Pfizer strikes global licensing deal for Covid pill

Yahoo – AFP, Robin MILLARD, November 16, 2021 

Pfizer's Covid pill showed an 89 percent reduction in hospitalisation and
death in clinical trials. (AFP/Don EMMERT)

US pharmaceutical giant Pfizer on Tuesday announced a deal to make its prospective antiviral Covid-19 pill available more cheaply in the world's least wealthy countries. 

Pfizer will sub-licence production of its promising Paxlovid pill to generic drug manufacturers for supply in 95 low- and middle-income nations covering around 53 percent of the world's population. 

Under the deal struck with the global Medicines Patent Pool (MPP), Pfizer -- which also produces one of the most widely-used Covid vaccines with German lab BioNTech -- will not receive royalties from the generic manufacturers, making the treatment cheaper. 

The agreement is subject to the oral antiviral medication passing ongoing trials and regulatory approval. 

The Pfizer drug is to be taken with the HIV medicine ritonavir. 

Interim data from ongoing trials demonstrated an 89 percent reduction in the risk of Covid-19-related hospitalisation or death compared to a placebo, in non-hospitalised high-risk adults with Covid-19 within three days of symptom onset, said Pfizer. 

Similar results were seen within five days of symptom onset, it added. 

The Geneva-based MPP is a United Nations-backed international organisation that works to facilitate the development of medicines for low- and middle-income nations. 

If approved, the pill could be on the market in "a matter of months", MPP policy chief Esteban Burrone told AFP. 

HIV drug mix

Pfizer will forego royalties on sales in all countries covered by the agreement while Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization. 

Last month, the WHO maintained the highest level of alert over the spread of the SARS-CoV-2 virus that causes Covid-19. 

Paxlovid, or PF-07321332, is an investigational antiviral therapy designed to block the activity of the SARS-CoV-2-3CL protease -- an enzyme that the coronavirus needs to replicate. 

Taking it together with a low dose of ritonavir helps slow the breakdown of PF-07321332. It therefore remains active in the body for a longer period at a high concentration, to help combat the virus. 

The pill could potentially help patients avoid severe illness, which can lead to hospitalisation and death, Pfizer said. 

"We believe oral antiviral treatments can play a vital role in reducing the severity of Covid-19 infections, decreasing the strain on our healthcare systems and saving lives," said Pfizer chairman and chief executive Albert Bourla. 

While a multitude of vaccines have been rolled out in the pandemic, the hunt for treatments for those who have already caught the disease has not been as fruitful. 

Agreement follows Merck deal 

The MPP was founded by Unitaid, which works on innovations to prevent, diagnose and treat major diseases in poorer countries. 

"During a pandemic, saving time means saving lives. This agreement could help us to reach more people more quickly as soon as the medicine is approved," said Unitaid executive director Philippe Duneton. 

Potential sublicensees have until December 6 to register an expression of interest. 

The announcement comes after the MPP signed a similar voluntary licensing deal with Pfizer's US rivals Merck & Co last month for its investigational oral antiviral medicine molnupiravir. 

Subject to regulatory approval, the deal will help create broad access to molnupiravir in 105 low- and middle-income countries. 

Pills are easier to make than vaccines, do not require a cold chain for delivery and can be self-administered by the patient. 

In terms of relieving health systems by preventing hospitalisations, "it's a game changer", said Burrone. 

He said pricing for the Pfizer pill had not yet been set, but said that "in a competitive environment... the prices tend to come down" to a low level. 

Doctors Without Borders (MSF) meanwhile suggested it might cost around $700 per Pfizer treatment course, in line with molnupiravir. 

The medical charity said it was disheartened by the deal, saying restrictive voluntary licences were no substitute for guaranteed global access to Covid tools to bring the pandemic under control.

New rules for tattoo artists create confusion ahead of EU pigment ban

DutchNews, November 1, 2021

Photo: Depositphotos.com

Tattoo artists in the Netherlands will have to abide by new rules from January, in line with both Dutch and EU legislation, but with two months before the switch, much remains unclear, tattoo shop owners have told broadcaster NOS. 

The biggest changes involve new regulations for inks which contain substances which can cause cancer and genetic mutations, or irritate the skin. 

This means thousands of hazardous chemicals found in tattoo inks and permanent make-up will be restricted from 2022, the European ChemicalsAgency has said. 

Two colours – Pigment Blue 15:3 and Pigment Green 7 – do not yet have safer and technically adequate alternatives and will not be banned until 2023, the agency said. 

Tattoo artist Amanda Remmington told NOS she understands little of the European rules. ‘My colleagues and I have never had a complaint,’ she said. ‘The only colour that causes irritation is red.’ 

The ink ban will also have an impact on larger tattoos which take time to complete and may not now be finished, said tattoo artist Timen from Assen. 

Chaos 

The Netherlands’ most famous tattoo artist Henk Schiffmacher, told the AD in September, he is furious about the new rules. 

‘This is the work of an overzealous civil servant and will create chaos,’ Schiffmacher said. ‘I’ve been doing it for 45 years and now you are telling me I am doing it wrong?…The people in charge don’t know a thing about tattooing, but are being influenced by all kinds of lobbyists when making their decisions.’ 

Coloured ink is only an health risk when it starts to move to other parts of the body, as it does when a tattoo is being removed. 

Hygiene 

The new Dutch rules involve stricter hygiene measures, and also state that the area where tattoos are placed must be separate from the rest of the shop. 

In the longer term, the Netherlands may also raise the minimum age to get a tattoo from 16, or 12 with a parent’s permission and increase training requirements, NOS said. 

Monitoring compliance with the new rules will be up to the Dutch food and product safety board and will start from January, the health ministry has said.