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COVID-19 drug Baricitinib: Eli Lilly signs voluntary licensing agreement with Natco Pharma

Natco has received approval from the Drug Controller General of India (DCGI) for Baricitinib earlier in May. Natco went ahead and launched the drug under brand name Barinat even as its compulsory licensing application is still pending before India. The patents of Baricitinib are owned by Lilly.

May 17, 2021 / 09:28 AM IST
Eli Lilly has partnered with Cipla, Lupin, Sun Pharma to manufacture and distribute Baricitinib in India

Eli Lilly has partnered with Cipla, Lupin, Sun Pharma to manufacture and distribute Baricitinib in India

 
 
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Eli Lilly, on May 17, announced that it had issued an additional royalty-free, non-exclusive voluntary license to Natco Pharma to manufacture and distribute Baricitinib in the country.

The rheumatoid arthritis drug is used in treating COVID-19 patients. The drug has to used as co-treatment with Remdesivir as per approval granted by the CDSCO/DCGI for Emergency Use Authorisation.

"Natco will be collaborating with Lilly to further accelerate and expand the availability of Baricitinib in India during this pandemic, improving the local treatment options available to positively impact the lives of people who are currently battling COVID-19 in India," Lilly said.

Natco has received approval from the Drug Controller General of India (DCGI) for Baricitinib early this month. Natco went ahead and launched the drug under brand name Barinat even as its compulsory licensing application is still pending before India. The patents of Baricitinib are owned by Lilly.

Meanwhile, Lilly announced the signing of six Voluntary License Agreements Cipla, Lupin, Sun Pharmaceutical Industries, Dr. Reddy’s , MSN Laboratories and Torrent Pharmaceuticals. But Moneycontrol learned that none of the licensees are ready to launch the drug in next two months.

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Please read here to know how Natco has put pressure on Lilly to COVID-19 drug through compulsory licensing filing.

On  May 10, Lilly also announced the signing of three Voluntary License Agreements with key local pharmaceutical manufacturers of generic medicines - Cipla, Sun Pharma and Lupin - to further ensure equitable access to Baricitinib for people who are currently impacted by the burden of COVID-19.

Meanwhile, Lilly said it would continue to engage in active dialogue with the regulatory authorities and government in India to deliver Baricitinib donations through the humanitarian aid organisation - Direct Relief and to donate Lilly’s anti-COVID-19 treatments, including Lilly’s neutralizing antibodies.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: May 17, 2021 09:28 am

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