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.

US pharma firm signs deal with Dutch researchers for coronavirus medicine

DutchNews, May 31, 2020

Illustration: Depositphotos.com

A big US pharmaceuticals company has partnered up with a Dutch researchers to develop a medicine from an antibody which can block infection by coronavirus. 

Erasmus university researcher Frank Grosveld told NOS radio on Sunday evening that the company, which he declined to name, would carry out mass production of a medicine deriving from the antibody after initial trials on animals proved positive. 

‘We have been negotiating for a while with several pharmaceuticals companies and have now reached agreement with one which will produce a medicine in line with protocols’ he said. ‘It will first have to be tested on a number of volunteers and then we can start treating patients.’ 

The company has said it will take five or six months before the medicine has been developed, Grosveld said. 

The Dutch team, which is based in Rotterdam and Amsterdam, did receive a grant of ‘several hundred thousand euros’ to carry out the initial research, Grosveld said. 

Asked if this meant that the Netherlands would get a cheap deal on the eventual medicine, Grosveld said he hoped so, but he did not know. 

In an earlier interview, team leader Berend Jan Bosch said that the patent would remain in the hands of the researchers, while the pharmaceuticals company in question will take a licence to the antibody. 

Two uses 

The antibody has been shown to both inhibit development of coronavirus in hamsters and to combat the disease in animals which have already been infected.

‘This mean that the antibody protects in living organisms, which means we can go through to the next stage in the research, with the US pharmaceuticals company,’ Grosveld said. 

The team first went public with their finding in mid March. The antibody, a remnant of earlier research into coronaviruses like SARS and MERS, was found in a freezer at the Utrecht university lab for animal science. 

The presence of the old material meant the team had a head start in the international scramble to find a medicine or vaccine to combat the virus which has killed 370,000 people worldwide so far.

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Small-scale testing of Dutch corona medicine ‘within six months’

DutchNews, May 15, 2020

Illustration: Depositphotos.com

Dutch research into an antibody which can block infection by coronavirus has found potential sponsors in three big pharmaceuticals and small-scale testing could begin within six months months, broadcaster NOS reports. 

To turn the antibody into a medicine and enable large-scale production, the research team at Utrecht and Erasmus universities will need to partner up with a big pharmaceutical company. 

Principal investigator Berend Jan Bosch told the broadcaster that he has been approached by two or three big companies who are ready to ‘invest millions’ in developing a medicine. The patent would remain in the hands of the researchers, while the pharmaceutical in question will take a licence to the antibody. None of the interested parties were named. 

The antibody is currently being tested on animals. If all goes according to plan, a small-scale trial among consenting patients could be carried out within six months, Bosch said. 

Bosch, fellow researcher Frank Grosveld  and a team of international investigators went public with the finding in mid March and recently published a paper in the prestigious scientific journal Nature. 

Left-over material 

The antibody, a remnant of earlier research into coronaviruses like SARS and MERS, was found in a freezer at the Utrecht university lab for animal science. ‘We started work on it and found that one of the antibodies not only bind to the virus but block the infection of the cells as well,’ Bosch said. 

The presence of the old material meant the team had a head start in the international scramble to find a medicine or vaccine to combat the virus which has killed 303,000 people worldwide so far. Israel too has discovered antibody, Bosch said, but is about three months behind the Dutch team. 

The medicine will be used in two ways, Bosch said. ‘It can be given to people who already have the virus but also to people who don’t have it so the antibody protects them if they are exposed to the virus.’ 

Even if a vaccine were to be ready next year, the medication will still be useful for people who react badly to vaccines and people with underlying medical problems who are unable to produce antibodies at all, Bosch said.

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Roche urged to share info with Dutch corona test labs: FTM

DutchNews, March 26, 2020

Photo: Depositphotos.com

Swiss pharmaceuticals company Roche is unable to meet demand for coronavirus testing kits but is unwilling to share key information with labs to help them carry out mass testing, Dutch investigative website FollowThe Money said on Thursday. 

Most Dutch testing labs work with Roche equipment and depend on the Swiss firm for supplies. And due to special deals known as a ‘vendor lock-in’ they are not able to turn to alternative sources to stock up on essential items, FTM says. 

The Volkskrant reported earlier that most Dutch labs use Roche testing equipment and that the shortage of lysis buffer – a liquid used to break open cells – is one reason why the Netherlands is not carrying out mass testing. 

According to broadcaster NOS, Roche has 80% of the Dutch market. 

Commitment 

Roche told DutchNews.nl is a statement that it is committed to delivering as many tests as possible to areas where they can be most effective. However, to safeguard supply, the company said it strongly advised focusing testing on patients with symptoms, not with broad testing. 

‘Today, media in the Netherlands reported that Roche Netherlands is not providing enough test material to laboratories and asked Roche to publish the recipe for one reagent, called lysis buffer solution. We clearly state that this story is wrong,’ Roche said. 

‘There is no patent protection on lysis buffer itself. Roche will not guarantee safety and reliability of the quality and test results if the reagents required for the test are manufactured outside our own production network as well as those qualified production sites we are already working with. Safety and reliability of our components have been approved by regulatory authorities.’ 

Talks 

Meanwhile, health minister Hugo de Jonge has told parliament he is in talks with Roche about the recipe for making the liquid so that Dutch pharmacies can make it themselves and expand testing in the Netherlands. 

‘Talks are underway. We are doing all we can to get the formula,’ he said. 

The government has appointed Feike Sijbesma, the former chief executive of DSM, as its corona test expert. Sijbesma will focus on assessing and the availability of tests on the market and those being developed.

Taxpayers are funding expensive drug development, report says

DutchNews, May 10, 2019

Photo: Depositphotos.com

The Dutch government invests tens of millions of euros every year in small biotech companies which are developing the expensive medicines ministers are trying to make cheaper, according to a new report. 

The government places no conditions on its loans and grants to biotech and pharma start-ups about the eventual prices they will charge for their drugs, the report, by multinational research groups Somo and Wemos said.

‘Pharmaceutical companies argue that the reason their drugs are so expensive is because research and development is expensive, but this is simply not true,’ said Somo researcher Esther de Haan.

‘Much of the cost of research and development is borne by unconditional public investment. Because of this, the government loses its chance to influence drug pricing.’ 

In addition to funding fundamental research conducted by universities, national and regional governments also invest heavily in start-up and spin-off biotech companies – companies founded by researchers wanting to commercially develop promising scientific findings. 

Large private investors usually move in later, when the medicine looks more promising and the risk to investors is therefore lower, the report points out. ‘These private investors then make a huge profit by selling their shares at a high price to other companies in the pharmaceutical industry,’ the report said. 

The researchers look at several case studies including Acerta’s development of Calquence, a cancer drug currently on sale in the US for $15,000 a month. The drug was developed with the help of both Dutch national and regional government funding. 

Health minister Bruno Bruins told the Volkskrant that the researchers ‘had a point’ and that he would discuss the findings with the economic affairs ministry, which runs most of the investment funds.

‘We should not be paying big prices for drugs which were partly developed with taxpayers’ money,’ the minister said. 

Campaign 

Bruins has criticised the pharmaceutical industry following two high profile cases involving soaring drug prices. In January, Bruins reacted angrily to a decision by Swiss pharmaceuticals giant Novartis to put up the price of a drug to treat a rare form of cancer five fold, describing it as ‘outrageous‘. 

And in November, Amsterdam’s AMC teaching hospital was given the green light to make its own version of a licenced drug to treat a rare metabolic disorder. 

The hospital began making its own version of the drug after manufacturer Leadiant ramped up the price by around 500% to €200,000 per patient per year. 

The Dutch healthcare institute Zorginstituut Nederland has also said insurers should stop paying for expensive drugs if pharmaceutical companies continue to refuse to say how they arrive at the price.

Israeli pharmaceutical giant Teva has vowed to defend itself after being accused of orchestrating price-fixing among drugmakers in a US antitrust lawsuit https://t.co/VGSZSsPCOw

— AFP news agency (@AFP) 11 mei 2019

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Health insurer takes pharma giant to court for ‘evergreening’

DutchNews, September 20, 2018

Photo: DutchNews.nl

Health insurance group Menzis is taking legal action against Astra Zeneca, accusing the pharmaceuticals firm of ‘dragging out’ patents to make it pay too much for drugs. 

Menzis wants €4m in compensation for its clients, whom, it says, paid too much for a drug named Seroquel. The case will be heard by judges in The Hague on Friday. 

Seroquel is a drug which helps people who suffer from schizophrenia, bipolar disorder, and major depressive disorders. The patent on one variety expired in 2012 but Menzis says Astra Zeneca prolonged it until 2014 by a process known as ‘evergreening‘. 

Once the patent expired, the price of the drug plunged 90% as other generic drugs firms began making their versions.

‘It is the first time that a health insurance has taken a drugs company to court for this kind of thing,’ Henk Eleveld, a pharmacist who advises Menzis, said in a statement. 

‘We are taking this step because of ethics. Pharmaceuticals companies keep the price of medicine artificially high and it is people who pay for health insurance who pick up the bill.’

EU judges offer no 'break' to Kit Kat trademark war

Yahoo – AFP, 25 July 2018

The European Court of Justice ordered the EU's intellectual property office to
consider its trademark recognition of Nestle's iconic Kit Kat chocolate bar

The European Union's top court on Wednesday ordered the EU's intellectual property office to "reconsider" Kit Kat's bloc-wide trademark, prolonging Nestle's decade-long battle to claim exclusive rights over the chocolate bar's distinctive shape.

Nestle has been locked in a blockbuster legal war with US rival Mondelez, maker of Cadbury chocolate, over the four-fingered wafer biscuit which was first sold in 1935.

In a closely watched case, the European Court of Justice said the EU's intellectual property office must go back to the drawing board and revisit its 2006 to decision to grant Kit Kat an EU trade mark based on its shape.

But in a break for Nestle, the Luxembourg-based ECJ did not cancel the trade mark outright, as suggested by the court's top advisor in April, with the EU intellectual property office now tasked to re-visit the basis for awarding the trademark.

"Today no one has won, no one has lost. Nestle has saved time because its brand remains registered for the time being," a court source told AFP.

"But Nestle did lose a battle as it would have preferred a full confirmation of the EU Intellectual Property Office (EUIPO) decision," the source added.

The EU's intellectual property office allowed Nestle in 2006 to trademark what the court calls the "three-dimensional shape of the 'Kit Kat 4 fingers' product".

This trademark has helped keep copycat candy-bars out of grocery stores, and punished the development of similar treats owned by Mondelez, including the Norwegian favourite Kvikk Lunsj, a Kit Kat doppelganger.

The EU's intellectual property office "must reconsider whether the three-dimensional shape of a '4 Finger KitKat' can be retained as an EU trade mark," a court statement said.

At issue is that the food giant specifically failed to provide evidence that the Kit Kat shape was well enough known in Belgium, Ireland, Greece and Portugal.

A lower EU court "was right to annul the EU's intellectual property office decision, in which it concluded that distinctive character had been acquired" without including those countries in the case, a statement said.

The trade mark criteria "must be shown throughout the EU," it said.

Nestle has already lost a legal bid in Britain -- currently an EU member state but set to leave next year -- to trademark the Kit Kat shape.

"Today?s judgment is not final," a Nestle spokesperson said in an email.

"We think the evidence proves that the familiar shape of our iconic four finger KitKat is distinctive enough to be registered as an EU Trademark," Nestle added.

The European Court of Justice ordered the EU's intellectual property office to consider its trademark recognition of Nestle's iconic Kit Kat chocolate bar

Health think-tank calls for unorthodox measures to cut drugs bill

DutchNews, November 10, 2017

The Dutch government should take unorthodox measures if pharmaceutical firms are not prepared to ask a ‘socially acceptable price for their products in negotiations’, according to the government-backed Council for Health and Society. 

The council, which looks at the relationship between the public health sector and society, said in a new report that if pharmaceutical firms don’t cut their prices, ‘the authorities will have to make use of the options that national and international regulations offer for making the medicine available for patients.’ 

These include allowing individual pharmacies to make the drugs themselves, allowing patients to order medicines themselves via the internet on a doctor’s prescription and giving other firms licences to produce the drugs. 

Enforcing socially acceptable pricing will, the council says, encourage the commercial sector to develop medicines better, faster and more cheaply. They will also be forced take more account of failures in the development of new medicines.

‘The high prices are partially the consequence of an inefficient development process. The costs of failures are set off against the price of the medication that does reach the market,’ said chairwoman Pauline Meurs. 

Limited powers 

‘Another factor is the market power of the pharmaceutical companies and the limited counterweight provided by government, hospitals and health insurers.’ 

Health technology professor Carin Uyl-de Groot told the Volkskrant on Friday that she backs the idea of awarding licences to other drugs firms. ‘I think that the patient’s right to healthcare is more important than the pharmaceutical company’s patent rights,’ she said. 

Last month, former health minister Edith Schippers refused to include the drug Orkambi in the basic healthcare package after failing to reach a deal on price with its maker Vertex. The drug costs some €170,000 per patient per year. 

However,  Schippers said several days later she had  managed to strike a deal with Vertex – the details of which remain confidential – and the drug has been included in the basic package from November 1.

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 "The Addictive Old Energy" + "Timing", US (3), August 12-13, 2017 (Kryon Channelling by Lee Carroll) (Text version) - New

" .....  Is He Alone? How About You?

What kind of addiction does the old energy have for you? Are you continuing to do things that you think are absolutely correct, working with perceptions that have been given to you in an old energy that you are still wallowing in? Of course, reading this you will say, "Not me." Remember the Korean leader. He still thinks he is right and never saw it. How invested in struggle are you? I have some news. You can't do it for long. First, you lose friends. You can't claim to be one thing and be another anymore.

So let's start extending this teaching. If the darkness is so attractive, is it affecting anything else? The answer? It is absolutely affecting everything else. There's an entire industry we have told you about that will eventually fail because it has been developed in an older energy, worked in an older energy, and has no integrity. The industry is Big Pharma. We've told you that its fall is imminent and the attributes will come from the ones within it, who will expose it. When this actually happens is up to you, since this is free choice of the developing consciousness of your country. However, let's look for a moment, not at the event, but what it may then lead to.

Big Pharma is invested in an old idea that designer chemistry is the answer to healing. This idea has been prevalent for decades and many feel that it is the highest technology available. However, instead, and in the light, there starts to appear another idea entirely: The Human body has an unrealized awareness and it is actually the master healer! The Human body is designed to self-correct. So, therefore, don't put foreign chemistry into it, but instead find out how to give it elegant, specific instruction sets to heal itself. Make them high-technology instruction sets to inform it to heal itself!

This is homeopathy expanded, you might say. There are processes coming that understand that this Human body of yours is so much better than any chemist has ever realized, and the new energy is starting to expose this fact. The answer to healing is not chemistry. The answer to health and healing is by addressing the "smart part" of the Human body, giving it instructions to utilize former unknown systems that are ready to create spontaneous remission and beyond.

Remember my channelling given on the "youthing template" or the fact that you all have dormant "genesis cells" within your body (cells that have the full body blueprint and a source for very young stem cells)? These both were expositions of systems that are smart and ready to create new cells and healing in ways that will seem miraculous! But they need to be "instructed". 

Funding Will Trail for Awhile

How much money do you think is invested in the old ways? Right now, there is an industry of investment that is going to fail. So, do you think all this money will then be invested into the new methods? The answer is NO, not right away. Just like the North Korean leader's blindness, the old ways are just too addicting. "Keep it the same," they will yell. "The fall is temporary," they will say. "It always worked before, and it always will." Many investors will lose fortunes. The dysfunction is already being seen clearly. When you turn on your media at night, much of what you hear in the commercial breaks is how the chemistry didn't work! Now you get a chance to join others and sue the pharma companies for bad chemistry! You think something is beginning to break? It is. You see, they are already wallowing in something that's going to make them fail. They are advertising how broken the very system is. Both big pharma and their investors don't see the light coming yet, even though it is becoming dysfunctional before their eyes.

Major Medicine Has the Same Addiction

Think about those who have studied medicine. They study for years and years, then they take oaths that say, "Do no harm." They become fine physicians doing their very best to help humanity. Then along comes an amazing non-standard healing revelation, but it doesn't suit them because it was not what they were taught would work. In fact, many of them were told during their training that it doesn't work at all! In an older paradigm, their medical education, taught by instructors who they respected, informed them that homeopathy and all that it represented wasn't science at all. Many will still believe this, even with overwhelming new evidence that there are things they simply didn't know back then. So, expect many doctors to also reject new provable science! The reason is because they are wallowing in their addiction to what they thought was accurate and what they thought worked. It's almost a betrayal for them to even examine it! It's a betrayal of those very good teachers who told them something completely different.

Younger doctors and researchers will come along and say, "Look, I can prove this new approach to you. Just look at this, look at this proof we have. Take a day with me and look at this amazing proof!" Many physicians will say, "No thanks." Younger researchers will say, "Why not? It won't hurt you to see it!" And they'll say, "Because I don't believe it." This scenario doesn't even make sense, but it represents how addicting the old energy is. Watch for it, even within your own physicians. Human nature says that if it worked before, it's going to work again. "This is what I understand. This is what I do. Don't show me anything new because I was taught that what you have simply cannot work."

Dear ones, physics and biology discoveries will change everything, and suddenly the sun comes out [a metaphor]. Suddenly, there are new ideas. Can you imagine telling some of the greatest inventors in history to cease and desist? Could you tell the Wright brothers they were crazy? Two bicycle makers should stop trying to create powered flight? Should someone have told Louis Pasteur to stop believing in "germs"? How stupid can you be - invisible microorganisms? It's fantasy! Can you look at Tesla and say, "That's foolishness! You're going to electrocute people with that system"? Well, there are those who actually said those very things to all of them! The doubters were invested in old paradigms that were so addicting that they actually believed them. It's the same attitude as what is coming soon. So now let's switch and make it a little more personal. ...."

Hospitals to buy cancer drugs collectively to drive costs down

DutchNews, February 20, 2017

Amsterdam’s VU medical centre. Photo: VUmc.com

The eight Dutch teaching hospitals are to purchase cancer medicines collectively in an attempt to cut down the spiralling cost of treatment. 

Representative body NFU said the experimental plan concerned an immunotherapy treatment that currently costs tens of thousands of euros per patient per year. Experts have warned in recent weeks that the system for funding production and development is reformed, otherwise cancer drugs could become unaffordable as survival rates increase. 

The hospitals taking part in the initial scheme are the AMC and VU Medical Centre in Amsterdam, Rotterdam’s Erasmus Medical Centre and the university hospitals in Utrecht, Leiden, Groningen, Nijmegen and Maastricht. 

The Erasmus hospital says it spent €180 million on medicines last year, compared to €100 million last year. New cancer treatments accounted for much of the increase. 

René Bernards, of the Antoni van Leeuwenhoek cancer hospital in Amsterdam, said taking the production of medicines out of the hands of pharmaceutical companies could slash the cost per patient from €100,000 a year to around €2,000. ‘We can do it in a different and cheaper way and we need to take the iniative,’ he said. ‘That’s what society expects of us.’ 

They have also said they want to publish details of the discounts on the cost price that they are able to negotiate with pharmaceutical firms, but the NFU admitted that this may contravene marketing rules.

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