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Canada stops bulk drug exports to counter America’s new rules; UK grants EUA to Pfizer’s Covid vaccine
This week, Phispers is packed with news on Covid vaccines. Britain granted emergency authorization to Pfizer-BioNTech’s coronavirus shot and said it will begin mass vaccinations next week. After this announcement, Russian President Vladimir Putin told authorities to begin mass vaccinations with Sputnik V starting next week.
Both Pfizer-BioNTech and Moderna applied to the EMA for an emergency authorization in Europe. In the US, the FDA said it will take up Pfizer and Moderna’s applications on December 10 and 17, respectively.
After the controversy regarding the efficacy of its vaccine, AstraZeneca’s CEO, Pascal Soriot, said the company will conduct an additional study to validate the 90 percent efficacy shown in one group during the Phase 3 trials. Meanwhile, safety concerns over the AstraZeneca-Oxford vaccine emerged in India as a volunteer in Chennai developed adverse side-effects.
Canada has blocked bulk exports of prescription drugs if they create shortages at home. This step was taken in anticipation of the ‘Importation Prescription Drugs’ rule that the Trump administration put into effect on November 30.
Alphabet-owned DeepMind has developed an AI software that can accurately predict the structure that proteins will fold into in a matter of days. Biogen has entered into a partnership with Sage Therapeutics to develop and commercialize two experimental depression drugs. And the role of consultancy firm McKinsey has come up in the opioid crisis case involving Purdue Pharma.
Canada brings in new rule to block America’s drug import order aimed at lowering prices
Days before a US “Importation Prescription Drugs” rule came into effect, Canada blocked bulk exports of prescription drugs if they would create a shortage at home. The new rule in the US, that came into effect on November 30, allows licensed US pharmacists or wholesalers to bulk import certain prescription drugs intended for the Canadian market.
“Certain drugs intended for the Canadian market are prohibited from being distributed for consumption outside of Canada if that sale would cause or worsen a drug shortage,” Health Minister Patty Hajdu said in a statement. When requested, companies will now also be required to provide information to assess existing or potential shortages within 24 hours if there is a serious or imminent health risk, the statement said.
Canada sources 68 percent of its drugs internationally, and has repeatedly mentioned that the US’ importation rule won’t be effective in lowering prescription drug prices.
Trump had signed an executive order back in July calling for the US Food and Drug Administration (FDA) to complete the “rule-making process” to allow the importation of Canadian prescription drugs. And last week, he announced plans to implement the “most favored nations” rule, which would tie prices in the US to those in other developed countries and end certain rebates paid to middlemen.
Meanwhile, drug body PhRMA has sued Trump government over the drug importation rule. Its litigation alleges that through this rule, the US Department of Health and Human Services (HHS) is violating federal law and flouting key protections under the Federal Food, Drug, and Cosmetic Act (FDCA).
UK grants emergency nod to Pfizer’s vaccine; to be distributed within days
The UK became the first country in the West, ahead of the US and Europe, to formally approve the Pfizer-BioNTech coronavirus vaccine, paving the way for mass vaccination of its people.
The first 800,000 doses will be available in the UK from next week, the country’s Health Secretary Matt Hancock said. Britain’s medicines regulator has said the vaccine is safe to be rolled out.
Hancock said people should wait to be contacted by the NHS. Elderly people, those in care homes, and some NHS staff will be given the vaccine first.
The UK has ordered 40 million doses of the Pfizer-BioNTech vaccine candidate — enough to vaccinate 20 million people. The country has also secured an additional 2 million doses of the Moderna Covid-19 vaccine candidate. In all, the UK has secured access to 357 million doses of vaccines from seven different developers. This includes 100 million doses of the vaccine being developed by drugmaker AstraZeneca and the University of Oxford.
Russia tells authorities to begin mass vaccinations: After news from the UK, there was news that Russian President Vladimir Putin has ordered authorities to begin mass vaccinations of its people with the Sputnik V vaccine from next week.
Pfizer, Moderna apply to EMA for emergency authorization: Moderna and Pfizer-BioNTech are in a tight race to launch their Covid-19 vaccines in Europe, after both applied for emergency use authorization (EUA) to the European Medicines Agency (EMA). In the US, Pfizer-BioNTech submitted its application for an EUA to the US Food and Drug Administration (FDA), a week before Moderna did the same. The applications to the EU regulator came a day after Moderna sought EUA for its vaccine in the US.
The European regulator could deliver an opinion on applications “within weeks” for the Pfizer-BioNTech and Moderna vaccines. “Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the EMA has said. It said it is “very hopeful” it will be able to give a positive scientific opinion on the vaccines before Christmas.
FDA to meet on Dec 10 and 17 to approve vaccines: This week, Moderna applied to the US Food and Drug Administration (FDA) for an EUA for its Covid-19 vaccine after full results from a late-stage study showed it was 94.1 percent effective. The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 17 to discuss the EUA request from Moderna. The FDA is also meeting on December 10 to discuss whether to authorize use of the Pfizer-BioNTech vaccine.
Cargo teams gear up to deliver vaccines: The messenger RNA vaccines from Pfizer-BioNTech and Moderna are heavily dependent on cold-storage and stringent operational handling processes. For instance, Pfizer’s vaccine must be stored in -103 degrees Fahrenheit and the United Airlines flights reportedly have a special approval to carry 15,000 pounds of dry ice. While chartered United Airlines flights from Brussels to Chicago are carrying Pfizer’s coronavirus vaccine, the American Airlines Cargo team is also preparing for its critical role in transporting vaccines. In mid-November, America’s cargo operations began conducting trial flights that simulate the conditions required for the Covid-19 vaccines.
Astra’s CEO says it will conduct another trial; safety concerns emerge in India
Last week, there were reports about the controversy that shrouds the efficacy of the AstraZeneca-Oxford vaccine. AstraZeneca and Oxford had touted positive results from two studies conducted in the UK and Brazil. Interestingly, the vaccine proved 90 percent effective in a dosing regimen given to a small group of volunteers due to an error. Among a larger cohort, the vaccine was 62 percent effective. The average efficacy rate was 70 percent.
AstraZeneca CEO Pascal Soriot, has since put an end to questions around its interim Phase 3 vaccine data by announcing that the company will conduct a new study.
“Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,” Soriot said in an interview, adding it will probably be another “international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients.”
Meanwhile, AstraZeneca-Oxford will approach regulators with a large part of the results from the existing Phase 3 vaccine trial for an emergency use authorization.
Safety concerns in India: A volunteer in Chennai (India) has alleged that the Oxford coronavirus vaccine has adverse side-effects, and has demanded US$ 678,111 (INR 50 million) in compensation. His wife says he lost an American job as he found it difficult to do even simple tasks.
In India, AstraZeneca-Oxford have partnered with the Serum Institute of India (SII) to manufacture its coronavirus vaccine. Pune-based SII has, in turn, slapped a US$ 13.56 million (INR 1,000 million) lawsuit on the volunteer.
In a statement, SII said the Oxford vaccine is “safe and immunogenic”. It defended its legal notice to the volunteer, saying it wanted to “safeguard the reputation of the company which is being unfairly maligned.”
Meanwhile, some participants of the trials have asked why they were not informed of this adverse event. These participants have reached out to the principal investigators of the trials and the director general of the Indian Council of Medical Research (ICMR). They told The Economic Times that they are considering taking legal action against the company, the Drugs Controller General of India and the ICMR.
Merck's CEO says we are pushing science too far: As the vaccine race heats up, Merck's CEO, Ken Frazier, has warned against pushing things fast. He has called upon politicians with will and integrity to tell people the truth. “What worries me most is that the public is so eager, so desperate to get back to normal, that they are pushing us to move things faster and faster,” Frazier said. He is of the view that drug companies maybe pushing science too far in the rush to end the pandemic.
DeepMind solves 50-year protein folding challenge
Alphabet-owned DeepMind, a UK-based artificial intelligence (AI) company and research laboratory that was acquired by Google in 2014, has developed an AI software — AlphaFold — that can accurately predict the structure that proteins will fold into in a matter of days.
This way, DeepMind has solved a 50-year-old “grand challenge” that could pave the way for better understanding of diseases and drug discovery.
Every living cell has thousands of different proteins inside that keep it alive and well. Nearly all diseases, including cancer and dementia, are related to how proteins function. Therefore, predicting the shape that a protein will fold into is important.
This breakthrough was welcomed by Google CEO, Sundar Pichai, who tweeted that “DeepMind's incredible AI-powered protein folding breakthrough will help us better understand one of life’s fundamental building blocks + enable researchers to tackle new and hard problems, from fighting diseases to environmental sustainability,”.
So how important is DeepMind’s discovery for drug discovery? In a blog published last year, medical chemist Derek Lowe said that protein structure determination simply isn’t a rate-limiting step in drug discovery in general. However, after reading the DeepMind press release, he said “I’m impressed”. According to him, getting to DeepMind’s level of structural accuracy on that many varied proteins is something that has just never been done before. Though for drug discovery what you absolutely need are safety and efficacy data. Not so much the protein sequence!
Biogen bets US$ 1.5 billion on Sage’s depression drugs
Biogen, the world’s largest biotech focused on brain diseases, has entered into a global collaboration with Sage Therapeutics to develop and commercialize two experimental depression drugs — zuranolone and SAGE-324. It is potentially a US$ 3 billion deal.
As per the terms of the deal, Biogen will receive an exclusive license to develop and commercialize zuranolone and SAGE-324 outside of the US, excluding rights to zuranolone in Japan, Taiwan, and South Korea.
Sage, in turn, will receive over US$ 1.5 billion to begin with, including a US$ 875 million payment and a US$ 650 million equity investment that gives Biogen a 10.7 percent stake in the company. If the two programs hit certain milestones, Sage may take home up to an additional US$ 1.6 billion from Biogen. The deal comes at a time when both companies are under pressure to get new drugs to market.
After Purdue Pharma pleads guilty, role of McKinsey comes under scrutiny
Last week, Purdue Pharma, the producer of the prescription painkiller OxyContin, formally pleaded guilty to three criminal charges, including getting in the way of the US Drug Enforcement Administration’s efforts to combat the opioid crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions.
The criminal violations include paying illegal kickbacks to both doctors and an electronic healthcare records vendor to help keep opioid prescriptions flowing.
Interestingly, documents released last week in a federal bankruptcy court in New York show the involvement of consulting firm McKinsey & Company in the case. The documents include emails and slides revealing details about McKinsey’s advice to Purdue’s billionaire owners — the Sackler family.
According to the records, in a 2017 presentation, McKinsey had laid out several options to shore up sales. One such option was to give Purdue’s distributors a rebate for every OxyContin overdose attributable to the pills they sold.
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