiravir with the Medicines Patent Pool. As a result of the arrangement, generic drug manufacturers could sell a five-d…

Merck rises on Street-beating Q3

Merck (NYSE:MRK) shares ticked up today on third-quarter results that beat the consensus forecast.

MRK shares were up 4.9% at $85.55 per share in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually unchanged.

The Kenilworth, N.J.-based company posted profits of $4.6 billion, or $1.80 per share, on sales of $13.2 billion for the three months ended Sept. 30, 2021, for a 96.5% bottom-line gain on sales growth of 20.4%.

Adjusted to exclude one-time items, earnings per share were $1.75, 20¢ ahead of Wall Street, where analysts were looking for sales of $12.3 billion.

“Merck delivered another strong quarter with positive momentum across our business and meaningful progress across our pipeline. Our teams continued to excel as we focus on evolving our operations, while driving innovations in our labs that exemplify the best of Merck science,” Merck …

EMA begins rolling review of Merck’s and Ridgeback’s COVID-19 pill molnupiravir

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics has announced that the European Medicines Agency (EMA) has begun a rolling review for molnupiravir, the experimental antiviral that could be the first oral treatment for COVID-19 to hit the market.

Merck has also submitted emergency use authorization (EUA) paperwork related to the drug to FDA.

The company is also pursuing marketing authorization in other countries across the globe.

“This application to the EMA is another step in our efforts to bring molnupiravir forward to patients globally,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, in a statement.

Interim data from the Phase 3 MOVe-OUT clinical trial found that the drug effectively reduced symptom progression in non-hospitalized patients with mild-to-moderate COVID-19. The patients in that study were deemed to have an elevated risk of developing severe COVID-19 or hospitalization.

O…

Xeris enters collaboration with Merck

Xeris Biopharma (NSDQ:XERS) announced today that it entered into a collaboration agreement with Merck (NYSE:MRK) for its XeriJect technology.

Chicago-based Xeris’ collaboration with Merck includes an option to license the XeriJect suspension-based formulation technology for use with undisclosed monoclonal antibodies (mAbs) for the purpose of engineering ultra-high concentration, ready-to-use formulations.

Get the full story at our sister site, Drug Delivery Business News.

ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older

CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy.

CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins at the age of 19.

In addition, ACIP was unanimous in backing Merck’s (NYSE:MRK) and Pfizer’s (NYSE:PFE) pneumococcal vaccines in elderly and immunocompromised adults.

ACIP will share the recommendations with the director of the CDC and the US Department of Health and Human Services for review and approval.

Shingrix first won FDA approval in 2017 to prevent shingles in adults aged 50 and older. In July of this year, the agency extended approval to include adults aged 18 and older with an elevated risk of developing shingles as a result of immunodeficiency …

A course of Merck’s COVID-19 pill could cost more than $700

Merck’s (NYSE:MRK) oral drug molnupiravir (MK-4482) could be a COVID-19 game-changer, assuming it wins emergency use authorization.

The medicine could also be lucrative for Merck, assuming it finds widespread use.

Costing $712 for a treatment course, according to a contract obtained by Knowledge Ecology International, molnupiravir’s retail cost would be almost 40 times more than its production cost. It takes about $17.74 to produce a five-day course of the drug, according to an estimate from a pricing analysis from the Harvard School of Public Health and King’s College Hospital in London.

Knowledge Ecology International obtained the contract via a Freedom of Information Act lawsuit targeting the HHS and the Army regarding U.S. government COVID-19 contracts.

Merck did not immediately respond to a request for comment on its pricing plans related to the drug.

In initial contracts with the U.S., the Pfizer-BioNTech vaccine has a price tag of $1…

Early safety concerns accompanied Merck’s molnupiravir, the first potential oral COVID-19 therapy

The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%.

One potential hurdle for the drug is whether unvaccinated individuals will accept the treatment, given their higher likelihood of contracting severe COVID-19. According to McKinsey, unvaccinated individuals tend to be most concerned about the potential of COVID-19 vaccines to cause long-term side effects.

The lack of long-term safety data concerning molnupiravir could be an obstacle for skeptical patients. That’s especially the case given early conclusions that there are “persistent side-effect concerns with mutagenic molnupiravir,” as a Clinical Trials Arena article observed. That article goes on to cite Ron Swanstrom, a professor at the University of North Carolina, Chap…