Pharmaceutical company Merck reported, that has developed an effective medicine from COVID-19 (Molnupiravir Molnupiravir). Merck and most airlines are up sharply, while vaccine developer Moderna's papers fell by 11,4%.
Merck and Ridgeback's research oral antiviral drug Molnupiravir reduced the risk of hospitalization or death by about 50 percent compared to placebo for patients with mild to moderate COVID-19 in a positive interim analysis of a phase study 3
What kind of medicine for COVID 19 from Merck?
As Merck said., the drug for oral administration "Molnupiravir" can reduce the risk of hospitalization or death of the patient on 50%. According to tests, the drug is effective against all strains of the virus, including against the more contagious delta strain.
In the third phase of trials of the drug participated 775 COVID-19 patients. Of those, who took Molnupiravir, within a month hospitalized 7%. But the proportion of hospitalized patients, taking placebo, made up 14%. The study was conducted with the participation of unvaccinated patients with such risk factors, how old is, diabetes and heart disease.
“Given the convincing results, we hope, that Molnuviravir will be an important medicine in the global fight against the pandemic", — said the head of Merck. American infectious disease specialist Anthony Fauci reported, that the regulator will review the test data as soon as possible.
Molnuviravir may be the first oral cure for COVID-19. Other coronavirus medications, such as "Remdesivir", administered intravenously in medical institutions.
Merck and Ridgeback Biotherapeutics are already producing a new drug and are negotiating supplies with different countries.. Pfizer and Roche are also conducting final trials of their antiviral drugs..
What's up with Merck stock
Investors reacted positively to Merck's message. On Friday, 1 october, the company's shares rose by 8,4%, to 81,4 $. Since the beginning of the year, Merck securities have risen in price by 5,4%.
"In recent quarters, Merck has been kind of dead to investors.. Now we see, that their R&D department is not dead. They were the first in that, what can bring billions ", Bahl Management Company said & Gaynor.
But shares of COVID-19 vaccine maker Moderna fell by the end of the day. 11,4%, to 341,1 $. Thanks to the vaccine, the company's revenue in the first half 2021 year increased strongly compared to the same period last year: from 75 to 6300 million dollars.
Even with Friday's fall in Moderna stock in 2021 year added 205%. "The latest news is a great reason to lock in profits on Moderna shares", — advise in Wedbush Securities.
Shares of vaccine developers BioNTech and Novavax also fell by 6,7 and 12,2%. Papers of manufacturers of injectable drugs for COVID-19 Regeneron and Gilead fell by 5,7 and 1,9%.
If Merck's new drug is approved, this will help to cope with the pandemic faster. And it will reduce people's fear of traveling and being in public places.. For this reason, shares of the largest American air carriers on Friday rose.: American Airlines — on 5,5%, United Airlines — on 7,9%, Delta Air Lines — to 6,5%.
Shares of pandemic-hit Hilton and Carnival added 4,6 and 4,3%.
More about Molnupiravir :
Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, and Ridgeback Biotherapeutics today announced, what lightnupiravir (MK-4482, PROPERTY-2801), experimental oral antiviral drugs, significantly reduced the risk of hospitalization or death in the planned interim analysis of the phase study 3 MOVe-OUT in non-hospitalized adult patients at risk for mild to moderate COVID-19. According to the intermediate analysis, molnupiravir reduced the risk of hospitalization or death by about 50%; 7,3% patients, receiving molnupiravir, were either hospitalized, either died before 29 days after randomization (28/385) compared with 14,1% patients, receiving placebo (53/377); p = 0,0012. On the 29th day in patients, receiving molnupiravir, no deaths were reported. compared with 8 deaths among patients, receiving placebo. On the recommendation of an independent data monitoring committee and in consultation with the U.S. Food and Drug Administration (FDA) enrollment in the study is terminated early due to these positive results. Based on these findings, Merck plans to apply for emergency use as soon as possible. (USA) in the US FDA, as well as submit marketing applications to other regulatory bodies around the world.
"More tools and treatments are urgently needed to combat the pandemic. COVID-19, which has become a leading cause of death and continues to have a profound impact on patients, families and society and puts strain on health systems around the world. With these compelling results, we are optimistic about, that molnupiravir could be an important drug in the global pandemic response and will complement Merck's unique legacy of advancing infectious disease breakthroughs, when they are most needed. In line with Merck's unwavering commitment to saving and improving lives, we will continue to work with regulators on our applications and do our best, to deliver molnupiravir to patients as soon as possible ", - said Robert M. Davis, CEO and President. Merck. "On behalf of all Merck employees,
“In view of the, that the virus continues to circulate widely, and as currently available therapeutic options are introduced and / or require access to a medical facility, antiviral drugs are badly needed, which can be taken at home, to keep people with COVID-19 out of the hospital, - said Wendy Holman, Chief Executive Officer of Ridgeback Biotherapeutics. "We are very encouraged by the results of the interim analysis and hopefully., what lightnupiravir, if it is approved for use, will be able to have a serious impact on the fight against the pandemic. Our partnership with Merck is critical to providing fast global access, if this medicine is approved, and we appreciate the joint efforts to reach this important development milestone. ".
About the results of planned interim analysis
As part of the planned interim analysis, the data were assessed 775 patients, which were originally included in the MOVe-OUT phase study 3 not later 5 August 2021 r. At the time of the decision to discontinue recruitment, based on convincing interim results of efficacy, the study was approaching the full sample for the phase 3 the size 1550 patients, more than 90% the estimated sample size has already been included.
The selection criteria required, that all patients have mild to moderate laboratory-confirmed COVID-19 with symptoms on 5 days after study randomization. At the time of inclusion in the study, all patients must have had at least one risk factor., associated with an adverse outcome of the disease. Molnupiravir reduces the risk of hospitalization and / or death in all key subgroups; Effectiveness was not affected by the time of onset of symptoms or the underlying risk factor.. Moreover, according to participants with available viral sequencing data (about 40% participants), molnupiravir has demonstrated consistent efficacy against viral gamma variants, delta and mu.
The incidence of any adverse events was comparable in the molnupiravir and placebo groups (35% and 40% respectively). Similarly, the frequency of adverse events, medication-related, was also comparable (12% and 11% respectively). Fewer subjects discontinued the study therapy due to an adverse event in the molnupiravir group. (1,3%) compared to placebo group (3,4%).
Merck's Efforts to Provide Access to Molnupiravir, if provided by EUA or approved
Waiting for MOVe-OUT results, Merck produces molnupiravir from the risk group. Merck expects to produce 10 million treatments by the end 2021 of the year, it is expected, what in 2022 more doses will be produced in the year.
Earlier this year, Merck concluded Procurement Agreement with the U.S. Government, under which Merck will supply the US government with about 1,7 million courses of molnupiravir subject to EUA approval or U.S. FDA approval. Moreover, Merck enters into supply and procurement agreements for molnupiravir with governments around the world, pending regulatory approval, and is currently negotiating with other governments.
Merck is committed to ensuring timely access to lightning pyravir worldwide, if it is sanctioned or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria, to reflect the relative ability of countries to fund their health response to the pandemic.
As part of its commitment to universal global access, Merck has previously announced, that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with recognized generic manufacturers, to accelerate the availability of lightnupiravir in more than 100 low- and middle-income countries (SNSD). after obtaining permits or permits from local regulatory authorities.
More about the MOVe-OUT study
MOVe-OUT research (MK-4482-002) ( NCT04575597 ) was a global, randomized, placebo-controlled, double-blind, multicenter phase study 3 involving non-hospitalized adult patients with laboratory-confirmed COVID- mild to moderate severity. 19, at least, one risk factor, associated with poor disease outcomes, and the onset of symptoms within five days of randomization. The main goal of MOVe-OUT efficacy is to evaluate the effectiveness of molnupiravir compared to placebo, as measured by percentage of participants, who were hospitalized and / or died from randomization to day 29.
Phase 3 MOVe-OUT research has been conducted around the world, including more than 170 planned locations in countries, including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, UNITED Kingdom and USA. For more information about the MOVe-OUT study, visit Clinicaltrials.gov .
Obesity was the most common risk factor for poor outcome., elderly age ( > 60 years), diabetes mellitus and heart disease. To date, Delta variants, Gamma and Mu were almost 80% evaluated cases in the trial. Recruitment in Latin America, Europe and Africa amounted to 55%, 23% and 15% study population, respectively.
About Molnupiravir Molnupiravir
Molnupiravir (MK-4482 / PROPERTY-2801) is an investigational oral form of a potent ribonucleoside analog, which inhibits the replication of SARS-CoV-2, covid-19. Was shown, that molnupiravir is active in several preclinical SARS-CoV-2 models, including prevention, treatment and prevention of transmission. Moreover, preclinical and clinical data showed, that molnupiravir is active against the most common variants of SARS-CoV-2. Molnuviravir was invented by Drug Innovations at Emory (DRIVE), LLC, non-profit biotechnology company, wholly owned by Emory University, and developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Ridgeback received an advance payment from Merck, and is entitled to contingent payments depending on the achievement of certain stages of development and approval by regulatory authorities. Any profit from cooperation will be divided equally between partners. After obtaining a Ridgeback license, all tools, used to develop molnupiravir, were provided by Merck and Wayne and Wendy Holman of Ridgeback.
Molnupiravir is also being evaluated for PEP in MOVe-AHEAD, global multicenter, randomized, double-blind, placebo-controlled phase trial 3, which assesses the efficacy and safety of molnupiravir in preventing the spread of COVID-19. within households. For more information, visit http://merckcovidresearch.com .
О Ridgeback Biotherapeutics
Ridgeback Biotherapeutics LP headquartered in Miami, Florida, is a biotechnology company, specializing in new infectious diseases. Ridgeback sells Ebanga TM for the treatment of Ebola and has the last stage of development, which includes molnupiravir to treat COVID-19. The development of molnopiravir is fully funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All Ridgeback Biotherapeutics share capital, LP belongs to Wayne and Wendy Holman, who seek to invest in medical technology, who will save lives, and support them. Ridgeback team searches for life-saving and life-changing solutions for patients and diseases, who need champions.
More 130 years Merck, known as MSD outside the US and Canada, invents for life, offering medicines and vaccines for many of the world's most difficult diseases, pursuing our mission to save and improve lives. We demonstrate our commitment to patient and public health, expanding access to health care through ambitious policies, programs and partnerships. Today, Merck continues to be at the forefront of disease prevention and treatment research., threatening people and animals, including cancer, infectious diseases, such as HIV and Ebola, and new animal diseases, as we strive to become a leading research biopharmaceutical company. in the world.
Merck forward-looking statement & Co., Inc., Kenilworth, New Jersey, USA.
This Merck press release & Co., Inc., Kenilworth, state of new jersey, USA (hereinafter - "company"), includes "forward-looking statements" within the meaning of "safe harbor" US Private Securities Litigation Reform Act 1995 of the year. The statements are based on the current beliefs and expectations of management and are subject to significant risks and uncertainties.. There can be no guarantees for pipeline products, that the products will receive the necessary regulatory approvals or prove to be commercially successful. If the underlying assumptions prove to be inaccurate or risks or uncertainties arise, actual results could differ materially from those, which are set out in forward-looking statements.
Risks and uncertainties include, among other things, general industry conditions and competition; general economic factors, including fluctuations in interest rates and exchange rates; impact of the global outbreak of the novel coronavirus disease (COVID-19); impact of pharmaceutical industry regulation and health care legislation in the United States and around the world; global trends to contain health spending; technical progress, new products and patents, received by competitors; Problems, related to the development of new products, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; production difficulties or delays; financial instability of the world economy and sovereign risk; dependence on the effectiveness of the company's patents and other means of protecting innovative products; and susceptibility to litigation, including patent disputes, and / or regulations.
The company assumes no obligation to publicly update any forward-looking statements., whether as a result of new information, future events or otherwise. Additional factors, which may lead to, that the results will differ materially from those, which are described in forward-looking statements, can be found in the company's Annual Report for 2020 year on Form 10-K and other company documents to the Securities and Exchange Commission (SEC), available in the SEC. Internet site ( www.sec.gov ).
A source : https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/