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Zydus Cadila receives emergency approval for virafin, as it makes remdesivir affordable for India (Source:Alamy)

Zydus Cadila has announced receiving emergency use approval from the Drugs Controller General of India for the use of pegylated interferon alpha-2b, virafin, in treating moderate COVID-19 infection in adults.

The company noted that a single dose of the antiviral virafin administered subcutaneously early on shows significant clinical and virological improvement in moderate COVID-19 in adult patients and help patients to recover faster and avoid complications. “The treatment significantly reduces the hours of supplemental oxygen in the patients,” the company said.

Managing director Sharvil Patel commented, “The fact that we are able to offer a therapy which significantly reduces viral load when given early on can help in better disease management.” He added, “It comes at a much-needed time for patients and we will continue to provide them access to critical therapies in this battle against COVID-19.”

As the drug shows efficacy against other viral infections as well, virafin is being made available by Zydus on the prescription of medical specialists for use in the hospital/institutional context.

 

At the same time, to make remdesivir more affordable in India, Zydus Cadila has also slashed the price of its brand of remdesivir, Remdac, from INR2800 ($37.40) to INR899 for a 100mg lyophilized injection. The company believes that “this move to further revise the prices will go a long way in helping patients during these critical times.”

Patel commented, “Remdac has been one of the critical drugs in the disease management of COVID and we hope that this price cut will enable people from every strata of the society to access this critical drug.”

After entering into a non-exclusive agreement with Gilead Sciences to manufacture and sell remdesivir, the company had launched Remdac in India in August 2020.

Patel added, “Through the course of this pandemic, our efforts have been focused on making therapies accessible and affordable to people.”

Pfizer Commits To Supporting Indian Government’s Immunization Program

Pfizer has announced that it will make its coronavirus vaccine available for India to help the government in its immunization program. The company’s spokesperson told Generics Bulletin, “Pfizer remains committed to continuing our engagement with the government of India towards making the Pfizer-BioNTech COVID-19 vaccine available for use in the country’s immunization program.”

Without revealing details of the agreement with the government around  potential ‘not-for-profit’ vaccine prices as reported by local media, Pfizer said, “during this pandemic phase, Pfizer will prioritize supporting governments in their immunization programs and supply the COVID-19 vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval. This would be our approach in India as well.”

“Further,” the spokesperson added, “in all our agreements we have adopted a distinct pricing structure for high, middle, and low/lower-middle-income countries consistent with our commitment to work towards equitable and affordable access for our COVID-19 vaccine for people around the world.”

Natco Seeks Approval Of Molnupiravir For Indian Market

Natco Pharma is seeking emergency approval for molnupiravir capsules for the treatment of COVID-19 positive patients from the Central Drugs Standard
Control Organization in India. The company said that it was ready to launch the product within days of receiving the approval.

Natco said that it was hoping that the CDSCO would give emergency approval for the drug based on “compassionate use” for patients with an immediately life-threatening condition.

Natco’s pre-clinical data showed that molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication.

The company noted that patients treated with molnupiravir achieved response within five days of therapy, indicating that the duration of treatment with molnupiravir is short, with the additional advantage of being an oral therapy.

Strides Pharma’s Stelis And Dr Reddy’s Partner With RDIF For Sputnik V Vaccine

Stelis Biopharma, the biopharmaceutical division of Strides, has partnered with the Russian Direct Investment Fund to produce and supply a minimum of 200 million doses of the Russian Sputnik V vaccine to India, sufficient to vaccinate 100 million people.

The parties intend to commence supplies of the two-dose vaccine from the third quarter of 2021.

Strides founder Arun Kumar said, “We are delighted to partner with RDIF to make a substantial contribution towards providing global supply of the Sputnik V vaccine which is one of the most efficacious approved vaccines commercially available.”

Kumar added, “We will also work with RDIF to increase the availability of the vaccine beyond our initial commitments.”

“The significant vaccine volumes which will be produced jointly with Stelis will help to widen access to the vaccine on a global scale,” said Kirill Dmitriev, CEO of the RDIF.

RDIF noted that the agreementwas reached under the aegis of Enso Healthcare LLP (part of Enso Group), RDIF'’s coordination partner for sourcing Sputnik V vaccines in India.

“We are delighted to announce our agreement with Stelis Biopharma for a significant capacity of Sputnik V,” added Dmitriev. “The Russian vaccine with efficacy of 91.6% is one of the best vaccines against coronavirus in the world.”

Separately, Dr Reddy's has announced receiving permission from the Drug Controller General of India to import the Sputnik V vaccine into India for restricted use in emergency situations.

Co-chairman and managing director GV Prasad said, “We are very pleased to obtain the emergency use authorization for Sputnik V in India.”

“With the rising cases in India, vaccination is the most effective tool in our battle against COVID-19,” added Prasad. “This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population.” 

In September 2020, Dr Reddy’s had partnered with the RDIF to conduct clinical trials of the Sputnik V vaccine, which is now approved in 60 countries.

In addition to the trials conducted in Russia by RDIF, Dr Reddy’s noted that the Phase II/III clinical trials of the vaccine were carried out by the company in India.

Biocon Announces A Dedicated 24x7 Pandemic-Care Helpline

Biocon has also come out with a dedicated 24x7 pandemic-care helpline to give information on the availability of its COVID-19 products and to handle the pandemic related queries.

Kiran Mazumdar-Shaw, executive chairperson of Biocon, shared the details of the free COVID-care helpline on LinkedIn. “Please call this helpline in case of need,” said Mazumdar-Shaw.

SII Scales Up Production To Meet Vaccine Demand

The Serum Institute of India has announced plans to scale up vaccine production over the next two months. “Going ahead, 50% of our capacities will be served to the government of India’s vaccination program, and the remaining 50% of the capacity will be for the state governments and private hospitals,” said CEO Adar Poonawalla. He added, “considering the global vaccine prices, we are ensuring that our vaccines are affordable in comparison to any other vaccines in the world.”

“Furthermore, owing to the complexity, and urgency of the situation it is challenging to supply it independently to each corporate entity.” As a result, the company has urged all corporate and private individuals to access the vaccines through the state facilitated machinery and private health systems.

“Post 4-5 months, the vaccines will be made available in retail and free trade,” Poonawalla assured.

Celltrion Works On Rekirona Clinical Trials

Celltrion has announced completing registration of 1,300 patients from 13 countries for global Phase III clinical trials of the firm’s COVID-19 antibody treatment, Rekirona.

Rekirona is a conditional treatment for patients with mild and moderate symptoms in high-risk groups who are 60 years of age or older or have an underlying disease (cardiovascular disease, chronic respiratory system disease, diabetes, or hypertension), and was approved by Korea’s Ministry of Food and Drug Safety in February.

 

A Celltrion official said, “COVID-19 is still prevalent in many global countries and thanks to the efforts of the head office clinical team and local staff, it was possible to recruit a sufficient number of patients in a short time.”

“In anticipation, we will concentrate our capabilities to derive excellent results through Phase III clinical data analysis in the first half of this year,” the official added.

Emphasizing the safety of Rekirona, Celltrion said that it plans to analyse data for Phase III clinical trials by the end of June and submit them to domestic and overseas licensing agencies, to accelerate the review rate for the current permit application.

The company noted that to date, there have been no specific safety issues among patients who have completed the medication, and there have been no cases of discontinuation of the study due to adverse events after medication.

Celltrion said that it has already completed the production of Rekirona for 100,000 people last year and the company is equipped with a system that can additionally produce Rekirona for 1.5 to 3 million people per year depending on global demand.

Formycon Announces Efficiency of FYB207 Against SARS-COV-2 Mutant B.1.1.7

Formycon, the developer of biopharmaceuticals with a focus on biosimilars, has announced new results on the in vitro neutralization of SARS-CoV-2 variants by Formycon’s COVID-19 drug FYB207. The company is receiving funding from the Bavarian Research Foundation for the initial development steps of this project.

The German company, together with its academic research partners – Ulrike Protzer, chair of virology and Johannes Buchner, chair of biotechnology, Technical University of Munich – announced, “The results show that FYB207 is even more efficient against the B.1.1.7 mutant of the virus, which is considered particularly infectious, than against earlier variants.”

Talking about increasing concern  around neutralizing antibodies or vaccines losing their activity against emerging SARS-CoV-2 mutants, CEO Carsten Brockmeyer commented, “While studies with neutralizing antibodies and sera from vaccinated individuals in vitro have indicated a reduction in neutralizing activity against B.1.1.7 and further SARS-CoV-2 mutants, our new in vitro data show that FYB207 neutralizes SARS-CoV-2 mutant B.1.1.7 even more.”

Brockmeyer added, “These results support our strategy to develop FYB207 as a treatment option for COVID-19 patients, but also to contribute to the preparedness for the outbreak of new coronavirus mutants.”

The company noted that pre-clinical activities as well as the preparations for the entry into clinical trials with FYB207 are proceeding according to plan. In addition, Formycon said that it had a successful scientific advice meeting with the Paul Ehrlich Institute and has already secured Good Manufacturing Practice approved capacity for FYB207.

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