Edwards Lifesciences Sees 2021 Sales $4.9-5.3B

 Edwards Lifesciences Corp. said it projects 2021 global sales of $4.9 billion to $5.3 billion, for underlying growth in the mid-teens.

The FactSet consensus is for 2021 sales of $5.1 billion.

Edwards guided for 2021 adjusted earnings per share of $2.00 to $2.20. The FactSet consensus is $2.21.

The company projected 2021 Transcatheter Aortic Valve Replacement sales of $3.2 billion to $3.6 billion, for underlying growth 15% to 20%.

Shares were up about 3% to $87.35 in morning trading.

The provider of medical products for heart disease and critical care monitoring said it is discussing its strategy for longer-term growth, providing an update on its technology pipeline and giving financial guidance during its annual investor conference Thursday.

"Although we expect the pandemic to have a continuing impact on the global healthcare system, we are very optimistic about 2021 and we anticipate returning to strong, double-digit top-line growth," said Chief Executive Michael A. Mussallem.

Edwards said it continues to believe the global TAVR opportunity will reach more than $7 billion by 2024, with continuing growth thereafter, fueled by therapy expansion, technology advances and geographic expansion.

The company said it expects the current $1.8 billion surgical structural heart opportunity to grow mid-single digits through 2026 driven by global cardiac procedure growth.

https://www.marketscreener.com/quote/stock/EDWARDS-LIFESCIENCES-CORP-12521/news/Edwards-Lifesciences-Sees-2021-Sales-4-9-Billion-to-5-3-Billion-31984806/

Cyber attacks seen on coronavirus vaccine infrastructure -U.S. Senator Peters

 Cyber attacks have been waged against COVID-19 vaccine distribution infrastructure, including a cold-chain storage company, U.S. Senator Gary Peters said on Thursday.

“IBM recently released a very disturbing report detailing cyber attacks on COVID-19 vaccine distribution infrastructure,” Peters told a congressional hearing. “Just last month a cold-chain storage company also reported that they were the target of a cyber attack.”

Peters, a Democrat, made his remarks during a U.S. Senate Commerce Committee hearing on shipping procedures and capabilities for the vaccines, which are expected to start moving throughout the United States in coming weeks and months.

Richard Smith, a vice president at FedEx Express, said his company has been “hardening” its network to protect shipments from cyber attack but did not say whether it had experienced any problems.

Republican Senator Deb Fischer, who chaired the hearing, said IBM had identified phishing email attacks. She asked FedEx and United Parcel Service executives whether their companies or employees had been the target of cyber attacks.

Wesley Wheeler, president of UPS’ Global Healthcare, said, “We are not in a position to say that today,” but added that broadly, the company is the target of “attacks every day” and that it has an “incredibly tight email system.”

https://www.reuters.com/article/health-coronavirus-vaccine-cyber/cyber-attacks-seen-on-coronavirus-vaccine-infrastructure-u-s-senator-peters-idUSKBN28K2BR

Santa takes a back seat to COVID vaccine: UPS, FedEx

 United Parcel Service and FedEx Corp plan to deliver millions of doses of COVID-19 vaccines before holiday gifts - giving them VIP handling that includes GPS tracking, special labels and first-loaded status on planes and trucks.

The largest U.S. package delivery companies are partners in the federal government’s Operation Warp Speed (OWS) vaccine program and each has specialized capabilities to handle fragile medical products - including Pfizer Inc’s mRna vaccine that requires shipment at sub-Arctic temperatures.

“We’re giving priority to all the vaccine shipments,” Wesley Wheeler, president of the global healthcare unit at UPS, told the U.S. Senate Committee on Commerce, Science & Transportation on Thursday.

A panel of outside advisers to the U.S. Food and Drug Administration is meeting on Thursday to weigh whether to recommend that the agency authorize Pfizer’s coronavirus vaccine for emergency use, one of the last steps before vaccinations could begin.

If the vaccine is approved, UPS will put Gold-level service labels, which are embedded with four radios, on every vaccine and dry ice shipment.

UPS GPS trackers will also provide temperature, light exposure and motion data, backing up sensors provided by Pfizer. All of that information will stream into command centers run by UPS and OWS.

“We have three ways of looking at the packages through the system,” said Wheeler. “We are watching the packages all day long.”

UPS will load the suitcase-sized vaccine packages onto planes and trucks first and give them special handling in hubs and sorting centers. The company also will inform drivers who are transporting vaccines, and provide security escorts.

Vaccine distribution could start just as the U.S. holiday shipping peak hits record-pandemic fueled e-commerce volumes.

Some experts are already warning that the number of packages tendered for delivery could be 5% greater than the capacity carriers have to handle them - resulting is as many as 700 million gifts not arriving on time.

UPS and FedEx executives said they are giving vaccines top priority and have reserved capacity for them.

Before vaccine deliveries start, UPS will deliver supplies needed to administer Pfizer inoculations - including diluent, mixing vials, needles, syringes, protective equipment for healthcare workers and COVID-19 vaccination record cards for vaccine recipients.

The delivery companies will split next-day Pfizer vaccine deliveries in the United States, and UPS will deliver the first dry ice refills needed to keep vaccine in Pfizer’s suitcase-sized shipping boxes at minus 70 degrees Celsius (minus 94°F), Wheeler said.

Dr. Rachel Levine, Pennsylvania’s secretary of health and the president of the Association of State and Territorial Health Officers, said in prepared remarks that a quarter of states experienced a lag in receiving supply kits during a dry run.

“You’re going to have three different components ... that all need to arrive at the exact same place, at the right time so that the vaccine can be administered,” Levine said at the hearing.

The executives reassured Senators that they are ready to tackle the biggest and complex vaccination distribution effort in U.S. history.

“We deal with the unforeseen every day: weather, traffic ... regulatory holds, customs delays. We don’t expect anything that we won’t be able to handle,” Richard Smith, executive vice president of global support for FedEx Express.

https://www.reuters.com/article/us-health-coronavirus-usa-distribution/santa-takes-a-back-seat-to-covid-vaccine-ups-fedex-officials-say-idUSKBN28K2P2

Walmart readies pharmacies for COVID-19 vaccine roll out

 Walmart Inc said on Thursday it was entering into agreements with U.S. states to administer COVID-19 vaccines, when approved, to customers and employees.

The retailer said it was preparing over 5,000 Walmart and Sam’s Club pharmacies with freezers and dry ice to handle vaccine storage requirements. It was also working with states to support vaccinations in long-term care facilities, if needed.

Pharmacy chains CVS Health Corp and Walgreens Boot Alliance have also signed agreements with the U.S. government to administer COVID-19 vaccines to residents of long-term care facilities.

The United States has agreed to buy 100 million doses of Pfizer Inc’s COVID-19 vaccine - closest to approval by the U.S. Food and Drug Administration (FDA). A panel of advisers to the FDA was set to review and recommend on Thursday whether the U.S. agency should authorize emergency use of the vaccine.

“States will determine who should receive the first doses of the vaccine and when. Walmart will not have any say in who can receive the vaccine, but we are ready to support states once they do,” Walmart said.

It said it was educating its employees about COVID-19 vaccine, and they can choose to receive it once they are eligible.

https://www.reuters.com/article/us-health-coronvirus-vaccines-walmart/walmart-readies-pharmacies-for-covid-19-vaccine-roll-out-idUSKBN28K2XA

Editas surges as Wells Fargo sizes up sickle cell candidates

 

• Editas Medicine (EDIT) gains +26.0% in value as Wells Fargo upgrades the stock from Equal Weight to overweight, citing the company’s recent ASH update on EDIT-301, its candidate for sickle cell disease.
• Highlighting the recent validation of fetal hemoglobin (HbF) as a target against the disease, the researchers have observed ‘a significant upside potential given the current valuation gap relative to SCD gene editing peer.’
• Announcing a large-scale manufacturing process for edited CD34+ cells, the component of the therapy, Editas said it was on track to file an IND submission for EDIT-301 or the treatment of sickle cell disease by the end of 2020 as it prepares for Phase 1/2 clinical trial.
• With high levels of editing in CD34+ cells from normal donors and sickle cell patients, the data in the pre-clinical studies have demonstrated what the company identified as ‘a robust fetal hemoglobin (HbF) induction in their erythroid progeny in a pan-cellular fashion’.
• As appeared in a peer-reviewed article, CRISPR Therapeutics (CRSP) has already demonstrated a rapid and sustained increases in total hemoglobin and fetal hemoglobin in a small subset of patients undergoing a Phase 1/2 clinical trials for its SCD candidate, CTX001. Fetal hemoglobin (HbF) protects against sickle cell disease by inhibiting HbS polymerization.
• On EV to TTM sales, Editas trade at ~28.5x with a ~75.6% discount to CRISPR.
• https://seekingalpha.com/news/3643445-editas-surges-26-wells-fargo-sizes-up-scd-candidates

Covid-19: Oxford vaccine could be 59% effective against asymptomatic infections

Elisabeth Mahase 

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4777 

PDF: https://www.bmj.com/content/371/bmj.m4777.full.pdf

The Oxford and AstraZeneca covid-19 vaccine prevented some asymptomatic covid-19 infections in phase III trials, but the effect was mainly seen in the group who received a half dose first, followed by a full dose, the peer reviewed efficacy results have shown.1

The study, published in the Lancet, found that vaccine efficacy against asymptomatic transmission was 59% in the group that received a half dose followed by a standard dose (seven cases among 1120 participants versus 17 cases among 1127 participants in the control group), but just 4% in the group that received two standard doses (22 among 2168 participants versus 23 among 2223 for the control). The researchers said, however, that as this was a secondary outcome, additional confirmation was still required.

Analysis of the primary outcome—efficacy against symptomatic cases of covid-19—showed that the vaccine was 62.1% effective in participants who received two standard doses (n=4440) and 90% effective in those who received a low dose followed by a standard dose (n=1120). This analysis was based on 131 symptomatic cases, of which 30 were in the vaccine arm (27 in the two full doses group, three in the low dose group) and 101 in the control group.

Between April and November 2020, 23 848 participants were enrolled to the trial. Half of the participants were given the covid-19 vaccine and the other half given a control (either a meningococcal conjugate vaccine or saline). After a dosing error led to a small group of participants receiving half a dose of the covid-19 vaccine, the researchers—with approval from the Medicines and Healthcare Products Regulatory Agency—added a half dose plus full dose group.2 This group, however, did not include adults over 55 years old as the low dose was given in an early stage of the trial, before older adults were recruited.

The interim analysis included 11 636 participants (7548 in the UK, 4088 in Brazil, 12% older adults, and 83% white). Most were aged 18-55 years (82%); people aged 56 years and older will be studied in future analyses of the trial, the researchers have said.

Merryn Voysey, study author and lead statistician at the Oxford Vaccine Group said, “In future analyses, with more data included as it becomes available, we will investigate differences in key subgroups such as older adults, various ethnicities, doses, and timing of booster vaccines, and we will determine which immune responses equate to protection from infection or disease.”

Alongside asymptomatic infections, another secondary outcome of the trial was prevention of severe disease. The paper found that, from 21 days after the first dose, 10 cases of patients being admitted to hospital for covid-19 were reported, all of which were in the control arm. Two of these cases were classified as severe, including one death.

The trial also monitored safety for a median of 3.4 months in all 23 745 participants from the UK, Brazil, and South Africa. Of these participants, 168 experienced a total of 175 severe adverse events over the period, but 172 of these were deemed unrelated to the covid-19 or control vaccines. Of the three events remaining, one was in the control group (a case of haemolytic anaemia), one was in the covid-19 vaccine group (a case of transverse myelitis considered possibly related to the vaccine), and the third was a case of severe fever (>40°C) reported in a participant who remains masked to group allocation and recovered rapidly without an alternative diagnosis or being admitted to hospital. All three participants have recovered or are recovering and remain part of the trial.

https://www.bmj.com/content/371/bmj.m4777

Pfizer plans to file for full FDA approval of COVID-19 vaccine in April 2021

 Pfizer Inc said on Thursday it planned to file for full U.S. approval of its experimental coronavirus vaccine by April next year, even as the vaccine awaits emergency use authorization by the U.S. Food and Drug Administration.

The remarks were made by Pfizer executive William Gruber at a meeting of independent U.S. FDA advisers that are weighing emergency authorization of the vaccine made by Pfizer and German partner BioNTech SE.

https://www.reuters.com/article/us-health-coronavirus-pfizer-fda/pfizer-plans-to-file-for-full-fda-approval-of-covid-19-vaccine-in-april-2021-idUSKBN28K2Z5