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Wednesday, April 1, 2020

Arena Pharma announces encouraging data on controlled-release etrasimod

Arena Pharmaceuticals (NASDAQ:ARNA) is stoked over topline data from a Phase 1 clinical trial evaluating controlled-release (CR) delivery profiles of lead drug etrasimod.
Results showed that CR delivery enabled more than a 75% reduction in average heart rate effect during the 4-hour monitoring period. Heart rate slowed by low single digits from baseline with no titration. Over 24 hours, the etrasimod CR heart rate was reduced or similar to etrasimod.
The company intends to rapidly develop the CR formulation and integrate it into multiple clinical programs.
Management will host a conference call today at 4:30 pm to discuss the data.
https://seekingalpha.com/news/3557468-arena-pharma-announces-encouraging-data-on-controlled-release-etrasimod

CryoLife withdraws guidance amid COVID-19

Citing uncertainties related to the COVID-19 pandemic, CryoLife (NYSE:CRY) has withdrawn its 2020 guidance, although it expects Q1’s top line to be ~$65.5M, a bit shy of its previous outlook of $67M – 69M.
As a precautionary measure, it borrowed the entire available amount under its $30M credit revolver. As of the end of March, it had over $60M in cash and equivalents.
https://seekingalpha.com/news/3557547-cryolife-withdraws-guidance-amid-covidminus-19

Coronavirus pandemic issues delay key Eiger BioPharma study

Citing COVID-19 disruptions, Eiger BioPharmaceuticals (NASDAQ:EIGR) announces that enrollment in its Phase 3 D-LIVR study evaluating the combination of lonafarnib and ritonavir with or without PEGylated interferon-alfa-2a in patients with chronic hepatitis D virus (HDV) infection will not be completed until sometime in 2021. It says it has enough product to complete the trial.
It is also supplying Peginterferon Lambda and helping with protocol design in multiple studies in COVID-19 patients. Preclinical results were apparently encouraging, demonstrating “potent” antiviral effects against influenza, SARS coronavirus, rotavirus, norovirus, and reovirus.
Shares up 6% after hours.
https://seekingalpha.com/news/3557537-coronavirus-pandemic-issues-delay-key-eiger-biopharma-study

J&J postpones medical device review

Citing COVID-19 disruptions, Johnson & Johnson (NYSE:JNJ) has decided to reschedule its May 13 Medical Device Review. It says it will closely monitor the situation and follow guidance from health authorities to determine a new date.
https://seekingalpha.com/news/3557541-j-and-j-postpones-medical-device-review

COVID-19 Slows Drug Studies, Curbs Clinical Trials

When patients with terminal diagnoses run out of hope, they often turn to clinical trials for one more “Hail Mary pass” at a successful treatment or cure.
Many in this situation have been extremely anxious over the last few weeks, with COVID-19 fears on top of the anxiety of having a fatal illness. Then they began to worry that their clinical trial would be canceled.
The good news is that most companies and researchers seem to be continuing trials for life-threatening conditions. The bad news: Most studies not considered critical are being deferred. This won’t have much effect in the short term, but if this continues, it could delay patient care and the federal approval of drugs that treat a wide range of conditions.
At Dana-Farber Cancer Institute in Boston, roughly 10% to 20% of patients are taking part in clinical trials at any one time.
“We consider the treatment through clinical trials as part of the therapy, and oftentimes, it is the best therapy for people with cancer,” says Bruce Johnson, MD, chief clinical research officer for the Harvard-affiliated institute.
He says patients will continue to be placed on trials as long as Dana-Farber has enough of the drug being tested, the patient can travel as needed for treatment and checkups, their doctor can monitor them for side effects, and there are enough healthy doctors and nurses to provide that care.
“I registered someone yesterday,” Johnson says. “We haven’t taken anybody off a study because of problems so far.”
The institute has shut down studies that don’t involve treatments that could be life-saving. And it’s too soon to tell, Johnson says, whether fewer patients are volunteering for clinical trials. “We’re looking at this multiple times a week to make sure we can continue to do this safely,” he says. “This information is unfolding by the day.”

Major Drug Companies React

Like many companies, Eli Lilly, of Indianapolis, recently announced it would delay the start of most new studies, pause enrollment in most ongoing studies, but continue clinical trials for patients who are already enrolled.
Biogen is “continuing the clinical trials we have underway in sites across the globe,” according to an email from a spokesperson. “We are monitoring this dynamic situation closely and expect that COVID-19 precautions may impact the timeline of some of our trials, particularly those that are actively enrolling and monitoring patients.”
Other companies have similar policies, with most delaying recruiting into new or ongoing trials — to avoid putting any burden on health care facilities and doctors during the pandemic. At Pfizer, for instance, studies for patients with life-threatening conditions will continue, the company told Reuters. Bristol Myers Squibb has said that it will not start any new trials or add trial sites until at least April 13, though it will continue most research trials that have already begun meeting with patients.

Testing Returns to China

The best place in the world for clinical research right now appears to be China.
COVID-19 apparently originated from a market in Wuhan, China, that sold meat from wild animals, including the pangolin, a scaly creature resembling an anteater. The virus exploded from there, infecting more than 80,000 people in China, mostly in the province that includes Wuhan, but also in other hot spots across China, before taking off across the world. But China, as well as other Asian countries, have been largely successful at bringing their epidemics under control over the last month.
Now, companies like Swiss pharmaceutical giant Novartis are seeing Asia as a place to do clinical trials.
“Through the end of February, we were actually rotating and moving patients away from China and looking at moving those patients in terms of recruitment to Europe and the U.S.,” says John Tsai, head of global drug development and chief medical officer at Novartis. Now, the company is rotating its clinical trial recruiting back to Asia and China; Pfizer and Merck also said they are resuming research trials in Asia.
“I won’t say we’ve not been impacted by COVID-19, but what it has allowed us to do,” he says, “is we’ve been able to come up with contingency plans of how we’d actually make changes along the way.”
About 240 of the company’s 30,000 drug trials were affected as of March 22, “which is not in the grand scheme of things that significant,” Tsai says. Similarly, only 645 people out of 93,000 taking part in trials worldwide had missed safety check-ins, he says.

Turning to Tech

The company has a digital platform that allows Tsai and other company executives to see the status of their trials and patients in real time. If they notice that new recruits are backing out of appointments in one area, they can quickly shift recruitment elsewhere, he says.
Novartis has also moved to at-home care and monitoring wherever appropriate, Tsai says.  Quick check-ins can be done by video chat or phone; medication can be shipped to homes, instead of doled out by nurses.
In Wuhan during the worst of the outbreak, for instance, Novartis was able to continue a trial of the breast cancer drug Kisqali (ribociclib). The company tracked down participants’ home addresses through their databases and used couriers to get them their drugs within a week, “so we wouldn’t have any drug interruptions,” Tsai says.
He says he sees the crisis as an opportunity for those who do clinical trials to streamline the process. Novartis is now helping the Gates Foundation set up a similar electronic system for its ongoing trials.
“I think this has been a really good learning case for the entire industry,” Tsai says.
https://www.medscape.com/viewarticle/927887#vp_1

FCC chief unveils $200M program to boost telehealth services amid COVID-19

Federal Communications Commission (FCC) Chairman Ajit Pai wants to use $200 million from the economic stimulus package to expand telehealth services across the country.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed by Congress and signed into law by President Donald Trump last week, earmarks the funds for the FCC to help healthcare providers offering telehealth.
The COVID-19 Telehealth Program, which Pai proposed as a draft order Monday, would have to be approved by the commission before launching.
Pai said the program will provide immediate support to healthcare providers using virtual care in combating the COVID-19 pandemic.
“As we self-isolate and engage in social distancing during the COVID-19 pandemic, telehealth will continue to become more and more important across the country. Our nation’s health care providers are under incredible and still increasing, strain as they fight the pandemic,” Pai said in a press release.
If adopted by the commission, the program would offer qualified healthcare providers full funding to buy “telecommunications services, information services and devices necessary to enable the provision of telehealth services during this emergency period.”

The use of telehealth services is surging as the coronavirus outbreak expands across the country. Private companies like Teladoc and Amwell have reported massive spikes in visit volume. Teladoc is averaging 15,000 patient visits a day in the U.S., 50% higher than in February. Amwell has seen a 350% increase from the normal expected volume of calls this time of year.
Many hospitals and physician practices are ramping up their own telehealth services to continue caring for patients while limiting exposure to the virus from face-to-face patient encounters.
The new  COVID-19 Telehealth Program won’t benefit for-profit hospitals, according to Chip Kahn, president and CEO of the Federation of American Hospitals.
In a tweet, Khan said Pai’s proposed program “leaves millions of patients without access to vital telehealth.”
Pai also circulated final rules for a pilot program that would steer $100 million of its universal service funds over three years toward providers to help cover telehealth costs,
The Connected Care Pilot Program, proposed in 2018, is a broader, longer-term initiative to support telehealth and remote patient monitoring services to improve healthcare access to underserved populations.
In July 2019, FCC commissioners voted to adopt a notice of proposed rule-making (PDF) calling for public comment on testing the new program.
Pai proposed final rules for the Connected Care Pilot Program on Monday to move that initiative forward. He said the program could be a broader study on how connected care can be permanently integrated into the universal service fund.
The CARES Act, passed by Congress and signed into law by Trump last week, also includes many provisions to lift barriers for providing telehealth services and relaxed guidelines for Medicare coverage.
The $2 trillion relief package loosened many restrictions which paved the way for the Centers for Medicare and Medicaid Services to announce Monday that it will begin paying physicians for virtual visits that take place by audio telephone only.
Under the law, Federally Qualified Health Centers and rural health clinics can serve as distant sites for telehealth during the COVID-19 emergency period.

The CARES Act also provides $14.4 billion to support increased demand for healthcare services at Department of Veterans Affairs facilities and through telehealth, including the purchase of medical equipment and supplies, testing kits and personal protective equipment.
The law helps eliminate barriers to full-scale adoption and will provide much needed support to healthcare providers who are migrating patients to virtual care platforms to reduce exposure to COVID-19, Ann Mond Johnson, CEO of the American Telemedicine Association (ATA), said.
“We believe the bill reflects the scale of challenges we face as a country and recognizes that expanding virtual care is necessary to defeat COVID-19,” Johnson said. “We commend Congress for recognizing the power of telehealth, and the bipartisan effort to lift telehealth barriers in the Medicare program while prioritizing federal funding for telehealth access and infrastructure during this emergency.”
The ATA offers a summary of key telehealth provisions in the CARES Act on its website.
https://www.fiercehealthcare.com/tech/fcc-chief-unveils-200m-program-to-boost-telehealth-services-amid-covid-outbreak-0

HCA CEO donates salary to employee aid fund as hospital system cuts hours

The CEO of major hospital system HCA Healthcare announced he will donate the next two months of salary to a fund to help system workers struggling with reduced hours during the COVID-19 pandemic.
The senior leadership team of the system also will take a 30% cut in pay for the duration of the pandemic, CEO Sam Hazel announced in a letter to employees Tuesday.
He added the board has waived cash compensation for the rest of the year.
The decision comes as some hospital systems across the country are reducing hours or furloughing workers due to low patient volumes and a lack of revenue from elective procedures that have been canceled.
HCA Healthcare, which has 184 hospitals, has had to reduce hours for employees.
“Many of our outpatient facilities, clinics and departments have closed,” Hazel wrote.

Any employee that can’t be redeployed can be eligible for a pandemic pay program that continues paying 70% of their base salary for up to seven weeks.
“This is not a furlough,” Hazel said. “Instead, it is a pay continuation program to assist colleagues until we better understand the long-term implications of this pandemic on the organization.”
He added that the patient volume declines are likely temporary and that “we hope we can return to taking care of more patients sometime in May, which should lead to scheduling work for you.”
The HCA Healthcare Hope Fund helps with financial needs and also has counseling services.
https://www.fiercehealthcare.com/hospitals-health-systems/hca-s-ceo-donates-salary-to-employee-assistance-fund-as-hospital-system