By David Wallace 01 Mar 2021
Samsung Bioepis has announced that its SB17 proposed biosimilar ustekinumab rival to Janssen’s $7.7bn Stelara brand has moved into Phase...
As part of its response to the COVID-19 pandemic, Teva Canada has secured a four-week supply of Salamol (salbutamol) 100mcg 200-dose inhalers through its global supply chain, from Teva UK, in order to mitigate shortages in the Canadian market.
Due to COVID-19, Teva said, the demand for salbutamol inhalers had tripled since January 2020 and “Health Canada indicated this had resulted in reported shortages and limited supply.”
“Salbutamol inhalers are a critical medication that patients are dependent on in order to breathe and we understand their fear about potential shortages,” said Christine Poulin, Teva Canada’s general manager.
Teva Canada became the first company to import an emergency supply of salbutamol inhalers for Canadian patients, having been able to expedite approval for the import by working closely with Health Canada and through an interim order signed by the country’s minister of health.
“Our ability to reach out to Teva’s international supply chain and secure this critical medication for fellow Canadians reinforces for us the value of being part of a global pharmaceutical company and hopefully provides peace of mind for patients during these uncertain times,” said Poulin.
Teva Canada will also assess ongoing Canadian inventory and demand to determine if additional supply will need to be sourced.
David Boughner, Teva Canada’s senior director for partnerships and corporate communications, said that “while the demand that continues to escalate for salbutamol inhalers due to COVID-19 could not have been anticipated, Teva Canada has demonstrated that at this unprecedented time we remain focused on meeting Canadian patients’ needs.”
Teva also said that its global supply chain has secured additional active pharmaceutical ingredient and scaled production of salbutamol inhalers to maximum capacity.
To fight COVID-19 related drug shortages in the UK, Accord Healthcare has announced a deal to secure long-term domestic supply of hydroxychloroquine, which is under investigation for the prevention and/or treatment of COVID-19.
Since the UK’s existing supply of the API of hydroxychloroquine comes from abroad, the UK government’s new deal with Accord for UK-manufactured hydroxychloroquine re-establishes “a long-lost domestic supply chain that will secure a reliable UK supply of a potentially vital medicine in the battle against COVID-19,” Accord said.
James Burt, executive vice president of Accord for the Europe, Middle East and North Africa region, said that “should the result of the trials with hydroxychloroquine prove that there is potentially a population-wide benefit, there is likely to be a significant world-wide shortfall in the API.”
Accord’s new deal will create a UK-based manufacturing capability which it says “could be highly significant to the government’s ability to alleviate mandated lockdowns and restart the UK economy.”
Accord, one of the largest suppliers of generic medicines to the UK National Health Service, expects to be able to supply approximately 50 million tablets of hydroxychloroquine per month starting October 2020.
In April, the government announced an extended list of medicines that cannot be parallel exported from the UK. (Also see "UK Blocks 82 From Parallel Export" - Generics Bulletin, 20 Mar, 2020.) Hence, Accord has also “scaled-up production of other vital COVID-19 medicines announced by the government as being in critically short supply.”
“We have already switched 70% of our production to COVID-19-related medicines and, from next month, we will increase this even further as we start producing the larger volume batch sizes that are needed at the moment,” said Tony Cordrey, vice-president of operations for Accord in the EMENA region.
Accord said that it has “increased its production by 100 million extra doses of COVID-19-essential medicines in a month” and the supplies of the wide range of critical medicines in short supply “should be arriving imminently into UK hospitals to help meet this urgent need.”
Further, Accord is also donating to the COPCOV clinical study into the prevention of COVID-19 using hydroxychloroquine. The company has donated over two million tablets to enable this trial to go ahead. The COPCOV study, which was recently paused, is intended to test whether hydroxychloroquine can be used “to effectively protect our valued frontline medical staff by allowing them to undertake their vital roles more safely.”
Anthony Grosso, vice-president and head of scientific affairs for Accord EMENA, said that “based on the known pharmacology of hydroxychloroquine, coupled with the emerging knowledge surrounding SARS-CoV-2 viral replication and COVID-19 pathophysiology, we were very keen to test the effectiveness of this molecule in a preventative, rather than late-stage treatment setting.” Accord noted that 20 UK hospitals are to participate in COPCOV, the results from which are expected later this year.
“A large-scale, prospective, randomized, double-blind clinical trial in a high-risk setting is the only way to robustly determine if this medicine can lessen or prevent human infection,” added Grosso. “Previous studies have not adequately tested this hypothesis; the results of COPCOV are therefore of critical importance to public health.”
Burt said “our teams are working around the clock to manufacture the required hydroxychloroquine and matching-placebo for this vital study.”
Responding to increased demand for key medicines from patients and governments, Sandoz has expanded its manufacturing capacity “to maintain a stable supply of generic medicines for patients, while also delivering on a number of additional commitments to contribute to the global COVID-19 response.”
Sandoz has taken measures to increase its inventory of antibiotics and respiratory medicines to tackle coronavirus-related supply chain issues. The company said that its manufacturing sites and suppliers “have continued full production and delivery throughout this crisis.”
Richard Saynor, CEO of Sandoz, commented that “we are proud that we have so far managed to ensure a dependable supply of medicines through swift action to increase production in the face of rapidly surging demand and multiple new obstacles throughout the supply chain.”
“This crisis is exceptional, both in how it impacts our patients and the complexity it presents to us in how we respond, said Saynor, “This is because we see a demand surge combined with major supply restrictions.”
Highlighting the hurdles, Saynor said “the lockdown of borders and limitations on trade, export and air traﬃc, as well as the additional demands placed on employees both at sites and elsewhere, have made the production and delivery of medicines incredibly hard.” But “despite these challenges, we continue to deliver quality generic and biosimilar medicines to those patients we serve, while also meeting additional commitments to ﬁght COVID-19.”
Earlier this year, Sandoz sponsored the hydroxychloroquine to be used for a US Phase III clinical trial in approximately 440 coronavirus patients. Sandoz has also donated up to 130 million doses of hydroxychloroquine globally to support the COVID-19 pandemic response. (Also see "Sandoz, Mylan And Teva Take Bigger Steps To Tackle COVID-19" - Generics Bulletin, 23 Apr, 2020.)
In February, Sandoz also pledged to ensure stable pricing for a basket of its essential medicines, which may help to treat COVID-19 patients. (Also see "Sandoz Pledges Price Stability Amid Coronavirus" - Generics Bulletin, 27 Feb, 2020.)
Addressing the European market’s demand for critical medicines, Sandoz said that its antibiotics production facility in Kundl, Austria, “is the only remaining fully-integrated large-scale manufacturing plant for these critical medicines in Europe, primarily serving the European market.” Kundl “recently set a new internal production record, in the face of an unprecedented COVID-driven demand surge,” the firm observed.
Meanwhile the Sandoz Wilson site in North Carolina, US, has begun shipping 30 million doses of hydroxychloroquine to the US Department of Health and Human Services for immediate use in controlled clinical studies.
Sandoz also donated 20,000 hydroxychloroquine tablets to the University of Washington for a clinical trial, sponsored in part by the Bill & Melinda Gates Foundation, to determine prevention of COVID-19 in 2,000 people who have previously been exposed to the disease. Results of this clinical trial will be available in late 2020.
Another new Sandoz initiative is to educate healthcare professionals about COVID-19 through specialists who have discovered something new about the epidemiology of the disease, the clinical manifestations of the infection, the immunity that develops in those who recover, the psychological impacts, and which treatment protocols are more suitable and more useful to ﬁght the coronavirus.
“One of the biggest concerns for physicians is how to continue to treat and care for these patients, while protecting both patients and medical staﬀ against SARSCoV-2 infections,” said Rebecca Guntern, Sandoz’ head of the Europe region. “Our initiative is designed to accelerate physicians’ exchange of their hands-on experience as promptly as possible, across specialty areas and country borders.”
Tobias Vogt, medical head at Sandoz Europe, said “we have launched our webcast initiative to accelerate crucial exchange in the ﬁelds of patient management, internal organization of the wards and hospital structures or pharmacies.” Sandoz said its ﬁrst four webcasts had already reached around 10,000 healthcare professionals globally, including general practitioners, specialists and pharmacists.
Sandoz parent company Novartis has created a $40m global fund to support communities around the world aﬀected by the COVID-19.
Canada’s Apotex has announced that it will donate 300,000 vials of US Food and Drug Administration approved injectables used regularly in treating pneumonia, in hospitalized patients with COVID-19 in intensive care units, to the US Department of Health and Human Services.
“Given the company’s existing footprint in the US, combined with our portfolio and manufacturing capabilities, we are well-positioned to donate these much-needed medicines to the US federal government,” said Kiran Krishnan, senior vice-president of global regulatory affairs, Apotex.
According to Apotex, it was able to make this donation thanks to continuous assessment regarding product demand, and adjustments to manufacturing and distribution schedules, while ensuring no impact on patients who rely on these essential medicines every day.
“Now more than ever,” Krishnan said, “we play a critical role in ensuring patients have access to essential medicines.”
Apotex has also announced that it is donating thousands of bottles of hand sanitizer to hospitals across Quebec, “to help protect frontline workers and patients in the fight against COVID-19.”
Ray Shelley, Apotex’ senior vice-president of commercial operations for Canada and the Caribbean, said “we recognize that the number of COVID-19 cases remains high in Quebec, and we are pleased to step up and support the province’s frontline workers and patients in hospitals with much-needed hand sanitizer.”
Last month, Apotex announced donating two million dosages of hydroxychloroquine to the Public Health Agency of Canada to support a clinical trial and form part of a national emergency strategic stockpile. (Also see "Sandoz, Mylan And Teva Take Bigger Steps To Tackle COVID-19" - Generics Bulletin, 23 Apr, 2020.)
Further, the Toronto company said it had continued hiring during COVID-19 “to fill hundreds of roles, including many in the manufacturing and production area.”
Jeff Watson, president and CEO of Apotex said that “as an essential business, we’ve been fortunate to keep growing and now find ourselves looking for others to share in our company purpose of ensuring patients have access to affordable, innovative medicines.”
“As we’ve seen demand climb for some products, we have been able to modify our schedule and increase production of more in-demand products,” said Watson. “But there’s no doubt we need to create a more resilient pharmaceutical supply chain with increased supply redundancy in this country.”
MedPharm has announced that it is expanding its innovative testing models to target COVID-19 treatments to “help de-risk development programs and screen drugs for therapeutic eﬀectiveness to accelerate development prior to clinical trials.”
The new models by MedPharm are based on air liquid interface tissue culture of primary human cells from diﬀerent regions of the respiratory system which are then infected with relevant corona viral strains.
“This new model allows companies to screen compounds and formulations to answer critical questions about eﬀectiveness against viral infections in the coronaviridae family prior to the clinic,” said Jon Lenn, MedPharm’s chief technology oﬃcer.
Jon Volmer, MedPharm’s senior director, commented that the firm was “looking forward to applying such a useful high throughput model to the development of new therapies for current and future coronaviruses”.
MedPharm’s facility in North Carolina, US, has a dedicated innovation laboratory that will be able to “rapidly support the development of new types of in vitro pharmacodynamic/infection models.”
Beximco Pharma has announced that amid global shortages of APIs, it has manufactured hydroxychloroquine, favipiravir and ivermectin. “These drugs have been suggested as potential promising treatment options for COVID-19 and are being used in some circumstances in a number of countries around the world,” said Beximco.
The Bangladeshi company recently launched the world’s first generic version of Gilead’s remdesivir in its home market. (Also see "Beximco Launches First Remdesivir Generic" - Generics Bulletin, 21 May, 2020.) The generic has also been licensed for Pakistan by Searle. (Also see "Searle Licenses Beximco’s Remdesivir For Pakistan" - Generics Bulletin, 29 May, 2020.)
Beximco has also announced that it has set up an emergency response team to provide its employees with medical support if they exhibit COVID-19-related symptoms. The team of qualified doctors and healthcare professionals will be available 24 hours a day.
While its manufacturing operations are currently unaffected, the company said it has implemented new work practices at its manufacturing sites, where “at all facilities employees are screened upon entry and disinfectants and masks have been made available.”
By David Wallace 01 Mar 2021
Despite turbulence in 2020 from the coronavirus pandemic as well as from difficulties relating to two of its key US...
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