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Eli Lilly India chief says company in talks with generic firms here on royalty free voluntary licensing of COVID-19 drug Baricitinib

They are also working with regulatory authorities and the government of India to donate Lilly’s COVID-19 treatments, including Baricitinib, if authorities deem it appropriate to potentially provide relief

May 05, 2021 / 02:48 PM IST
 
 
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US-drug maker Eli Lilly said it is engaged in active talks with several local pharmaceutical companies to explore potential royalty-free voluntary licensing agreements for Baricitinib to ensure accelerated availability of life saving medicines to patients under best quality conditions.

Eli Lilly didn't specify which companies it is in talks with.

The American pharmaceutical major is trying to fend off the challenge posed by Indian drug maker Natco Pharma, which has filed a compulsory license application in India to manufacture and distribute Baricitinib, a patented drug

Baricitinib in combination with Remdesivir is used for the treatment of COVID-19 positive patients.

In an exclusive email interview with Moneycontrol, Luca Visini, Managing Director for India, Nepal, Sri Lanka and Bangladesh at Eli Lilly, said the company is also working with regulatory authorities and the government of India to donate Lilly’s COVID-19 treatments, including Baricitinib, if authorities deem it appropriate to potentially provide relief. Below are the excerpts from the interview:

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COVID-19 Vaccine

Frequently Asked Questions

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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.

How many types of vaccines are there?

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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Is Baricitinib protected by patents?

Baricitinib is currently patented and registered in India as an oral JAK 1/ JAK2 inhibitor for the treatment of moderate to severe active rheumatoid arthritis in adult patients, who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.

On May 3, Lilly received permission for restricted emergency use by the Central Drugs Standard Control Organization (CDSCO), India's national regulatory body for pharmaceuticals and medical devices, for Baricitinib to be used in combination with Remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Natco has applied for compulsory licensing? Any comment on that?

We learned through the media that Natco has possibly received Emergency Use Approval (EUA) for Baricitinib tablets in combination with Remdesivir, to be used for treatment of COVID-19 positive patients. Lilly has not been notified about filing of a compulsory license application by the Indian patent office.

Lilly is committed to adhering to local laws and regulations while doing its best to ensure Lilly treatments are available to patients in India under the best quality and accessibility conditions.

Towards this end, Lilly has been promptly engaging in an active dialogue with regulatory authorities and the government of India to donate Lilly’s COVID-19 treatments, including Baricitinib, if authorities deem it appropriate to potentially provide relief.

With this intent in mind, Lilly has already engaged with several local pharmaceutical companies to explore potential royalty-free voluntary licensing agreements for Baricitinib, which will ensure accelerating further availability of life saving medicines to patients under best quality conditions.

What is Eli Lilly doing to make Baricitinib more widely available in India? Is there any possibility of voluntary licensing agreements?

On May 3, Lilly received permission for restricted emergency use by the Central Drugs Standard Control Organization (CDSCO), which is also a division of the Ministry of Health, for Baricitinib to be used in combination with Remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Given the surge that India is currently experiencing, a considerable initial donation of Baricitinib tablets is being made immediately available to the government for eligible hospitalized COVID-19 patients in India and further donations would be offered in the coming weeks. Simultaneously, Lilly has already engaged with local pharmaceutical companies to explore potential voluntary licensing for Baricitinib to accelerate wider availability of life saving medicines to patients under best quality conditions. These licensing collaborations build upon Lilly's access principles and potentially speed up the manufacturing and distribution of Baricitinib to hospitalized COVID-19 patients in India.

Is there any possibility of reducing the price of this critical drug?

To fight the COVID-19 pandemic, Lilly is committed to making Baricitinib available and accessible and will work with global and local health systems (health authorities and providers) to ensure equitable access to our medicines; our goal is to ensure that Lilly treatments are available to patients who need them, no matter where they live in India.

Given the surge that India is currently experiencing, Lilly has been promptly engaging in an active dialogue with the regulatory authorities and government of India to donate Baricitinib to the Indian government through Direct Relief, if authorities deem it appropriate to potentially provide relief. Donations of Baricitinib tablets are being made immediately available to the Indian government for eligible hospitalized COVID-19 patients in the country.

Also, is there any possibility of seeking approval from the Indian drug regulator for antibody cocktails (bamlanivimab-etesevimab)?

We are committed to working closely with regulatory authorities to contribute to alleviating the burden of COVID-19 in India through our antibody therapies and Baricitinib.

Given the surge that India is currently experiencing, Lilly has been promptly engaging in an active dialogue with the regulatory authorities and government of India to donate Lilly’s COVID-19 treatments (including Baricitinib and antibody cocktail - Bamlanivimab-Etesevimab) through Direct Relief, if authorities deem it appropriate to potentially provide relief.
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 5, 2021 02:45 pm

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