Market Place
Sanofi overhauls executive committee; FDA recalls metformin due to unacceptable levels of NDMA impurity
This week, Phispers brings news on various developments across the world as a result of the Covid-19 pandemic.
While US President Donald Trump ended America’s association with the WHO and thereby its US$ 400 million annual funding to the agency, Europe launched a global fundraising campaign to finance testing, vaccines and treatments against Covid-19.
The WHO and 37 other nations appealed for common ownership of vaccines, medicines and diagnostic tools to tackle the pandemic.
After the US, EU also announced a plan to stockpile essential drugs in the wake of the pandemic, even as India relaxed its export restrictions on paracetamol APIs.
And Pfizer tied up with vial manufacturer Corning Inc, in anticipation of unprecedented demand for its experimental vaccine.
In non-Covid news, Sanofi overhauled its executive committee and hired new leaders, even as its vaccines chief quit the company to head Ipsen. After claiming that metformin does not carry NDMA impurity risk in February, the US Food and Drug Administration recalled the diabetes drug as unacceptable levels of the impurity were found in the drug’s extended release tablets. And crab blood continues to remain the standard for endotoxin tests as US Pharmacopeia abandons proposal to use a synthetic substitute.
Trump terminates relationship with WHO; 37 nations join alliance to share Covid tools
After threatening to pull out of the World Health Organization (WHO) for weeks, US President Donald Trump finally terminated America's relationship with the agency last week.
The move to quit the Geneva-based body has come amid growing tensions between Washington and Beijing over the Covid-19 pandemic, which first emerged in China’s Wuhan city.
Trump accused the WHO of protecting China as the pandemic took off.
Speaking in the White House Rose Garden, Trump said Chinese officials “ignored their reporting obligations” to the WHO about the virus and pressured the agency to “mislead the world.”
An exposé by Associated Press strengthened Trump’s allegations against the agency. The AP investigation said the WHO publicly praised China for what it called a speedy response to the new coronavirus and thanked the Chinese government for sharing the genetic map of the virus “immediately.” In reality, Chinese officials sat on releasing the genome of the deadly virus for over a week, the report said.
The WHO is funded by fees from its 194 member states, as well as by voluntary contributions that comprise three-quarters of the agency’s financing. The US has been the agency’s top benefactor, accounting for more than 14 percent of WHO’s financing at around US$ 400 million a year.
It is unclear whether Trump can fully withdraw US funding for the WHO without an act of Congress, which controls all federal government spending. Democrats have argued that doing so would be illegal, with House Speaker Nancy Pelosi threatening last month that such a move would be “swiftly challenged.”
The announcement has alarmed health experts. “Certainly there needs to be a good, hard look at mistakes the World Health Organization might have made in connection with coronavirus, but the time to do that is after the crisis has been dealt with, not in the middle of it,” said Senator Lamar Alexander. However, experts are also of the view that if the US leaves the WHO, the influence of China on the agency will only grow.
Covid-19 Technology Access Pool: The WHO and 37 countries have appealed for common ownership of vaccines, medicines and diagnostic tools to tackle the pandemic. The initiative is led mostly by developing nations, and takes aim at patent laws they fear could become a barrier to sharing crucial supplies.
Known as the Covid-19 Technology Access Pool, the initiative won praise from groups including humanitarian NGOs like Doctors Without Borders.
Expectedly, the drug industry is opposed to such a move. Albert Bourla, CEO of Pfizer, termed the move as “dangerous”. Similarly, AstraZeneca CEO Pascal Soriot said intellectual property is “a fundamental part” of the drug industry. If IP is not protected, then essentially, there is no incentive for anybody to innovate.
Europe launches global fundraising campaign: As US and China favor national initiatives, the EU is pushing for global cooperation.
The EU has launched a new global fundraising campaign — “Global Goal: Unite For Our Future” — to finance the development and worldwide distribution of testing, vaccines and treatments against Covid-19.
“No one is safe until we are all safe,” EU Commission president Ursula von der Leyen said while launching this initiative, which will end with a pledging summit on June 27.
This new initiative seeks to raise tens of billions of dollars with private and public donations, and follows another EU-led global campaign with the same goal. In less than a month, the previous campaign raised nearly US$ 11 billion, with more than half of it coming from EU nations and institutions.
Of the nearly US$ 11 billion donated so far by governments, only US$ 50 million came from China, while the US shunned the initiative altogether, EU officials said.
Sanofi overhauls executive committee; its vaccines chief quits to head Ipsen
At a crucial time when Sanofi is working on two vaccine projects to protect against Covid-19, the French drugmaker’s head of vaccines David Loew quit the company to join as CEO of Ipsen from July 1.
There was a management vacuum at Ipsen which has been struggling to find a new CEO since the departure of David Meek in December. Loew will finally fill that space.
Ipsen is working to get back on track with its rare bone disease drug palovarotene, acquired through its US$ 1.3 billion Clementia buyout that misfired. The company is also looking to strengthen its portfolio to offset the long-term generic threat to its top-selling cancer treatment, Somatuline.
Meanwhile, Sanofi has named four new leaders to its executive committee. “These appointments now complete the announced changes in February to further simplify the Company’s executive leadership team,” a company statement said. The company also said that Alan Main, the head of their consumer healthcare unit, is out.
Three of the four new executives joining Sanofi are coming from outside of the pharmaceutical industry. Natalie Bickford is joining Sanofi from Merlin Entertainments as the chief people officer. Arnaud Robert, who is currently working with Viking Cruises, will join Sanofi as its chief digital officer. And Julie Van Ongevalle will replace Alan Main as the head of consumer healthcare. She is currently the global brand president of Origins, a division of the Estée Lauder Companies, based in New York City. And Thomas Triomphe, who currently serves as head of franchises and product strategy at Sanofi Pasteur, will be promoted as the head of Sanofi Pasteur, replacing David Loew from June 15.
These moves were expected when Sanofi hired a new CEO, Paul Hudson, in September last year.
“We need leaders who come to Sanofi with a fresh perspective as well as leaders who have grown up within the company,” Hudson said.
After US, EU announces stockpile plan for essential drugs; India relaxes paracetamol export ban
A fortnight back, we had reported on how the Trump Administration was preparing an executive order that would require certain essential drugs and medical treatments for a variety of conditions to be made in the US. Trump Administration had also roped in a startup — Phlow Corp — to build the nation’s first stockpile of key drug ingredients.
This week, we bring you news that the European Commission is doing quite the same — it wants to set up a permanent reserve of essential drugs and medical equipment to address shortages that have plagued EU for years. Like the US, EU also plans to build drug manufacturing capacities.
In a speech, European Commission President Ursula Gertrud von der Leyen said: “We will also create for the first time a new Strategic Investment Facility. This will help invest in key value chains crucial for our future resilience and strategic autonomy, such as the pharmaceutical sector. Europe must be able to produce critical medicines itself.”
The stockpile would be funded through a new health budget of around US$ 10.3 billion (Euro 9.4 billion) which the EU executive commission proposed last week.
The reserve would complement a US$ 427 million (Euro 380 million) emergency stockpile created at the onset of the pandemic after many EU countries faced acute shortages of face masks, testing kits, ventilators, intensive care drugs and other vital items.
The EU is seeking to stockpile disinfectants, testing and diagnostic reagents, protective gear and essential medicines, according to an EU document.
The extra funding would also be used to acquire vaccines. The Commission also said it wants to offer incentives to drug companies to develop and produce vaccines in Europe, and relocate manufacturing capacity of medicines and their chemical ingredients which are, at present, being imported largely from India and China.
India ends restrictions on export of paracetamol API: While the US and Europe were busy devising plans to manufacture essential drugs in their own countries, India ended restrictions on export of active pharmaceutical ingredients (API) of paracetamol.
In March, the Indian government had restricted exports of several drugs, including paracetamol, to secure supplies for its people after the pandemic disrupted the industry’s supply chain globally.
FDA recalls metformin due to unacceptable levels of NDMA impurity
Back in early February, we had carried news that type 2 diabetes drug metformin doesn’t carry any N-Nitrosodimethylamine (NDMA) risk. This had been announced by the US Food and Drug Administration (FDA) after it tested samples of the drug for unacceptable levels of NDMA impurity and found that no FDA-tested sample exceeded the acceptable intake limit.
But last week, the FDA recalled some extended-release (ER) formulations of the diabetes drug as it had unacceptable levels of the NDMA impurity. The acceptable limit for NDMA, set by the FDA, is 96 nanograms per day for drugs. The substance can raise the risk of cancer with long-term elevated exposure of NDMA.
Currently, the FDA has notified five drug companies that have detected NDMA in their metformin preparations in quantities that are above the acceptable intake limit. Only two drugmakers — Apotex Corp and Amneal Pharmaceuticals — are named on the FDA website currently. The agency is in contact with five firms to recommend they voluntarily recall their products.
In December, the agency had started an investigation into metformin. Online pharmacy Valisure had said in March that its independent tests had shown high levels of NDMA in metformin made by 11 companies, including Amneal Pharmaceuticals Inc and Aurobindo Pharma Ltd.
Crab blood remains standard for endotoxin tests as USP drops synthetic substitute plan
Horse-shoe crabs’ copper-rich blood clots in the presence of bacterial endotoxins have long been used in tests to detect contamination in shots and infusions. More recently, we have seen man-made versions — known as recombinant Factor C (rFC) — from manufacturers like Swiss drugmaker Lonza and France’s bioMerieux.
However, an industry battle had been brewing in the US. Charles River Laboratories had criticized the synthetic option on safety grounds. Maryland-based US Pharmacopeia (USP) had initially proposed adding rFC to the existing chapter governing international endotoxin testing standards. But last week, USP announced it has abandoned that proposal, opting instead to put rFC in a new stand-alone chapter. USP is a nonprofit scientific organization that develops and disseminates public compendial quality standards for medicines and other articles
Therefore, for now, the crabs’ blood will remain the drug industry’s standard for safety tests.
“Given the importance of endotoxin testing in protecting patients ...the committee ultimately decided more real-world data” was needed, USP said in a statement.
Wildlife groups have been urging drugmakers to curb the use of crab blood. Post USP’s announcement, the National Audubon Society, Defenders of Wildlife and other groups called for greater use of rFC in a statement released by their umbrella organization, the Horseshoe Crab Recovery Coalition. Fishermen catch hundreds of thousands of crabs off the US East Coast and Asia every year for using their blood in medical safety tests.
Glass vial shortage stares at Covid vaccine aspirants; Pfizer ties up with Corning
It seems like the Covid-19 vaccine isn’t the only Holy Grail in humanity’s fight against the pandemic. The world will likely need billions of doses of any vaccine that proves to be safe and effective. And to hold those doses, the industry needs glass vials. This need is creating another supply-chain challenge for drugmakers to address as they work overtime to complete the phased clinical trials of their vaccine candidates.
“The challenge is not so much to make the vaccine itself, it’s to fill vials,” Pascal Soriot, CEO of AstraZeneca, said last week. “There’s not enough vials in the world.”
AstraZeneca, along with Pfizer, Johnson & Johnson and Sanofi, are working to quickly produce hundreds of millions of doses of its vaccine candidate even before studies prove their safety and efficacy. In an effort to conserve limited supplies, AstraZeneca, J&J and Pfizer are all exploring whether they could safely fit five or 10 doses of vaccine into one vial.
“Typically, we are producing vaccines in single-dose vials,” said Pfizer CEO Albert Bourla. Pfizer has signed a long-term agreement with Corning Inc to procure vials for storing drugs.
“We’re also exploring with the governments right now if it would be more convenient if there are five- or 10-dose vials,” Bourla added.
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