JPM21: Rite Aid CEO braces for 'chaotic' few weeks as vaccine rollout expands

 The CEO of major pharmacy chain Rite Aid is bracing for a “chaotic few weeks” in the rollout of the COVID-19 vaccine, which has been marred by inconsistencies among states and localities.

Rite Aid CEO Heyward Donigan detailed the pharmacy chain’s role in vaccine distribution during a session as part of the J.P. Morgan virtual healthcare conference Monday. Donigan said that there could be changes in how vaccines are distributed with the incoming Biden administration, which has hinted at giving out all first doses and not holding any back for a second dose.

“I can’t predict what is going to happen,” Donigan said. “They have reached out to us and we are in contact to them.”

Rite Aid is one of the retail pharmacy chains alongside CVS and Walgreens partnering with the federal government to distribute vaccines.

The pharmacy chain will be distributing later phases of the vaccine as other chains have given out doses to long-term care facilities.

Donigan did have one prediction, however.

“One thing for sure it is going to be pretty chaotic for the next few weeks as people try to move through this,” she said.

She said she has witnessed from afar that other organizations have had a hard time figuring out how many doses to send out to which facility to “orchestrate getting those doses to people’s arms,” Donigan said.

Some states have also differed on who should get the initial doses, which can cause challenges for pharmacies to determine how much vaccine supply to have available on a given day.

“If you open up a bottle and only get one dose, you have to figure out what to do with rest of the vial,” Donigan said. “We don’t want doses going unused, but it is extremely complicated how to figure out how to find the right people in that moment in that day.”

Jim Peters, Rite Aid’s chief operating officer, added the pharmacy chain is “absolutely prepared” to give a record of immunization and proof of immunization for any doses.

Rite Aid also detailed how it is preparing pharmacists to get ready to balance the surge of vaccinations coming when more of the public is eligible to get doses.

One of the areas the chain is looking to improve is having pharmacy technicians shoulder more responsibility to alleviate some of the burden on pharmacists. Rite Aid also hopes to improve workflow systems to become more efficient.

“We do believe it will free up another 20% of the pharmacist time in order to do these clinical services and vaccines,” Donigan said. “We will need a lot more for vaccines for sure.”

https://www.fiercehealthcare.com/payer/jpm-rite-aid-ceo-braces-for-chaotic-few-weeks-as-vaccine-rollout-expands

JPM21: Humana CEO expects Biden admin to be friendly to Medicare Advantage

 Humana CEO Bruce Broussard said he's confident the Medicare Advantage program enjoys broad, bipartisan support.

With a Democratic administration set to take over the White House in short order, payer execs at the J.P. Morgan Healthcare Conference were questioned as to whether they were concerned that this could negatively impact MA.

The Affordable Care Act cut MA rates, which drew concerns from skittish investors that a Biden administration could make similar moves.

But Broussard said that the Medicare Advantage program of today is far different from the one that saw those cuts a decade ago. For one, he said, payment rates were "out of wack" with the Medicare fee-for-service population, typically between 110% and 130% of traditional Medicare.

In addition, the MA population has grown significantly since then — and as such represents a much more sizable group of voters for legislators to consider. At the time, fewer than 20% of Medicare beneficiaries were enrolled in the program.

Now, nearly 40% of beneficiaries are enrolled in MA, and that's only growing.

"What you've seen over the last decade is really a change in the number of people that are in the program — who are a voting bloc," Broussard said.

In addition, MA has significantly evolved in terms of quality, as at the time the star ratings program was not fully fleshed out, he said. Health plans have invested significantly in innovation to improve the quality of the member's experience with their plans, and in the quality of the care they receive.

Medicare Advantage has also expanded significantly into underserved areas and plays a crucial role in addressing health inequities, which it was not circa 2010, Broussard said. 

"You've just seen an entirely different program in totality, even since 2015-2016," he said.

Broussard added that the incoming Biden administration will also have plenty on its plate already and that he doesn't see significant changes to Medicare Advantage as a likely early priority. Typical adjustments, such as to the star ratings, are more expected, however, and Humana is planning for those scenarios.

Overall, MA is a "really solid" program compared to a decade ago, Broussard said. Officials cite it frequently as a model for other ways to improve healthcare, he said.

"We hear Medicare Advantage is an example of a program that should be carried out in other parts of the healthcare system," Broussard said.

https://www.fiercehealthcare.com/payer/jpm21-humana-s-broussard-expects-biden-admin-to-be-friendly-to-medicare-advantage

At all-virtual CES, spotlight on touchless tech, robot companions, smart bathrooms

 CES typically draws thousands of people to Las Vegas in January to see and demo the latest gadgets and tech innovations.

One of the largest technology shows in the world, CES has gone completely online this year due to the COVID-19 pandemic. So instead of crowded aisles and gimmicks like giant slides and roaming robots, CES 2021 features virtual press conferences and live-streamed events.

But there's no shortage of digital health and wellness products being showcased at CES this year and the pandemic appears to have inspired new products designed to remotely track health conditions and mental wellbeing as consumers spend more time at home. Companies have developed robots to help around the house and to even keep you company, "smart home" technologies to provide more hygienic, touchless experiences, and devices to help older adults age in place.

The conference kicked off Monday with media day presentations. Here are some of the biggest health tech themes and wackiest new wellness ideas among the product announcements this year:

Remote monitoring

The use of remote monitoring technologies and wearables has accelerated during the pandemic as a way to track health conditions while consumers stay safely at home.

Health technology giant Philips showcased its digital health solutions that focus on moving healthcare outside the four walls of the hospital.

The company has integrated the BioIntelliSense BioSticker wearable sensor into its remote patient monitoring system to help monitor at-risk patients from the hospital into the home. The Biosticker is a disposable, small patch that’s worn on the skin and monitors physiological biometrics and symptomatic events including skin temperature, resting heart rate, resting respiratory rate, body position, activity levels, and cough frequency.

BioIntelliSense also is collaborating with the American College of Cardiology (ACC) to offer the BioButton as a COVID-19 screening tool to ACC members at its annual conference in May, the organizations announced Monday. 

"We have witnessed the reinvention of our homes as a core element of the healthcare pathway, with telehealth, virtual and remote care technologies as the key drivers for change during COVID-19. And these changes are here to stay," said Deeptha Khanna, chief business leader, personal health at Philips in a statement.

HD Medical launched a remote monitoring solution called HealthyU that it says can monitor multiple vital signs while providing a built-in 7-lead ECG and stethoscope in one simple device. The technology can track lung sounds, heart rate, temperature, respiratory rate, and cuffless blood pressure trends, the company said.

Wearables also are being designed to help older adults a smarter way to age in place with advanced fall detection. FallCall Solutions designed an Apple Watch app that can distinguish between falls with greater force that are more likely to cause injury and falls that occur from a sitting position. If a high-impact fall is detected, FallCall's medical monitoring service is automatically contacted and will send emergency services if needed. 

Medical device company Omron Healthcare also unveiled its first remote patient monitoring device for hypertension management. The VitalSight solution can be delivered to patients' homes and can include a digital blood pressure monitor with cuff, weight scale, and digital medication tracker, as well as a data hub to share measurements with the patient's physician and care team. The solution directly links to a physician’s electronic health record (EHR) system.

"Smarter" homes to support wellness

As consumers spend more time at home, companies are putting a greater focus on advanced digital living. 

"Intelligent" toilets are not a brand-new innovation—there were plenty on display at CES 2020—but Kohler continues to expand on the trend with a focus on wellness and touchless experiences.

The company's debuted its Innate Intelligent Toilet that offers a heated seat, auto opening and closing, a remote, as well as a personal bidet function. That will set you back about $3,000 when it's available.

Kohler also unveiled a touchless bathroom faucet that offers hands-free activation for washing hands to decrease the potential spread of bacteria and germs and a "stillness bath" that includes light, fog, and aromas and "draws its inspiration from Japanese forest bathing." 

The Themis Smart Mirror from CareOS can support home health and wellness including hygiene, mental health, skincare, and preventive healthcare, according to the company. The device collects data from several sensors such as a high-quality RGB camera, an IR temperature sensor, and a UV light for skin analysis. 

The need to take care of hygiene and health concerns at home has intensified since the COVID-19 pandemic, and the smart mirror acts as a personal wellness assistant to perform skin analysis, daily temperature checks, smart alerts, and fertility cycle reminders. The device can interoperate with smart scales, ECG trackers, and digital showerheads, resulting in a fully connected bathroom. 

Digital self-care 

At-home fitness also became a hot trend in 2020. Health and fitness platform Ultrahuman unvieled a new fitness platform that helps people meditate, workout efficiently, and optimize their sleep with the help of athletes, neuroscientists, artists, and psychologists. There's also bedtime stories written by award-winning authors designed to relax users into sleep.

The app also integrates biofeedback via its Apple watch integration to measure and improve the efficacy of meditation and workouts. 

A startup called AlphaBeats designed a system that uses a person’s favorite music to relax their brain. Based on real-time monitoring of brain and heart activity, an algorithm enables a slight modification of the music, enticing the brain to go into an “alpha mode” and relax.

Robots for everyday life

During a keynote presentation Monday, technology giant Samsung presented new products as part of its focus on a "Better Normal for All." The company's solution use AI to make daily life seamless, Samsung said.

“Our world looks different, and many of you have been faced with a new reality–one where, among other things, your home has taken on a greater significance,” said Sebastian Seung, president and head of Samsung Research.

Samsung Bot Care, the latest development in Samsung’s growing robotics lineup, is designed to use AI to recognize and respond to user's behavior. It will act as both a robotic assistant and companion, such as learning a user's schedule and habits and sending reminders about important tasks, the company said.

Samsung Bot Handy will rely on advanced AI to recognize and pick up objects of varying sizes, shapes, and weights to help with work around the house.

While it might not fall under digital health, robotics startup Yukai Engineering has come up with a product that could count as therapy during these challenging times. Petit Qoobo is a portable-sized therapeutic robot in the shape of a cat, sort of. The robot is in the form of a cushion with a tail that swings and wags at the sound of the user's voice and is designed to help soothe the user.

https://www.fiercehealthcare.com/tech/at-all-virtual-ces-spotlight-health-monitoring-robotics-and-smart-devices-home

Baird Upgrades Walgreens Boots, Expects Turnaround Of 'Train Wreck'

 Shares of pharmacy retailer Walgreens Boots Alliance Inc 

WBA 5.51% ended 2020 lower by nearly 30%, but Baird sees several catalysts for the company that it said should put an end to years of "train wreck" performance.

The Walgreens Analyst: Eric Coldwell upgraded Walgreens from Neutral to Outperform with a price target lifted from $41 to $55.

The Walgreens Thesis: Walgreens reported Thursday with first-quarter 2021 results that "weren't good" but still "much better" than expected, Coldwell said in a Monday upgrade note.

The retailer's second-quarter outlook could have been worse, and growth should "accelerate handsomely" in the May quarter as COVID-19-related comp headwinds improve, the analyst said. 

The bullish case for Walgreens is also based on Thursday's announcement that the company will divest its pharmaceutical wholesale business to AmerisourceBergen Corp. ABC 2.33%, he said.

This will generate $6 billion in net cash that Walgreens can redeploy on its business along with accelerating the pace of investments and turnaround initiatives, Coldwell said, adding that the agreement will also help synergize the ongoing partnership with Amerisource.

Walgreens "gets little credit" for its portfolio of investments in public and private companies, the analyst said.

Some of these include a $1-billion stake in VillageMD, a $416-million investment in GuoDa in 2018 that likely more than doubled and Option Care, which he said could also be worth $1 billion.

"We are not capable of assessing precisely how much is currently captured in WBA's enterprise value, but logic would dictate that the Street may still be undervaluing the positions."

Finally, Walgreens stock is trading at just nine times P/E, while its P/E on a next-12-months basis represents a 60% discount to the S&P 500 index versus a long-term average multiple discount in the mid-single digits, according to Baird. 

https://www.benzinga.com/analyst-ratings/analyst-color/21/01/19103020/baird-upgrades-walgreens-boots-expects-turnaround-of-train-wreck-performance

J&J Plans to Submit South African Vaccine Trial Data by Jan. 21

 

Johnson & Johnson’s preliminary data from the South African arm of a phase 3 Covid-19 vaccine trial will be ready for submission to U.S. regulators by Jan. 21, according to the head of the country’s Medical Research Council.

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The timing ties in with the U.S. drug giant’s statement that interim data from the late-stage trial it is conducting in a number of countries is expected by the end of this month. If the data show the one-dose vaccine to be safe and effective, J&J will approach U.S. regulators for an emergency use authorization in February, and “other health regulatory applications around the world will be made in parallel,” according to the company.

Moncef Slaoui, the chief scientific adviser to the U.S. Operation Warp Speed program, has said the emergency clearance could be granted by U.S. regulators by early February.

J&J is one of four vaccine developers running late-stage trials in South Africa. Business Day, a Johannesburg-based newspaper, reported the planned timing of the data submission earlier. It was confirmed by Glenda Gray, president of the research council and co-chair of the local study.

https://www.bloomberg.com/news/articles/2021-01-11/j-j-plans-to-submit-south-african-vaccine-trial-data-by-jan-21

Sanofi makes a pre-JP Morgan splash with Kymab

 Sanofi’s bid to catch the wave of enthusiasm surrounding the JP Morgan healthcare conference getting under way today has seen it buy Kymab for $1.1bn. True, this is nothing like Bristol swooping on Celgene, or even Lilly buying Loxo, deals that kicked off JP Morgan 2019, but it is one of the UK’s biggest biotech takeouts.

The driver seems to be Kymab’s Ox40L blocker KY1005, which generated phase II data in atopic dermatitis last August. Kymab also has an interesting pipeline of oncology projects, but this is at a rather early stage; thus the move again sees the French group putting up big bucks where others have preferred not to.

In Kymab’s case, those that have apparently chosen to remain on the sidelines include banks willing to underwrite a public market flotation. Kymab had been eyeing a US IPO as long ago as May 2019, revealing that it had filed a confidential registration statement with the SEC, but no IPO came about.

The proposed size of any IPO had never been revealed, but it is clear why valuation might have been an issue: private investors had pumped $280m of funding into Kymab, but with only two clinical assets, and no clinical validation until the KY1005 data, a big return on this investment seemed a long shot in the near term.

Front-end loaded

Until Sanofi stepped up, that is. Today’s deal is unusually front-end loaded, with $1.1bn of cash up front and just $350m contingent on future milestones.

Armed with $8bn from the sale of most of its Regeneron stake, Sanofi has been acquisitive as its chief executive, Paul Hudson, has been given a brief to build an oncology and rare disease pipeline fast. It has recently paid $358m for Kiadis, $3.7bn for Principia Biopharma and $2.5bn for Synthorx.

Still, Kymab’s lead asset is in neither disease category, though of course Sanofi is already active in autoimmune conditions. KY1005’s phase II success came in moderate to severe atopic dermatitis, with the project beating placebo in 12-week EASI score; though Kymab did not release any statistical data, it said the primary EASI score endpoint was met, and that the effect was “clinically meaningful”.

The project inhibits Ox40L, the ligand for the co-stimulatory immune checkpoint Ox40, which is better known as an oncology target. However, Ox40 MAbs for cancer use have activating rather than inhibitory activity, so Moderna’s phase I/II stage asset mRNA-2416, for instance, is an mRNA that encodes human Ox40L.

In cancer, agonising Ox40 has, like many follow-on checkpoint approaches, yet to record any notable successes. While Roche has scrapped its contender RG7888, Glaxosmithkline remains committed to this target through GSK3174998. Astrazeneca, which has two different Ox40 agonists, MEDI6469 and MEDI6383, is keeping faith too.

Kymab’s most advanced oncology asset is the anti-Icos MAb KY1044, an approach where Glaxo, Astra and Jounce are all active. Meanwhile, other projects inhibiting Ox40 interaction for autoimmune use include Kyowa Kirin’s KHK4083.

Sanofi will hope that Kymab’s atopic dermatitis success is a sign of better things for Ox40 in autoimmune disease than in cancer, though of course the reported phase II win has yet to be repeated in a large, pivotal setting.

Selected clinical projects targeting Ox40 interaction in autoimmune disease
Project	Company	Mechanism	Study
ISB 830	Ichnos Sciences (Glenmark spinout)	Anti-Ox40 MAb	468-pt placebo-controlled study in atopic dermatitis, ended Nov 2020
KHK4083	Kyowa Kirin	Anti-Ox40 MAb	274-pt placebo-controlled study in atopic dermatitis, ended Feb 2020
KY1005	Kymab	Anti-Ox40L MAb	88-pt placebo-controlled study in atopic dermatitis showed clinically meaningful effect on 12-wk EASI score
Source: EvaluatePharma. https://www.evaluate.com/vantage/articles/news/trial-results/sanofi-makes-pre-jp-morgan-splash-kymab

Moderna eyes 3 new mRNA-based vaccines for seasonal flu, HIV, Nipah virus

 Moderna, the biotech company behind one of the two mRNA-based vaccines currently being rolled out globally to stem the tide of COVID-19, has announced that it will purse development programs around three new vaccine candidates in 2021. These include potential vaccines for HIV, seasonal flu and the Nipah virus. Moderna’s development and clinical trial of its COVID-19 vaccine is among the fastest in history, and thus far its results have been very promising, buoying hopes for the efficacy of other preventative treatments being generated using this technology which is new to human clinical use.

An mRNA vaccine differs from typical, historical vaccines because it involves providing a person with just a set of instructions on how to build specific proteins that will trigger a body’s natural defenses. The mRNA instructions, which are temporary and do not affect a person’s actual DNA, simply prompt the body’s cells to produce proteins that mirror those used by a virus to attach to and infect cells. The independent proteins are then fought off by a person’s natural immune response, which provides a lasting lesson in how to fight off any future proteins that match that profile, including those which help viruses attach to and infect people.

Moderna’s new programs will target not only seasonal flu, but also a combinatory vaccine that could target both the regular flu and SARS-CoV-2, the virus that leads to COVID-19. The HIV candidate, which is developed in collaboration with both the AIDS Vaccine Initiative and the Bill and Melinda Gates Foundation, is expected to enter into Phase 1 trials this year. Nipah virus is a highly lethal illness that can cause respiratory and neurological symptoms, and which is particularly a threat in India, Bangladesh, Malaysia and Singapore.

Indeed, mRNA-based vaccines have long held potential for future vaccine development, in part because of their flexibility and programmability, and in part because they don’t use any active or dormant virus, which reduces their risks in terms of causing any direct infections up front. The COVID-19 pandemic spurred significant investment and regulatory/health and safety investment into the technology, paving the way for its use in other areas, including these new vaccine candidate trials by Moderna.

https://techcrunch.com/2021/01/11/moderna-is-developing-three-new-mrna-based-vaccines-for-seasonal-flu-hiv-and-nipah-virus/