Pfizer Lookout For A Partner For Drug Manufacturing

Major pharmaceutical company Pfizer is on a lookout for potential contract manufacturing options. This is because Pfizer is ensuring that the Covid-19 antiviral drug can be accessed across the low- and middle-income countries including India. Through this potential manufacturing options, the company wants that there must be an easy access to Covid-19 antiviral drug among the countries. Nevertheless, the company has not specified any names with which the company is in touch for manufacturing the antiviral drug.

A Pfizer company spokesperson spoke with ET that the company has begun investing $1 billion, at risk, in the manufacture of its potential Covid-19 oral antiviral drug with the goal of making treatment courses available as quickly as possible, pending authorisation.

“We expect to use our strong manufacturing capabilities and our extensive supplier to improve output rapidly,” the spokesperson said.

Pfizer even stated that the there are several countries with which it is under discussion and with some it has entered into advance purchase agreements. The company didn’t mention whether India is part of its discussions. “We cannot share the specifics of any future agreements as discussions are ongoing,” the spokesperson said.

Paxlovid is a drug of Pfizer which is a combination of antiviral drugs nirmatrelvir (PF-07321332) and ritonavir tablet, is most awaited as the world is bracing for a potential spike in Covid-19 cases due to highly transmissible Omicron variant. Understanding the results for the Phase-3 clinical trials, Paxlovid demonstrated reduction of hospitalization or death by 89% within three days of symptom onset, and 88% within five days of symptom onset compared to placebo in the high-risk patients. This drug has worked against the Omicron variant, which also worked in laboratory studies. World Health Organisation has classified Omicron variant as a variant of concern. Nevertheless, Paxlovid has not yet received emergency use authorization (EUA) from the USFDA.

Last month, Pfizer announced for licensing antiviral intellectual property through an agreement with the UN’s medicines patent pool (MPP). The goal was simple and this was to provide with the drug in low- and middle-income countries. Such licensing will allow medicine patent pool to sub-license qualified generic medicines manufacturers worldwide. This will result in the supply of antiviral drug to those countries covered in the agreement and even to those where there are no patents. This also includes India, where the local manufacturers can secure sub-license for the purpose of manufacture and supply the drug. There are companies who are in the process of applying for manufacturing license.

Not only to this, Pfizer have decided for not receiving any royalties on sales in low-income countries and even waiving royalties for countries which are covered under agreement which are almost 95 low- and middle-income countries. Such factors will remain as Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

“We believe the MPP model represents an efficient way to work within the current innovation ecosystem to hopefully achieve broader and faster access, particularly for small molecules, where the MPP model has already been proven successful,” Pfizer spokesperson said.

Author: Saransh Chaturvedi (Advocate, LLM (IIT Kharagpur)-an associate at IIPRD,  in case of any queries please contact/write back to us via email saransh@iiprd.com

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