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China approves vaccine candidate for military use; Big Pharma joins ‘Stop Hate for Profit’; discontinue Facebook ads
This week, Phispers brings you updates on vaccine development for Covid-19.
While China’s military received the greenlight to use a Covid-19 vaccine candidate developed by CanSino Biologics, Tesla’s CEO Elon Musk said he is building mobile molecule printers to make CureVac’s potential Covid vaccine.
Novavax and Regeneron received funding under the US government’s Operation Warp Speed program to accelerate deliveries of Covid-19 therapies.
And, there was news from J&J, Sanofi and GSK on deals pertaining to vaccine development.
The Trump Administration formally notified the United Nations that it is withdrawing from the WHO.
The agency, on the other hand, accepted the recommendation of the Solidarity Trial’s international steering committee to discontinue the trial’s HCQ and lopinavir/ritonavir arms.
However, Trump highlighted a study undertaken by the Henry Ford Health System on HCQ to prove how Democrats had disparaged the drug.
Swiss drugmaker Novartis agreed to pay over US$ 642 million in separate settlements to resolve claims that it had violated the False Claims Act of the US. Novartis’ generic unit, Sandoz lost a patent case against Amgen in the US.
This would further delay the launch of its biosimilar for Amgen’s Enbrel in the market.
Takeda signed an R&D deal with Carmine for developing two non-viral gene therapies.
And pharma companies Pfizer, Takeda, Novartis and AbbVie joined the ‘Stop Hate for Profit’ campaign and boycotted advertising on Facebook for the month of July.
Vaccine updates: CanSino shot okayed for military use; Elon Musk ties up with CureVac; J&J, Sanofi, GSK in deal-making mode
This week, we have lots of updates on vaccine developments from across the world. First, China’s military received the greenlight to use a Covid-19 vaccine candidate, developed by its research unit and CanSino Biologics, after Phase 1 and 2 clinical trials showed it has the potential to prevent diseases caused by the coronavirus. The trials also proved it was safe and showed some efficacy.
The CanSino vaccine — Ad5-nCoV — is one of China’s eight vaccine candidates approved for human trials. The shot also won approval for human testing in Canada. China’s Central Military Commission approved the use of the vaccine by the military on June 25 for a period of one year, CanSino said in a filing.
Second, Elon Musk has joined the vaccine manufacturing bandwagon. According to a Reuters report, Tesla Inc is building mobile molecule printers to help make the potential Covid-19 vaccine being developed by CureVac in Germany.
CureVac is developing portable, automated mRNA production units that it calls printers. Musk refers to them as “RNA microfactories”. They are being designed to be shipped to remote locations, where they can churn out vaccine candidates and other mRNA-based therapies depending on the recipe fed into the machine.
Third, Johnson & Johnson expanded its Covid-19 vaccine pact with Catalent. The latter will now help produce J&J’s Covid-19 shot at its Anagni, Italy, site. J&J had initially tapped Catalent in April to reserve fill-finish capacity for its Covid-19 shot at its Bloomington, Indiana, plant.
J&J also inked a five-year work order with Maryland-based CDMO Emergent BioSolutions worth around US$ 480 million to help produce J&J’s Covid-19 vaccine candidate. Emergent will provide “large-scale” drug substance manufacturing for J&J's recombinant DNA shot beginning in 2021. The contract comes at a time when J&J is gearing up to start human testing of its candidate — Ad26.COV2-S — later this month in a phase 1/2a trial.
There was also news from J&J’s Ebola vaccine. J&J won its first major approval for the vaccine from the European Commission. The regimen is a combination of J&J’s Ad26.ZEBOV, approved as Zabdeno, followed eight weeks later by Bavarian Nordic’s MVA-BN-Filo, approved as Mvabea. This is the second approved Ebola vaccine after Merck’s Everbo bagged the FDA approval in December last year.
Fourth, the UK government is learnt to be close to signing a US$ 625 million (£500 million) deal with GlaxoSmithKline and Sanofi to buy 60 million doses of their investigative shot, if it proves successful. The UK government has also signed on AstraZeneca and its partner Oxford University for 100 million doses of their Covid-19 vaccine candidate.
Tensions between US govt scientists and Moderna: Even though the US government is supporting Moderna’s vaccine project with US$ 483 million in funding and has chosen it as one of the first to enter large-scale human trials, tensions have erupted between the US government scientists and Moderna.
According to reports, Moderna has squabbled with the government scientists over the process, trial protocols and resisted experts’ advice on how to run the study. These tensions have contributed to a delay of more than two weeks in launching the trial of Moderna’s vaccine candidate, now expected in late July.
Novavax, Regeneron get funding under OWS: Novavax, Inc, a late stage biotechnology company, has been selected to participate in Operation Warp Speed (OWS), a US government program that aims to begin delivering millions of doses of a safe, effective vaccine for Covid-19 in 2021.
Novavax has been awarded US$ 1.6 billion by the US government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial, establishing large-scale manufacturing and delivering 100 million doses of Novavax’s Covid-19 vaccine candidate— NVX‑CoV2373 — as early as late 2020.
The Trump administration also announced it is awarding US$ 450 million to Regeneron Pharmaceuticals to help ramp up manufacturing of a potential Covid treatment the company is developing. This funding is also part of OWS.
Big Pharma joins ‘Stop Hate for Profit’ campaign; discontinue Facebook ads
This month, social media platform Facebook is witnessing an advertising boycott from hundreds of companies. And this includes large pharmaceutical companies such as Pfizer, Novartis, Takeda and AbbVie, as they joined the Stop Hate for Profit campaign.
Last month, civil rights organizations had asked businesses to pull their advertising on Facebook during July. The website — Stop Hate for Profit — says Facebook “allowed incitement to violence against protesters fighting for racial justice in America in the wake of George Floyd, Breonna Taylor, Tony McDade, Ahmaud Arbery, Rayshard Brooks and so many others.”
“For us, it’s clear that to live our value of Equity, demonstrating respect for all people and making it clear that any hate speech is unacceptable, we must speak up and take action,” Pfizer said in a statement.
Chairman and CEO Albert Bourla added: “Today, we are asking Facebook to take proactive steps to ensure their platforms are safe and trusted spaces for all.”
Novartis echoed Pfizer’s views. “Novartis stands with our African American/Black colleagues and their families and remains committed to our basic tenet: We have no tolerance for racism or bias of any kind. We believe unequivocally that Black Lives Matter,” Novartis spokesperson said.
Data from the AdComplyRx platform found that of the 90 prescription drug brands it tracks, 52 brands (58 percent) have paused ads on Facebook and its other social media platform, Instagram, so far in July. Up to this point, over 660 businesses have joined the campaign by pausing ads on Facebook. However, according to a CNN report, the vast majority of Facebook’s biggest advertisers have stayed quiet.
Novartis reaches another multi-million dollar settlement on doctor kickbacks
Last week, we had reported that a subsidiary of Swiss-drugmaker Novartis AG in Greece and Alcon had agreed to pay over US$ 233 million in criminal monetary penalties to resolve the US Department of Justice’s (DOJ) probe into violations of the Foreign Corrupt Practices Act (FCPA). The allegations pertain to the companies running schemes to bribe public hospitals and clinics in Greece, Vietnam and South Korea.
Soon after that, Novartis agreed to pay over US$ 642 million in separate settlements resolving claims that it violated the False Claims Act (FCA).
The first settlement pertains to the company’s alleged illegal use of three foundations as conduits to pay the copayments of Medicare patients taking Novartis’s drugs Gilenya and Afinitor. The second settlement resolves claims arising from the company’s alleged payments of kickbacks to doctors.
In a statement, Novartis CEO Vas Narasimhan labeled the settlements as “an important milestone on our journey to build trust with society”, stressing that it’s a different company now “with new leadership, a stronger culture, and a more comprehensive commitment to ethics embedded at the heart of our company.”
The civil suit, first filed by a Novartis whistleblower in 2011, covers company conduct from 2002 to 2011. A DOJ statement said that Novartis made “extensive factual admissions” in the settlement.
Amgen wins key Enbrel patent case against Sandoz
There was more bad news for Novartis in a case where its generic unit, Sandoz had challenged Amgen’s patents for its autoimmune and inflammatory drug Enbrel. A new court ruling has strengthened Amgen’s case, keeping biosimilars of Enbrel away from the US market until 2029.
Enbrel is a biologic that treats five inflammatory conditions. Last year, its global sales were US$ 9.6 billion, with the US accounting for approximately US$ 5 billion. Amgen sells Enbrel within the US and Canada, while Pfizer sells it in other countries.
In 2016, the US Food and Drug Administration (FDA) had approved Erelzi, Novartis’ biosimilar for Enbrel. But, since then its launch has been delayed by ongoing legal wrangling over patents.
However, Novartis isn’t giving up yet. Sandoz said it was reviewing all options, including a possible appeal to the Supreme Court. Novartis argues that the launch of a lower-cost Enbrel knockoff in the US is long overdue. The original patent of Enbrel, which was launched in 1998, expired in 2012.
Takeda signs R&D deal with Carmine for developing two non-viral gene therapies
Japanese drugmaker Takeda Pharmaceutical has signed an R&D agreement with Carmine Therapeutics for the development of two non-viral gene therapies. The agreement marks the second foray this year into gene therapy space for Takeda after the company signed a research agreement with Evotec in April.
Takeda will pay Carmine an undisclosed sum and up to US$ 900 million in milestone payments as part of a deal to develop gene therapies for two rare diseases using Carmine’s blood cell extracellular vesicles (RBCEVs) platform.
The biotech said its RBCEV-based gene therapy “has the potential for repeat dosing, a significantly larger transgene payload capacity in excess of 11KB, and enhanced bio-distribution in selected tissues through RBCEV surface modification.”
WHO drops HCQ from Solidarity Trial; Trump highlights new study to politicize HCQ
We have been reporting on the various flip-flops on the anti-malarial drug hydroxychloroquine (HCQ), which has been touted as a “game-changer” by the US President Donald Trump. Earlier this week, the World Health Organization (WHO) accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s HCQ and lopinavir/ritonavir arms.
The Solidarity Trial was established by the WHO to find an effective treatment for hospitalized patients suffering from Covid-19. The committee’s recommendation was formulated on the basis of interim trial results which showed that HCQ and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized Covid-19 patients when compared to standard of care.
The WHO’s decision does not affect the possible evaluation in other studies of HCQ or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for Covid-19.
Last month, the US Food and Drug Administration (FDA) had withdrawn the emergency use authorization for HCQ and chloroquine.
Meanwhile, a new study published by the Henry Ford Health System said that HCQ cut the death rate significantly in sick patients hospitalized with Covid-19.
This was a large-scale retrospective analysis of 2,541 patients hospitalized between March 10 and May 2, 2020 across the system’s six hospitals. It found 13 percent of those treated with HCQ alone died compared to 26.4 percent not treated with HCQ.
President Trump was quick to take to Twitter, and alleged that Democrats had disparaged the drug. He tweeted that the “highly respected Henry Ford Health System just reported, based on a large sampling, that HYDROXYCHLOROQUINE cut the death rate in certain sick patients very significantly. The Dems disparaged it for political reasons (me!). Disgraceful. Act now.”
However, scientists from the Henry Ford Health System have urged that medicine shouldn't be politicized.
Moreover, the Henry Ford Health System study wasn’t a randomized and double-blind study — the Henry Ford doctors carefully selected who should be given the drug. Therefore, the results from this study could be skewed. Some of the patients in the study were also treated with a steroid called dexamethasone, which could have additionally impacted the findings.
Trump Administration serves WHO notice of withdrawal
On May 29, in a speech in the White House Rose Garden, the US President Donald Trump had said the US would terminate its relationship with the World Health Organization (WHO). This week, the US formally notified the United Nations that it is withdrawing from the WHO.
The move, however, would not be effective until July 6, 2021, officials said. In case Trump loses reelection, the new President of the US could reverse the decision.
“Americans are safer when America is engaged in strengthening global health. On my first day as President, I will rejoin the WHO and restore our leadership on the world stage”, Joe Biden, the Democratic Presidential candidate, had tweeted earlier this week.
The withdrawal of the US from the WHO would create several uncertainties around global health governance and ongoing health programs, while also raising questions about the economic viability of the WHO.
Jeremy Konyndyk, a fellow at the Center for Global Development, called the move “reckless and entirely unjustified.” Similarly, Lawrence Gostin, the faculty director at Georgetown’s O’Neill Institute for National and Global Health Law, called the move “ruinous”. Gostin and more than 750 public health leaders, deans of schools of public health, even former heads of the Centers for Disease Control and Prevention and the US Food and Drug Administration have signed a letter asking Congress to block the withdrawal.
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