NEWS

Lupin launches Molnupiravir under the brand name Molnulup for the treatment of COVID-19 in adults in India

Clinical data suggests that it is effective on patients with co-morbidities

Mumbai, India, January 07, 2022: Global pharma major Lupin Limited (Lupin) announced the launch of Molnupiravir in India under the brand name Molnulup. This drug has been given emergency use authorization by the Drug Controller General of India (DCGI) for treatment of adult patients with Covid-19, with SpO2 > 93%, and the ones who have a high risk of progression of the disease including hospitalization.

Internationally, Molnupiravir is an oral antiviral that has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S Food and Drug Administration (FDA) for the treatment of mild-to-moderate cases of COVID-19 in adults.

Administered orally, Molnupiravir inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Pre-clinical and clinical data have shown Molnupiravir to be effective against the most common SARS-CoV-2 variants including Gamma, Delta, and Mu variants. Molnupiravir should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of onset of symptoms.

Clinical data points suggest that Molnupiravir may be a gamechanger for the most vulnerable and immunosuppressed patients. This would include factors such as obesity, older age (>60 years), diabetes, or heart disease.

Commenting on the development, Rajeev Sibal, President – India Region Formulations (IRF) said, “The approval for Molnulup is timely as India is again experiencing an upward spike in COVID-19 incidences. In the past two years since COVID-19 has emerged, there is a need for an oral antiviral medicine that can be prescribed by the Healthcare practitioners and then taken by the patients conveniently at home. Through our strong distribution network, we will make Molnulup readily available at pharmacies Pan India to meet patient demand.”

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue in research and development in FY21.

Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.








https://www.lupin.com/lupin-launches-molnupiravir-under-the-brand-name-molnulup-for-the-treatment-of-covid-19-in-adults-in-india/

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Bangladesh drug maker Beximco launches worlds first generic of Pfizers COVID antiviral


Beximco Pharma will market this product under the brand name Bexovid, initially in Bangladesh.


Pfizer's drug is protected by patents, but countries such as Bangladesh classified as least-developed countries (LDCs) by the United Nations can ignore such patents and make drugs more affordable in those markets. The TRIPS transition period for LDCs was extended till July 2034.



https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/bangladesh-drug-make-beximco-launches-worlds-first-generic-of-pfizers-covid-antiviral/articleshow/88593018.cms



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Dr Reddys introduces anti-COVID drug molnupiravir at Rs 35 per capsule

"Dr Reddy's Molflu™ will be priced at Rs 35 per capsule with 10 capsules contained per strip, and the total course of 40 capsules over 5 days costing Rs 1,400 making it among the most affordable treatment options available to patients," Dr Reddy's Laboratories said in a statement. 

It added that Molflu is expected to be available from early next week in pharmacies throughout the country with particular focus on states with high caseload of COVID-19.  

 

Earlier this year, Dr Reddy's had entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply molnupiravir to India and over 100 low and middle-income countries (LMICs). A consortium of pharma companies, led by Dr Reddy's, collaborated to jointly sponsor, supervise and monitor the phase III clinical trials in India, and presented its findings to the Subject Expert Committee (SEC). 


https://www.msn.com/en-in/money/topstories/dr-reddys-introduces-anti-covid-drug-molnupiravir-at-rs-35-per-capsule/ar-AASqm9M?ocid=BingNewsSearch




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Square and Renata for Covid oral medicine production

Six other pharmaceutical companies are also waiting for the green light The Directorate General of Drug Administration (DGDA) has granted Beximco, Square, Eskayef and Renata pharmaceutical companies approval for the production and marketing of molnupiravir, the first-ever Covid-19 pill developed by US drugmaker Merck & Co Inc and Ridgeback Biotherapeutics.



NewsSource


https://www.haberahali.com/siyaset/square-and-renata-for-covid-oral-medicine-production-17946.html

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FDA to authorize COVID-19 pills this week: Bloomberg

The U.S. Food and Drug Administration (FDA) is expected to authorize two COVID-19 treatment pills, people familiar with the matter told Bloomberg.

The treatments would include Pfizer’s pill, Paxlovid, as well as Merck’s molnupiravir, which are meant to treat higher-risk COVID-19 patients, according to Bloomberg. 

The people who spoke to the outlet said the approval could come as soon as Wednesday, though they acknowledged that the plan was subject to change.



news source

https://thehill.com/policy/healthcare/586767-fda-to-authorize-covid-pills-this-week-bloomberg


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Molnupiravir – what you need to know

Molnupiravir has been approved by the MHRA for early treatment of mild-moderate covid-19 in vulnerable adults, it was announced on 4th November.

It is good news that at last the Government and the pharma industry have recognised the need for early treatment of covid-19. Health care practitioners will doubtless be having to answer questions about this so IMI has prepared this short briefing.

Molnupiravir is an orally-active prodrug for N4-hydroxycytidine (NHC) – an antiviral ribonucleoside analogue that acts as a competitive substrate for virally encoded RNA-dependent RNA polymerase (RdRp). The ribonucleoside form of NHC (rNHC) has the ability to pair as either cytidine or uridine, thereby introducing mutations.

Basically, this means that when RNA is being assembled NHC is substituted in place of cytidine. This is sufficiently close to the correct nucleoside that the viral proof-reading enzyme does not remove it, but it results in a nonsense version of the RNA and slows or stops viral replication. This process is described as ‘lethal mutagenesis’ or ‘error catastrophe’.

NHC has powerful in vitro and in vivo activity against a number of RNA viruses. It is more than 100-fold more active than ribavirin or favipiravir against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), with antiviral activity

correlated to the level of mutagenesis in virion RNA.1

So far so good.

What could possibly go wrong?

Due to their mechanism of action, there is a possibility that mutagenic ribonucleoside analogues could be metabolised by the host cell and then incorporated into DNA, leading to mutagenesis of the host.1 It follows that the mutagenic activity of rNHC in vivo would be limited to dividing cells where the synthesis of DNA precursors is ongoing.

Others have expressed concern about the possibility of the emergence of supercharged variants – viable, mutated viruses as a result of molnupiravir treatment. They argue that the companies behind the drug must provide data on the effects of mutagenesis at suboptimal doses in primate and rodent models.

Molnupiravir trial

On 1st October 2021 Merck (MSD) and Ridgeback Biotherapeutics announced that early treatment with molnupiravir reduced the relative risk of hospitalization or death by approximately 50% in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19, according to the interim analysis of the Phase 3 MOVe-OUT trial (NCT04575597). The results showed that 7.3% of patients who received molnupiravir (800mg, 12-hourly for five days) were either hospitalized or died by Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. There were no deaths in the molnupiravir group compared to eight deaths in the placebo group. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study was stopped.

Women who were pregnant, breastfeeding, or anticipating becoming pregnant were excluded from the trial. Men who enrolled in the trial were instructed not to have unprotected sex with women for at least four days after the last dose of drug.

Other commentators noted that, “From a methodological perspective, a trial with a small number of events that is stopped early for apparent treatment effects might be prone to the risk of overestimation”.2 In this trial the total number of outcome events was 81.

MHRA approval

The UK Government has been quick to seize the initiative here. On 4th November it announced that molnupiravir had been approved by the MHRA for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.

Dr June Raine, MHRA Chief Executive, said:

“Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval.

“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”

The MHRA points out that Lagevrio is not intended to be used as a substitute for vaccination against COVID-19.

The Government and the NHS will confirm how this COVID-19 treatment will be deployed to patients in due course.

There is no information on the cost of molnupiravir in the UK. However, the United States has agreed to purchase 1.7 million courses of molnupiravir for US$1.2 billion, which works out to about $700 per 5-day course. That is far less than the price of remdesivir or monoclonal antibodies, but still many times more than the cost of other drugs that have been successful in early treatment of covid-19. Drugs such as ivermectin, indomethacin and fluvoxamine have all proved highly effective in early treatment of covid-19 and have the advantage of good safety profiles and low acquisition costs.3,4,5 It would seem prudent to weigh the costs, benefits and risks of molnupiravir against these drugs before the purchasing decisions are made.




News Source

https://medicalupdateonline.com/2021/12/molnupiravir-what-you-need-to-know/


 

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What to know about molnupiravir, the COVID pill that could be coming to a pharmacy near you

Almost lost in last week’s blockbuster release of Omicron: Fear and Loathing — The Rise of the Next Variant was an FDA panel’s recommendation that a drug named molnupiravir be given Emergency Use Authorization (EUA). 

The drug would be the first of its kind, a treatment for COVID that can be taken at home, as a pill. Its most well-recognized “relative” might be the anti-influenza pill Tamiflu (oseltamivir), which works by blocking the influenza virus’ ability to exit an infected cell. If taken within 48 hours of the onset of symptoms, Tamiflu has been shown to reduce the intensity and complications of the flu, and perhaps even death. 

Molnupiravir (Lagevrio) works a little differently. The virus mistakenly inserts a metabolite of the drug into its RNA — as if an extra number or symbol were inserted into one of your computer passwords. The substitution causes the virus to produce mutated versions of itself, calamitously referred to as “viral error catastrophe.” With no meaningful viral replication, the flame goes out.


News source

https://www.minnpost.com/health/2021/12/what-to-know-about-molnupiravir-the-covid-pill-that-could-be-coming-to-a-pharmacy-near-you/



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Experimental Antiviral Drug To Become Available in Fight Against COVID

The experimental antiviral drug Molnupiravir is expected to become available in Slovenia from tomorrow to treat vulnerable patients with COVID-19.

The experimental antiviral drug Molnupiravir is expected to become available in Slovenia from tomorrow for the treatment of COVID-19, especially for vulnerable patients who have higher risk factors or underlying health issues.

The drug was originally developed to treat a different virus but showed strong results in fighting other viruses, such as influenza and Ebola.

It's name was inspired by the name of Thor's hammer, Mjolnir.

Voluntary vaccination of children aged between 5 and 11 is also expected to begin next week.




news source

https://www.rtvslo.si/radio-si/news/experimental-antiviral-drug-to-become-available-in-fight-against-covid/604769

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COVID-19: Thousands to take part in trial of game-changing coronavirus pill molnupiravir that can be taken at home

Molnupiravir is the first of several antiviral treatments that will be tested during the study, which is being led by the University of Oxford.


A nationwide trial of a "game-changing" antiviral pill for vulnerable people who test positive for coronavirus is now under way.

Molnupiravir is the first of several antiviral treatments that will be tested during the study, which is being led by the University of Oxford.

The trial is aiming to recruit 10,600 people to test whether the pill reduces the need for the over 50s and those with underlying health problems to be admitted to hospital.

Those who take part in the trial, which has been named PANORAMIC, will have to have tested positive following a PCR test.

Participants will have to complete a daily diary for 28 days through the trial's website, or receive a phone call from the trial team on days days seven, 14 and 28 to speak about their symptoms.

The first set of results from the trial are anticipated in early 2022.

Those at highest risk who test positive for the coronavirus - for example, people who are immunocompromised, certain cancer patients or those with Down's syndrome - will be able to access either Ronapreve, an antibody treatment which is taken through an IV infusion in hospital or one of the new COVID Medicines Delivery Units (CMDUs), or molnupiravir, from 16 December.

news source

https://news.sky.com/story/covid-19-thousands-to-take-part-in-trial-of-game-changing-coronavirus-pill-molnupiravir-that-can-be-taken-at-home-12490154


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Molnupiravir Anti Covid 19 drug Movinavir 200mg and 400mg

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