Basilea-Pfizer China application for antifungal isavuconazole accepted for review

 

• Basilea Pharmaceutica (OTC:BPMUF) and its license partner Pfizer (NYSE:PFE), down 0.2% premarket, have submitted a marketing application seeking approval for the antifungal isavuconazole (Cresemba) for the treatment of adult patients with invasive aspergillosis to the National Medical Products Administration in China.
• Isavuconazole is an intravenous and oral azole antifungal, commercialized under the trade name Cresemba for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.
• As of June 2020, total in-market sales of Cresemba amounted to $230M, 30% growth Y/Y.
• In November 2017, Basilea and Pfizer extended their existing license agreement, under the agreement with Pfizer, Basilea is eligible for regulatory and sales milestone payments of up to ~USD 630M, in addition to receiving mid-teen royalties on sales.
• Previously in August 2020, Basilea had announced that an MAA for Cresemba for the treatment of mucormycosis was accepted for review by the NMPA.
• https://seekingalpha.com/news/3639328-basilea-files-china-application-for-antifungal-isavuconazole-submitted-pfizer-accepted-for

Covaxx to deliver over 140M vaccine doses to emerging countries

 Covaxx, a subsidiary of United Biomedical, has received purchase commitments of more than 140 million doses of its UB-612 COVID-19 vaccine, totaling over $2.8 billion. The vaccine will be delivered to multiple countries including Brazil, Ecuador, and Peru.

These commitments follow the initiation of human trials in Taiwan and an agreement with Diagnosticos da America to conduct phase II/III clinical trials and distribute the vaccine within Brazil. In October, the company announced a global logistic partnership with Maersk for transportation and supply chain services to deliver UB-612 around the world.

Covaxx's UB-612 is a multitope, synthetic peptide-based vaccine candidate. Covaxx is currently completing phase I clinical trials of UB-612 in Taiwan and has an agreement with the University of Nebraska Medical Center, home of the National Pandemic Center, to also conduct trials in the U.S.

The vaccine candidate is boostable, meaning the technology can effectively boost repeatedly without side effects, and it is stable at 2-8° C, so it can be distributed and stored at normal refrigeration, according to the company. Clinical efficacy data is expected to be available in the next few months.

The company plans to manufacture up to 100 million doses in the first half of 2021 and up to 1 billion by the end of 2021.

https://www.scienceboard.net/index.aspx?sec=ser&sub=def&pag=dis&ItemID=1757

Russia's Sputnik V developers call on AstraZeneca to try combining vaccines

 Developers of the Sputnik V COVID-19 vaccine said on Thursday that AstraZeneca should try combining its experimental shot with the Russian one to boost efficacy.

Russia said its Sputnik V vaccine is 92% effective at protecting people from COVID-19, according to interim trial results, while AstraZeneca said its COVID-19 vaccine was 70% effective in pivotal trials and could be up to 90% effective.

“If they go for a new clinical trial, we suggest trying a regimen of combining the AZ shot with the #SputnikV human adenoviral vector shot to boost efficacy,” the developers of the Russian vaccine said on their Twitter account.

“Combining vaccines may prove important for revaccinations.”

AstraZeneca has said it will have as many as 200 million doses of its vaccine by the end of 2020.

The British developed vaccine is viewed as offering one of the best hopes for many developing countries because of its cheaper price and ability to be transported at normal fridge temperatures.

With 2,187,990 infections, Russia has the fourth-largest number of COVID-19 cases in the world behind the United States, India and Brazil.

AstraZeneca is likely to run an additional global trial to assess the efficacy of its vaccine, its chief executive Pascal Soriot was quoted as saying by Bloomberg News, after questions were raised over the results from its late-stage study.

The British government’s Chief Scientific Adviser Patrick Vallance said the main point about the AstraZeneca vaccine was that it worked, when asked about these doubts.

“The headline result is the vaccine works and that’s very exciting,” Vallance said during a news briefing with British Prime Minister Boris Johnson.

https://www.reuters.com/article/health-coronavirus-astrazeneca-sputnik/russias-sputnik-v-developers-call-on-astrazeneca-to-try-combining-vaccines-idUSL1N2IC1GN

AstraZeneca Likely to Run New Global Trial of COVID-19 Vaccine: CEO

 ASTRAZENECA is likely to run an additional global trial to assess the efficacy of its COVID-19 vaccine using a lower dosage, its chief executive was quoted as saying on Thursday amid questions over the results from its late-stage study.

Instead of adding the trial to an ongoing U.S. process, AstraZeneca might launch a fresh study to evaluate a lower dosage of its vaccine that performed better than a full dosage, Pascal Soriot was quoted as saying in a Bloomberg News report.

"Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study," he said.

Soriot said it would probably be another "international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients."

The news comes as AstraZeneca faces questions about its success rate that some experts say could hinder its chances of getting speedy U.S. and EU regulatory approval.

Several scientists have raised doubts about the robustness of results released on Monday showing the experimental vaccine was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose.

Soriot said he did not expect the additional trial to delay UK and European regulatory approvals.

Asked about the Bloomberg report, an AstraZeneca spokesman said there was "strong merit in continuing to further investigate the half-dose/ full dose regimen."

"We are further evaluating the data and will work with regulators on the best approach for further evaluation," he said.

"This would add to data from existing trials which are currently being prepared for regulatory submission."

AstraZeneca told Reuters earlier on Thursday that administering of the half dose had been reviewed and approved by independent data safety monitors and the UK regulator, adding that the regulator publicly confirmed there was "no concern".

Clearance from the U.S. Food and Drug Administration (FDA) may take longer though because the agency is unlikely to approve the vaccine based on studies carried out elsewhere, especially given the questions over the results, Soriot said.

Authorisation in some countries is still expected before the end of the year, he added.

AstraZeneca research chief Mene Pangalos told Reuters on Monday that researchers had stumbled upon the half-dose regime by accident, saying a sub-group of the trial was given a smaller initial dose by mistake.

Earlier he had said that the firm would start discussions with the FDA to change the design of its experimental COVID-19 vaccine trial to add the more-effective dosage regime.

Running an additional trial might not be too much of a complication for the British drugmaker in the race to develop a successful vaccine to help tame the pandemic, which has killed more than a million people and roiled the global economy.

Helen Fletcher, professor of immunology at the London School of Hygiene & Tropical Medicine, said that another trial would not necessarily delay getting a green light as efficacy in the higher dose regime still met the World Health Organization's target, and it was not unusual to run new studies on approved vaccines.

"It’s entirely possible AZ and Oxford could license the high dose and then quickly seek an amendment to use the low dose when they have sufficient data," she said.

The vaccine is one of three that could get approved before the end the year. Earlier this month, Pfizer and Moderna reported that their vaccines were about 95% effective in preventing illness, setting the bar sky-high.

Even so, the AstraZeneca shot developed with Oxford University is cheaper to make, easier to distribute and faster to scale up than its rivals.

A peer-reviewed analysis of the trial data will be published in a medical journal in the coming weeks.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is continuing its rolling review of the vaccine, the regulator's Chief Executive June Raine said in an email on Thursday.

"Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency (MHRA), and no vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met," she said.

The European Medicines Agency did not immediately respond to requests for comment on the potential for another study.

https://www.usnews.com/news/world/articles/2020-11-26/ceo-says-astrazeneca-likely-to-run-new-global-trial-of-covid-19-vaccine-bloomberg-news

AstraZeneca’s ‘mistake’ in COVID-19 vaccine trials could halt approval

 Maybe not such a “happy” accident after all.

AstraZeneca’s coronavirus vaccine is coming under intense scrutiny after its UK scientists made a major “mistake” during trials — one that could even halt it from getting approved, according to reports.

The UK drugmaker and its partner, Oxford University, admitted — after reporting its vaccine tested up to 90 percent effective — that the promising results came after a batch of volunteers were accidentally given half doses. The efficacy of the vaccine was significantly lower at 62 percent for those who received the correctly administered two full doses.

Lead researcher Mene Pangalos insisted it was “serendipity,” but the error, which was not reported in the initial findings, has brought the vaccine under intense scrutiny from scientists and industry experts.

The half-dose group was just 2,741 volunteers — and all were under 55, raising questions as to whether the relative youth of the participants created the positive results, not the size of the dose.

“It pains me to say this, but… I think the claims made for the Oxford/AstraZeneca Covid-19 vaccine are on *very* shaky ground. We should wait for a solid large trial,” scientist Hilda Bastian tweeted after the testers’ confessions.

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Chemist Derek Lowe said the revelations put the UK vaccine makers “in a bit of a bind.”

“They have solid data for a relatively weak vaccine and weaker data for a relatively strong one,” he warned of the low numbers accidentally given the half-dosage.

“This is really not being handled well at all … it’s a good thing this wasn’t the first vaccine to read out,” he added, referring to earlier vaccine test announcements from Pfizer and Moderna.

The former head of research and development at one of those rivals, Pfizer, questioned whether it would derail the AstraZeneca vaccine getting approved.

“Hard to believe that the [US Food and Drug Administration] will issue [emergency use] for a vaccine whose optimal dose has only been given to 2,300 people,” Dr. John LaMattina tweeted. “More data for this dosing regiment will be needed.”

Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida, gave the UK team “a poor grade for transparency and rigor.”

“It is awfully confusing for experts and non-experts alike,” she wrote.

The error and confusion over results caused shares in the company to slump 6.2 percent as industry experts also lose confidence, according to Bloomberg News.

“Any time you have confusion in trials it’s not a good thing because it effectively removes any kind of credibility you had,” Ketan Patel, a fund manager at EdenTree Investment Management, told Bloomberg.

“I think there will be a lot more scrutiny of Astra’s product due to the manufacturing issue.”

Geoffrey Porges, an SVB Leerink analyst, was another to predict that it could be enough to prevent the FDA from approving the vaccine for use.

“I don’t believe that the FDA will look positively at any trial where the dose, or the age cohorts, or any other variable were changed mid-trial, inadvertently or deliberately,” Porges told Bloomberg News. “I think that they have really damaged confidence in their whole development program,” he told The Times.

Other experts are also concerned at the suggestion that the low-dose group raised the overall effectiveness to 70 percent.

“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses,″ said David Salisbury, an associate fellow of the global health program at the Chatham House think tank. “I think many people are having trouble with that.″

A spokesman for Astra told Bloomberg that the trials were conducted “to the highest standards” and more analysis is being done to refine the efficacy reading.

https://nypost.com/2020/11/26/astrazenecas-covid-19-vaccine-mistake-could-halt-approval/

Novartis set to overcome $14 billion patent cliff, say analysts

 Novartis’ pipeline is strong enough to overcome a $14 billion patent cliff as blockbuster drugs face generic competition in the coming years, analysts have said.

Following a briefing with management, a team of Jefferies analysts led by Peter Welford said that the big Swiss pharma will be propped up by its psoriasis and infectious diseases blockbuster Cosentyx for some time.

Although the drug has lost market share to rivals in psoriasis, there is still more to come from Cosentyx thanks to potential new uses in ankylosing spondylitis, psoriatic arthritis and six new indications.

This will be helped by a new 300mg pre-filled syringe and auto-injector have halved administrations, although there is an intravenous option for administration by doctors treating US Medicare patients.

This is supported by the company’s portfolio of other approved medicines and revenues from its Sandoz biosimilars and generics division.

In the short term, the analysts predict “flattish” Q4 sales, although they noted that the company may benefit from cost savings introduced during the COVID-19 pandemic.

Jefferies expects that the company expects sales of $14 billion could be at risk by 2027 from patent expiries of Tasigna, Promacta, Jakavi, Gilenya and Entresto.

But the analysts said that sales growth will continue despite the headwind thanks to “underappreciated” drugs in the late-stage pipeline.

Four key drugs outlined by Jefferies have combined peak potential of $14 billion –  the high lipoprotein cardiovascular disease drug pelacarsen, iscalimab for organ transplant and Sjogren’s syndrome, the rare disease drug iptacopan and the leukaemia drug sabatolimab.

Other important phase 3 drugs that are due to read out are Lu-PSMA in prostate cancer and canakinumab in lung cancer.

The company’s Sandoz division will also chip in with growing sales from its portfolio of biosimilars – cut-price near-copies of established biologic drugs that have been shown to be as safe and effective in rigorous tests and clinical trials.

Uptake of biosimilars in the US has been better than hoped, perhaps aided by hospitals focusing on cost because COVID-19 has curtailed income from surgery.

https://pharmaphorum.com/news/novartis-set-to-overcome-14-billion-patent-cliff-analyst/

EU drugs watchdog expects first application for COVID-19 vaccine in days

 

Europe's drugs watchdog said on Thursday it expects to receive the first application for conditional marketing approval for a COVID-19 vaccine "in the coming days", the latest step towards making a shot available outside the United States.

The European Medicines Agency (EMA) did not name the company it expects to file the application, but Pfizer Inc and BioNTEch are the most advanced in the regulatory process among the three companies that have published late-stage trial data for their vaccines.

The companies applied on Nov. 20 for U.S. approval and the UK said it has asked its medical regulator to assess the vaccine for its suitability.

Asked about its co-operation with the U.S. Food and Drug Administration (FDA), it said in an email the agency may not be able to synchronise the decision making process with other international regulators.

The EMA started a real-time review of the Pfizer-BioNTech vaccine on Oct. 6 to speed up the process of approving a successful vaccine in the bloc, by allowing researchers to submit findings in real time, without waiting for studies to conclude.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/EU-drugs-watchdog-expects-first-application-for-COVID-19-vaccine-in-days-31871009/