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.

The Board of Administrators of G5 Leisure Makes use of Authorization of Repurchase of Personal Strange Shares

STOCKHOLM – () – The board of directors of G5 Entertainment AB (publ) (the “Company” or “G5 Entertainment”) has decided to initiate the repurchase of common shares through authorization by the company’s annual general meeting on June 15, 2020 To give the board of directors greater opportunities to adjust the company’s capital structure from time to time to the capital requirements and thus to be able to contribute to increasing shareholder value. In addition, the authorization is intended to enable the Management Board to transfer shares in connection with company acquisitions by paying in own shares or to use repurchased shares to implement the company’s long-term incentive program, which is less likely to be diluted in future.

Ordinary shares can be bought back one or more times until the end of the company’s next ordinary general meeting. However, the number of own shares may at no time exceed ten (10) percent of the total number of shares in the company. At the time of this press release, the Company already holds 172,200 Class C shares and 278,200 common shares and has a maximum of 460,200 common shares for repurchase. The buyback will take place at a price per share within the price range of Nasdaq Stockholm at a certain point in time, ie the interval between the current highest purchase price and the lowest sale price, which is published regularly by Nasdaq Stockholm. The shares are paid in cash.

As of the date of this press release, the Company holds 172,200 Class C shares and 278,200 common shares, representing 4.95 percent of the total number of shares in the Company.

This information is information that G5 Entertainment AB must publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on June 16, 2021 at 8:30 a.m. (CET) by the contact person mentioned above.

About G5 Entertainment

G5 Entertainment AB (Publ) (G5) develops and publishes high quality free games for smartphones, tablets and PCs that are family-friendly, easy to learn, and aimed at the broadest audience of experienced and inexperienced gamers. The company sells its games via the Apple App Store, Google Play, Microsoft Store, Amazon Appstore etc. The company’s portfolio includes popular games such as Jewels of Rome®, Sherlock: Hidden Match-3 Cases®, Jewels of the Wild West®. Hidden City®, Mahjong Journey®, The Secret Society® and Wordplay: Train Your Brain ™.

Via its main company G5 Entertainment AB (Publ), the G5 Entertainment Group is listed under the trading symbol G5EN.ST in the main market mid-cap segment of Nasdaq Stockholm. For six years in a row, G5 Entertainment was named one of Deloitte’s 50 Fastest Growing Technology Companies in Sweden.

For more information on G5 Entertainment, see https://www.g5e.com/corporate

J&J requests FDA emergency use authorization

Johnson & Johnson applied for an emergency permit from the Food and Drug Administration for his Coronavirus Vaccine after data was released last week that showed it was 66% effective against the virus.

If the application is approved by J&J, this will be the third Covid-19 vaccine approved for use in the US emergency after that of Pfizer-BioNTech and Modern. Pfizer’s vaccine was approved by the FDA on December 11, and Moderna’s vaccine was approved a week later.

“Today’s filing for the emergency approval of our single vaccine COVID-19 is a critical step in reducing the burden of disease for people around the world and ending the pandemic,” said Dr. Paul Stoffels, Scientific Director of J & J., in a statement.

“With our emergency COVID-19 vaccine approved, we will be ready to begin shipping,” he said. “With our filing with the FDA and ongoing reviews with other health authorities around the world, we are working urgently to make our investigational vaccine available to the public as soon as possible.”

The FDA has scheduled a meeting of its Advisory Committee on Vaccines and Related Biological Products on Feb.26 to discuss emergency approval.

“A public discussion by the members of the Advisory Committee on the data submitted in support of the safety and effectiveness of the COVID-19 vaccine by Janssen Biotech Inc. will help ensure that the public has a clear understanding of the scientific data and information, which the FDA will review to make a decision on whether to approve this vaccine, “Acting FDA Commissioner Janet Woodcock said in a statement. “The FDA continues to seek to keep the public informed of our analysis of the COVID-19 vaccine data so that the American public and medical community have confidence in FDA-approved vaccines.”

US officials and Wall Street analysts are curious; excited approval of the vaccine by J & J, which could come as early as this month. president Joe Biden is trying to speed up the pace of vaccination in the US, and experts say his government will need a range of drugs and vaccines to fight the virus that killed more than 450,000 Americans in the past year, according to Johns Hopkins University .

Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J & J’s drugs only require one dose, making logistics easier for healthcare providers.

NOT A WORD said on January 29th that his vaccine was 66% effective against Covid-19 overall. However, the vaccine appeared to be less effective against other variants. The level of protection was only 57% in South Africa, where a new, highly contagious strain called B.1.351 is spreading rapidly. South Carolina officials discovered the first known US case of this strain last month.

Infectious disease experts suggest that J & J’s numbers cannot be used as a direct comparison with Pfizer and Moderna vaccines, which were found to be 95% and 94% effective, respectively. That’s because J & J’s vaccine is a single dose, and the company’s study came about when there were more infections and new, more contagious variants.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the key finding from the J&J data was that the vaccine was 85% effective at preventing major diseases.

“The most important thing, which is more important than preventing someone from getting a pain and a sore throat, is preventing people from getting serious illnesses,” said the director of the National Institute of Allergies and Infectious Diseases, speaking to reporters on Jan. January. 29. “This will alleviate so much stress and human suffering and death in this epidemic.”

The FDA has announced that it will approve a vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces people’s risk of influenza by 40% to 60% compared to people who are not vaccinated, according to the Centers for Disease Control and Prevention.

J&J has announced that it will ship the vaccine at 36 to 46 degrees Fahrenheit. For comparison: Pfizer’s vaccine is a must stored in ultra-cold freezers that keeps it between negative 112 and negative 76 degrees Fahrenheit. Moderna vaccine must be delivered between 13 and 5 degrees Fahrenheit.

The Department of Health and Human Services announced in August that it has signed a deal with Janssen, J & J’s pharmaceutical subsidiary, worth approximately $ 1 billion for 100 million doses of its vaccine. The deal gives the federal government the opportunity to order another 200 million cans, according to the announcement.