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Wednesday, February 2, 2022

At Nursing Homes, Long Waits for Results Render COVID Tests 'Useless'

 More nursing homes are waiting longer for covid-19 test results for residents and staffers, according to federal data, making the fight against record numbers of omicron cases even harder.

The double whammy of slower turnaround times for lab-based PCR tests and a shortage of rapid antigen tests has strained facilities where quickly identifying infections is crucial for keeping a highly vulnerable population safe.

A KHN analysis of data from the Centers for Medicare & Medicaid Services finds that 25% of nursing homes that sent tests to a lab waited an average of three or more days for results as of Jan. 16. In early December, that number was 12%.

At Lutheran Life Villages in Fort Wayne, Indiana, the long wait for results renders PCR tests "useless," President Alex Kiefer said. "If we send somebody off to get a PCR test, sometimes it takes two days for them to get an appointment. And then it takes two, three, four days to get a read."

So Kiefer's organization mainly relies on rapid antigen tests. But on Jan. 12, long-term care sites in the state were alerted to shortages of Abbott Laboratories' rapid BinaxNOW antigen tests, according to the Indiana Department of Health. Lutheran Life Villages was using 125 rapid tests a day, including on vaccinated people. Now as transmission rates remain high, "we are scrounging to try to find enough," Kiefer said. He called the state shipments sporadic. "The scariest thing is, if we get to a point where we can't get those, we will have to rely on PCRs, and the timing of that is just really challenging," Kiefer said.

Federal officials require the country's 15,000 nursing homes to submit data on covid in their facilities; KHN's analysis of testing speeds is based on reports of turnaround times in early December and mid-January from about 10,900 homes. Nursing home residents have high vaccination rates — more than 87% are fully inoculated, and 67% have received boosters. Still, experts warn, delays can pose significant safety risks. For one, in the time it takes to receive results, outbreaks can emerge undetected. And with omicron, breakthrough infections appear to cause more severe symptoms for older people.

This many nursing homes haven't waited three or more days for test results since March 2021, CMS data show.

Broadly, PCR tests are considered the gold standard for accuracy and are more likely to be used for regular surveillance testing because rapid tests can miss asymptomatic cases. The drawback is that labs can take days to return PCR results under normal circumstances, let alone when testing demand and staffing shortages delay processing.

Dr. Naveen Patil, deputy state health officer of the Arkansas Department of Health, said the state recommended that long-term care facilities shift to PCR tests during covid outbreaks because they are more reliable, even when plenty of antigen tests are available.

"But now," he said, "most of them are doing PCR because they don't have adequate supply of antigens."

The Biden administration, which is sending 1 billion rapid covid tests to U.S. households, has been shipping long-term care facilities 2.5 million tests a week. But that supply has proved measly against omicron's winter surge, which has fueled even greater infections among nursing home residents, according to CDC data.

The American Health Care Association, which lobbies for nursing homes and assisted living facilities, recently said the administration plans to send the sector an additional 5 million rapid tests in the coming weeks, but the industry says that's not nearly enough. A spokesperson for the U.S. Department of Health and Human Services did not respond to questions about the new shipments.

Two years into the pandemic, nursing homes are still managing a crisis. Testing is "a bit of a mess," said David Grabowski, a long-term care expert and health policy professor at Harvard Medical School. "It's déjà vu all over again."

Industry workers say rapid test shortages also complicate their efforts to honor residents' right to receive visitors while ensuring the virus doesn't come in with them.

A survey in early January by LeadingAge, which lobbies for nonprofit nursing homes and other care providers for older adults, found that 76% of nursing homes had adequate testing supplies, but facilities said restocking was getting harder. The American Health Care Association asked the Biden administration to increase the sector's testing supplies and related equipment. The group estimates the sector needs 5 million tests per week.

Dr. Swati Gaur, medical director for New Horizons Nursing Facilities in Georgia, said some facilities "are having to kind of pivot to PCR" tests because of antigen test shortages.

Before omicron arrived, Tina Sandri, CEO of Forest Hills of DC in Washington, would get PCR test results back in about a day. In January, that turnaround time increased to two or three days. Sandri's company, which operates skilled nursing and assisted living facilities, relies on PCR testing to have more confidence that they'll catch asymptomatic cases.

"Those antigen test kits are really hard to get," she added. "We would need hundreds of them every single day, and there just aren't enough of them for us to use as a practical solution." Their most valuable use, Sandri said, would be for employees to test themselves at home after an exposure or infection before returning to work.

Covid infections among nursing home residents and staff members have begun to decline nationally, but the total in the week ending Jan. 23 — 42,584 resident cases — surpasses the numbers from last winter's surge, when initial doses of the covid vaccine were becoming available. In the past month, the number of resident deaths has increased each week — and was 1,298 for the week ending Jan. 23. That is well below the 4,100 deaths reported in the same week a year ago, CDC data shows.

Long-term care facilities that aren't worried about covid testing say they can reliably get test results in less than a day or two. And they have ample supplies of rapid antigen tests from federal shipments.

"I maybe get two or three shipments a week" of rapid tests, said Karen Venis, CEO of Sayre Christian Village in Lexington, Kentucky. The lab that processes Sayre's PCR test samples — which they use for routine surveillance — sends staffers to test residents and workers twice a week. Results are typically provided within 24 hours, and Venis estimated they use about 100 antigen tests a week, saving them mostly for people with symptoms.

"We've got the support that we need," she said.

For Kiefer in Indiana, though, using more PCR tests isn't tenable.

"That's how we were making decisions early on in the pandemic," he said. "It was difficult to do everything."

At least with rapid tests, he said, "we can take action right away."

https://www.medscape.com/viewarticle/967759

Biogen goes back to 1995 to grab mosunetuzumab

It might come as a surprise to all but the most avid readers of US regulatory filings that Biogen owns a significant stake in Roche’s anti-CD20 franchise, including Ocrevus. Investors were reminded of this 27-year-old arrangement yesterday when Biogen exercised an option to license the Swiss group’s anti-CD20 bispecific mosunetuzumab.

The deal has already enabled Biogen to collect billions from these products, including Rituxan, which since becoming the first ever MAb approved to treat cancer has generated cumulative sales of over $100bn. Biogen also collects cash on Gazyva and Ocrevus; it will now do so on mosunetuzumab, and could in future repeat the trick with other Roche assets, including glofitamab.

In a sense mosunetuzumab will help offset the declining cash Biogen gets from a share of Rituxan and Gazyva’s profits, which have been hit by biosimilars and other competitors. Still, by far the biggest contributor to Biogen’s CD20 revenue line will be royalties on the multiple sclerosis blockbuster Ocrevus; extrapolating from Evaluate Pharma consensus forecasts these might exceed $1bn over at least each of the next six years.

The fruit of Roche & Biogen's 27-year CD20 marriage ($m)
 201820202022e2024e2026e
The current arrangement…
Rituxan US sales4,2893,0221,192810640
Gazyva US sales195312399561697
Profit on Rituxan & Gazyva US sales3,8152,9011,3841,1931,163
Biogen's share of the above1,4321,080512441430
Biogen co-promotion profits on Rituxan in Canada7052000
Ocrevus global sales2,4064,6146,2427,1277,639
Biogen royalty on Ocrevus4788451,1241,2831,375
Total booked by Biogen1,9801,9781,6361,7241,805
…and possible future Roche products?
Mosunetuzumab global sales0068248525
Biogen has opted in to mosunetuzumab, and will receive a low to mid-30% US profit share plus low single-digit ex-US royalties
Glofitamab global sales00071236
Glofitamab is wholly owned by Roche, but Biogen could negotiate a future opt-in
Source: Evaluate Pharma & SEC filings.

These forecasts have mosunetuzumab, which could be filed this year for follicular lymphoma, hitting 2026 sales of $525m, though the sellside sees $1bn at peak. Under the opt-in exercised yesterday Biogen paid $30m, and will contribute to development costs incurred in 2021, in return for a low to mid-30% share of US profits, plus a low single-digit ex-US royalty.

Though this might look like Biogen moving away from neurology and into oncology, the group has denied this to analysts. As such this is likely a financial exercise – seizing on a legacy tie-up to secure a large revenue line for a relatively small outlay.

But how did this all come about? For the answer you have to go back to 1995, when Idec Pharmaceuticals struck an anti-CD20 antibody discovery deal with Roche’s Genentech unit.

This originally focused on molecules coded Y2B8 and In2B8, which later became Zevalin, Idec’s radiolabelled anti-CD20 MAb that was the first US-approved radio-immunotherapy; and C2B8, which in Roche’s hands became the blockbuster Rituxan. In 2003 Idec underwent a $6.8bn merger with Biogen, assigning rights to the current Biogen entity.

Certain additional products

Meanwhile the deal underwent several amendments, perhaps the most significant of which was an expansion to include “certain additional products whose mechanism of action is initiated by interaction with CD20, including ... the humanised molecule created by Genentech known as G2H7”.

It is not clear whether G2H7 became Gazyva or Ocrevus, but either way Biogen now has rights to both of these. And now it owns a share of mosunetuzumab, a project that impressed at each of the last two Ash meetings, and one of the most promising bispecifics looking to push the increasingly competitive CD20 space forward once more.

Interestingly, mosunetuzumab is not the only late-stage anti-CD20 T-cell engaging MAb in development at Roche’s Genentech division; the other is glofitamab.

While mosunetuzumab uses a straight “1+1” format, glofitamab has a more complex “2+1” structure, with a silent Fc region to increase its half life. One question for Roche has been whether it would end up prioritising one asset over the other, though Biogen opting in to mosunetuzumab will probably not influence the Swiss group's thinking.

This is because the 1995 deal’s key amendment gives Biogen certain broad rights to anti-CD20 assets beyond “G2H7”, including “new products”, as well as a right of negotiation for third-party anti-CD20 products. Such assets might include glofitamab as well a RG6035, a brain-shuttle anti-CD20 in phase 1 for multiple sclerosis.

Roche said it was too early to speculate on RG6035, but confirmed to Vantage that Biogen "may have the opportunity to participate in the US commercialization of glofitamab, the details of which have yet to be negotiated".

https://www.evaluate.com/vantage/articles/news/deals/biogen-goes-back-1995-grab-mosunetuzumab

Novartis mulls shifting Sandoz

If the rumoured sale of its Sandoz generics business to private equity goes ahead Novartis will be very rich indeed, and many are hoping that the company will use the proceeds on a big M&A move to refresh its pipeline. But its chief executive, Vas Narasimhan, did his best to dash these hopes on the company’s fourth-quarter conference call today: “Our focus is not larger M&A, our focus is bolt-on deals,” he said – but he would hardly be expected to spell out such an aim if it existed. The sweet spot for the Swiss group are deals with an up-front cost of less than $1bn, and a total deal value of less than $2bn, Mr Narasimhan added, and this would certainly be in keeping with its recent acquisitions. But a sizeable deal is still a strong expectation, regardless of the group’s recent track record. Sandoz could fetch up to $25bn if Novartis does sell it, and of course Novartis is already sitting on the $21bn it got for its stake in Roche. So Novartis has the wherewithal to do a big buy, its two-year $15bn share buyback programme notwithstanding. 

Novartis’s sweet spot - its recent bolt-on M&A  
Announcement dateTargetValue
Dec 22, 2021Gyroscope Therapeutics$800m up front; $700m in milestones
Sep 21, 2021Arctos MedicalUndisclosed
Dec 17, 2020Cadent Therapeutics$210m up front; $560m in milestones
Oct 29, 2020Vedere Bio$150m up front; $130m in milestones
Source: Evaluate Pharma & company releases. 

https://www.evaluate.com/vantage/articles/news/deals-snippets/novartis-mulls-shifting-sandoz

Army separating unvaccinated soldiers

 The Army announced on Wednesday that will begin separating soldiers who are not vaccinated against COVID-19.

Under a directive issued by Army Secretary Christine Wormuth, commanders will begin involuntary administrative separations for soldiers who have refused to be vaccinated and don’t have a pending or approved exemption request.

“Army readiness depends on Soldiers who are prepared to train, deploy, fight and win our nation’s wars,” Wormuth said in a statement. “Unvaccinated Soldiers present risk to the force and jeopardize readiness.”

Defense Secretary Lloyd Austin mandated vaccinations for the military in late August but left it up to each service to implement its own deadlines. 

The Army gave active-duty soldiers until Dec. 15 to comply with the mandate, but Reservists and Army National Guard members still have until June 30 to be fully vaccinated.

As of Wednesday, service had yet to involuntary separate any soldiers solely for refusing the vaccine.

The Army has relieved six active-duty leaders — including two battalion commanders — for not complying with the mandate. It has also issued 3,073 written reprimands to soldiers who are not in compliance.

Ninety-seven percent of active-component Army troops are partially vaccinated, according to data released on Jan. 27, while 96 percent are fully inoculated. Additionally, 83 percent of reserve component forces are partially vaccinated, while 79 percent are fully vaccinated 

The Army has approved six of the 709 requests for medical exemptions it received in its active component, and has approved none of the 2,910 requests for religious exemptions.

Wormuth’s order applies to regular Army soldiers, reserve-component soldiers on Title 10 active duty, and cadets.

The exception to this is for soldiers who will complete separation or retirement or begin their transition to leave on or before July 1. These soldiers will be granted an exemption so they can complete their separations or retirements.

Service members separated for not complying with the mandate won’t be eligible for involuntary separation pay and may be subject to “recoupment of any unearned special or incentive pays,” the Army said in a statement.

https://thehill.com/policy/defense/army/592470-army-separating-from-its-unvaccinated-soldiers

Kodiak Sciences upped to Overweight from Neutral by JP Morgan

 Target to $124 from $90 

https://finviz.com/quote.ashx?t=KOD&ty=c&ta=1&p=d

Edwards upped to Buy from Neutral by UBS

 Target to $126 from $121

https://finviz.com/quote.ashx?t=EW&ty=c&ta=1&p=d

NovoCure upped to Outperform from Perform by Oppenheimer

 Target $98

https://finviz.com/quote.ashx?t=NVCR&ty=c&ta=1&p=d