Pharma news – June 20 Updates

Gilead signs licensing pacts with four more drug firms for manufacturing Remdesivir

Pharma news – June 20: Gilead Sciences Ltd has recently been signing pacts with various drug firms for the manufacture and marketing of its antiviral drug, #Remdesivir. This drug had received emergency use authorization (EUA) in many countries for treating Covid-19. This decision was made after the preliminary trials conducted by the #NIH (US National Institute of Allergy and Infectious Diseases showed promising results.

The phase 3 clinical trials of Remdesivir are underway to check its efficacy and safety. Despite this, countries like the US and India have approved the use of this drug to treat #Covid-19 patients.

On 1 June 2020, the Drugs Controller General of India had approved the marketing of Remdesivir in the country. It had granted authorization to Gilead Sciences to market two dosage forms of this drug. These include the Remdesivir injection (5 mg/ml) and Remdesivir lyophilized powder for injection (100 mg) for treating severe cases of Covid-19.

The company had signed non-exclusive licensing pacts on May 2020 with Jubilant Life Sciences Ltd, Hetero Drugs Ltd, Mylan, Cipla Ltd. and Pakistani-based Ferozsons Laboratories.

On 12 June 2020, Zydus Cadila claimed that it has signed a non-exclusive voluntary licensing agreement with #GileadSciences. This pact has enabled #ZydusCadila to manufacture and market Remdesivir in nearly 127 countries.

Gilead Sciences also confirmed this by stating that four more drug firms have signed this pact. The newly added ones are Dr. Reddy’s Laboratories Ltd, Biocon arm Syngene International Ltd, Zydus Cadila Ltd and Egypt-based Eva Pharma Pvt. Ltd.

These 9 drug firms have the right to market Remdesivir in almost all the countries. This includes the low-income, lower-middle-income, upper-middle-income and several high-income countries. These companies also have the right to receive technology transfer of the Gilead manufacturing process of Remdesivir. This term was included as it aids in the faster production of the drug.

The licenses given to these 9 companies are royalty-free till an alternative drug/vaccine is found to treat Covid-19. This however becomes invalid if the World Health Organization (#WHO) declares the end of the Public Health Emergency of International Concern status of Covid-19.

Indian Health Ministry restricts the use of Remdesivir in the country by laying down certain rules:

Pharma news – June 20: The Union Health Ministry of India has recently allowed the use of the antiviral drug, Remdesivir for treating severe cases of Covid-19. It has also approved the use of tocilizumab and convalescent plasma therapy for treating moderate cases. However, on 14 June 2020, the ministry announced that the use of these therapies is solely based on the available evidence as the phase 3 trials of all these drugs are yet to be completed.

Remdesivir was included as a part of the “investigational therapy” and this restricted its use to emergency cases alone. However, a few protocols are expected to be completed before beginning the treatment with Remdesivir.

The written consent of the patient is collected before the use of Remdesivir. The results of the clinical trials conducted so far and active surveillance of all the treated patients need to be submitted. The risk management plan and the reporting of adverse side effects must also be presented prior to the treatment.

Apart from this, the first three batches from the import consignments also need to be tested. The results of this evaluation are sent to the #CDSCO^[1].

On 13 June 2020, the health ministry approved the implicit use of Remdesivir for moderate cases of Covid-19 who are on oxygen support. The health ministry also added that the USFDA^[2] had not granted market authorization to Remdesivir in the USA even though Remdesivir is approved under the emergency use authorization.

Gilead Sciences had applied to the CDSCO on 29 May 2020 to get the permission to import and manufacture Remdesivir in India. And after proper evaluation, the CDSCO approved this on 1 June 2020.

Six Indian companies namely Cipla, Jubilant, Hetero, Mylan, BDR pharma and Dr.Reddy’s laboratories have recently applied to the CDSCO to get permission for the manufacturing Remdesivir. Five out of the six companies have already signed an agreement with Gilead Sciences regarding the manufacturing processes and marketing of Remdesivir.

These companies are currently being thoroughly investigated by the CDSCO. They are also expected to submit the assay, test for identity, impurities and bacterial endotoxins as Remdesivir is to be sold in the injection form. These results will be sent to the CDSCO and decisions will be made based on this. The CDSCO has also waived off the need for local clinical trials of Remdesivir by invoking the emergency use authorization.

Abbreviation:

1. Central Drug Standard Control Organization
2. United States Food and Drug Administration

AstraZeneca agrees to supply Covid-19 vaccine to Europe:

Pharma news – June 20: AstraZeneca has struck a deal with Europe’s Inclusive Vaccine Alliance on 13 June 2020. As per this deal, the pharma giant has agreed to supply around 400 million doses of its Covid-19 vaccine to the European alliance. This agreement also ensures the availability of the vaccine to all the European countries that wish to take part in the alliance.

This European alliance was set up by Germany, Netherlands, Italy and France for hastening the production of the Covid-19 vaccine. It is producing the Covid-19 vaccine that is currently being tested at the University of Oxford and plans to begin the marketing by the end of 2020.

The production costs are expected to be covered by the funding from the governments.

Apart from this alliance, the drug firm has also signed similar agreements with Britain, the CEPI^[1] and Gavi, the Vaccine Alliance for about 700 million doses. It has also collaborated with the Serum Institute of India for the production of around 1 billion doses of the vaccine.

Abbreviation: 1. Coalition for Epidemic Preparedness Innovations

References:

• Pharma news – 4 June,2020
• Pharma News Update– 9 August 2020
• Pharma News – 22 June 2020
• ^[1] – Four firms in pact with Gilead Pharma Hindustan Times – 13 June 2020
• ^[2] – Remdesivir convalescent plasma use The Hindu – 14 June 2020
• ^[3] – inclusive vaccine-Astrazeneca Hindustan Times – 15 June 2020