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Friday, August 13, 2021

UnitedHealth, Change Healthcare in timing agreement with DOJ over mega-merger

 UnitedHealth Group and Change Healthcare have entered into a timing agreement with the Department of Justice for their planned $8 billion merger.

In late March, DOJ made a second request for additional details and documentary information related to the merger. Under the timing agreement, which was reached on Aug. 7, UnitedHealth and Change agree to not "consummate" their merger before 120 days have passed since the two certified their compliance with the agency's request.

The exception is if they receive written confirmation from DOJ that it has completed its investigation in that window, according to a Securities and Exchange Commission filing from Change Healthcare.

Additionally, both companies agreed they would not certify their compliance any earlier than Sept. 15, according to the filing.

The companies and the agency reached an agreement shortly after news reports surfaced that DOJ was considering a lawsuit to block the merger.

Critics of the merger, such as the American Hospital Association, have warned that the deal could lead to a "massive consolidation" in healthcare data.

UnitedHealth and Change expect the deal to close during the second half of 2021.

https://www.fiercehealthcare.com/payer/unitedhealth-change-healthcare-enter-timing-agreement-doj-over-mega-merger

FDA Approves Merck's (MRK) Belzutifan For Cancers

 FDA Says It Approves Merck's (NYSE: MRK) Belzutifan For Cancers Associated With Von Hippel-lindau Disease

https://www.streetinsider.com/Corporate+News/FDA+Says+It+Approves+Mercks+%28MRK%29+Belzutifan+For+Cancers+Associated+With+Von+Hippel-lindau+Disease+-+Reuters+News/18815068.html

FDA declines emergency authorization for Rigel Covid therapy

 - FDA declines to issue emergency use authorization for fostamatinib for the treatment of COVID-19 in hospitalized adults --

-- Rigel's COVID-19 program continues to actively enroll patients and will provide a robust data set to support the potential benefits of fostamatinib in COVID-19 --

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization (EUA) at this time. The FDA noted in their response that they remain committed to working with Rigel in the development of fostamatinib for COVID-19 as the Company is currently conducting a larger Phase 3 clinical trial evaluating fostamatinib in hospitalized patients with COVID-19.

"With new virus variants spreading and vaccination rates plateauing, there remains a need for therapies that can improve outcomes for hospitalized patients, particularly patients suffering from hyperinflammatory COVID-19-related complications," said Raul Rodriguez, president and CEO of Rigel. "The Rigel team continues to focus on enrolling our Phase 3 clinical trial, which we anticipate completing later this year, and we look forward to providing further safety and efficacy data from this larger, 308-patient trial of fostamatinib in COVID-19 patients. If this trial meets its endpoints, we plan to resubmit our EUA application with this additional data."

https://finance.yahoo.com/news/rigel-pharmaceuticals-provides-covid-19-113000708.html

CytoDyn Receives FDA Guidance for its HIV BLA Dose Justification Report

 Company Believes All Issues Are Addressable and it Will Be Able to Continue BLA Resubmission

CMC and Non-Clinical Sections Will Be Fully Resubmitted as Early as September 2021

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it received comments from the U.S. Food and Drug Administration (“FDA”) on the Company’s recently submitted dose justification report, an important component to the Company’s resubmission of its Biologics License Application (“BLA”) for HIV.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are encouraged by the guidance and comments received from the FDA. Our management team and regulatory advisory team are confident that we will be able to successfully address these comments, allowing the further advancement of our BLA resubmission. In our view, this is a major step forward in our BLA process.

“This is an exciting period for CytoDyn. With the continuation of the BLA resubmission, the near-term initiation of two important COVID-19 trials in Brazil, and possibly a strong clinical trial in the U.S. for COVID-19 long-haulers, the next two to three months could be transformative for the Company.”

https://www.cytodyn.com/newsroom/press-releases/detail/549/cytodyn-receives-fda-guidance-for-its-hiv-bla-dose

UK Advisor Says Lockdowns Can No Longer Be Justified

 Paul Joseph Watson via Summit News,

A top SAGE (Scientific Advisory Group for Emergencies) adviser to the UK government says that COVID lockdowns can no longer be justified and that measures to control the virus should instead be aimed at protecting the most vulnerable.

Professor Andrew Hayward, a University College London epidemiologist, said that the days of disruptive restrictions imposed on everyone should end in favor of a more targeted approach.

“I think as we generally move into an endemic rather than pandemic situation the potential harm that a virus can cause at a population level is much less,” Hayward told BBC Radio 4.

“So you can’t really justify such broad population-wide control measures and we tend to target the control measures more to those who are most vulnerable,” he added.

“And so I think, not only in testing but in all sorts of forms of control, as we move into a situation where we’re coming to live with this virus forever, then we target the measures to the most vulnerable rather than having the more disruptive measures,” said the professor.

Hayward’s view that we need to learn to live with the virus was echoed by signatories to the Great Barrington Declaration, in which 12,000 scientists asserted that the strategy should be centered on “focused protection,” not endless lockdowns.

However, the UK government is still pursuing the idea of vaccine passports for some venues from September onwards while eliminating the option of negative COVID tests, despite the fact that fully vaccinated people can still catch and spread the virus.

The domestic passports have proven highly controversial in France, where police were seen earlier this week checking the medical papers of people sitting outside at cafes.

As we previously highlighted, some lockdown advocates appear to be upset that the restrictions might not make a return, with a Guardian journalist writing about how he is “going to miss being locked down.”

https://www.zerohedge.com/covid-19/uks-sage-advisor-says-lockdowns-can-no-longer-be-justified

J&J, Amgen and Roche face growing biosimilar competition driving down prices

 Five years since the U.S. saw its first mimic of a biologic drug with Sandoz’s Zarxio, new evidence suggests some innovator biologics are starting to feel the heat from their complex copycats. 

Between 2019 and 2020, the percentage of specialty claims for treatments with an available biosim plummeted at a greater pace compared with previous years, according to the latest “State of Specialty Spend and Trend Report” from the Pharmaceutical Strategies Group (PSG) released on Thursday.

That includes claims for the likes of Johnson & Johnson’s Remicade and Amgen’s Neulasta as well Roche’s oncology heavyweights Avastin, Herceptin and Rituxan. 

In its report, which analyzed 62.1 million medical claims and 50.4 pharmacy claims, PSG compared several biosimilars with their originator biologic treatments, many of which ranked among the most expensive drugs in the world last year. A biosimilar is approved based on showing that it is highly similar to an already-approved biological product, which is derived from a living organism and can come from many sources including humans, animals, microorganisms or yeast. 


In the case of immunology blockbuster Remicade, or infliximab, biosimilars accounted for about 18% of all claims last year while they didn't account for much at all in 2018, graphs shared in the report suggest. Remicade’s list of copycat foes includes Pfizer’s Inflectra, Organon’s Renflexis and Amgen’s Avsola.

That group of biosimilars forced Remicade’s average sales price down from $75 per unit at the start of 2019 to $45 by the end of 2020, PSG found. It’s notable that Avsola was a latecomer among Remicade’s rivals, launching in July last year, which will likely add more pressure to its price soon, PSG said. 

A similar situation played out with Amgen’s on-body injectable Neulasta, which now rivals against Pfizer’s Nyvepria, Novartis Sandoz’s Ziextenzo, Coherus BioSciences’ Udenyca and Mylan and Biocon’s Fulphila.

The biosims for the treatment now account for 34% of all claims, marking a "rapid" uptake, PSG’s report states. That’s driven Neulasta's average sales price down from $4,500 in early 2019, when it was jostling with just one biosim, Fulphila, to under $3,500 per unit by the end of 2020. 

Roche’s portfolio of oncology biologics also saw a gradual decline in their sales price, but the drugmaker was able to fend off the steep price drops seen with Neulasta and Remicade, PSG found. 

Avastin's average sales price dropped from about $88 per unit to just above $70, Herceptin's went from roughly $100 to slightly above $90, and Rituxan dropped from $90 to about $87, the report's graphs show. 

“Biosimilars are putting price pressure on innovator brands and driving savings for payers and plan sponsors,” Renee Rayburg, RPh, vice president of specialty clinical consulting at PSG, said in a statement. 


The report comes as Congress and the White House step up their calls for drug pricing reform that would allow for easier access to generic and biosimilar drugs, although it’s unclear whether those calls will materialize to actual legislation in a divided Congress. 

In late July, the Senate Judiciary Committee voted unanimously to advance four pieces of legislation aimed at reining in the cost of prescription drugs. Those laws would take aim at some of the anticompetitive behavior pharma companies undertake to stifle generic and biosim competition. 

https://www.fiercepharma.com/pharma/j-j-amgen-and-roche-face-growing-competition-from-biosimilars-are-driving-down-prices-report

Pfizer, Moderna seen reaping billions from COVID-19 vaccine booster market

 

Drugmakers Pfizer Inc, BioNTech and Moderna Inc are expected to reap billions of dollars from COVID-19 booster shots in a market that could rival the $6 billion in annual sales for flu vaccines for years to come, analysts and healthcare investors say.

For several months, the companies have said they expect that fully inoculated people will need an extra dose of their vaccines to maintain protection over time and to fend off new coronavirus variants.

Now a growing list of governments, including Chile, Germany and Israel, have decided to offer booster doses to older citizens or people with weak immune systems in the face of the fast-spreading Delta variant. The UK and United States, among many others, are expected to follow suit.

    Pfizer, along with its German partner BioNTech, and Moderna have together locked up over $60 billion in sales of the shots just in 2021 and 2022. The agreements include supply of the initial two doses of their vaccines as well as billions of dollars in potential boosters for wealthy nations.

Going forward, analysts have forecast revenue of over $6.6 billion for the Pfizer/BioNTech shot and $7.6 billion for Moderna in 2023, mostly from booster sales. They eventually see the annual market settling at around $5 billion or higher, with additional drugmakers competing for those sales.

    The vaccine makers say that evidence of waning antibody levels in vaccinated people after six months, as well as an increasing rate of breakthrough infections in countries hit by the Delta variant, support the need for booster shots.

Some early data suggests that the Moderna vaccine, which delivers a higher dose at the outset, may be more durable than Pfizer's shot, but more research is needed to determine whether that is influenced by the age or underlying health of the people vaccinated.

    As a result, it is far from clear how many people will need boosters, and how often. The profit potential of booster shots may be limited by the number of competitors who enter the market. In addition, some scientists question whether there is enough evidence that boosters are needed, particularly for younger, healthy people. The World Health Organization has asked governments to hold off on booster shots until more people worldwide receive their initial doses.

    "We don't know what the market forces will be," Moderna President Stephen Hoge said in an interview last week. "At some point, this will become a more traditional market - we'll look at what are the populations at risk, what value are we creating, and what are the number of products that serve that value. That will ultimately impact price."

Pfizer declined to comment for the story. During the company's second-quarter earnings call, executives said they believe a third dose will be necessary 6 to 8 months after vaccination, and regularly afterward.

    A MODEL IN FLU SHOTS

    If regular COVID-19 boosters are needed among the general population, the market would most resemble the flu shot business, which distributes more than 600 million doses per year. Four competitors split the U.S. flu market, which is the most lucrative and accounts for around half the global revenue, according to Dave Ross, an executive at CSL's flu vaccine unit Seqirus.

    Flu vaccination rates in developed countries have settled at around 50% of the population, and COVID boosters would likely follow a similar pattern if approved widely, said Atlantic Equities analyst Steve Chesney.

    Flu shots cost around $18 to $25 a dose, according to U.S. government data and competition has kept price increases in check, with producers raising prices 4 or 5 percent in 2021.

    Pfizer and Moderna may have greater pricing power for their boosters, at least at the outset, until competitors arrive. Pfizer initially charged $19.50 per dose for its vaccine in the United States and 19.50 euros for the European Union, but has already raised those prices 24% and 25%, respectively, in subsequent supply deals.

    AstraZeneca Plc and Johnson & Johnson are both gathering additional data on boosters of their vaccines. Novavax, Curevac, and Sanofi could also potentially be used as boosters, though their vaccines have yet to receive any regulatory authorization.

    "A lot of these firms aren't even in the market yet. I think within a year's time, all these companies will have booster strategies," said Morningstar analyst Damien Conover, who covers Pfizer.

    Mizuho Securities analyst Vamil Divan expects at least 5 players in the COVID-19 booster market within a few years.

There's still a lot of uncertainty around how boosters would be rolled out in the United States. Still, it is possible or even likely that people will be boosted with different vaccines than they were originally vaccinated with. The National Institute of Allergy and Infectious Diseases is already testing mixed boosting, and other countries that have used so-called mix and match vaccination have not had problems with that strategy.

   One factor that could curb prices is if the U.S. government continues paying for most or all of the shots administered in the country, rather than leave it in the hands of private health insurers. In that scenario, the government would still be negotiating prices directly with vaccine makers, and could use its buying power to stave off price increases.

    Bijan Salehizadeh, managing director at healthcare investment firm Navimed Capital, said the U.S. government is likely going to want to keep paying in order to keep vaccination rates high and prevent new COVID surges, particularly if a Democratic administration is still in power.

"It's going to be paid for until the virus disappears or mutates to be less virulent," Salehizadeh said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Pfizer-Moderna-seen-reaping-billions-from-COVID-19-vaccine-booster-market-36155711/