Lilly's Verzenio could hit $4.6B, thanks to early breast cancer win

 In the kinase inhibitor class of breast cancer drugs, Pfizer’s Ibrance has held a strong lead in market share—and sales—over Eli Lilly’s Verzenio.

But on the heels of Verzenio's strong showing in HR+/HER2- early breast cancer—and Ibrance's miss—one influential analyst figures the Lilly drug will quickly pick up steam. The upshot? About $4.6 billion in sales at the peak, significantly more than most pharma watchers now expect from the med.

Since its launch in 2017, Verzenio’s share of the market in metastatic breast cancer has been “steadily growing,” from 12% early last year to 20% now, Bernstein analyst Ronny Gal wrote in a Monday note to clients. And with a potential launch in HR+/HER2- early breast cancer, the drug's sales are set to ramp up considerably, he said. 

Lilly is “showing success with arguing for differentiation from Ibrance, and the growth will continue when the drug gains approval” in early breast cancer, the analyst wrote. The prediction comes after Verzenio posted impressive data in HR+/HER2- early breast cancer—and after Ibrance failed two studies in early breast cancer.

Pfizer’s drug won an FDA approval in 2015 and generated $5.4 billion in sales last year. Verzenio, for its part, scored an FDA approval in 2017—giving Pfizer a considerable head start—and brought in $913 million last year. 

While Pfizer’s drug is already on a strong sales trajectory, Gal says Lilly can expect Verzenio to not only pass the $1 billion blockbuster threshold but gin up billions more than that each year.

Ibrance will “retain market leadership” in metastatic breast cancer, Gal wrote, but he sees Verzenio snagging 28% of that market by 2024. With those share gains plus a potential FDA nod in early breast cancer, Bernstein analysts project $4.6 billion in Verzenio sales in 2024, significantly higher than consensus Wall Street estimates of $3.2 billion. 

Last summer, Lilly’s drug—added to standard endocrine therapy after surgery—showed it could significantly reduce the risk of cancer recurrence by 25.3% in patients with high-risk HR-positive, HER2-negative early breast cancer.

One expert said the findings would "change practice." The company filed the data with regulators in the fourth quarter of 2020, according to its recent annual SEC filing.

Meanwhile, Pfizer's Ibrance has failed two studies in early breast cancer. After the second failure, SVB Leerink analyst Geoffrey Porges wrote that there's “no saving adjuvant for Ibrance."

https://www.fiercepharma.com/pharma/look-for-eli-lilly-s-verzenio-to-reach-4b-after-early-breast-cancer-win-analyst

Hims & Hers upped to Buy by Citi

 From Neutral; target $23.

https://finviz.com/quote.ashx?t=HIMS

EU, under pressure over vaccine rollouts, eyes switch to emergency OKs

 The European Commission said on Tuesday that it was considering emergency approvals for COVID-19 vaccines as a faster alternative to more rigorous conditional marketing authorisations which have been used so far.

The move would mark a big shift in approach to vaccine approvals, as it would entail using a procedure that the EU had considered dangerous and that before the COVID-19 pandemic had been reserved for exceptional authorisation at national level of drugs for terminally ill patients, including cancer treatments.

The potential change comes as the EU executive and the bloc’s drug regulator come under increasing pressure for what some consider slow vaccine approvals, which have contributed to a slower rollout of COVID-19 shots in the 27-nation union, compared to the United States and former EU member Britain.

“We are ready to reflect with the member states on all possible avenues to indeed accelerate the approval of the vaccines,” an EU Commission spokesman told a news conference after the matter was discussed earlier on Tuesday at a COVID-19 meeting with EU Commission President Ursula von der Leyen.

One option could be “an emergency authorisation of vaccines at EU level with shared liability among member states”, the spokesman said, adding that work on this could start very quickly if EU governments supported the idea.

It was not clear whether an EU-wide emergency authorisation procedure, if agreed upon, would entail the same conditions as emergency approvals granted at national level, the commission spokesman told Reuters.

The European Medicines Agency (EMA) cannot currently issue emergency approvals but in exceptional circumstances has recommended the compassionate use of drugs before marketing authorisation.

This procedure was used in April to initially authorise doctors to use Gilead’s antiviral drug remdesivir as a treatment against COVID-19. The drug was later given conditional approval by EMA.

CHANGE OF TACK

National emergency approvals are allowed under EU laws, but they force countries to take full responsibility if something goes wrong with a vaccine, whereas under the more rigorous marketing authorisation, pharmaceutical companies remain liable for their vaccines.

The EU Commission had said that national emergency authorisations should not be used for COVID-19 vaccines because faster approvals could reduce regulators’ ability to check efficacy and safety data.

This could also boost vaccine hesitancy, which is already high in some countries, EU officials had said.

One senior EU official said the emergency procedure had so far usually been used at national level for terminally ill patients and the EU had instead chosen the lengthier conditional marketing authorisation because with vaccines “we inject healthy people” and the risk was disproportionate.

The change of tack would come after Eastern European countries, including Hungary, Slovakia and the Czech Republic, approved or said they were considering approval of Russian and Chinese vaccines with national emergency procedures.

Britain has also used the emergency procedure to approve COVID-19 vaccines.

The EU Commission also said last month it was working on a possible fast-track approval of upgraded anti-variant vaccines, which had already been authorised and would need fewer comprehensive checks before they are made available to the public.

https://www.reuters.com/article/us-health-coronavirus-eu-vaccines/eu-under-pressure-over-vaccine-rollouts-considers-switch-to-emergency-approvals-idUSKBN2AU1PC

Lucira started at Outperform by Blair, Neutral by B of A

 B of A target $22.

https://finviz.com/quote.ashx?t=LHDX

CHF Solutions: Q4 Earnings

 Shares of CHF Solutions (NASDAQ:CHFS) moved higher by 4.6% in pre-market trading after the company reported Q4 results.

Quarterly Results

Earnings per share fell 0.89% year over year to ($1.13), which beat the estimate of ($1.26).

Revenue of $2,044,000 up by 49.52% year over year, which beat the estimate of $1,300,000.

Outlook

CHF Solutions hasn't issued any earnings guidance for the time being.

CHF Solutions hasn't issued any revenue guidance for the time being.

Conference Call Details

Date: Mar 02, 2021

View more earnings on CHFS

Time: 09:00 AM

ET Webcast URL: https://edge.media-server.com/mmc/p/humhci47

Price Action

Company's 52-week high was at $10.59

52-week low: $0.28

Price action over last quarter: Up 32.06%

Company Overview

CHF Solutions Inc is a medical device company. It focuses on commercializing the Aquadex FlexFlow System. The Aquadex FlexFlow System is used for temporary and extended ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. It is designed to remove excess fluid ( primarily excess salt and water) from patients suffering from fluid overload who have failed diuretic therapy. The company only operating segment is Cardiac and coronary disease products.

https://finance.yahoo.com/news/chf-solutions-q4-earnings-insights-132105515.html

Pfizer COVID vaccine may be less effective in obese people: study

 Pfizer’s vaccine may be less effective in protecting obese people from coronavirus, scientists said.

Researchers in Rome found that obese people who had received two doses of the vaccine generated a weaker antibody response, according to a report on the pre-print server Medrxiv.

The study, which has not been peer-reviewed, evaluated the effect of the vaccine on 248 health care workers seven days after the final dose, the Guardian reported.

Researchers at the National Cancer Institute Regina Elena found that those considered obese — which is defined as having a body mass index (BMI) over 30 — produced about half the amount of antibodies compared with people who had a healthy body weight, the Guardian reported.

It’s not currently known what level of antibodies is necessary to neutralize the virus, but experts fear that a reduced antibody response may hinder innoculation efforts.

The team said their findings highlight important implications on vaccination strategies for obese people.

“Since obesity is a major risk factor for morbidity and mortality for patients with Covid-19, it is mandatory to plan an efficient vaccination program in this subgroup,” the study’s authors wrote.

One option that could be considered would be to give them an extra or stronger dose.

“Although further studies are needed, this data may have important implications to the development of vaccination strategies for Covid-19, particularly in obese people. If our data was to be confirmed by larger studies, giving obese people an extra dose of the vaccine or a higher dose could be options to be evaluated in this population,” the researchers wrote.

https://nypost.com/2021/03/01/pfizer-covid-vaccine-may-be-less-effective-in-obese-people-study/

NYC eateries enticing staff to get COVID-19 vaccine

 Now that Big Apple restaurant workers are eligible for coronavirus vaccines, eatery owners are walking a fine line trying to encourage them. 

Shake Shack staffers get an extra six hours of pay to get jabbed. 

“While Shake Shack won’t be requiring vaccinations, we are strongly encouraging it,” a spokeswoman for the New York City-based burger chain told Side Dish. 

Starbucks is shelling out four hours’ pay to employees who get protected against the virus, as is McDonald’s at all of its corporate-owned outposts. 

It’s not just the big chains that are doing it. Smaller restaurateurs are also coming up with ways to encourage staffers to get the vaccine — ranging from a one-shot payment to time off without pay and assistance setting up appointments. 

Jeremy Wladis, president of The Restaurant Group, which operates Harvest Kitchen, Hachi Maki and Good Enough to Eat on the Upper West Side, is offering to pay his employees $25 each to get vaccinated. 

“I want everyone who is willing to be vaccinated. I think it is so important. It’s a good way to give back and to give people a few bucks and incentivize them to do something good. It will help the staff, the world and our business,” Wladis said, adding that he now has 65 staffers, down from around 100 pre-pandemic. 

It’s not something he wants to force on workers, however. 

“I don’t want to push it. You never know when you are stepping over that line,” Wladis said, adding that if some employees don’t take him up on his offer to pay them to get vaccinated, then “we certainly aren’t mentioning it.” 

Indeed, while it is perfectly legal for hospitality employers to require their staffers to get vaccinated, there are medical and religious-based exemptions that could lead to problems for employers without a full-time human-resources team, said James Mallios, a top restaurant lawyer and owner of Bar Marseille and Amali in New York City and Calissa in the Hamptons. 

“You can legally mandate people to get vaccinated, but it’s an HR nightmare to do it the right way,” Mallios said. 

“You have to make sure people are treated the same,” he added. “It sounds normal and intuitive, but it’s a lot of work, and I don’t have 30 hours a week to spare, so we decided we’d take a different approach — to positively encourage people to get vaccinated.” 

In the past, Mallios has paid for his employees to get flu shots. Now he’s paying for their travel and time to get the COVID-19 vaccine and setting up their appointments. Around 55 people work in all three restaurants, he added. 

In addition to the legal issues, many restaurant workers also don’t have health insurance. That could lead to problems if they’re forced to have the vaccine and end up having a reaction.

“Forget the legality, just the guilt I would feel,” Mallios said. 

A recent survey suggests fears over side effects loom large among workers. According to the 2021 Hospitality Vaccination and Employment Status Report from Harri, a hospitality and retail recruiting Web site, 29 percent of 4,250 current and former hospitality workers surveyed said they would not get the vaccine, with 57 percent citing fears of side effects. 

“God forbid we tell them to do it and something happens and they have an allergic reaction. We could be liable,” said Stratis Morfogen, director of operations at the Brooklyn Chop House and Brooklyn Dumpling Shop. 

“But we are offering paid time off for the days they get it, and if they feel tired or discomfort, we’ll give them a paid sick day leave,” Morfogen said. 

Giselle and Roberto Deiaco of Avena in Greenwich Village and on the Upper East Side say their staffers are anxious to get vaccinated because they saw up close the danger of the coronavirus. 

“Everyone is eager to get vaccinated. I don’t need to incentivize them. Eighty percent of my staff had COVID-19 last March, and four of them had really bad cases where they were violently ill and thought they would die. They don’t want to go through that again,” Giselle Deiaco said of her 25 staffers. 

Still, she is doing what she can to help, including booking staffers’ appointments, providing them with documentation and giving them time off. 

“I wrote letters for them and helped book online appointments. I told them we will do whatever it takes for them to get the vaccine,” Deiaco added. 

“We are supportive and cooperative and give them time off. Everyone can’t wait to get it.” 

https://nypost.com/2021/03/01/nyc-eateries-enticing-staff-to-get-covid-vaccine/