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Europe confirms link between Astra jab and clots; Baltimore plant mixes ingredients of J&J, Astra shots
AstraZeneca-Oxford’s Covid-19 vaccine has received many setbacks over the last few months, and this week’s Phispers brings you more updates. While the European drugs regulator has confirmed a link between the vaccine and the ‘unusual’ blood clots, the UK has said it will offer young people Moderna’s shot as an alternative. To make matters worse, a manufacturing subcontractor in Baltimore mixed ingredients from the Covid-19 vaccines of Johnson & Johnson and AstraZeneca. And now, the US government has asked the British drugmaker to move its production elsewhere.
In the US, the Internal Revenue Service (IRS) is investigating an Irish amortization scheme deployed by Bristol Myers Squibb in 2012 and believes the drugmaker could owe the government US$ 1.4 billion in back taxes.
In India, several drugmakers have joined hands to support the government’s national digital health mission.
In M&A news, Canadian drugmaker Bausch Health Companies said it plans to reduce its debt by selling all its stake in Egypt’s Amoun Pharmaceutical to Abu Dhabi-based ADQ for about US$ 740 million. And Indian drugmaker Piramal Pharma is acquiring peptide maker Hemmo Pharmaceuticals.
EMA confirms link between clots and Astra jab; UK offers alternatives to those under-30, halts trials in kids
AstraZeneca’s Covid-19 vaccine continues to face more setbacks. While the European Medicines Agency (EMA) has confirmed a link between the Oxford-AstraZeneca vaccine and the ‘unusual’ blood clots, the UK has said it will offer young people an alternative jab due to the risks involved with this vaccine. More than a dozen countries in Europe have suspended use of the Astra jab.
The EMA has said that a particular combination of unusual blood clots with low blood platelet counts should be listed as a side effect of the Astra vaccine. However, it stopped short of recommending that its use be limited. The benefits of the shot outweigh the risks and Covid-19 is a “very serious disease,” it added.
Trouble for the Astra jab began earlier this year when several European countries reported cases of cerebral venous sinus thrombosis (CVST), an extremely rare clot in the brain, among recipients of the jab. As of April 4, the EMA had received reports of 169 cases of CVST. Until then, 34 million doses of the shot had been administered in Europe.
“So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed,” the EMA said in a statement.
Based on its own review of reported blood clots, Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has said people aged between 18 and 29 will be offered an alternative vaccine to the AstraZeneca shot.
This week, Britain began rolling out Moderna’s vaccine — the third jab to control the pandemic. The alternatives are from Pfizer-BioNTech and AstraZeneca. Boris Johnson, UK’s Prime Minister, said the country has ordered 17 million doses of the Moderna vaccine.
Meanwhile, AstraZeneca is learnt to have sent a legal notice to its manufacturing partner, Pune-based Serum Institute of India (SII), for vaccine supply delay. Adar Poonawalla, CEO of SII, said the Indian government’s pause on major Covishield shipments to other countries and the ‘first claim’ deal with India were difficult to explain abroad, where the vaccine was sold at a substantially higher cost per dose.
Baltimore plant mixes ingredients of J&J, Astra shots; US tells Astra to move production elsewhere
A manufacturing subcontractor in Baltimore mixed ingredients from the Covid-19 vaccines of Johnson & Johnson and AstraZeneca. The mix-up has delayed the shipments of J&J’s one-shot jab to the United States. The plant is run by Emergent BioSolutions.
The mix-up happened several weeks ago. The lapse is a major embarrassment both for J&J whose one-dose vaccine has been credited with speeding up the immunization program in the US, and for Emergent. The US Food and Drug Administration (FDA) is investigating the matter.
A senior health and science reporter said in a Tweet that while an investigation is underway, federal and former company officials suspect that the lot was tainted because an employee had moved from the AstraZeneca section of the plant to the J&J section, “without showering and taking other precautions”. Other reports say workers at the Baltimore plant accidentally combined the ingredients, thereby contaminating up to 15 million doses of J&J’s vaccine. Last week, Emergent said it would destroy those doses.
The US government has put J&J in charge to strengthen its control over Emergent’s work in order to avoid additional quality lapses, and has also stopped AstraZeneca from using the facility. The US government’s Health and Human Services Department (HHS) has said the AstraZeneca vaccine will now be produced at another plant. Astra’s vaccine has not been approved in the US.
In a statement, AstraZeneca said it is working with the Biomedical Advanced Research and Development Authority (BARDA) to assist in the effort to maximize and accelerate US production of Covid-19 vaccines. “The company will work with the US government to identify an alternative location for domestic drug substance production of AZD1222,” it added.
According to a report published in The New York Times, a top federal pandemic official had warned last June that Emergent BioSolutions “lacked enough trained staff and had a record of problems with quality control.”
J&J said it is “assuming full responsibility” of Emergent’s facility in Baltimore, reiterating that it will deliver 100 million doses to the US government by the end of May. J&J met its target to supply 20 million doses of its vaccine to the US by March-end.
The HHS has also increased Emergent’s order by US$ 23 million for expansion of production specific to J&J’s vaccine doses. “The US$ 23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s Covid-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility,” Emergent said.
Off-shore patent scheme has BMS looking at US$ 1.4 billion in back taxes
Back in 2012, Bristol Myers Squibb had created a new offshore subsidiary in Ireland in order to reduce its tax bill by holding patent rights to some of its drugs in this subsidiary. Since Ireland had a lower tax rate than the US, the New York-headquartered Bristol Myers was able to substantially reduce its tax bill.
Moves like these are quite common. Through such schemes, companies are able to write off the value of an asset — such as patents— from their taxable income over a period of time. According to news reports, Bristol Myers’ effective corporate tax rate was -7 percent in 2012, as compared to 25 percent in 2011.
Now, the Internal Revenue Service (IRS) of the US government has accidentally caught what it calls an “abusive” tax shelter. It is alleging that Bristol Myers owes the IRS about US$ 1.38 billion in unpaid taxes, a report published in The New York Times said.
“Bristol Myers Squibb is in compliance with all applicable tax rules and regulations,” the company said in a statement. “We work with leading experts in this area and will continue to work cooperatively with the IRS to resolve this matter. Beyond that, we don’t comment on ongoing regulatory matters.”
Several other big drugmakers such as Johnson & Johnson’s, Pfizer and Abbott have been implicated in similar plans in the past. In a 2018 report, Oxfam estimated that offshoring schemes were saving the four drugmakers around US$ 2.3 billion per year in US federal taxes. Across nine developing countries including the US, Oxfam estimated the firms were writing off a total of around US$ 3.7 billion per year.
Bausch sells Egypt’s Amoun Pharma for US$ 740 million; Piramal picks up Indian API peptide maker
Last week, Canadian drugmaker Bausch Health Companies said it plans to reduce its debt by selling all its stake in Egypt’s Amoun Pharmaceutical to Abu Dhabi-based ADQ for about US$ 740 million, subject to certain adjustments.
Amoun is one of the largest and most recognized pharmaceutical companies in Egypt that manufactures, markets and distributes branded generics of human and animal health products.
Bausch has been working at reducing its debt burden. Last year, it had announced plans to spin off its eye care unit (Bausch + Lomb) into a separate company.
“The sale of Amoun marks significant progress in our efforts to reduce overall Bausch Health debt as we continue to pursue all opportunities to drive value for our shareholders, including preparing for the spinoff of Bausch + Lomb,” said Joseph C. Papa, chairman and CEO, Bausch Health. The transaction is expected to close in the first half of 2021.
Meanwhile, Indian drugmaker Piramal Pharma Limited (PPL) has entered into an agreement to acquire complete stake in Hemmo Pharmaceuticals for an upfront consideration of US$ 100.76 million (INR 7.75 billion) and other payouts linked to achievement of milestones.
Post the acquisition, Hemmo Pharmaceuticals will become a wholly-owned subsidiary of PPL. The acquisition marks PPL’s CDMO, Piramal Pharma Solutions’ (PPS) “foray into the development and manufacturing of peptide APIs, a capability that complements PPS’ existing service offering,” a company statement said. Hemmo is one of India's largest manufacturers of synthetic peptides. With the addition of Hemmo's capabilities, PPS will gain access to the growing peptide API market.
Leading Indian drug players join hands to bet big on govt’s digital health mission
Around March-end, India’s leading drug manufacturers — Sun Pharma, Lupin, Cadila Healthcare and Torrent Pharma — had announced that they have subscribed to partnership interest in healthcare services firm ABCD Technologies LLP, a company incorporated in February this year. ABCD Technologies will be rechristened IndoHealth Services LLP.
The four drugmakers are investing US$ 5.38 million (INR 400 million) each in IndoHealth Services LLP. In the regulatory filings, the drugmakers had said they want to “facilitate, enable and promote efficiency and good distribution practices, including digitizing healthcare infrastructure in India, inter alia, in support of the National Digital Health Mission of Government of India.”
Soon after this announcement, there was news that DigiHealth Technologies LLP, a wholly-owned entity of ABCD Technologies LLP, has acquired AIOCD Pharmasofttech AWACS Private Limited (AWACS) and Pharmarack Technologies Private Limited.
The investment has been made with a view to develop a world-class pharmaceutical supply chain and distribution IT ecosystem and support the Indian government’s National Digital Health Mission (NDHM).
The mission aims to develop the backbone necessary to support the integrated digital health infrastructure in India and will bridge the existing gap amongst different stakeholders of the healthcare ecosystem through digital highways.
“Our investee entity i.e. ABCD Technologies (to be renamed as IndoHealth Services) has through its wholly-owned entity DigiHealth Technologies, acquired 66.02 per cent ownership interest in AIOCD Pharmasofttech Awacs Private (AWACS),” informed various pharma firms, including Cipla, Torrent Pharma, Dr Reddy’s, and Cadila Healthcare, in regulatory filings.
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