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Thursday, October 14, 2021

UnitedHealth 3Q Earnings Grow on Higher Revenue

 UnitedHealth Group Inc. Thursday posted revenue and profit growth for the third quarter as its membership roles expanded.

The Minnetonka, Minn.-based health insurer logged earnings attributable to stockholders of $4.28 a share, a rise from $3.30 a share in last year's third quarter. Total earnings attributable to shareholders were $4.09 billion, up from $3.17 billion a year earlier.

Stripping out one-time items, UnitedHealth's adjusted earnings were $4.52 a share. Analysts surveyed by FactSet had been forecasting adjusted earnings of $4.41 a share.

Revenue rose to $72.34 billion, up from $65.12 billion in last year's third quarter. Analysts were anticipating revenue of $71.35 billion.

Premiums rose to $56.97 billion from $50.86 billion a year earlier.

Revenue from the UnitedHealthcare insurance division grew as more customers joined. People served is up by 2 million since the end of last year, the company said.

The Optum health-services business saw revenue rise by 14%. The recovery in healthcare behavior continued, with prescriptions handled by OptumRx rising 6% as more people returned to their doctors' offices compared with earlier in the pandemic, UnitedHealth said.

https://www.marketscreener.com/quote/stock/UNITEDHEALTH-GROUP-14750/news/UnitedHealth-3Q-Earnings-Grow-on-Higher-Revenue-36679824/

IP waiver for vaccines is on life support ahead of a December deadline

 The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries.


Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.


But he said that the odds of meeting the December deadline are “already looking slim given the blocking countries’ time wasting with redundant counter proposals that offer more of a failed IP trading system and the US not putting its whole weight into negotiations and an actual text.”


Despite initial support from the Biden administration, the biopharma industry and European countries — predominantly the UK, Germany and Switzerland — have remained firmly opposed to the waiver. Pfizer went so far as to call it a “distraction” and Moderna CEO Stéphane Bancel said it wouldn’t help supply any more mRNA vaccines over the next two years.


Even some prominent Democrats are now raising doubts about the waiver too.


Gary Locke, former Commerce Secretary and ambassador to China under the Obama administration, told Endpoints via email, “The proposed TRIPS waiver would do nothing to expand mRNA manufacturing capacity. Every scientist and company that knows how to make the vaccines is already working to scale production. And every facility on earth that can safely and reliably produce shots is doing so.”


He also said he didn’t think the US should give away its taxpayer-funded mRNA research to countries like China as that could “jeopardize American economic competitiveness.”


But nonprofits like Public Citizen have called on the US government to start building new sites and retrofitting older ones to make more vaccines.


“A $25 billion investment in vaccine production by the US government would produce enough vaccine for low- and middle-income countries in one year,” the group says.


Locke agreed that wealthy nations “should focus on donating surplus Covid-19 vaccine doses to developing countries, while also investing in solutions to actually help distribute those doses. For example, The Democratic Republic of the Congo returned 1.3 million doses to COVAX, the global vaccination-sharing initiative, in part because it couldn’t get the doses into rural areas.”


Over the next two days, all eyes will be on the IP waiver, and whether it can actually ramp up vaccine supplies.


“I’m hoping, albeit not confident, the US will table some language/text in support of the India/South Africa’s waiver — even if it does not totally match the current revised waiver text. It will be needed to push the countries blocking to come with something more in line with a broader IP waiver,” Amin said.

https://endpts.com/as-trips-council-meets-the-ip-waiver-for-vaccines-is-on-life-support-ahead-of-a-december-deadline/

Walgreens ups stake in primary-care VillageMD with $5.2B investment

 Walgreens Boots Alliance said Thursday that it has agreed to become the majority owner of VillageMD, as it opens hundreds of doctor offices with the primary-care company.

As part of the deal, the drugstore chain will invest $5.2 billion in VillageMD. That will increase Walgreens’ ownership stake from 30% to 63%. VillageMD will remain an independent company with its own management and board.

Walgreens said it expects the deal to close by the end of this year, pending regulatory approval.

The investment is part of Walgreens’ broader effort to turn its stores into health-care destinations that not only fill prescriptions, but also have doctors who can write them and provide other types of care, such as annual checkups. The company is speeding along its plans to open Village Medical clinics at existing Walgreens drugstores. The goal is to have at least 600 primary-care clinics in more than 30 U.S. markets by 2025 and 1,000 by 2027.

Walgreens CEO Roz Brewer said in an interview with CNBC’s Bertha Coombs that the clinics will simplify care for patients. She said Walgreens and VillageMD will have pharmacists and physicians who work together. They will have access to the same tech platform that pulls together medical records. And they’ll be at a convenient location, a short walk or ride away.

“Your physician recommendations are being shared directly with the pharmacist,” Brewer said. “I think that’s a game changer when you think about what we’re able to do.”

Most of the clinics will be about 3,300 square feet — nearly a quarter of the drugstore’s average size of 13,500 square feet.

Walgreens has about 9,000 stores in the U.S. and more than 75% of Americans live within five miles of one of them. Brewer said it plans to use that footprint to reach people who have few — if any — nearby doctors. It said it plans to open more than half of its VillageMD clinics in urban neighborhoods and rural communities that are medically underserved.

Walgreens and VillageMD have said the doctor offices will accept different kinds of health insurance and offer an out-of-pocket option, along with a sliding scale for people who don’t have insurance.

With the move, Walgreens is following in the footsteps of competitors, including CVS Health and Walmart. Many CVS stores already have a MinuteClinic, which administers vaccines and offers walk-in, urgent care appointments. CVS is also turning more stores into a HealthHub, which has a wider range of medical services like testing for sleep apnea and management of diabetes. Walmart is opening a growing number of primary clinics with a low-cost model, but so far, they are concentrated in Georgia, Florida and the Chicago area.

Walgreens and VillageMD have already opened 52 primary-care clinic locations and have an additional 33 on track to start by the end of the calendar year. The company announced the partnership for the first time 2019 and decided to expand the effort after a pilot of five clinics in the Houston area.

https://www.cnbc.com/2021/10/14/walgreens-buys-majority-stake-in-primary-care-company-villagemd.html

More getting Covid vaccine boosters than first doses in US rush for third shots

 

  • The U.S. is reporting an average of about 362,000 boosters administered per day over the past week, 57% higher than the 231,000 average daily first doses.
  • About 8.9 million boosters overall have been administered as of Wednesday, covering 4.7% of all fully vaccinated Americans and more than 12% of the immunized 65 and older population. 
  • A key FDA advisory panel meets Thursday and Friday to discuss the efficacy and safety of extra doses of the Moderna and J&J vaccines.
  • https://www.cnbc.com/2021/10/14/more-americans-are-getting-covid-vaccine-boosters-than-first-doses.html

Novartis: FDA, EMA filing acceptances of Beovu for diabetic macular edema

 

  • Regulatory decisions for Beovu (brolucizumab) in diabetic macular edema (DME) are expected in mid-2022 in the US and Europe
  • DME is the leading cause of blindness in adults in developed countries; unmet needs in DME include improving fluid resolution and addressing the burden of frequent treatment schedules1-3
  • The regulatory applications are based on year one data from the Phase III KESTREL and KITE trials investigating Beovu 6 mg versus aflibercept 2 mg in DME patients4
  • In KESTREL and KITE, Beovu was non-inferior to aflibercept in change in BCVA from baseline and showed potential for fluid resolution in more DME patients with fewer injections4
  • Beovu demonstrated a favorable benefit-risk profile in KESTREL and KITE4
  • The Japanese PMDA also accepted an application for Beovu in DME

NRx: Positive Trial Data in High Comorbidity Patients with Critical COVID-19

 NRx Pharmaceuticals (Nasdaq: NRXP), today announced the publication of peer-reviewed results from a prospective, open-label, administratively controlled trial of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19. The study reported 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment at the Houston Methodist Hospital (P<.0001). A similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure (P<.0001). The study appears in the Journal of Infectious Diseases and Treatment.

"We view this study as supportive evidence that aviptadil protects the lung against the lethal effects of the SARS-CoV-2 virus," said Jihad Georges Youssef, M.D., Lead Author of the study.

Patients enrolled in this study were at the highest possible risk for death based on serious comorbidities that rendered them ineligible for participation in the phase 2b/3 pivotal study of aviptadil for the treatment of COVID-19 with respiratory failure. In addition, patients in the study failed to respond to all treatments approved for COVID-19 during the first surge of the pandemic in the summer of 2020.

In addition to the substantial differences seen for both survival and recovery, the study demonstrated statistically significant advantages in the aviptadil-treated group on two important intermediate endpoints: Respiratory Distress Ratio and Cytokine IL-6. Statistically significant differences on these endpoints have previously been noted in reports from the phase 2b/3 randomized controlled trial of aviptadil vs. placebo conducted at 10 sites across the United States. Aviptadil-treated participants in this open-label study demonstrated a rapid (48-96 hour) 2-fold improvement in the Respiratory Distress Ratio (RDR- a measure of the lung's ability to transmit oxygen to the blood), whereas no short-term improvement was seen in patients who were treated with standard of care (P<0001). A 100% reduction in cytokine IL-6 was also seen in aviptadil-treated patients (along with changes in other cytokines). It was not possible to compare the cytokine reduction to standard of care-treated participants because of the low survival in this control group.

FDA Accepts REGEN-COV for Priority Review for Covid-19

 European Medicines Agency also announced earlier this week it would review Marketing Authorization Application for the antibody cocktail

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for REGEN-COV® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has assigned a target action date of April 13, 2022 and informed us that they currently are planning to hold an advisory committee meeting to discuss this application in advance of that date.

The BLA is supported by two positive Phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts). A second BLA submission focusing on the treatment of patients hospitalized due to COVID-19 is expected to be submitted later this year.

Regulatory submissions are also progressing in the European Union (EU). Earlier this week, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for the same antibody cocktail, known as Ronapreve™ in the EU and other countries outside of the U.S., for use in certain people either as a treatment in infected non-hospitalized patients, or as prophylaxis. The submission approach for the EMA is similar to that used for the FDA, with a Type II Variation planned in those already hospitalized because of COVID-19.

https://finance.yahoo.com/news/fda-accepts-regen-cov-casirivimab-112100903.html