Remdesivir is the only USFDA approved Emergency Use Authorisation (EUA) treatment for covid-19

The Homegrown pharma major Cipla Ltd announced the launch of its generic version of remdesivir. It has been authorised for emergency use in treatment of COVID-19 patients by the USFDA, under its brand name Cipremi. The USFDA had issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc for emergency use of the drug for the treatment of COVID-19 patients.

Remdesivir is the only USFDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients who are hospitalised with suspected or laboratory confirmed COVID-19 infection.

In May, Gilead Sciences Inc, extended a voluntary non-exclusive license to Cipla pharmaceuticals to manufacture and market generic version of remedisvir called Cipremi.

Cipla said it has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need in the country.

Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients, as a part of risk management plan.

 
To enable speedy and equitable access to this drug of interest and in anticipation of demand, Cipla will be commercialising remdesivir through its own facilities and partnered sites.

The drug will be supplied through the government and open market channels of country to ensure equitable distribution.

Commenting on the launch, Cipla Ltd MD and Global CEO Umang Vohra said, "Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by COVID-19 pandemic, and this launch is a significant milestone in that direction".

The company will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with the belief that no patient should be denied access to life-saving treatments, he added.

Glenmark Pharmaceuticals Ltd launches a drugs for COVID-19 -Fabi flu

Glenmark Pharmaceuticals Ltd launches a drugs for COVID-19, and would begin a clinical trial in India to test a combination of these two anti-viral drugs, favipiravir and umifenovir, as a potential treatment.

In present situation, all over the world is in search of vaccine and medication to fight back against the corona virus, which has infected 5.5 million people globally, killing more than 345,000, according to a Reuters tally. In India, now among the 10 most affected nations, the death toll reached 4,167. And the success of this trial would take Glenmark pharmaceutical to next level and world will get a breathe of relief.

Glenmark has been successful in securing the approval of Indian regulatory for conduct of the study. The study will aim to enroll 158 hospitalized patients with moderate COVID-19. 

Favipiravir is made under the brand name Avigan by Japan's Fujifilm Holdings Corp and was approved for use as an anti-flu drug in 2014 in Japan, while umifenovir is licensed as a treatment for some types of flu infections in Russia and China.

Generics drugmaker Beximco (AIM: BXP and fellow Bangladesh-based Beacon Pharmaceuticals have developed version of favipiravir. Although the drug is patented in Japan, according to Beximco, Bangladesh could market and produce favipiravir until 2033 under the relaxed guidelines of the World Trade Organization (WTO).

Glenmark is also conducting clinical trials in India of just favipiravir as a potential COVID-19 treatment, for which it expects results by July or August. However Favipiravir is also undergoing trials in other countries.

These two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy, the Mumbai-headquartered drugmaker stated.

Another Indian drugmaker - Strides Pharma - is also set to begin clinical trials of favipiravir as a potential COVID-19 treatment.

Shares in Indian drugmakers have been on a tear this year. India's Nifty pharma index has risen 18% this year, compared with a 26% slide in the blue-chip NSE Nifty 50.

But still the question remains the same, will the drug prove itself efficacious, and will we be able to find the treatment, and will the world find peace again from this pandemic?

Note: This news is confirmed by Economic times India.

https://health.economictimes.indiatimes.com/news/pharma/glenmark-pharma-to-study-potential-covid-19-drug-combination/76004935

COVID-19 vaccine development is getting closer to success in India

In new delhi, Scientists have identified regions of the SARS-CoV-2 virus that causes COVID-19 to target with a vaccine, by harnessing tools used for the development of cancer immunotherapies. The researchers at Children's Hospital of Philadelphia (CHOP) in the US employed the same approach used to elicit an immune response against cancer cells to stimulate an immune response against the novel coronavirus.

Using this strategy, the researchers believe a resulting vaccine would provide protection across the human population and drive a long-term immune response.

"In many ways, cancer behaves like a virus, so our team decided to use the tools we developed to identify unique aspects of childhood cancers that can be targeted with immunotherapies and apply those same tools to identify the right protein sequences to target in SARS-CoV-2," said John MMaris, a pediatric oncologist at CHOP, and a professor at the University of Pennsylvania.

"We think our approach provides a roadmap for a vaccine that would be both safe and effective and could be produced at scale," said Maris, senior author of the research published in the journal Cell ReportsMedicine.

The COVID-19 pandemic has led to an urgent need for the development of a safe and effective vaccine against SARS-CoV-2, the virus that causes the COVID-19 disease, the researchers said.

An optimally designed vaccine maximises a long-lasting immune response, while minimising adverse reactions, autoimmunity, or disease exacerbation, they said. To increase the likelihood that a vaccine is both safe and effective, the research team prioritised parameters in identifying regions of the virus to target.

The researchers looked for regions that would stimulate a memory T-cell response that, when paired with the right B cells, would drive memory B cell formation and provide lasting immunity and do so across the majority of human genomes.

They targeted regions of SARS-CoV-2 that are present across multiple related coronaviruses, as well as new mutations that increase infectivity, while also ensuring that those regions were as dissimilar as possible from sequences naturally occurring in humans to maximize safety.

The researchers propose a list of 65 peptide sequences that, when targeted, offer the greatest probability of providing population scale immunity.

The team will now test various combinations of a dozen or so of these sequences in mouse models to assess their safety and effectiveness.

Note: The above news is confirmed by newspaper, Economic Times, India.

Read more at:
https://economictimes.indiatimes.com/https://economictimes.indiatimes.com/news/science/targets-for-covid-19-vaccine-identified-by-scientists/articleshow/76280489.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

 

The Corona Outbreak And May be Vaccines.

The Coronavirus outbreak

The contagious coronavirus outbreak at the end of 2019, which the WHO named as Covid-19, led to a medical emergency across the world.

Caused by human alpha and beta coronaviruses such as 229E, NL63, OC43 and HKU1, the infection is responsible for SARS and MERS.

The mysterious Corinavirus outbreak in the Chinese city Wuhan now termed as Covid-19, and its fast spread to many other countries, endangers thousands of lives. The pandemic has catalysed the development of novel vaccines across the biotech industry, both by pharmaceutical companies and research organisations such as the National Institutes of Health (NIH), US.

Companies such as Inovio Pharmaceuticals, Moderna, and Novavax have been reported to be developing coronavirus vaccines. A total of 30 therapies are planned to be tested, including few traditional medicines, by Chinese scientists.

Meanwhile, clinical-stage biotech company GeoVax signed a letter of intent with BravoVax, a vaccine developer based in Wuhan, China, to jointly develop a coronavirus vaccine using genetic sequences of the 2019-nCoV.

NanoViricides, a clinical-stage company, is working on developing a treatment for nCoV-2019 using its nanoviricide^® technology. The company’s technology is used to develop ligands that can bind to the virus in the same way as a cognate receptor and attack various points of the virus.

Vir Biotechnology, a clinical-stage immunology company, announced on 12 February that it has identified two monoclonal antibodies that can bind to the virus that causes COVID-19. The antibodies target the spike (S) protein of the virus by entering through the cellular receptor ACE2.

Here is a list of the major pipeline drugs that pharmaceutical companies across the world are developing that have the potential to become major coronavirus vaccines or antivirals for treating the contagious coronavirus infection.

Novel coronavirus vaccines

INO-4800 by Inovio Pharmaceuticals and Beijing Advaccine Biotechnology

Inovio Pharmaceuticals has collaborated with Beijing Advaccine Biotechnology Company to advance the development of the former’s vaccine, INO-4800, as a potential treatment for 2019-nCOV. The company has started pre-clinical testing for clinical product manufacturing.

The vaccine development is supported by a $9m grant from the Coalition for Epidemic Preparedness Innovations (CEPI).

Inovio aims to progress the vaccine through phase one human testing in the US to test safety and efficacy. A phase one clinical trial is planned to be conducted in parallel in China, by Beijing Advaccine.

Recombinant subunit vaccine by Clover Biopharmaceuticals

Clover Biopharmaceuticals is developing a recombinant subunit vaccine using its patented Trimer-Tag^© technology. The company is developing the vaccine based on the trimeric S protein (S-Trimer) of the 2019-nCoV virus, which is responsible for binding with the host cell and causing a viral infection.

Using Trimer-Tag^© technology, Clover successfully produced the subunit vaccine in a mammalian cell-culture based expression system on 10 February. The company also identified antigen-specific antibody in the serum of fully recovered patients who were previously infected by the virus.

A highly purified form of the S-Trimer vaccine is expected to be available in six to eight weeks for performing pre-clinical studies. The company is equipped with in-house cGMP biomanufacturing capabilities to scale-up production if the vaccine is proven to be successful.

Vaxart’s coronavirus vaccine

Vaxart is developing an oral recombinant vaccine in tablet formulation using its proprietary oral vaccine platform, VAAST.

The company plans to develop vaccines based on the published genome of 2019-nCOV to be tested in pre-clinical models for mucosal and systemic immune responses.

CytoDyn-leronlimab

CytoDyn is examining leronlimab (PRO 140), a CCR5 antagonist, as a potential treatment for 2019-nCOV.

The drug is already being investigated in phase two clinical trials as a treatment for HIV and has been awarded fast-track approval status by the United States Food and Drug Administration.

Linear DNA Vaccine by Applied DNA Sciences and Takis Biotech

Applied DNA Sciences’ subsidiary LineaRx and Takis Biotech formed a joint venture on 07 February to develop a linear DNA vaccine as a treatment for coronavirus. The JV will use Polymerase Chain Reaction (PCR)-based DNA manufacturing technology to develop the vaccine.

The PCR technology offers several advantages including high purity, increased production speed, and absence of antibiotics and bacterial contaminants. Further, the vaccine gene developed through this technology can be effective without being inserted into the patient’s genome.

BXT-25 by BIOXYTRAN to treat late-stage acute respiratory distress syndrome (ARDS)

BIOXYTRAN announced that it exploring partners to develop its lead drug candidate, BX-25, as a treatment for Acute Respiratory Distress Syndrome (ARDS) in late-stage patients infected with the coronavirus. The diffusion of oxygen to the blood is comprised in patients suffering from ARDS leading to fluid build-up in the lungs.

BX-25 is designed to be 5,000 times smaller than blood cells and efficiently transport oxygen through the body for a period of nine hours before being processed by the liver. The drug can help in supplying oxygen to the vital organs and enable the patient to recover and survive.

MERS CoV vaccines

Novavax’s MERS coronavirus vaccine candidate

Novavax developed a novel Middle East Respiratory Syndrome (MERS) coronavirus vaccine candidate in 2013, post the identification of the first MERS coronavirus ((MERS-CoV) in Saudi Arabia in 2012. It is a crucial target for vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI) and is a priority disease for the World Health Organisation (WHO).

The candidate is designed to primarily bind to the major surface S-protein and developed using the company’s recombinant nanoparticle vaccine technology. Tested along with the Novavax’s proprietary adjuvant Matrix-M^™, it inhibited infection by inducing immune responses in the laboratory studies.

The MERS coronavirus is related to the severe acute respiratory syndrome (SARS) coronavirus for which the company had previously developed a recombinant nanoparticle vaccine candidate.

Inovio Pharma’s INO-4700

The investigational DNA immunotherapy, INO-4700 (GLS-5300) is being developed by Inovio in partnership with GeneOne Life Science. It is delivered as vaccine intramuscularly, using the Cellectra^® delivery device.

The vaccine was well-tolerated and demonstrated high immune responses against the MERS-CoV in 94% of patients in the early-stage clinical trial in July 2019.

It also generated broad-based T cell responses in 88% of the subjects.

“Research organisations such as the National Institutes of Health (NIH), US are also developing a vaccine for the coronavirus.”

Coronavirus medicines: Drugs being developed for the novel coronavirus

Remdesivir (GS-5734) by Gilead Sciences

An ebola drug developed by Gilead Sciences that was found to be ineffective is now being tested in phase III randomised clinical trial in partnership with China.

The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan, the epicentre of the novel coronavirus outbreak.

According to a report by The New England Journal of Medicine (NEJM), remdesivir, when administered to a coronavirus patient in the US, appeared to have improved the clinical condition.

Biocryst Pharma’s Galidesivir, a potential antiviral  for coronavirus treatment

The antiviral drug Galidesivir (BCX4430) has shown broad-spectrum activity against a wide range of pathogens including coronavirus. It is a nucleoside RNA polymerase inhibitor that disrupts the process of viral replication.

The drug has already shown survival benefits in patients against deadly viruses such as Ebola, Zika, Marburg, and Yellow fever.

Galidesivir is currently in advanced development stage under the Animal Rule to combat multiple potential viral threats including coronaviruses, flaviviruses filoviruses, paramyxoviruses, togaviruses, bunyaviruses, and arenaviruses.

Regeneron’s REGN3048-3051

Discovered by Regeneron, the combination of neutralising monoclonal antibodies REGN3048 and REGN3051 is being studied against coronavirus infection in a first-in-human clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The safety and tolerability of the drug will be studied in 48 patients.

Both the antibodies bind to S-protein of MERS coronavirus. The intravenous administration of the drug in the mouse model of MERS resulted in the high-level neutralisation of the MERS coronavirus in circulating blood with reduced viral loads in the lungs.

Can HIV drugs treat coronavirus infection?

An HIV protease inhibitor, lopinavir is being studied along with ritonavir for the treatment of MERS and SARS coronaviruses. The repurposed drug is already approved for the treatment of HIV infection under the trade name Kaletra^®.

The combination is listed in the WHO list of essential medicines. Lopinavir is believed to act on the intracellular processes of coronavirus replication and demonstrated reduced mortality in the non-human primates (NHP) model of the MERS.

Lopinavir/ritonavir in combination with ribavirin showed reduced fatality rate and milder disease course during an open clinical trial in patients in the 2003 SARS outbreak.

Cipla is also reportedly planning to repurpose its HIV drug LOPIMUNE, which is a combination of protease inhibitors Lopinavir and Ritonavir, for the treatment of coronavirus.

A licensed generic of Kaletra^®, LOPIMUNE is currently available in packs of 60 tablets each, containing 200mg of Lopinavir and 50mg of Ritonavir.

Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, donated its PREZCOBIX^® HIV medication (darunavir/cobicistat) for use in research activities aimed at finding a treatment for Covid-19.

Janssen is also working on developing a vaccine candidate in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR). It is using its AdVac^® and PER.C6^® technologies. The technology was previously used to develop an investigational Ebola vaccine.