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Friday, January 18, 2019

Deaths with Paclitaxel-Coated Devices in Peripheral Artery Disease Draw FDA Eye


The FDA is investigating a potential safety signal with paclitaxel-coated balloons and stents used to treat peripheral artery disease, it said Thursday in a Dear Doctor letter.
“This review will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes. Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks,” the letter said.
The agency is taking action after a meta-analysis in the Journal of the American Heart Associationshowed that patients getting these devices placed in femoropopliteal lesions had more deaths in 2 years compared with controls.
Within days, the BASIL-3, SWEDEPAD 1, and SWEDEPAD 2 investigators announced that they were pausing enrollment for these drug-coated balloon trials.
Until there is more information available, the FDA recommended healthcare providers continue monitoring patients that got these paclitaxel-coated devices, discuss the risks and benefits of these balloons and stents with patients considering them, and report adverse events through MedWatch.
“Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use,” according to the agency.
The educational non-profit group VIVA Physicians is hosting a forum in February to discuss the safety of these devices.
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Access to VA Health Services Now Better Than Private Hospitals?


Efforts to stir up access to Veterans Affairs (VA) hospitals have cut down on wait times for new patient appointments, according to a report.
In 2014, the average wait for a new VA appointment in primary care, dermatology, cardiology, or orthopedics was 22.5 days, compared with 18.7 days in private sector facilities (P=0.20). Although these wait times were statistically no different in general, there was a longer wait for an orthopedics appointment in the VA that year (23.9 days vs 9.9 days for private sector, P<0.001), noted David Shulkin, MD, former VA secretary under President Trump, and now at the University of Pennsylvania’s Leonard Davis Institute of Health Economics, and colleagues.
The study, published in JAMA Network Open, found that wait times in 2017 favored VA medical centers (17.7 days vs 29.8 days for private sector facilities, P<0.001). This was observed for primary care, dermatology, and cardiology appointments — but not orthopedics, which continued to produce appointment lags in the VA system (20.9 days vs 12.4 days, P=0.01), the authors stated.
“Although the results reflect positively on the VA, we intend to continue improving wait times, the accuracy of the data captured, and the transparency of reporting information to veterans and the public,” the researchers wrote.
Their study included VA medical centers in 15 major metropolitan areas and compared them with private sector facilities. Wait times were calculated differently based on VA records and secret shopper surveys, respectively, which was a limitation of the study, the team said.
Shulkin and colleagues found that VA wait times trended toward improvement in 11 of 15 regions, whereas private medical centers had significant increases in wait times in 12 of the 15.
Prompting the scrutiny over VA hospital wait times was a 2014 report showing that at least 40 veterans died waiting for appointments at the Phoenix VA Health Care System in Arizona. Even worse, the wait times had apparently been deliberately manipulated to look better than they were.
“This incident damaged the VA’s credibility and created a public perception regarding the VA health care system’s inability to see patients in a timely manner,” Shulkin and co-authors said. “In response, the VA has worked to improve access, including primary care, mental health, and other specialty care services.”
Meanwhile, VA medical centers continue to suffer from staffing issues such as high turnover and employee vacancies in the tens of thousands.
The study authors noted a modest increase in the number of patients going to VA hospitals for the four services studied, although that number still stayed around five million per year.
From 2014 to 2017, patient satisfaction scores also increased by 1.4%, 3.0%, and 4.0% for specialty care, routine primary care, and urgent primary care, respectively (P<0.05 for all).
Another problem with the methodology of the study was that it failed to address how easily established patients could obtain return appointments, noted an accompanying editorial by Peter Kaboli, MD, MS, of Iowa City Veterans Affairs Healthcare System, and Stephan Fihn, MD, MPH, of the University of Washington in Seattle and JAMA Network Open‘s deputy editor.
Furthermore, they pointed out, a patient returning for a 6-month follow-up visit may show up in the scheduling system as having a long delay.
“As this study highlights, measuring access to healthcare remains dodgy. Even so, the seven million veterans who receive care from the VA seem able to obtain routine and urgent care in a time frame that is on par for other Americans despite increasing demand, although there are and always will be exceptions,” Kaboli and Fihn noted.
“As resources in the VA are increasingly diverted to purchase care in the community, it remains to be seen if access to healthcare services can be maintained while access in the private sector continues to deteriorate,” they continued, adding that virtual care may be one way to improve access given the non-infinite supply of face-to-face appointments.
Penn and coauthors and Kaboli reported having no conflicts of interest.
Fihn is Deputy Editor of JAMA Network Open.
LAST UPDATED 
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3 Biotech Stocks Appear Poised To Beat Fourth-Quarter Forecasts


Biotech stocks Gilead Sciences (GILD), Biogen (BIIB) and Celgene (CELG) are poised to beat some aspects of their fourth-quarter earnings, an analyst predicted Friday.
And they won’t be alone, Leerink analyst Geoffrey Porges wrote in a note to clients.
Porges acknowledged political pressure has kept drug-price increases to a minimum in recent years. Still, the fourth quarter featured volume increases for new products and a low single-digit price increase across the cadre of large-cap biotech stocks.
“We estimate that the companies in our large-cap biotechnology universe should report mixed revenue results skewed toward beats,” Porges said. “And all of them will report earnings beats of consensus estimates.”
That should help valuations rise from a trough, he said. Biotech stocks have risen around 12% this month, including a fractional lift on the stock market today. But they struggled at the end of 2018. A month ago, the group was ranked No. 95 out of 197 groups Investor’s Business Daily tracks. Today, the group is No. 55.

These Biotech Stocks Could Beat Estimates

Porges calls for Gilead and Regeneron Pharmaceuticals (REGN) to beat revenue estimates, and for Biogen and Celgene to top earnings forecasts.
Alexion Pharmaceuticals (ALXN) and AbbVie (ABBV) appear most likely to miss the consensus on sales, he says. But Porges predicts the biotech stocks’ revenue will lag by less than 1%. On earnings, he calls for Vertex Pharmaceuticals (VRTX) to be at risk of “falling merely in line.”
Overall, Porges expects the group of biotech stocks to maintain — or even beat — top-line growth of 7% from the third quarter. He credits volume trends in the U.S., stronger than anticipated after hitting a speed bump in mid-2018.
“The positive reaction to these trends is likely to be boosted by continued success for ongoing drug launches,” he said.
https://research.investors.com/ibdchartswp.aspx?cht=pvc&type=daily&symbol=GILD
Among those, he notes Vertex’s cystic fibrosis drug Symdeko, Gilead’s HIV treatment Biktarvy, Regeneron’s eczema medicine Dupixent and migraine prevention treatment Aimovig from Amgen (AMGN). All seem likely to report sequential growth and top estimates.
“We also believe that companies without these launches and tailwinds already have low expectations, and still appear likely to meet or beat consensus,” he said.

Guidance Will Likely Be Conservative

However, biotech stocks are likely to remain conservative on 2019 guidance with the hopes of increasing their targets later in the year. Porges notes political and commercial risks remain for biotech stocks in 2019.
“For these reasons, (we) don’t envisage major sector or stock re-rating breakouts as a result of earnings surprises,” he said.
Porges expects most companies to issue revenue guidance just under or in line with the consensus. These biotech stocks could also issue below-consensus estimates for profit. As a group, though, these large-cap firms tend to beat initial targets by 6%-7%.
“Investors are likely to anticipate this upside rather than respond negatively to conservative guidance,” he said.
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NASH Investigational Drugs With Catalysts This Year


Non-alcoholic fatty liver disease, or NAFLD, is a disorder resulting from accumulation of fat in the liver of people who do not consume alcohol.
NAFLD is a less serious condition, although non-alcoholic steatohepatitis, or NASH — a subset of NAFLD — is life-threatening, given its potential to cause liver scarring and cirrhosis.
NAFLD affects about 80-100 million people in the U.S. alone — roughly 25 percent of the total population.
NASH affects about 30 million people in the U.S., or about 12 percent of the adults, according to National Institutes of Health estimates.

No Approved Drug
Notwithstanding the prevalence of the disorder, there is no FDA-approved therapy for NAFLD or NASH. Treatment options are available for improving the insulin resistance often found in NAFLD and NASH patients.
Diagnosis of the disorder requires biopsy of the liver, which physicians do not want to do without a clear need. NASH is a silent killer that often does not manifest itself loudly enough for it to be diagnosed before it becomes lethal. Additionally, a lack of knowledge of the pathways that cause NAFLD is also a deterrent.
Potential Market Opportunity
NASH offers a $20 billion to $35 billion opportunity for companies developing drugs that target the condition, according to Biopharmadrive, which cited analyst estimates. The NASH biomarker market is estimated to reach $2.05 billion by 2025, according to Grand View Research estimates.
A biomarker is a biologic feature used to measure the presence or progress of a disease or the effects of treatment.
The NAFLD-NASH Pipeline
About 50 investigational drugs are in the pipeline that are being evaluated as treatment options for NAFLD/NASH, Biopharmadrive said. Of this, only four are in late-stage trials, while the mid-stage and early-stage pipeline is crowded out, with 14 and 30 candidates, respectively.
Could Gilead Win Development Race?
Gilead Sciences, Inc. (NASDAQ: GILD) has Selonsertib, a Phase 3 candidate it’s testing for NASH fibrosis. It is an apoptosis signal-regulating kinase 1, or ASK1, inhibitor.
The results from two separate late-stage studies, STELLAR 3 and STELLAR 4, are due in the first half of this year.
Apart from this Phase 3 asset, Gilead recently entered a collaborative agreement withScholar Rock Holding Corp (NASDAQ: SRRK), which gives it potential access to a mid-stage fibrosis candidate. The deal provides Gilead with options to license worldwide rights to product candidates from the latter’s TGFbeta programs, which have the potential to treat fibrotic diseases.
Gilead also entered into a licensing and collaboration agreement with South Korea’s Yuhan Corp. to co-develop therapeutics for treating advanced fibrosis due to NASH.
Gilead is evaluating a NASH combo comprised of Selonsertib, FXR agonist GS-9674 and ACC inhibitor GS-0976 in a midstage trial dubbed ATLAS. The results from this trial are also due in 2019.
Intercept Pharma Running Neck-And-Neck With Gilead
Intercept Pharmaceuticals Inc (NASDAQ: ICPT), a biotech specializing in therapies for non-viral liver diseases, is due to release top-line data from the interim analysis of a Phase 3 trial dubbed REGENERATE in the first quarter of 2019.
The trial is evaluating obeticholic acid, or Ocaliva, in non-cirrhotic NASH patients with advanced liver fibrosis.
The company said it expects to complete enrollment of its late-stage REVERSE trial evaluating Ocaliva in NASH patients with compensated cirrhosis in 2019.
Raymond James’ Steve Seedhouse assigned a 90-percent probability of at least one approvable endpoint of the study being met. Seedhouse also sees the possibility of Gilead making an offer for Intercept, given its quest to buy a commercially ready NASH asset.
Allergan
Allergan plc (NYSE: AGN)’s NASH asset Cenicriviroc is being evaluated in a Phase 3 study dubbed AURORA. This study is conducted in two parts, with the first evaluating the surrogate endpoint of improvement in fibrosis of at least one stage and no worsening of steatohepatitis at month 12. The second part will randomize the subjects from part one and additional subjects to evaluate long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes and all-cause mortality.
Genfit
French biotech Genfit SA (OTC: GNFTF)’s lead product candidate Elafibranor, or GFT505, is being evaluated in a Phase 3 study dubbed RESOLVE-IT.
In December, the company said the Data Safety Monitoring Board issued a positive recommendation for the continuation of the trial. The company said it has completed recruitment of the cohort needed for an interim analysis. Top-line results from the study are due by the end of 2019.
Others Waiting In The Wings
Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) and Viking Therapeutics Inc (NASDAQ: VKTX) are among the others that have midstage assets for NASH.
Madrigal’s MGL-3196 is a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor Î²-selective agonist. The company expects to begin a Phase 3 trial this year, having successfully completed a Phase 2 trial in 2018.
Viking’s VK2809 is being evaluated to treat patients with NAFLD and elevated low-density lipoprotein cholesterol. The candidate met the primary and secondary endpoints of a Phase 2 study and is likely to be advanced into a Phase 3 trial in 2019.
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KPC Group offers $610M for four Verity Health Cal. hospitals


KPC Group offered a $610 million bid to purchase four hospitals owned by bankrupt California health system Verity Health.
Verity filed a motion Thursday in Los Angeles bankruptcy court to implement a public auction where other buyers could outbid KPC for Francis Medical Center in Lynwood, St. Vincent Medical Center in Los Angeles, Seton Medical Center in Daly City and Seton Coastside in Moss Beach. The winning bid is subject to the approval of the court and the California attorney general, depending on the buyer.
“Verity has remained committed to finding the right buyer to provide uninterrupted service and operations for all employees, physicians and patients, and we will continue that commitment as this process advances,” Rich Adcock, CEO of Verity Health, said in prepared remarks. KPC pledged to keep current employees.
KPC Group, which is the parent company of KPC Healthcare that operates seven hospitals in Southern California, would pay $420 million for St. Francis, $120 million for St. Vincent and $70 million allocated for Seton Medical Center and Seton Coastside, according to bankruptcy filings.
Private investment firm BlueMountain Capital Management bought the six-hospital system spanning Southern and Northern California from the financially encumbered Daughters of Charity Health System in late 2015, when it changed its name to Verity Health. BlueMountain pledged to invest up to $260 million in exchange for a lease on its information technology assets.
Nantworks, led by controversial entrepreneur Dr. Patrick Soon-Shiong, bought its stake in July 2017 and infused another $148 million in capital as Soon-Shiong eyed a testing ground for his precision medicine endeavors.
But Verity filed for bankruptcy in September, overburdened more than $1 billion in bond debt and unfunded pension liability as well as its aging infrastructure.
The health system has been bleeding about $175 million a year, according to bankruptcy filings. Verity reported a $111.4 million operating loss in 2018, up from a $35.3 million operating loss in 2017.
The health system also aims to sell its other two hospitals, O’Connor Hospital in San Jose and St. Louise Regional Hospital in Gilroy, to the county of Santa Clara for $235 million. But the California attorney general has delayed the deal.
Santa Clara argues that it, as a public entity, doesn’t have to comply with the conditions imposed by the attorney general on the BlueMountain transaction. The attorney general disagrees.
The sticking point is related to assuming pension obligations or collective bargaining agreements, given that the county operates under different statutory requirements.
Notably, Daughters of Charity Health System tried to sell the organization to Prime Healthcare Services before it reached a deal with BlueMountain. But Prime pulled out of the deal because of the attorney general’s “onerous” conditions, the company said.
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Senate health committee leaders introduce key funding bill


This year’s healthcare package started taking shape Friday as the leaders of the Senate health committee introduced a bill that includes five years of funding for community health centers. The Health, Education, Labor and Pensions Committee will hold a hearing on the legislation on Jan. 29.
Committee Chair Lamar Alexander (R-Tenn.) and ranking Democrat Sen. Patty Murray of Washington laid out extensions of programs under their panel’s jurisdiction that are set to expire at the end of September.
That deadline, which also applies for Medicaid funding to the U.S. territories and the end of delays to disproportionate-share hospital payment cuts mandated by the Affordable Care Act, will drive the only healthcare package certain to pass Congress this year.
The bill also includes funding for the National Health Service Corps, the Teaching Health Center Graduate Medical Education Program, the Special Diabetes Program at the National Institutes of Health and the Special Diabetes Program for Indians.
Last week, Sens. Roy Blunt (R-Mo.) and Debbie Stabenow (D-Mich.) proposed a five-year funding measure for community health centers that has secured an array of bipartisan co-sponsors.
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Catalent: Pharma Solutions – Assay Automation to be presented


Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that one of its scientific experts will present at CASSS’s WCBP conference, the 23rd Symposium on the Interface of Regulatory & Analytical Sciences for Biotechnology Health Products, co-sponsored by the US Food and Drug Administration, at The Mayflower Hotel, Washington, D.C. on Jan. 29 – 31, 2019.
On Tuesday, Jan. 29 at 12:45 p.m., Mike Sadick, Ph.D., Principal Scientist, Catalent Biologics, will present ‘Automated Solutions for Relative Potency Assays, (GMP and Non-GMP), Now and Future State’. In his presentation, Dr. Sadick will use case studies to discuss the benefits of assay automation and discuss Catalent’s current automation platforms, as well as exploring the potential future direction of assay automation.
Dr. Sadick coordinates and oversees bioassay, ELISA and molecular biology projects for Catalent Biologics. Previously, he managed the company’s bioassay/relative potency team for 10 years at Catalent Biologics’ facility in Kansas City, Missouri. Prior to that, Dr. Sadick ran bioassay groups at Eli Lilly and Co. and Genentech. Dr. Sadick has an extensive background in cellular biology, cellular immunology and receptor signaling, molecular biology and biochemistry. He received his master’s degree and doctorate in immunology from University of Washington in Seattle, and his bachelor’s degree in biology from Johns Hopkins University in Baltimore, Maryland.
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