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Tuesday, May 4, 2021

Pfizer-BioNTech vax on track to make sales history

 If other big pharma groups have disappointed in the first quarter Pfizer has blown expectations out of the water, thanks to its Covid-19 vaccine Comirnaty. Sales of the mRNA jab were $3.5bn for the first three months, and Pfizer raised its annual guidance for the vaccine by $11bn to $26bn, meaning that this could account for 36% of full-year revenues. In fact, Comirnaty is set to achieve the highest annual sales of any drug to date, beating the $20.4bn forecast for Humira this year. Given Comirnaty's success it is not surprising that Pfizer plans to mine this rich seam further; an mRNA flu vaccine is set to enter the clinic in the third quarter, and other mRNA announcements are expected this year. But it has not been all plain sailing: as well as a previously disclosed delay for abrocitinib, Pfizer’s bispecific antibody elranatamab has been stopped owing to three cases of peripheral neuropathy in phase 1, and the US trial of the DMD gene therapy fordadistrogene has been halted over FDA questions about its potency assay mix. But against the backdrop of uninspiring updates from competitors, Pfizer is big pharma's pandemic winner, thanks to Biontech and Comirnaty.

Drugs booking at least $10bn in annual sales
CompanyProductPeak annual sales to 2021 ($bn)Year sales achievedNote
PfizerComirnaty26.02021Pfizer guidance
AbbvieHumira20.42021Consensus estimate
GileadHarvoni + Sovaldi19.12015Actual
ModernamRNA-127318.42021Consensus estimate
Merck & CoKeytruda17.52021Consensus estimate
Bristol MyersRevlimid13.02021Consensus estimate
PfizerLipitor12.92006Actual
Bristol Myers SquibbEliquis10.32021Consensus estimate
Source: Evaluate Pharma. Excludes forecasts after 2021; some products might record higher sales beyond 2021.

https://www.evaluate.com/vantage/articles/news/snippets/comirnaty-track-make-sales-history

Pfizer halts BCMA trial amid safety woes, hit by Duchenne delay

 Pfizer has paused (PDF) enrollment in a pivotal trial of its anti-BCMA bispecific antibody after seeing three cases of peripheral neuropathy in an earlier-stage study. The Big Pharma shared (PDF) the news alongside details of a delay to the start of the U.S. part of its Duchenne muscular dystrophy (DMD) phase 3.

In February, Pfizer took its BCMA bispecific elranatamab, also known as PF-06863135, into a pivotal phase 2 study on the strength of the 80% overall response rate it saw in 20 patients treated in phase 1. However, after dosing the first participant in the trial of relapsed and refractory multiple myeloma patients, Pfizer paused the study to give it time to gather information on a safety signal.

The pause was triggered by the discovery of three cases of peripheral neuropathy in the phase 1 trial. Pfizer had phase 1 data on 30 patients as of late last year but recruitment continued after that update. Investigators are aiming to recruit 80 patients.

Pfizer made no mention of cases of peripheral neuropathy, known as polyneuropathy when it affects many nerves, in its December update. The adverse event has been associated with a BCMA bispecific  before, though. Amgen saw two cases of peripheral polyneuropathy in a 42-subject study of its rival bispecific AMG 420. The BCMA bispecific is no longer featured in Amgen’s pipeline.

Faced with its own BCMA safety concern, Pfizer has paused dosing in the pivotal trial while it shares additional information on the cases of peripheral neuropathy for the FDA. Dosing can continue in patients who are already benefiting from the therapy. 

Pfizer disclosed the BCMA setback as part of a first-quarter update that also covered the status of its DMD gene therapy fordadistrogene movaparvovec, formerly known as PF-06939926. Dosing in a phase 3 trial of the gene therapy beegan at ex-U.S. sites late last year. However, Pfizer is yet to get the green light to start dosing at U.S. sites and does not expect to do so in the first half of 2021. 

The delay stems from the FDA’s request for answers to questions about Pfizer’s IND filing, including queries related to its potency assay matrix. Last year, the FDA held up a phase 3 trial of Sarepta’s rival DMD gene therapy by asking the biotech to use a new potency assay. Sarepta now aims to start a trial designed to support approval around the middle of this year.

Pfizer looked set to build a lead over Sarepta when it began dosing in its phase 3 trial. However, the FDA’s request for additional information from Pfizer means Sarepta may have begun enrollment by the time U.S. sites begin administering fordadistrogene movaparvovec.

The first-quarter update also brought news of the discontinuation of two projects. Pfizer is stopping work on IL-10 drug Dekavil in ulcerative colitis and JAK3/TEC inhibitor ritlecitinib in rheumatoid arthritis.

https://www.fiercebiotech.com/biotech/pfizer-stops-bcma-trial-due-to-adverse-events-reports-dmd-delay

NIH-backed device 1st to offer long-term wireless monitoring of Parkinson's patient brain activity

 In a veritable whirlwind of neurological discovery—a brain storm, if you will—researchers have developed a device with the potential to massively improve our understanding of the effects of Parkinson’s disease on brain activity.

The system includes a neurostimulation device implanted on a patient’s chest, with thin wires connected to electrodes in the brain. Those electrodes track brain activity and transmit the collected data to a nearby pocket-sized device. The receiver, in turn, uploads the data via Bluetooth to a tablet and cloud-based server.

Working in the opposite direction, neurologists can analyze the data to adjust the electrical signals sent to the brain through the electrodes. Those signals regulate activity in the motor control areas of the brain, offering a treatment option for neurological disorders that affect movement such as Parkinson’s.

Though other deep brain stimulation devices have already been cleared by the FDA for use in managing Parkinson’s symptoms, the technology has so far been limited to use only in controlled clinical settings and for short periods of time.

“This is the first device that allows for continuous and direct wireless recording of the entire brain signal over many hours,” Philip Starr said in a release, whose University of California, San Francisco lab helped develop the device. “That means we are able to perform whole brain recording over a long period of time while people are going about their daily lives.”

With that ability, the researchers were able to establish a baseline of patients’ day-to-day neurological patterns and better understand how certain activities impact brain function. Continued analysis of this long-term data would give researchers a closer look at the underlying causes of Parkinson’s and help them identify early changes in neurological behavior that could be used to predict future cases.

Additionally, with hours’ worth of daily data in hand, neurologists could begin to program neurostimulation devices to be tailored to each patient’s individual brain activity patterns throughout the day, allowing for more precise treatment of Parkinson’s and other movement disorders.


Despite the many potential benefits of continuous monitoring, however, the device’s makers noted that it does pose certain ethical concerns.

“Although we are not at the point where we can distinguish specific normal behaviors from brain activity recording, it is an absolutely legitimate concern,” Starr said. “We have told patients to feel free to remove their wearable devices and to turn off their brain recordings whenever they engage in activities they would like to keep private.”

The study was funded by the National Institutes of Health’s Brain Research through Advancing Innovative Neurotechnologies initiative. The BRAIN initiative also backed a 2018 project led by Starr that resulted in the initial development of the device, sans its new long-term capabilities.

https://www.fiercebiotech.com/medtech/nih-backed-device-first-to-offer-long-term-wireless-monitoring-parkinson-s-patients-brain

Why Neuronetics Blasted 39% Higher

 Neuronetics (NASDAQ:STIM), a company that focuses on what it describes as "products that improve the quality of life for patients who suffer from psychiatric disorders," shot 39% higher on Tuesday. Investors were likely impressed by the company's potential as indicated in its first-quarter results.


Neuronetics earned $12.3 million in revenue for the quarter, 7% higher on a year-over-year basis. As is its habit of late, the healthcare company posted a net loss. However, this narrowed to just under $7.9 million ($0.31 per share) from the Q1 2020 shortfall of $12.6 million.

Both headline figures beat the average analyst estimates of $11.6 million for revenue and a bottom-line deficit of $0.33 per share.

Neuronetics specializes in transcranial magnetic stimulation (TMS) in which magnetic fields are used to stimulate nerve cells located in a part of the brain associated with mood in order to help alleviate clinical depression.

With depression apparently on the rise due to the psychological effects of the coronavirus pandemic, Neuronetics is experiencing significantly higher demand for its TMS therapy. The company reported that it has witnessed a 30% rise in patients requesting appointments.


Neuronetics has increased its guidance for full-year 2021: Revenue should be $59 million to $63 million, up from the previous $58 million to $62 million estimate. A profitability estimate wasn't provided. 

Regardless, investors like the sound of a 30% demand rise; it's no wonder that the stock rose at a rate not far from that figure.

https://www.fool.com/investing/2021/05/04/why-neuronetics-blasted-39-higher-today/

Europe's Troubled Covid-19 Vaccine Rollout Turns the Corner

 A spring surge in Covid-19 cases is beginning to recede in Europe as the continent's vaccine rollout is finally gathering pace, boosting hopes of a broad reopening of the region's economy before the summer.

Unlike the U.S., the U.K. or Israel, which brought the coronavirus somewhat under control earlier this year thanks in part to an early and rapid vaccine rollout, continental Europe faced a late-winter rebound in infections as governments there struggled to get shots to people.

This is rapidly changing as rising vaccine deliveries to European Union member states and the lifting of bureaucratic and logistical hurdles that gummed up the effort early on are rapidly expanding access to vaccines.

Meanwhile, shutdowns, curfews and other restrictions put in place in March and April are beginning to push down case numbers, raising the prospect of a return to normalcy for businesses ahead of the summer tourism season that is crucial to the region's economy.

As of May 2, EU member states had administered 33.6 vaccine doses per 100 inhabitants, according to data compiled by Oxford University -- less than half the level in the U.K. and the U.S. but a big jump compared with just a month ago and far more than in most emerging and developing economies.

Daily coronavirus infections across the EU have been trending down since early April and daily Covid-19-related deaths began falling sharply since mid-April, according to government statistics.

With most EU countries having vaccinated about a quarter of residents at least once, scientists say it is too early for vaccinations to be pushing down infections. But this effect should kick in as soon as 40% to 60% of people have received at least one shot, which could come as early as late May, accelerating the drop in infections.

The acceleration in the pace of vaccinations is mainly due to a pickup in vaccine deliveries to the region, which were hampered in the first quarter by late orders and manufacturing hiccups. In the three months to June, the EU is expecting to receive 400 million doses -- including 250 million from vaccine leaders BioNTech SE and Pfizer Inc. -- compared with 107 million in the first quarter.

Even more could be on the way. On Tuesday, the European Union's medicines agency said it had begun reviewing the safety and effectiveness of Chinese drugmaker Sinovac Biotech Ltd.'s Covid-19 vaccine, which has faced questions about its efficacy and hasn't yet been approved for use in any Western countries.

"What happened in the last months is that we have been able to successfully increase the amount of vaccines that we produce and that we are delivering to Europe," BioNTech co-founder and CEO Ugur Sahin told The Wall Street Journal's CEO Council Summit on Tuesday. "The expectation is that [vaccinations] would have an impact on the infection rates in Europe...already at the end of May."

The boost in deliveries has allowed governments to relax some of the strict eligibility rules enacted when doses were scarcer. While these measures ensured only the most vulnerable people would get access to shots early on, they also slowed down the rollout.

In Germany, for instance, vaccines were initially only available in state-run vaccination centers and eligible recipients had to be invited before making an appointment, leaving local governments to sit on unused doses for weeks. Since mid-April, doctors have been allowed to vaccinate at their own facilities and some states have relaxed eligibility criteria. In Berlin, for instance, anyone can now get the vaccine made by AstraZeneca PLC.

As a result, vaccinations averaged more than 600,000 a week and exceeded one million last Wednesday for the first time. As of Friday, 28.2% of German residents had received at least one shot, according to the Robert Koch Institute for infectious diseases.

A model by the ZI institute, a research outfit overseen by the German health ministry, predicts that half of those eligible would have received a vaccine by the end of the month and two thirds by mid-June.

France last week opened up Covid-19 vaccinations to a larger group, including all adults suffering from obesity. President Emmanuel Macron said vaccinations would be open to all adults from June 15.

Some regions are going further: Last week, the mayor of Cannes, on the French Riviera, defied government guidelines, saying the city would open vaccinations for anyone over 40, regardless of medical condition.

In Italy, Prime Minister Mario Draghi at the beginning of March appointed Gen. Francesco Figliuolo, an expert in military logistics, to energize and bring order to an initially slow and chaotic vaccine rollout. By the end of April, Gen. Figliuolo had raised the number of daily vaccinations to half a million, double the average at the beginning of that month, and he aims to raise it even further in June.

Some 22% of Italy's population have now received at least one shot. Gen. Figliuolo's goal is to vaccinate 80% of the population by the end of September.

"What's important is to complete soon and well the vaccination of the elderly and of those with fragile health. Protecting these people means slashing the death rate in the medium term," Giovanni Rezza, the top epidemiologist at Italy's National Health Institute, said Friday.

With growing signs that the latest infection surge has peaked and with vaccinations picking up, European governments eager to restart their economies after the euro area fell into recession in the first quarter are beginning to lift some restrictions on businesses and residents.

Starting on Monday in France, some junior high and high-school students returned to the classroom after a period of remote learning. The French are now also allowed to venture more than 10 kilometers, or about 6 miles, from their homes without a permission slip. Shorter curfews, the return of outdoor dining for cafes and restaurants and the reopening of nonessential shops, museums, cinemas and theaters will be next, with gyms and indoor dining scheduled to restart early next month.

Weekly Covid-19 case numbers in Germany only began to fall last week for the first time since late February so the country isn't relaxing its lockdown yet. But on Tuesday, the government moved to exempt people who have been fully vaccinated from some restrictions, including the need to get tested before visiting hairdressers or nonessential shops, and quarantine requirements for travelers.

Some officials warn that governments should be cautious and gradual in their reopenings and be ready to clamp down again should new variants of the virus appear that might evade some of the protection afforded by current vaccines.

Yet many also expect their priorities to shift within the next few weeks -- from ensuring that anyone who wants a vaccine can receive one to persuading reluctant residents to get a shot and ensuring those who had one show up for their second dose.

"Within a few weeks, we could have more doses than we have requests for appointments," German Health Minister Jens Spahn told the Welt am Sonntag weekly in a report on Sunday.

https://www.marketscreener.com/quote/stock/BIONTECH-SE-66771992/news/Europe-s-Troubled-Covid-19-Vaccine-Rollout-Turns-the-Corner-33155363/

Merck KGaA ups forecast for full year 2021ahead of financial report

 Based on high demand expected to continue throughout the year and a very strong first quarter of

2021 with net sales of EUR 4.63 bn resulting in EBITDA pre^1 of EUR 1.51 bn and EPS pre^1 of EUR 2.18, Merck KGaA (the 
"Company") has raised its forecast for the entire group for fiscal 2021. The Company now projects net sales of approx. 
EUR 18.5 - 19.5 bn (previously "strong organic growth"). EBITDA pre^1 is anticipated to grow to approx. EUR 5.4 - 5.8 
bn for the group (previously "organic: high single-digit to low teens growth"). EPS pre^1 is projected to amount to 
approx. EUR 7.50 - 8.20. 
The Company will publish first-quarter 2021 figures as scheduled on 12 May 2021. 
https://www.marketscreener.com/quote/stock/MERCK-KGAA-436395/news/DGAP-Adhoc-nbsp-Merck-KGaA-raises-forecast-for-full-year-2021-33156322/

Working from home 'doesn't work for those who want to hustle' - Dimon

 

Working from home does not work for everyone, especially those who want "to hustle," JPMorgan Chase & Co's chief executive said on Tuesday at a conference in New York.

The largest American bank recently told it workers that it expects all U.S.-based employees back in offices on a rotational basis by early July, subject to current public health rules limiting office capacity to 50%.

Bank CEO Jamie Dimon said he wants people back at work because exclusively working from home "doesn't work for young people."

"It doesn't work for those who want to hustle. It doesn't work for spontaneous idea generation. It doesn't work for culture," Dimon said at a conference hosted by the Wall Street Journal.

Dimon said he is open to some employees working from home a few days a week, a policy other banks like Deutsche Bank, HSBC and UBS are reportedly exploring.

But starting on May 17, Dimon said he wants employees bank in the office a few days a week to reacclimate themselves to the workplace after working from home for over a year during the COVID-19 pandemic.

Dimon's "get used to it" approach, which could include requiring employees get vaccinated, has faced a backlash. Dimon said he received a "nasty email" from an employee's wife who disagreed with the push to return to work.

"But that's life," Dimon said, saying the bank will be more competitive and work better for clients with employees meeting in person again.

"In my view, September, October, it will look just like it did before and everyone's going to be happy with it."

https://www.marketscreener.com/quote/stock/DEUTSCHE-BANK-AG-56358396/news/Deutsche-Bank-nbsp-Working-from-home-doesn-t-work-for-those-who-want-to-hustle-JPMorgan-CEO-33154879/