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GSK CEO under pressure, to demerge consumer arm by mid-2022; Biden drops plans to donate Astra vaccine
This week, Phispers brings you updates on GlaxoSmithKline, whose CEO Emma Walmsley announced plans to turn its consumer healthcare arm into a separate listed company, a move that will generate US$ 11 billion for the British drugmaker.
In M&A updates, we bring you news that Danaher Corp struck a deal to buy Aldevron, one of the world’s leading manufacturers of plasmid DNA, mRNA, and recombinant proteins for US$ 9.6 billion. And Bristol-Myers Squibb and Japanese drugmaker Eisai entered into a tie-up for the co-development of MORAb-202, an antibody drug conjugate (ADC).
In regulatory news, the FDA approved the first oral blood thinner for children aged three months to 12 years — Boehringer Ingelheim’s Pradaxa. The agency also released memos to reveal disagreements over its decision to approve Biogen’s Alzheimer’s drug. The approval had met with fierce opposition by some scientists, culminating in the resignation of three members of its independent advisory panel.
The Biden administration dropped plans to send out doses of AstraZeneca’s vaccine to other nations following problems at the Baltimore plant. It will now send out 55 million doses of Pfizer, Moderna and J&J jabs to other nations.
In Covid-19 vaccine updates, we bring you news that CureVac’s experimental mRNA shot delivered disappointing preliminary data and J&J’s single dose vaccine posted the lowest uptake in Europe, as compared to Pfizer, Moderna and AstraZeneca’s jabs. South Korean drugmaker SK Bioscience announced plans to invest US$ 132 million in boosting its vaccine production over the next three years. And a Brussels court issued a verdict that supported AstraZeneca in a case regarding the vaccine’s supply in the EU.
GSK to generate US$ 11 billion from consumer arm demerger, planned for mid-2022
After weeks of being under pressure from activist investor Elliott Management that had increased its stake in GlaxoSmithKline in April this year, the British drugmaker’s CEO, Emma Walmsley, announced plans to turn its consumer healthcare arm into a separate listed company. The move will generate US$ 11 billion (£ 8 billion) and other financial benefits for GSK’s underperforming drugs business.
Investors have been waiting for details of the separation, which was first unveiled in December 2018 when GSK had agreed to a joint venture with Pfizer for consumer brands such as Sensodyne toothpaste and Advil painkillers.
GSK also gave details of a research pipeline and said it would pursue deals to further improve its drug development prospects. The split — planned for mid-2022 — will allow GSK to focus on its core drugs and vaccines business, which has been hit by a lack of fast-growing products and patients deferring treatments due to the pandemic.
Despite being the world’s biggest vaccine maker by sales, GSK is yet to deliver a Covid-19 vaccine. “I am very aware that GSK shares have underperformed for a long period,” Walmsley said on Wednesday, adding that she would stay at the helm of the drug and vaccines business called ‘New GSK’.
Last month, Elliot Management had threatened an attack on GSK, but had later backed off. Until last week, the investor was reportedly busy garnering the support of other investors to oust Walmsley.
According to a report published in Financial Times, one top-20 shareholder had said some investors that were attracted by a change of management after discussions with Elliott.
Walmsley had joined GSK in 2010, after working at L’Oréal for 17 years. Since she took over as CEO in 2019, Walmsley has recruited industry legend Hal Barron as GSK’s R&D chief (in 2017) and promised to overhaul its laggard operations and increase focus on oncology drugs.
M&A update: Danaher buys Aldevron for US$9.6 billion; Bristol-Myers acquires rights to Eisai’s ADC
Life sciences company Danaher Corp has struck a deal to buy Aldevron, one of the world’s leading manufacturers of plasmid DNA, mRNA and recombinant proteins for US$ 9.6 billion.
Danaher expects to finance the acquisition using cash at hand and/or proceeds from the issuance of commercial paper. Aldevron serves biotechnology and pharmaceutical customers across research, clinical and commercial applications. Aldevron will operate as a standalone operating company and brand within Danaher’s Life Sciences segment.
Aldevron’s products have become increasingly popular in recent years, and its clients range from biotechs working on early-stage research to commercial drugmakers. The company has additional operations in Madison, Wisconsin, and employs 600 people.
BMS buys rights to Eisai’s antibody drug conjugate: Bristol-Myers Squibb and Japanese drugmaker Eisai have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC). Bristol Myers is paying US$ 650 million to secure rights to Eisai’s ADC, but the deal is worth up to US$ 2.5 billion in milestones.
MORAb-202 is Eisai’s first ADC and combines the Japanese drugmaker’s in house developed anti-folate receptor alpha (FRα) antibody, and Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. Bristol Myers will work with Eisai to get the drug into a registrational study next year. Under the agreement, Eisai and Bristol Myers will jointly develop and commercialize MORAb-202.
Biden drops plans to donate Astra vaccine; to share 55 million doses of Pfizer, Moderna, J&J jab
This week, the Biden administration said it will no longer immediately send out doses of AstraZeneca’s vaccine to other nations following problems at the Baltimore plant. The FDA is still reviewing whether the AstraZeneca doses produced at the plant are safe to send abroad. The AstraZeneca vaccine has not been cleared as yet for use in the US.
The administration detailed plans for sharing 55 million doses with other countries, which will come entirely from the US supply of three vaccines — Pfizer-BioNTech, Moderna and Johnson & Johnson (J&J) — that have FDA’s clearance for emergency use. Earlier this month, the administration had said that the first 25 million doses it would donate abroad would also come from the US supply of these three jabs.
The announcement marks a reversal of the Biden administration’s original plans to share 60 million doses of AstraZeneca’s vaccine.
FDA memos reveal disagreements over decision to approve Biogen’s Alzheimer’s drug
Earlier this month, the US Food and Drug Administration (FDA) had granted accelerated approval to Biogen’s controversial Alzheimer’s drug Aduhelm. The drug was approved in spite of the fact that one of its two large-scale clinical trials had failed to show a benefit to patients.
The approval met with fierce opposition by some scientists, culminating in the resignations of three of the 11 members of its independent advisory panel.
This week, the FDA released a series of memos revealing a clear struggle within the agency, ahead of its controversial decision to approve Aduhelm. The memos reveal disagreements within the agency, with some departments in support of the traditional approval and others arguing against it. After months of internal deliberations, FDA officials approved the drug using its accelerated approval pathway, which requires a study to confirm that the drug works as intended.
Blood thinner for kids: The FDA has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication to treat children aged three months to less than 12 years in the US. The agency cleared Pradaxa (dabigatran etexilate) for use in children with venous thromboembolism, immediately after treatment with a blood thinner given by injection for at least five days. Pradaxa oral pellets have also been approved to prevent recurrent clots among children.
Vaccine update: CureVac’s mRNA shot disappoints; SK BioScience boosts manufacturing
German biopharmaceutical company CureVac NV has delivered disappointing preliminary data from its first-generation mRNA vaccine candidate, which showed that it was only 47 percent effective at preventing any severity of Covid-19. Other mRNA vaccines, such as the ones from Pfizer-BioNTech and Moderna, had reported efficacy rates of over 90 percent.
The European Commission had signed up to buy an initial 225 million doses of the vaccine late last year. However, last week, the company said the shot, failed to meet the pre-specified measure of statistical success in a phase 2b/3 study. The company said the initial data has been delivered to the European Medicines Agency (EMA).
The 40,000-subject trial, spanning Latin America and Europe, and conducted with help from Bayer, will still continue on to a final analysis in “the next few weeks.” According to a Reuters report, low dosage might be a key reason why CureVac’s vaccine reported a disappointing efficacy rate.
Meanwhile, the US National Institutes of Health has begun a study to evaluate the immune responses generated by Covid-19 vaccines in pregnant or postpartum women.
J&J’s vaccine has lowest uptake in Europe: Johnson & Johnson’s (J&J) single-dose Covid-19 vaccine was touted as a game-changer when it bagged the US Food and Drug Administration’s emergency use authorization in February this year. But the very next month, cross-contamination issues emerged at its contract manufacturer, Emergent BioSolutions’ facility in Baltimore, which was also manufacturing AstraZeneca’s Covid vaccine at the time.
Now, there is news that despite the J&J shot’s clear logistical advantage of not requiring a booster, the European Union has only administered about half of the delivered doses — an uptake rate much lower than that of any rival Covid-19 vaccine, including AstraZeneca, which has been impacted by supply and safety-related concerns.
In comparison, the EU has administered 90 percent of the 250 million vaccine doses shipped by Pfizer-BioNTech and 85 percent of over 30 million vaccine doses delivered by Moderna. Similarly, 75 percent of AstraZeneca’s nearly 70 million delivered shots have been administered in the EU.
SK Bioscience to invest US$ 132 million: South Korean drugmaker and a partner of AstraZeneca and Novavax — SK Bioscience — has announced plans to invest US$ 132 million in boosting its vaccine production over the next three years. The company also plans to get into mRNA and viral vector vaccines.
The company is expanding its existing plant in Andong and buying new land for the expansion. Its Andong plant produces Covid-19 vaccines developed by AstraZeneca and Novavax. SK Bioscience has raised US$1.33 billion from an initial public offering on the Korea Exchange.
Brussels court sides with Astra in EU vaccine supply case; EMA reports 415 cases of rare blood clotting
Earlier this year, the European Union had taken the unusual step of suing AstraZeneca for delaying the supply of its vaccine. However, in a significant win for the drugmaker, a Brussels court has sided with AstraZeneca.
So far, AstraZeneca has shipped more than 70 million Covid-19 vaccine doses to Europe. Instead of the 300 million doses Europe had sought by the end of September this year, the court has now ordered AstraZeneca to ship 80.2 million doses. The British-Swiss drugmaker says it is on track to “substantially exceed” this target. Further, the court found that Europe doesn’t have priority over other governments seeking Covid-19 vaccine doses.
However, the run may not be as smooth for AstraZeneca. Last week, the EU drug regulator said it has received reports of 415 possible cases of rare blood clotting with a low platelet count in the European Economic Area (EEA), out of more than 50 million people who have received the AstraZeneca and J&J vaccines. The condition is known as thrombosis with thrombocytopenia syndrome (TTS).
There have been 10 possible cases among just under 6 million people who received J&J’s shot in the EEA, and 405 cases among 45 million who received AstraZeneca’s shot, Georgy Genov, head of pharmacovigilance at the European Medicines Agency said.
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