Target $7.
Wednesday, November 11, 2020
Why Five Prime Is on Fire Today
Shares of the clinical-stage biotech Five Prime Therapeutics (NASDAQ:FPRX) are up by a jaw-dropping 364% in pre-market trading Wednesday morning. The biotech's stock is popping in response to positive midstage trial results for the stomach cancer drug candidate bemarituzumab.
Specifically, Five Prime and partner Zai Lab (NASDAQ:ZLAB) reported that the combination of bemarituzumab and mFOLFOX6 chemotherapy beat out placebo plus mFOLFOX6 on three efficacy endpoints -- median progression-free survival, median overall survival, and overall response rate -- in patients with fibroblast growth factor receptor 2b-positive, HER2-negative front-line advanced gastric or gastroesophageal junction cancer. Zai Lab owns the drug's developmental and commercial rights within China through a licensing deal with Five Prime.
Bemarituzumab will likely still have to pass muster in a larger pivotal stage trial to gain approval in either China or the United States. But a first-line stomach cancer drug unquestionably sports an enormous commercial potential. Stomach cancer, after all, is one of the most common types of malignancies, as well as a leading cause of death across the globe. With this background in mind, it's not surprising see investors pouring into this small-cap biotech stock this morning.
Five Prime and Zai Lab, per yesterday's press release, also noted that bemarituzumab may sport anti-cancer activity across a range of solid tumors, such as squamous non-small cell lung cancer, triple negative breast cancer, ovarian cancer, pancreatic cancer, and intrahepatic cholangiocarcinoma.
What this means is that bemarituzumab might turn out to be a franchise-level cancer medicine. As such rare gems rarely go unnoticed by big pharma, Five Prime will probably bubble to the top of the buyout rumor mill soon. Stay tuned.
https://www.fool.com/investing/2020/11/11/why-five-prime-therapeutics-stock-is-on-fire-today/
Brazil's health regulator allows resumption of Chinese vaccine trial
Brazil’s health regulator Anvisa announced on Wednesday the resumption of clinical Phase III trials for China’s Sinovac COVID-19 vaccine.
Anvisa on Monday suspended the trials of the Sinovac SVA.O vaccine after the death of a volunteer that was registered as a suicide.
The regulator said that it had not been informed of the cause of the volunteers’ death when it took the decision and was only provided with the details the following day by the Butantan biomedical center which is running the trials.
“After evaluating the new data presented by the sponsor... Anvisa understands that it has sufficient reasons to allow the resumption of vaccination,” the agency’s statement said.
“It is important to clarify that a suspension does not necessarily mean that the product under investigation does not offer quality, safety or efficacy,” Anvisa said.
Europe to pay less than U.S. for Pfizer vaccine under initial deal
The European Union has struck a deal to initially pay less for Pfizer's COVID-19 vaccine candidate than the United States, an EU official told Reuters as the bloc announced on Wednesday it had secured an agreement for up to 300 million doses.
The experimental drug, developed in conjunction with Germany's BioNTech, is the frontrunner in a global race to produce a vaccine, with interim data released on Monday showing it was more than 90% effective at protecting people from COVID-19 in a large-scale clinical trial..
Under the EU deal, 27 European countries could buy 200 million doses, and have an option to purchase another 100 million.
The bloc will pay less than $19.50 per shot, a senior EU official involved in talks with vaccine makers told Reuters, adding that partly reflected the financial support given by the EU and Germany for the drug's development.
The official requested anonymity as the terms of the agreement are confidential.
The United States agreed to pay $19.50 per shot for 100 million doses, a smaller volume than the EU. But it has an option to buy a further 500 million under terms to be negotiated separately, and the price it will pay is unclear.
BioNTech signalled this week that order size would impact the per-dose price in the developed world and said it would differentiate pricing between countries or regions for its potential vaccine.
The EU official said the EU had agreed a price that was closer to $20 than to $10 but declined to give a precise figure.
Pfizer and BioNTech declined to comment on the pricing. A spokesman for the EU Commission, which negotiates vaccine agreements on behalf of EU states, also declined to comment.
In June, the European Investment Bank, the EU's financial arm, granted a 100-million-euro ($118 million) loan to BioNTech for the development and manufacturing of its COVID-19 vaccine, which was followed in September by another 375-million-euro funding by Germany's research ministry.
"With this fourth contract we are now consolidating an extremely solid vaccine candidate portfolio, most of them in advanced trials phase," the President of the European Commission Ursula von der Leyen said, announcing the Pfizer deal.
The EU has already signed supply deals with AstraZeneca, Sanofi and Johnson & Johnson for their experimental COVID-19 shots, and is talking with Moderna, CureVac and Novavax to secure their vaccines.
Under the EU's deals with vaccine makers, the bloc offers a non-refundable down payment to companies in exchange for the right to book doses which EU states could buy at a pre-agreed price if the vaccine is approved as effective and safe by the EU drug regulator.
The Commission did not disclose the down payment made to Pfizer and BioNTech.
'NO COPY PASTE' ON LIABILITY TERMS
The prices agreed by the EU in previous deals with vaccine makers have partly been influenced by liability terms, which could cause large additional legal costs if inoculated people developed unexpected conditions because of the shots.
Asked about liability clauses in the Pfizer contract, which have been a bone of contention between EU negotiators and drugmakers, the EU official said conditions were different from those the EU agreed with other companies, and also different from those Pfizer had with the U.S. government.
There was "no copy paste" on liability terms from previous contracts, the official said.
French drugmaker Sanofi, which is working with GlaxoSmithKline as a partner, has agreed with the EU a price of about 10 euros ($11.8) per dose and did not get any liability waiver, while AstraZeneca would pay claims only up to a certain threshold if something goes wrong with its vaccine in exchange for a price of 2.5 euro per dose, an official told Reuters in September.
Bad side-effects after a vaccine is approved are rare but are considered more likely in this emergency because of the unprecedented speed with which vaccines are being developed.
The United States has granted immunity from liability for COVID-19 vaccines that receive regulatory approval.
COVID-19 'war games': computer program that could help save your job
Bank of England Chief Economist Andy Haldane has signed up to judge the winner of a 'war game' designed to help firms find alternatives to mass layoffs in the face of a coronavirus-driven slowdown.
Confronted with the most unpredictable pandemic in memory, cost-conscious firms have already axed millions of staff worldwide, while UK redundancies hit a record high of 314,000 in the quarter to Sept. 30, official data showed on Tuesday.
Unilever-owned tech firm uFlexReward created the COVID-19 War Game to allow executives to explore the impact of huge job cuts on their future earnings prospects.
"Many companies across the UK are facing financial strains as a result of the COVID crisis," Haldane told Reuters.
"Simulation tools can help us understand how best to alleviate these strains while preserving jobs, in a way that helps both businesses when making difficult commercial decisions and policymakers when making difficult economic decisions."
The game, designed during Britain's first lockdown this year and available free to play on the uFlexReward website, calls on players to devise a strategy to cut people costs of a fictional firm by 20%.
Participants weigh up the pros and cons of large-scale redundancies versus alternatives, for the long-term benefit of the firm as well as the broader economy.
It collates staff salaries, pensions, bonuses and share awards into one real-time cost-base, helping players see different ways of trimming overheads more clearly.
This can include making lots of smaller cost cuts in a so-called 'broad-front' approach, rather than one large saving in more focused cuts like scrapping entire business units or the staff bonus pool.
Financial firms have historically slashed highly paid workforces on the eve of recession, only to rehire rapidly when the economy rebounds.
Swapping this convention for a broad-front approach could minimise the risks that employers end up understaffed and under-skilled when the recovery kicks off, uFlexReward Chief Executive Ken Charman said.
'CHANGE IS COMING'
Employers in multiple sectors are facing the prospect of a broader revolution in the world of work, triggered by technology and mass remote working.
"We are still stuck in a very Victorian view of what work is - with fixed working days, for a single employer and in a typically narrow role," Charman said.
"But change is coming that will allow people to be several things at once ... if companies lose people who are highly trained, experienced and loyal, they won't get them back," he said.
Charman hopes the game might persuade employers to waive or cut dividends as well as executive pay increases, and offer job-sharing, reduced hours or part-time roles with flexibility to work elsewhere to staff who might otherwise end up unemployed.
Pushing through alternatives to mass layoffs will require strong leadership and communication, particularly when thousands of employee contracts need to be renegotiated, but retaining staff could leave firms better placed when the recovery begins, Charman said.
"Executives need to be willing to abandon the old conventions; there will be resistance and they've got to be able to convince people this is in their best interests," he said.
"Employers, big companies and big financial institutions are part of our critical national infrastructure as much as the National Grid. They are the engines of our growth, but they are under threat."
Judging of the head-to-head version of the game, featuring teams made up of executives from Unilever and NYSE-listed technology services provider Endava, will take place on Dec. 3.
Together with Haldane, AstraZeneca senior vice president of reward and inclusion Rebekah Martin, Unilever head of global reward Constantina Tribou, and author David Goodhart are among those judging the strategies.
https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/COVID-19-war-games-the-computer-program-that-could-help-save-your-job-31753394
Pfizer, BioNTech to supply 200M doses of COVID-19 vaccine in Europe
- Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have reached an agreement with the European Commission (EC) to supply 200M doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19, with an option for the EC to request an additional 100M doses.
- Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.
- “Today’s finalized supply agreement with the European Commission represents the largest initial order of vaccine doses for Pfizer and BioNTech to date and a major step toward our shared goal of making a COVID-19 vaccine available to vulnerable populations,” said Albert Bourla, Chairman and CEO, Pfizer..
- Pfizer and BioNTech announced the conclusion of exploratory talks with EC on September 9, 2020. The proposed supply agreement is now final.
- On November 9, PFE and BNTX announced their mRNA-based vaccine candidate, BNT162b2, against COVID-19 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of infection, based on the first interim efficacy analysis.
- Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
- https://seekingalpha.com/news/3634826-pfizer-biontech-to-supply-200m-doses-of-mrna-based-covidminus-19-vaccine-in-europe
Tuesday, November 10, 2020
Locations at highest risk of spreading COVID-19
Most COVID-19 cases in large US cities stem from visits to just a few types of places, a new study suggests.
Restaurants, gyms, hotels and houses of worship are among the 10 percent of locations that would appear to account for 80 percent of the infections, according to research published in the journal Nature on Tuesday.
“These are places that are smaller, more crowded, and people dwell there longer,” said study co-author and Stanford University Professor Jure Leskovec at a media briefing on the research, CNN reported.
Reducing the establishments’ capacity to 20 percent, as opposed to shutting them down entirely, could curb transmissions by 80 percent, the prof said.
“Our work highlights that it doesn’t have to be all or nothing,” Leskovec said.
The study, which included researchers from Northwestern University as well as Stanford, analyzed cell-phone data from 98 million Americans in 10 major cities, including New York, Philadelphia, Washington, DC, Los Angeles, Chicago and Houston.
The researchers tracked people’s movements to locations such as restaurants, cafes, grocery stores, gyms and hotels, as well as doctor’s offices and places of worship, while looking at the coronavirus counts in their areas.
“On average across metro areas, full-service restaurants, gyms, hotels, cafes, religious organizations, and limited-service restaurants produced the largest predicted increases in infections when reopened,” the study said.
Leskovec added that based on the research model, “Infections are happening very unevenly.
“There are about 10 percent of points-of-interest that account for over 80 percent of all infections,’’ he said, according to CNN.
Residents of low-income areas suffer the worst, the study indicated.
That’s at least partly because the residents have fewer of these locations available to them, so the sites become more crowded.
For example, “our model predicts that one visit to a grocery store is twice more dangerous for a lower-income individual compared to a higher-income individual,” Leskovec said.
“This is because of grocery stores visited by lower-income individuals have on average 60 percent more people by square foot, and visitors stay there 17 percent longer."
https://nypost.com/2020/11/10/new-study-reveals-the-locations-most-likely-to-spread-covid-19/
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