Market Place
MI5 says Russian spies stole design of Astra-Oxford jab; Sanofi, GSK, Pfizer, BI can’t escape Zantac lawsuits
This week, we bring you news from the UK, where security services have alleged that Russian spies stole the blueprint of AstraZeneca-Oxford’s Covid vaccine to create Sputnik V. Russia has dismissed it as fake news.
A federal court in the US has ruled that Sanofi, GSK, Pfizer and Boehringer Ingelheim can’t escape Zantac class action lawsuits. While another federal court dismissed a lawsuit filed by AbbVie, where it had accused Alvotech of stealing confidential and proprietary information about Humira’s manufacturing.
In M&A news, while Pacira BioSciences snapped up Flexion for US$ 630 million, Supernus has struck a deal to buy CNS drugmaker Adamas Pharmaceuticals.
Both Bayer and Moderna announced their plans to help out low and mid-income countries. While Bayer is setting up contraceptive plants in Finland and Costa Rica to produce hormonal implants and intrauterine devices, Moderna is investing up to US$ 500 million to build an mRNA vaccines factory in Africa.
And GSK is inching closer to the planned separation of the group next year when it would be split up into two leading UK-based companies — the global drugs and vaccine company and a consumer healthcare company. Last week, GSK announced plans of setting up a new UK-based headquarters and a global campus for the new consumer healthcare company, following the split-up.
‘Russian spies stole design of Astra’s Covid vaccine to create Sputnik V,’ says MI5
It’s a story that’s been doing the rounds for many months now. It became bigger this week when an article published in the Sun quoted sources from the United Kingdom’s security services (MI5), alleging that Russian spies stole the blueprint of AstraZeneca-Oxford’s Covid-19 vaccine to create Sputnik V.
British security services had told ministers they have proof that the data was “stolen by a foreign agent in person.” The agent stole vital information from AstraZeneca, including the blueprint, and that’s how the Sputnik V vaccine for Covid-19 was created, the MI5 alleged.
The article tied the incident to a warning issued over a year ago by British, Canadian, and American intelligence agencies, saying the Russian state-linked hacking group — Cozy Bear — had almost certainly targeted Western vaccine developers. The late security minister of the UK, James Brokenshire, had said last year that Britain was “more than 95 percent sure” Russian state-sponsored hackers had targeted the UK, US and Canada in attacks on drug companies.
The MI5 has said Russian hackers launched repeated attempts to carry out cyber attacks on Oxford University starting in March 2020, around a month after British scientists announced they had started developing a vaccine. In April last year, AstraZeneca-Oxford had said they were starting the first human trials, but the following month Moscow said they had invented their own vaccine and by August Vladimir Putin gave a TV address saying Russia had won the global race to create the first Covid-19 jab.
“I think we need to get serious about Russian and Chinese espionage. Whether it is stealing the design for Astra-Zeneca or blackmailing us over energy by these authoritarian and totalitarian regimes, we need to get wise to them,” Bob Seely, British conservative party politician, said.
Meanwhile, Russia and the team behind Sputnik V have strongly denied the Sun report. The spokesman for the Kremlin, Dmitry Peskov, said the British tabloid is a “very unscientific newspaper.” The Russian Direct Investment Fund (RDIF), which promotes and sells Sputnik V, termed the news as fake, and issued a statement on Monday where it emphasized that Sun’s claims "also make absolutely no sense scientifically as Sputnik V and AstraZeneca use different platforms."
The two vaccines share similar technology, with both using modified versions of pre-existing adenoviruses—a kind of virus that causes colds and bronchitis.
However, AstraZeneca's vaccine uses a modified version of a chimpanzee adenovirus while Sputnik V uses human adenoviruses that the Russian developers, the Gamaleya Center, had previously used for an Ebola vaccine. Each of Sputnik V's two doses is based on a different adenovirus, whereas all the other COVID-19 vaccines, AstraZeneca included, use the same substance repeatedly.
Sanofi, GSK, Pfizer, BI can’t escape Zantac class action lawsuits, says US federal court
Two years back, we had reported on how French drugmaker Sanofi had said it would recall popular heartburn medicine Zantac in the United States and Canada, after the medicine was linked to a probable cancer-causing impurity, known as N-nitrosodimethylamine (NDMA).
In April last year, the US Food and Drug Administration (FDA) had ordered the removal of Zantac and its generics from the market, due to the NDMA risk. However, even before the FDA order, law firms had sued the branded drugmakers for allegedly misleading consumers about the drug’s risks.
This week, branded drugmakers — GlaxoSmithKline, Sanofi, Pfizer and Boehringer Ingelheim — lost an attempt to escape class-action lawsuits over their marketing of the decades-old drug.
US District Judge Robin Rosenberg in West Palm Beach, Florida, allowed the proposed class actions to proceed against Sanofi, GlaxoSmithKline, Boehringer Ingelheim and Pfizer, which sold Zantac products for years, before widespread recalls of the drug began in 2019.
“We look forward to holding them accountable,” the lawyers said.
Generics companies had also faced lawsuits over Zantac copycats, but those companies had scored a major win in July when Rosenberg rejected claims against the defendants.
More than 800 lawsuits are now pending before Rosenberg, including lawsuits by people who say they developed cancer after using the medication.
Court dismisses AbbVie’s trade secrets theft lawsuit against Alvotech
The world’s bestselling drug — AbbVie’s Humira — is getting ready for competition from many biosimilar companies. One such company — Iceland’s Alvotech — is busy fighting AbbVie in court, and last week, it even scored a win.
AbbVie had sued Alvotech, alleging it had recruited one of its manufacturing executive — Rongzan Ho — who had emailed himself “confidential and proprietary” information about Humira’s manufacturing just before leaving the company. In the lawsuit, AbbVie had said when Ho joined Alvotech, he was heading manufacturing for the company’s proposed biosimilar — AVT02.
But last week, a federal judge in Illinois dismissed AbbVie’s trade secrets theft lawsuit against Alvotech. While the decision marks a win for Alvotech, the company has a long way to go before it can launch its proposed biosimilar in the lucrative US market.
According to a statement issued by Alvotech, “AbbVie’s lawsuit was another attempt to preserve its monopoly over Humira…” Incidentally, only last month, Alvotech had announced positive results for AVT02.
Pacira snaps up Flexion for US$ 630 million; Supernus to acquire Adamas
Pacira BioSciences is expanding its non-opioid pain management portfolio by acquiring Flexion Therapeutics for an equity value of about US$ 450 million, or US$ 630 million including debt.
With this deal, Pacira will gain access to Zilretta, an extended-release treatment for osteoarthritis knee pain. The addition of Zilretta plus two clinical-stage pain med candidates “aligns with the Pacira mission to provide an opioid alternative to as many patients as possible,” the company said in the statement.
Pacira will buy Flexion’s shares at a 47 percent premium to their previous closing price. The deal is heavily backloaded, with a cash payment of up to US$ 8-per-share saved as a non-tradeable contingent value right (CVR). The CVR is payable (subject to certain terms and conditions) in the event certain sales and/or regulatory milestones are achieved. The transaction was unanimously approved by the board of directors of both companies.
Supernus-Adamas deal: Central nervous system-focused drugmaker Supernus has struck a deal to acquire CNS drugmaker Adamas Pharmaceuticals. With the deal, Supernus gets rights to Gocovri, the first and only FDA-approved drug to treat both off-episodes and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy. The drug, which won its original FDA nod for dyskinesia in 2017, posted US$ 71 million in 2020 sales and US$ 37.7 million in the first six months of this year.
Earlier this year, the medicine won FDA approval for its second use — to treat Parkinson’s patients who are experiencing “off” episodes, or periods when their treatments stop working well.
With Adamas, Supernus also gets rights to Osmolex ER, a drug used to treat Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients. Aside from the US$ 400 million payment, the Supernus-Adamas deal also features two CVRs.
Bayer invests in contraceptive plants for poorer nations; Moderna to set up vaccine plant in Africa
Bayer is investing US$ 460 million in setting up two plants that will expand the company’s production capabilities for supplying contraceptives to low- and middle-income countries. By means of a deal that involves the UN Population Fund and the US Agency for International Development, Bayer is setting up one plant in Turku (Finland), and another in Alajuela (Costa Rica) to produce hormonal implants and intrauterine systems. Previously, Bayer had designated Turku the “world’s contraceptive capital,” as it makes IUDs and birth control implants.
Bayer has set a goal to provide 100 million girls and women access to family planning by 2030, as well as to help boost its commercial supply chain. The new site in Costa Rica is set to start manufacturing by 2024, while the facility in Finland will be completed by 2025. In June, Bayer announced it would pump US$ 303 million into the Finland site.
Another company that announced an investment plan for the less developed nations recently was Moderna. The company plans to invest up to US$ 500 million to build a factory in Africa to make up to 500 million doses of mRNA vaccines each year, including its Covid-19 shot.
African countries and the World Health Organization (WHO) have been urging drugmakers for months to set up vaccine plants in Africa. As of last week, only about 4.5 percent of Africans had been fully vaccinated against Covid-19.
Moderna’s proposed site is expected to include drug substance manufacturing as well as bottling and packaging capabilities. The US drugmaker said it would begin the process of deciding the country and location soon.
“We expect to manufacture our Covid-19 vaccine as well as additional products within our mRNA vaccine portfolio at this facility,” CEO Stephane Bancel said in a statement.
Last week, Boehringer Ingelheim inaugurated its large scale cell culture (LSCC) biologics manufacturing plant in Vienna, Austria. The facility boasts of 48 stainless-steel bioreactors, along with digitalization and automation technologies, and artificial intelligence applications.
According to a spokesperson, the facility will serve both the manufacturing of the Boehringer Ingelheim biologics portfolio and those of customers through its BioXcellence contract manufacturing business. However, the exact allocation between the two businesses has not been divulged.
GSK to leave global HQ after split-up; announces new campus for consumer health biz
GSK is inching closer towards the planned separation of the group next year when it would be split up into two leading UK-based companies — the global drugs and vaccine company and a consumer healthcare company. Last week, the British drugmaker announced plans of setting up a new UK-based headquarters and global campus for the new consumer healthcare company following the separation in 2022.
GSK will leave its headquarters in London, known as the GSK House, after 2023. The company is yet to identify a new site but said it intends to stay in the same area to maintain “access to the UK’s world-leading science and innovation hubs.”
GSK will provide an update on the new GSK global HQ around the time of the separation — i.e. around mid-2022. Nearly 3,500 employees will remain at the GSK House until at least the end of 2023, the spokesperson said.
Under the proposals, the new consumer healthcare company will build a new campus in Weybridge, UK. Once split up, the new consumer healthcare company will have annual sales of nearly US$ 13.7 billion (over £10 billion), including nine global power brands holding category leadership positions. By the end of 2024, the new consumer healthcare company will have its own new headquarters, subject to consultation and planning approvals.
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
