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Tuesday, October 4, 2022

Summit Therapeutics Seeks Partnership For Phase 3 Infection Candidate Development

 

  • In an SEC filing, Summit Therapeutics Inc  said it would seek partners or divestiture of ridinilazole as the path forward for the clinical development of the asset. 
  • Ridinilazole is the company’s Phase 3 product candidate for Clostridioides difficile infection (C. diff. infection or CDI). 
  • As a result of this determination, the company will discontinue its only active study for ridinilazole, a pediatric clinical trial evaluating ridinilazole, for treating adolescent patients with CDI.
  • As previously communicated, the company held a Type C meeting with the FDA, during which the FDA and Summit discussed a possible pathway to advance ridinilazole to achieve marketing authorization. 
  • This pathway would involve at least one additional registrational trial, for which Summit will seek a partner to perform.
  • Further, the company plans to present the data associated with ridinilazole's Phase 3 clinical trial, Ri-CoDIFy, at IDWeek 2022 later this month.

Despite Efficacy From Gene Therapy, RBC Cuts REGENXBIO Target

 

  • On Monday, REGENXBIO Inc  announced a program update from its ongoing clinical investigation of RGX-314 for wet AMD, a leading cause of vision loss globally.
  • RGX-314 showed a meaningful reduction in treatment burden across all dose levels.
  • The highest reduction in treatment burden was seen in Cohort 4 (Dose 3), with an 85% reduction in annualized injection rate and 67% injection-free.
  • On the safety front, a dose-dependent increase in inflammation rate/severity was observed.
  • RBC Capital said it remains on the sidelines given a limited conviction for the lead indications in non-life threatening indications where current SOC continues to progress.
  • The analyst lowered the price target from $47 to $29, reiterating the Sector Perform rating.
  • The analyst notes that the risk-benefit profile skews incrementally more negatively. The lowered price target reflects a mixed update today and a competitive landscape that continues to intensify.

NextCure Starts Phase 1b/2 Trial for KEYTRUDA Combo in Solid Tunors

 NextCure, Inc.  (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the initiation of a Phase 1b/2 clinical trial to evaluate NC410 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with immune checkpoint refractory or immune checkpoint naïve solid tumors. In addition, NextCure announced it has entered into a supply agreement for KEYTRUDA with Merck (known as MSD outside the United States and Canada).

NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells. Under the terms of the agreement, NextCure will sponsor the study and Merck will supply KEYTRUDA. The Phase 1b/2 trial will evaluate NC410 in combination with KEYTRUDA in patients with immune checkpoint refractory colorectal, esophageal, endometrial and head and neck cancers or immune checkpoint naïve patients with colorectal and ovarian cancers. The company expects to report initial Phase 1b data in mid-2023 followed by the initiation of the Phase 2 component of the study.

HHS buying $290M worth of Amgen drug Nplate for radiation emergency

 

HHS is purchasing $290M worth of Amgen's (NASDAQ:AMGN) Nplate (romiplostim) for acute radiation sickness due to a radiological or nuclear event.

Outlandish Logicbio premium looks like an outlier

 It is tempting to suggest that opportunistic takeovers of companies laid low by adverse market conditions generate huge share price premiums for those investors who keep the faith. Certainly yesterday’s move by Astrazeneca on Logicbio, done at an astonishing 667% premium to the previous day’s close, appears to back this up. However, broader data compiled by Evaluate Pharma suggest that Logicbio is an outlier, and takeover premiums this year, a turbulent time for biotech, have tended to average around the 100% seen in 2021. It seems that, whatever the market conditions, sellers adjust their view and apply a typical premium to the prevailing economic reality. This year, only the acquisitions of Epizyme and Checkmate Pharmaceuticals featured premiums well above 100% over the previous day’s close. Both groups had suffered significant share price falls before being bought out. Logicbio, whose GeneRide technology it says can bring about precise gene insertions using a cell’s natural DNA repair process, is also a win largely for short-term holders: the biotech had floated at $10 and was trading above Astra’s offer price as recently as January, but in August admitted that it had less than a year’s cash left.

The biggest takeover premiums of 2022* so far
Target company
Acquirer
Deal value ($m)Premium (vs prior day close)Premium (30-day avg)
Checkmate PharmaceuticalsRegeneron250336%216%
EpizymeIpsen247158%144%
Turning Point TherapeuticsBristol Myers Squibb4,100122%122%
ChemocentryxAmgen4,000116%111%
F-Star TherapeuticsSino16179%108%
Global Blood TherapeuticsPfizer5,4007%82%
La Jolla PharmaceuticalInnoviva14984%79%
Aerie PharmaceuticalsAlcon77039%62%
ZogenixUCB1,90066%57%
Sierra OncologyGSK1,90039%53%
Note: *until the end of Q3 2022, considering deals with disclosed valuations. Source: Evaluate Pharma.

https://www.evaluate.com/vantage/articles/news/deals-snippets/outlandish-logicbio-premium-looks-outlier

Nursing Home Surprise: Advantage Plans May Shorten Stays to Less Time Than Medicare Covers

 After 11 days in a St. Paul, Minnesota, skilled nursing facility recuperating from a fall, Paula Christopherson, 97, was told by her insurer that she should return home.

But instead of being relieved, Christopherson and her daughter were worried because her medical team said she wasn't well enough to leave.

"This seems unethical," said daughter Amy Loomis, who feared what would happen if the Medicare Advantage plan, run by UnitedHealthcare, ended coverage for her mother's nursing home care. The facility gave Christopherson a choice: pay several thousand dollars to stay, appeal the company's decision, or go home.

Health care providers, nursing home representatives, and advocates for residents say Medicare Advantage plans are increasingly ending members' coverage for nursing home and rehabilitation services before patients are healthy enough to go home.

Half of the nearly 65 million people with Medicare are enrolled in the private health plans called Medicare Advantage, an alternative to the traditional government program. The plans must cover — at a minimum — the same benefits as traditional Medicare, including up to 100 days of skilled nursing home care every year.

But the private plans have leeway when deciding how much nursing home care a patient needs.

"In traditional Medicare, the medical professionals at the facility decide when someone is safe to go home," said Eric Krupa, an attorney at the Center for Medicare Advocacy, a nonprofit law group that advises beneficiaries. "In Medicare Advantage, the plan decides."

Mairead Painter, a vice president of the National Association of State Long-Term Care Ombudsman Programs who directs Connecticut's office, said, "People are going to the nursing home, and then very quickly getting a denial, and then told to appeal, which adds to their stress when they're already trying to recuperate."

The federal government pays Medicare Advantage plans a monthly amount for each enrollee, regardless of how much care that person needs. This raises "the potential incentive for insurers to deny access to services and payment in an attempt to increase profits," according to an April analysis by the Department of Health and Human Services' inspector general. Investigators found that nursing home coverage was among the most frequently denied services by the private plans and often would have been covered under traditional Medicare.

The federal Centers for Medicare & Medicaid Services recently signaled its interest in cracking down on unwarranted denials of members' coverage. In August, it asked for public feedback on how to prevent Advantage plans from limiting "access to medically necessary care."

The limits on nursing home coverage come after several decades of efforts by insurers to reduce hospitalizations, initiatives designed to help drive down costs and reduce the risk of infections.

Charlene Harrington, a professor emerita at the University of California-San Francisco's School of Nursing and an expert on nursing home reimbursement and regulation, said nursing homes have an incentive to extend residents' stays. "Length of stay and occupancy are the main predictor of profitability, so they want to keep people as long as possible," she said. Many facilities still have empty beds, a lingering effect of the covid-19 pandemic.

When to leave a nursing home "is a complicated decision because you have two groups that have reverse incentives," she said. "People are probably better off at home," she said, if they are healthy enough and have family members or other sources of support and secure housing. "The resident ought to have some say about it."

Jill Sumner, a vice president for the American Health Care Association, which represents nursing homes, said her group has "significant concerns" about large Advantage plans cutting off coverage. "The health plan can determine how long someone is in a nursing home typically without laying eyes on the person," she said.

The problem has become "more widespread and more frequent," said Dr. Rajeev Kumar, vice president of the Society for Post-Acute and Long-Term Care Medicine, which represents long-term care practitioners. "It's not just one plan," he said. "It's pretty much all of them."

As Medicare Advantage enrollment has spiked in recent years, Kumar said, disagreements between insurers and nursing home medical teams have increased. In addition, he said, insurers have hired companies, such as Tennessee-based naviHealth, that use data about other patients to help predict how much care an individual needs in a skilled nursing facility based on her health condition. Those calculations can conflict with what medical teams recommend, he said.

UnitedHealthcare, which is the largest provider of Medicare Advantage plans, bought naviHealth in 2020.

Sumner said nursing homes are feeling the impact. "Since the advent of these companies, we've seen shorter lengths of stays," she said.

In a recent news release, naviHealth said its "predictive technology" helps patients "enjoy more days at home, and health care providers and health plans can significantly reduce costs."

UnitedHealthcare spokesperson Heather Soule would not explain why the company limited coverage for the members mentioned in this article. But, in a statement, she said such decisions are based on Medicare's criteria for medically necessary care and involve a review of members' medical records and clinical conditions. If members disagree, she said, they can appeal.

When the patient no longer meets the criteria for coverage in a skilled nursing facility, "that does not mean the member no longer requires care," Soule said. "That is why our care coordinators proactively engage with members, caregivers, and providers to help guide them through an individualized care plan focused on the member's unique needs."

She noted that many Advantage plan members prefer receiving care at home. But some members and their advocates say that option is not always practical or safe.

Patricia Maynard, 80, a retired Connecticut school cafeteria employee, was in a nursing home recovering from a hip replacement in December when her UnitedHealthcare Medicare Advantage plan notified her it was ending coverage. Her doctors disagreed with the decision.

"If I stayed, I would have to pay," Maynard said. "Or I could go home and not worry about a bill." Without insurance, the average daily cost of a semiprivate room at her nursing home was $415, according to a 2020 state survey of facility charges. But going home was also impractical: "I couldn't walk because of the pain," she said.

Maynard appealed, and the company reversed its decision. But a few days later, she received another notice saying the plan had decided to stop payment, again over the objections of her medical team.

The cycle continued 10 more times, Krupa said.

Maynard's repeated appeals are part of the usual Medicare Advantage appeals process, said Beth Lynk, a CMS spokesperson, in a statement.

When a request to the Advantage plan is not successful, members can appeal to an independent "quality improvement organization," or QIO, that handles Medicare complaints, Lynk said. "If an enrollee receives a favorable decision from the QIO, the plan is required to continue to pay for the nursing home stay until the plan or facility decides the member or patient no longer needs it," she explained. Residents who disagree can file another appeal.

CMS could not provide data on how many beneficiaries had their nursing home care cut off by their Advantage plans or on how many succeeded in getting the decision reversed.

To make fighting the denials easier, the Center for Medicare Advocacy created a form to help Medicare Advantage members file a grievance with their plan.

When UnitedHealthcare decided it wouldn't pay for an additional five days in the nursing home for Christopherson, she stayed at the facility and appealed. When she returned to her apartment, the facility billed her nearly $2,500 for that period.

After Christopherson made repeated appeals, UnitedHealthcare reversed its decision and paid for her entire stay.

Loomis said her family remains "mystified" by her mother's ordeal.

"How can the insurance company deny coverage recommended by her medical care team?" Loomis asked. "They're the experts, and they deal with people like my mother every day."

https://www.medscape.com/viewarticle/981858