Merck to hunt emergency authorization for oral Covid-19 therapy

A nurse tends to a Covid-19 patient at SSM Health St. Anthony Hospital in Oklahoma City on August 24, 2021.

Nick Oxford | Reuters

Merck and Ridgeback Biotherapeutics plan to apply for emergency approval for their oral antiviral treatment for Covid after the drug shows “compelling results” in clinical trials.

The drug molnupiravir reduced the risk of hospitalization or death in patients with mild or moderate cases of Covid by around 50%, the companies said on Friday. Molnupiravir is given orally and works by stopping the coronavirus from replicating in the body.

An interim analysis of a Phase 3 study found that 7.3% of molnupiravir-treated patients were hospitalized within 29 days. Of the patients who received a placebo, 14.1% were hospitalized or died on day 29. No deaths were reported in patients receiving molnupiravir within the 29-day period, while eight deaths were reported in placebo-treated patients.

All 775 study participants had laboratory-confirmed symptomatic Covid-19 and were randomly assigned molnupiravir or a placebo within five days of symptoms.

Each participant was unvaccinated and had at least one underlying factor that placed them at a higher risk of developing a more severe case of the virus. The most common risk factors included obesity, over 60 years of age, and diabetes or heart disease.

The phase 3 part of the study was conducted in more than 170 locations in countries such as the United States, Brazil, Italy, Japan, South Africa, Taiwan, and Guatemala.

The study showed that molnupiravir’s effectiveness was not influenced by the time when symptoms appeared or the patients’ underlying risk factors. It was also shown to be consistently effective in treating all variants of Covid, including the widely used and highly transferable delta expansion.

Side effects were similar in the molnupiravir and placebo groups, with approximately 10% reporting adverse events. Only 1.3% of the molnupiravir group discontinued therapy because of an adverse event – less than the 3.4% of the placebo group who did.

Recruitment for the study will be terminated prematurely based on the positive results on the recommendation of an independent data monitoring committee and in consultation with the US Food and Drug Administration.

Merck is also testing molnupiravir in a separate global phase 3 study to evaluate its effectiveness in preventing the spread of Covid in households.

“Profound Effect”

Robert M. Davis, CEO and President of Merck, said in a press release on Friday that the company would do everything possible to get molnupiravir to patients as soon as possible.

“With these compelling results, we are optimistic that molnupiravir can become a key drug in the global effort to fight the pandemic,” he said.

Wendy Holman, CEO of Ridgeback Biotherapeutics, added, “As the virus continues to be widespread and the therapeutic options currently available are infused or require access to a health facility, antiviral treatments can be taken at home to help people with Covid-19 from the To keep disease away hospital urgently needed. “

“We are very encouraged by the results of the interim analysis and hope that molnupiravir, if approved for use, can have a profound impact on the control of the pandemic,” she said.

Authorization to use in an emergency

Merck said Friday it plans to apply for emergency approval for the drug in the US as soon as possible. The company also plans to file regulatory filings with other international drug regulatory agencies.

If approved by regulators, molnupiravir could be the first oral antiviral drug for Covid. Currently used antiviral treatments, such as Remdesivir, are administered intravenously.

Merck has already started production of molnupiravir. The pharmaceutical giant expects to produce 10 million treatment cycles by the end of 2021 and more doses in 2022.

The company agreed earlier this year to ship approximately 1.7 million molnupiravir courses if it receives FDA emergency or full approval.

Merck has also entered into supply and purchase agreements with other governments for the drug – pending regulatory approval – and is in talks with other governments regarding the supply of molnupiravir.

The company plans to implement a tiered pricing approach based on World Bank income criteria to ensure molnupiravir is available worldwide. Merck previously announced that it had entered into non-exclusive, voluntary licensing agreements for molnupiravir with generic drug companies to facilitate access to treatment for low- and middle-income countries. Approvals or emergency approvals from the local supervisory authorities are also pending for these agreements.

Profit sharing

Ridgeback received an upfront payment from Merck as part of the company’s development of molnupiravir. The company is also eligible for contingent payments based on development and regulatory approval milestones.

Profits from the collaboration will be shared equally between Merck and Ridgeback.

Cramer’s Mad Cash Recap: Fb, Merck, Nvidia

There’s a lot more to investing than just owning index funds, Jim Cramer told Mad Money viewers on Tuesday. Anyone who tells you stock picking is a fool’s game is just plain wrong, Cramer said. Finding successful investments is a lot easier than you think.

Index funds certainly have a place in your portfolio. If you’re just starting out, your first $ 10,000 should be in an index fund. And if you don’t have the time or inclination to do little homework, then index funds are just the thing for you. But for everyone else, there are better ways to make money.

The problem with owning everything is that not every stock is worth owning, Cramer explained. Growing up, dividend paying stocks like Merck (MRK) – Get the report made millions for individual investors who reinvested those dividends year after year. But during that time there were also many soaring stocks that crashed and burned. Knowing the difference between these two types of stocks is the difference between gambling and investing.

What is it worth owning today? Merck is still there and still pays great dividends. In fact, there are dozen of high-paying dividend stocks in the S&P 500. There are also momentum stocks, as known to be preferred by ARK Invest’s Cathie Wood. As Cramer outlined last night, there are quality IPOs and SPACs too if you do your homework.

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Board decision: Shopify

In his first “Executive Decision” segment, Cramer spoke to Harley Finklestein, President of Shopify (BUSINESS) – Get the report, the e-commerce platform that helps thousands of small businesses sell their goods online. Shopify’s stocks are up 42% over the past three months.

Finklestein said the new product and feature announcements on Tuesday were about giving merchants more flexibility, scalability and performance. Whether they need to sell just a few items or hundreds of thousands of items in minutes, the Shopify platform now has the tools merchants need.

Shopify is also improving its checkout experience, which was used more than 450 million times last year. Finklestein said the new customization features allow more payment options than ever before.

The Shopify ecosystem continues to grow. Finklestein found that partners generated more than $ 12 billion in their platform over the past year. Shopify is a partnership with Facebook, Google (GoogL) – Get the report, TikTok, Pinterest (PINS) – Get the report.

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At the time of publication, Cramer’s Action Alerts PLUS held a position with FB, NVDA, and Demokratie.

Outspoken Merck CEO Kenneth Frazier, who challenged Trump on race points, to retire this yr

Ken Frazier, Chairman and CEO of Merck & Co., speaks during an Economic Club of New York meeting on October 3, 2018.

Brendan McDermid | Reuters

The outspoken chairman and CEO of Merck, Ken Frazier, is retiring after almost 30 years with the drug manufacturer, the company announced on Thursday.

The 66-year-old Frazier will be replaced by Chief Financial Officer Robert Davis as CEO on June 30 and will continue to serve as Chairman of the Board of Management of Merck, “for a transition period to be determined by the Board of Directors,” the company said. Frazier, one of the few black corporate executives in the United States, has been CEO of Merck since January 2011.

“It has been a privilege to serve as CEO of Merck for the past decade and to work with the most dedicated and talented employees and management team in the industry,” Frazier said in the statement. “As CEO, I look forward to working with Rob and our Board of Directors to help Merck be even more successful.”

Frazier’s final years at Merck were marked by his outspoken opposition to the former president Donald Trump. He was the first to lead a revolt among CEOs Resignation of Trump’s American Manufacturing Council shortly after the former president’s supportive comments on white nationalist and neo-Nazi groups at the deadly protest in Charlottesville, Virginia, in 2017.

He has called for managing directors to be a “unifying force” that can help resolve many of America’s racial inequalities by creating new opportunities and jobs. He said that education, and especially financial literacy, is the “great balance”.

Frazier’s June departure will leave only three black CEOs at Fortune 500 companies. Roger Ferguson Jr., CEO of TIAA, announced that he will be stepping down from his position in late March. Roz Brewer, the current Chief Operating Officer of Starbucks, will take the lead at Walgreens Boots Alliance in the same month.

After becoming a lawyer, Frazier rose to be one of the the most famous black CEOs in the country. Before joining Merck, Frazier helped free a black death row inmate who was falsely accused of murder.

Davis, 54, will become President of Merck on April 1. He joined the New Jersey-based pharmaceutical company as chief financial officer in 2014 after serving in leadership roles Baxter International. Davis also spent 14 years at Eli Lilly.

Davis, who holds a law degree and an MBA from Northwestern University, serves on the board of directors of Duke Energy and serves on the board of the international nonprofit Healthcare Project Hope.

Davis’ job at Merck has been expanded to include “the company’s global support functions which include corporate development, investor relations, information technology, procurement, real estate and corporate strategy.”

“Rob has been instrumental in helping Merck take the right steps to adapt to the changing healthcare environment, while continuing to invest in the scientific innovations that we expect will drive our future growth,” said Frazier.

Merck reported fourth quarter sales and earnings that fell too short on Thursday Wall Street expectations. Revenue rose 5% year over year to $ 12.5 billion, but fell short of investors’ forecast of $ 12.68 billion. The company reported adjusted earnings per share of $ 1.32 per share versus $ 1.38 expected.

The company’s shares fell around 1% in premarket trading.

Last week Merck announced that it would end the development of two Covid-19 vaccines intended to focus on treatments, citing poorer immune responses compared to people who had recovered from the disease as well as those reported for other vaccines.

The company, which entered the vaccine race later than its competitors, expects initial efficacy data for an experimental oral antiviral, expected in late March.

– Amelia Lucas and Reuters at CNBC contributed to this report.