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Thursday, June 6, 2019

US FDA and EMA Accept Applications for Celgene MS Med

Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Under the Prescription Drug User Fee Act, the FDA has set its action date as March 25, 2020. A regulatory decision from the EMA is expected in the first half of 2020.
Both applications are based primarily on ozanimod data from the SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials.
“The U.S. Food and Drug Administration and European Medicines Agency acceptances of our applications represent a crucial step forward in our efforts to bring ozanimod to people with multiple sclerosis,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator.”
Ozanimod is an investigational compound that is not approved for any use in any country.

Dermira upped to Buy from Neutral by Mizuho

Target $14 from $17

Cidera started at Outperform by Oppenheimer

Target $6

AstraZeneca blood cancer drug meets main goal in late-stage trial

AstraZeneca Plc said on Thursday its blood cancer drug met the main goal of a final stage trial, taking the treatment one step closer to a marketing approval as the drugmaker seeks to bolster its oncology portfolio.

In its second late-stage trial success in a month, the drug showed meaningful improvement in patients with chronic lymphocytic leukaemia when compared with a chemotherapy-based treatment, the company said.
The drug, Calquence, is a cornerstone product for AstraZeneca in haematology and its accelerated U.S. approval in 2017 marked its first entry into blood cancer treatment.
“The positive results from both the … trials will serve as the foundation for regulatory submissions later this year,” said R&D José Baselga, executive vice president of the company’s oncology division.
The drug, which is already approved by the U.S. drug regulator to treat a rare type of blood cancer, met the primary endpoint in a trial in May testing the drug in comparison with available treatment.
AstraZeneca acquired the drug, also known as acalabrutinib, when it bought a majority stake in Acerta Pharma in 2015.
Calquence is currently approved for treating adults with relapsed or refractory mantle cell lymphoma in the United States, Brazil, UAE and Qatar, and is being developed for the treatment of chronic lymphocytic leukaemia and other blood cancers.

Novartis presents first-of-kind histology data with kidney transplants

Novartis has announced first-of-its-kind histology data with iscalimab (CFZ533), suggesting the extended survival of transplanted organs may be possible.
The early stage data suggest that with investigational compound iscalimab it may be possible to prolong the durability of transplanted kidneys as well as to potentially improve long-term outcomes for kidney transplant patients.
The data, presented at the American Transplant Congress (ATC), examine whether calcineurin-free treatment with iscalimab preserves the quality of transplanted kidney grafts.
In this analysis, iscalimab demonstrated lower chronic allograft damage index (CADI) scores compared with tacrolimus (current standard-of-care), with normal renal histology seen in three of five patients (60%) on iscalimab vs none of seven on tacrolimus.
Low CADI scores have been associated with improved long-term outcomes. The findings, although in a limited number of patients, are to be confirmed in an ongoing Phase IIb trial (Cirrus I, NCT03663335).
Iscalimab is a new, fully human, monoclonal antibody preventing cluster of differentiation 40 (CD40) pathway signaling and activation of CD40+ cell types.
The analysis presented at the ATC included patients from this study that underwent either routine biopsies or biopsies as part of a follow-up protocol. The data was reviewed and scored by a blinded pathologist using the established Banff criteria and CADI.
Less than half of donated kidneys last 10 years, so durability is a significant unmet need for patients who are living with or waiting for a transplant. More than 100,000 patients are on the US transplant waiting list with a chronic shortfall of donors.
Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology, said: “Extending the life of transplanted kidneys would mean fewer patients going back on dialysis or needing a second transplant – relieving pressure on waiting lists that in the US are already three-to-five years long.
“In our journey to reimagine care for patients, I’m excited about the potential of durable transplants becoming a reality.”

Anthem to acquire behavioral health program

Anthem, Inc. (NYSE:ANTM) today announced that the company has entered into a definitive agreement to acquire Beacon Health Options (Beacon), the largest independently held behavioral health organization in the country. Beacon currently serves more than 36 million individuals across all 50 states, including nearly 3 million individuals under comprehensive risk-based behavioral programs. The acquisition aligns with Anthem’s strategy to diversify into health services and deliver market-leading integrated solutions and care delivery models that personalize care for people with complex and chronic conditions.
“As Anthem works to improve lives, simplify healthcare and serve as an innovative and valuable partner, we’re focused on providing solutions that address the needs of the whole person,” said Gail K. Boudreaux, President and CEO, Anthem. “With an extensive track record in behavioral health, Beacon fits well with our strategy to better manage the needs of populations with chronic and complex conditions, and deliver integrated whole health solutions. Together with Beacon, we will enhance our capabilities to serve state partners, health plans and employer groups as they seek to address consumer behavioral health needs.”
The acquisition of Beacon will offer Anthem the opportunity to combine its existing behavioral health business with Beacon’s successful model and support services to fully scale integrated behavioral and physical health capabilities to customers and consumers nationwide. Collectively, both businesses will be able to enhance whole person care and improve overall health outcomes with a stronger portfolio of specialized products, more clinical expertise, improved analytics and health data, and broader provider networks and relationships. The combination will also create one of the most comprehensive behavioral health networks capable of offering more accessible and affordable care for consumers throughout the country.
Upon completion, Beacon, combined with Anthem’s behavioral health business, will operate as an integrated team within Anthem’s Diversified Business Group. Russell C. Petrella, Ph.D., Beacon Health Options President and CEO, as well as other key members of Beacon’s senior team, will join Anthem’s Diversified Business Group to lead the efforts to offer innovative behavioral health solutions and further expand this business.

Wednesday, June 5, 2019

Telemedicine Makes The Living Room The Next Frontier For Healthcare Real Estate

Urgent and ambulatory care facilities are driving patient traffic away from main hospital campuses and into retail centers, but even the two burgeoning sectors in healthcare treatment aren’t immune to disruption.
The number of Massachusetts urgent care clinics grew from 18 to 145 between 2010 and 2018. Retail clinics, which are usually just staffed with nurse practitioners, went from 20 to 54 in the same period. The migration of treatment away from a main hospital is cost-effective as urgent care visits typically cost $150, with patients getting a $33 copay, according to the Massachusetts Health Policy Commission. Hospital emergency room visits typically cost just shy of $900.
But panelists at Bisnow’s National Healthcare New England event Thursday said patients want even more convenience than an urgent care center down the road from their home.
“We’re all in for a rude awakening,” Boston Medical Center Director of Ambulatory Operations Pamela Nettles-Gomez said. “Even if there is an urgent care center within 2 miles or closer, what I’m seeing with patients and my own friends is they are starting to get their care on a phone through an app. That’s a huge disrupter, and it’s not easy to compete with.”
Improved technology and an era where most patients have access to a smartphone are moving treatments out of the exam room and into one’s living room.  Telemedicine, when a doctor treats a patient via video conference or even just photos, is increasingly offered in everything from dermatology to psychiatry. Patients can reach a doctor within minutes, get treated and have a prescription to a pharmacy without having to leave the couch.  Doctors Without Borders now utilizes telemedicine from remote locations to get second opinions from doctors in its global network.
North America is a leading market for telemedicine, which has a current market value of nearly $7B, according to a report released Tuesday by Persistence Market Research. That number is expected to increase more than fivefold in the next 10 years , as 68% of U.S. physicians said they were strongly inclined to utilize remote patient monitoring and telemedicine in the future.
“We’re all working on trying to get up to speed with other industries in terms of technology and our own telestrategies,” Nettles-Gomez said.
The Steward Health Care System, the largest private hospital operator in the U.S., utilizes telemedicine in a variety of ways both on and off hospital campuses, which include St. Elizabeth’s Medical Center in Brighton and Norwood Hospital.  Intensive care unit patients are telemonitored from a center in Westwood, according to Steward Executive Vice President of the Northeast Hospital Region Dr. Mark Girard. The practice has helped reduce lengths of stay in the ICU as well as a decrease in morbidity and mortality rates.
“The telepresence in the ICU has been very comforting to the patients,” Girard said. “It takes a little getting used to the monitor, but they are very comforted they are being monitored by a doctor 24/7, 365.”
Steward also utilizes telehealth as a care management tool and to integrate behavioral health and physical health services. Since access to behavioral or mental health services is often difficult, Girard said payment providers incentivize healthcare providers to offer treatment any way they can, including telemedicine in lieu of in-person visits.  The telemedicine shift is also having an impact on the economics of primary care physician practices.
“Primary care physicians typically made their income on the quick and easy visits that supplemented the hourlong visits they spent with their chronic care patients, where they get paid maybe twice as much as they would on a sore throat where they spend five minutes,” Mount Auburn Cambridge President and Chairman Dr. Barbara Spivak said.
Quick visits were a key part of a primary care physician’s business model, but now those are being siphoned away by urgent care centers and, more recently, telemedicine providers.  Spivak expects primary care physicians to adapt in coming years by dealing primarily with chronic care conditions. That has real estate ramifications, as exam rooms will need to be larger and wheelchair-accessible.  While the tech disruption is almost certain to have further physical impact on U.S. healthcare, panelists at last week’s event still didn’t expect a complete brick-and-mortar death when it comes to getting treated for an ailment.
“I think there will still be plenty of bricks-and-mortar, but what those facilities will look like will change dramatically,” Brigham and Women’s Faulkner Hospital President David McCready said.