The U.S. Food and Drug Administration approved Dengvaxia for the prevention of dengue disease caused by serotypes 1 – 4 of the virus in individuals 9 through 16 years of age living in endemic areas of the U.S. with a laboratory-documented prior infection. Dengvaxia is the first and only vaccine approved for protection against dengue in endemic areas of the U.S. Dengvaxia is also approved for use in several endemic countries in Latin America and Asia where reducing the human and economic burden of dengue is a public health priority. In December 2018, the European Commission granted marketing authorization for Dengvaxia to prevent dengue in individuals living in endemic areas with a documented prior infection. “Dengue is endemic and prone to outbreaks in several U.S. territories, including Puerto Rico, the U.S. Virgin Islands and American Samoa. Despite this public health threat, there is no treatment and there has been no previously approved vaccine available in these areas,” said David Greenberg, MD, Regional Medical Head North America, Sanofi Pasteur. “Today’s FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue among children living in U.S. dengue endemic areas.”
https://thefly.com/landingPageNews.php?id=2901609
Wednesday, May 1, 2019
Teladoc expects to be cash-flow positive for the first time this year
Teladoc posted $128.6 million in revenue for the first quarter of 2019, driven by rises in both domestic and international subscription fees.
That’s up 43% from the $89.6 million in revenue the company reported during same period last year, according to earnings results released Tuesday. Net loss for the quarter totaled $30.2 million, compared with $23.9 million in the same period last year.
Subscription fees accounted for more than 82% of the company’s total first-quarter revenue at $106 million, with the remaining $22.6 million attributed to visit fees. Teladoc’s total visits were up 75% year-over-year at nearly 1.1 million.
Gorevic said he sees the U.S. health plan market as “one of the greatest potential areas for growth” in terms of population and visit volume. Health plans generally tend to expand their relationship with Teladoc over time after seeing initial savings, according to the company.
Teladoc’s expanding international footprint also played a role in its growing revenue and visit volume.
The company’s revenue from international subscription fees was up 133% at $25 million for the quarter. Total international visits topped 282,000, up from roughly 1,000 international visits reported during last year’s first quarter.
Teladoc took numerous steps to expand its international presence in the quarter, entering into an agreement to acquire a Paris-based telemedicine provider and rolling out a virtual care service in Canada.
Teladoc is scheduled to bring its first client live on the Canada service during the third quarter.
“We have continued to execute on our strategy of positioning Teladoc as the only global virtual care solution,” Gorevic said. Last year, Teladoc purchased of virtual care provider Advance Medical for an estimated $352 million.
Teladoc reaffirmed its financial expectations for 2019, projecting revenue to be in the range of $535 million to $545 million and net loss per share to be in the range of $1.52 and $1.66. In 2018, net loss per share was $1.47.
Gabriel Cappucci, Teladoc’s chief accounting officer, said that Teladoc also expects to be cash-flow positive for the first time in 2019.
Cappucci is coordinating the company’s finance activity until it names a permanent chief financial officer. Mark Hirschhorn, Teladoc’s former CFO and chief operating officer, resigned in December after investors filed a class-action lawsuit alleging he engaged in insider trading.
Gorevic said the CFO search remains a “high priority.”
“We’re seeing some great candidates, although our process is not yet concluded” he said. “I’m confident in Gabe and the finance team, which gives us the time we need to find the right fit for our organization.”
AHA asks DOJ to halt Centene-WellCare merger
The American Hospital Association urged the Trump administration on Wednesday to halt Centene’s $17.3 billion acquisition of WellCare Health Plans, claiming it will reduce competition in Medicaid managed-care and Medicare Advantage services.
Centene and WellCare are both major players in government-sponsored health plans, with both having a presence in Medicaid and on the Affordable Care Act’s exchanges. All told the two insurers would cover nearly 22 million people in Medicare, Medicaid and the exchanges.
The insurers’ markets overlap in several states, the AHA said in its letter, and they control over half of the Medicaid market in Florida, Georgia and Illinois.
Centene CEO Michael Neidorff has previously commented that there are states where the insurers have three plans each, and acknowledged they will have to divest some plans.
While the companies have said the merger should clear antitrust reviews because Medicaid rates are set by the states, the AHA said that shouldn’t negate DOJ’s scrutiny of the deal.
“There is no service more important to American consumers than healthcare, and vigorous competition among health insurance companies is necessary to ensure that consumers receive high quality at affordable rates,” the AHA wrote.
WellCare is the fourth-largest provider of Medicaid managed-care plans and Centene has more than 2 million members on the exchanges.
Both companies reportedly competed to purchase Aetna’s Medicare Advantage business when that insurer attempted to merge with Humana, which the AHA said is a sign they want to “enroll the exact same consumers in the exact same plans.”
CBO warns of complexities, disruption of a single-payer system
The Congressional Budget Office’s highly anticipated report released Wednesday largely put a damper on the idea of a U.S. single payer healthcare system.
While the office didn’t present a formal cost estimate, the analysis laid out ideas policymakers should consider as they design a potential single payer universe.
Specifically, the CBO issued familiar warnings that a single payer system could increase demand and overtax hospitals and clinicians while imposing hefty new costs. The report also echoed hospital arguments that adoption of universal Medicare fee for service rates for hospitals would “probably reduce the amount of care supplied and could also reduce the quality of care.”
Yet in highlighting the potential economic disruption of a single payer overhaul, the agency pointed to one of the key reasons Medicare for All is gaining traction: the costs in the status quo.
“Because healthcare spending in the United States currently accounts for about one-sixth of the nation’s gross domestic product, those changes could significantly affect the overall U.S. economy,” the report said.
Its release came on the heels of a high-profile House committee hearing on Medicare for All.
Throughout the analysis, the CBO showed reasons for the current costliness. For instance, the office found that in 2013 the “three major insurers” paid hospital rates that were 89% higher on average than Medicare rates for the same services.
Additionally, the federal government’s administrative costs for Medicare were about 1.4% of total Medicare expenditures in 2017. For Medicare Advantage and Part D plans, administered by commercial insurers, those costs rose to 6% of total expenditures.
For commercial insurers, those expenditures averaged about 12% of total costs.
The CBO said that the projected administrative savings could be one of the “opportunities” of developing a single payer system. The report also said the system would have more incentive to invest in preventive medicine and improve overall population health if it could eliminate the turnover seen in the employer and individual markets.
“Whether the single-payer plan would act on that incentive is unknown,” CBO analysts wrote.
The CBO’s report also argued the benefits of expanding coverage using the Affordable Care Act model of guaranteed issue, heavily regulated insurance markets and an individual mandate, which is effectively gone with the 2017 tax bill.
Many elements of the report will likely be embraced by industry, which is pushing for policies to build on subsidies for the ACA, particularly as it comes while momentum is building for Medicare for All. This policy has remarkably and rapidly taken hold among Democrats in Washington over the past few months although House Speaker Nancy Pelosi (D-Calif.) has stayed focused on ACA-building proposals.
After the report’s release Chip Kahn, CEO of the Federation of American Hospitals that represents investor-owned health systems, said the analysis “raises sobering questions.”
“But what needs to be asked, is it worth the risk of upending healthcare for every American when the law on the books already contains a roadmap to universal coverage?” Kahn said. “Instead of such a high stakes gamble, lawmakers should build upon the current foundation so we can continue to improve quality and affordability for families across the country.”
Single payer advocates have embraced the same points made in the CBO report about administrative costs, insurance industry costs and poor general population health despite the expense of the U.S. system.
These arguments were a key part of testimony in Tuesday’s Medicare for All hearing by the House Rules Committee.
Dr. Doris Browne, a retired military medical officer and immediate past president of the National Medical Association representing black physicians and their patients, argued that a universal coverage option would force widespread adoption of preventive medicine, which has so far baffled the U.S.
“I think you would practice medicine in a more appropriate way, increase the educational components and practice prevention,” Browne told the committee. “If you put prevention into practice, you’re not going to have many of these hospitalizations that end up in the ICU. We have not practiced prevention. We have been talking about it for years and years and it has gone by the wayside.”
New York City emergency physician Dr. Farzon Nahvi also homed in on these arguments before the committee, using personal anecdotes from the treatment room to advocate for single payer.
In one instance, he said he treated a woman who had overdosed on fish antibiotics she bought from a pet store to manage a fever, as she didn’t think she could afford seeing a doctor. The overdose affected her brain, and she fell down a staircase and was rushed to the emergency room.
In another story, a patient who had a urinary infection treatable with antibiotics couldn’t get her insurer to cover the $300 medicine. She bought cranberry juice instead only to come to the emergency room with sepsis from a subsequent infection — costing thousands of dollars.
“We’re paying more for bad outcomes, and that needs to be part of the discussion too,” Nahvi said. “There’s no way to account for what we’re seeing on the ground level.”
The Medicare for All debate has heated up simultaneously with an alternative measure to consolidating and capping costs. Last week the Trump administration unveiled an ambitious proposal to cap traditional Medicare spending through direct contracting with health systems and others.
Fitbit results beat Street as demand for wearable devices climb
Wearable device maker Fitbit Inc reported better-than expected first-quarter results and reaffirmed its full-year revenue forecast on Wednesday, as it sells more smartwatches and wearable devices that track health at affordable prices.
Shares of the company rose 1.5 percent to $5.45 in late trade.
Fitbit, which helped pioneer the wearable devices craze, posted year-over-year trackers growth for the first time in three years, getting a boost from its new Inspire line. Smartwatch sales also more than doubled in the quarter.
The San Francisco-based company said new devices launched in the past 12 months, including the Inspire brand, made up 67 percent of revenue in the quarter.
Fitbit said it sold 2.9 million devices in the quarter, 36 percent higher than a year-ago. Average selling prices fell 19 percent to $91 per device as it focused on cheaper devices to compete with tech-heavyweights Apple Inc and Samsung .
Analysts expected the company to sell 2 million devices at an average selling price of $109.33, according to data from FactSet.
To keep pace with rivals, Fitbit has focused on value prices – selling Inspire at $69.95 and the HR version, capable of heart rate monitoring, at $99.95. Apple’s smartwatches start at $279 and Samsung’s watches and trackers lead in at $200.
Fitbit’s Health Solutions business grew 70 percent in the quarter and posted revenue of $30.5 million. The unit is focused on subscription-based fitness coaching services that connect users with doctors, hospitals and lifestyle coaches.
“We think Fitbit is on the right track pushing to get its trackers and smartwatches on as many wrists as possible, and then ultimately leveraging the user-base and technology for its healthcare initiatives,” said Alicia Reese, senior associate, equity research, Wedbush Securities Inc.
The company’s net loss narrowed to $79.5 million, or 31 cents per share, in the first quarter ended March 30 from $80.9 million, or 34 cents per share, a year earlier.
Excluding items, Fitbit reported a loss of 15 cents per share, beating analysts’ average estimate of a loss of 22 cents, according to IBES data from Refinitiv.
Revenue rose to $271.9 million from $247.9 million, above Wall Street expectations of $259.7 million.
Fitbit reaffirmed its full-year revenue forecast of $1.52 billion to $1.58 billion, expecting to sell more devices at cheaper prices.
For the second quarter, Fitbit forecast revenue between $305 million and $320 million, the midpoint of which is slightly below the average analysts’ estimate of $312.8 million.
The company forecast an adjusted loss for the second quarter between 17 cents to 20 cents per share. Analysts’ estimate a loss of 16 cents.
Biogen’s antisense ALS drug shows promise in early clinical trial
Biogen is still reeling from the pivotal failure of aducanumab in Alzheimer’s disease, but it is celebrating some positive news from another pipeline asset in neurology.
Preliminary results from a phase 1 trial showed that tofersen (BIIB067), which Biogen in licensed from Ionis Pharmaceuticals, was well tolerated in amyotrophic lateral sclerosis (ALS) patients. The results suggest the drug could slow the progression of the disease in people with a mutant SOD1 gene.
Mutations in SOD1 can cause the protein the gene expresses to misfold in ways that are toxic nerve cells in the brain and the spinal cord, leading to loss of control over muscles, then paralysis and eventually death. About 10% of all ALS cases emerge from inherited gene mutations, and among these familial cases, around 20% are caused by the SOD1 gene.
Tofersen is an antisense oligonucleotide that aims to reduce production of the toxic protein. It works by binding to and inhibiting the SOD1 mRNA, which turns off the malfunctioning gene.
During the phase 1 trial, 50 SOD1-mutated ALS patients received either 20 mg, 40 mg, 60 mg or 100 mg of tofersen or placebo via a lumbar puncture over about three months. Investigators found that the 10 people who got the highest dose of tofersen experienced a 37% reduction of the SOD1 protein in their spinal fluid when compared to 12 people who received placebo, according to a study presented at the American Academy of Neurology’s 71st annual meeting in Philadelphia.
“Lower concentrations of the protein in the spinal fluid suggest that there were also lower concentrations in the brain and spinal cord. Such reductions could lead to preservation of motor neurons and slow progression of the disease, but more study is needed to examine this further,” the study’s senior author Timothy Miller of Washington University in St. Louis said in a statement.
What’s more, patients on the 100 mg dose performed better on tests that measure clinical decline in ALS, including breathing capacity, muscle strength and other body functions. On a score of 48, patients on 100-mg tofersen experienced an average decline of 1.1 points, while those on placebo suffered an average 5.3-point drop, according to Miller’s team.
The drivers behind most ALS cases are unknown, so targeting SOD1, a known cause of the familial form of the disease, offers a clear strategy for researchers. Swiss biotech Neurimmune used healthy elderly people’s memory B cells as the basis to develop a recombinant antibody targeting SOD1. (The company had previously used the same technology to discover aducanumab before licensing it to Biogen.) Neurimmune’s drug, called α-miSOD1, recently showed promise in postmortem spinal cord samples from ALS patients and in mouse models with SOD1 mutations.
A team of scientists at the Umeå University in Sweden has been analyzing the SOD1 clumps found in ALS, providing a roadmap for researchers developing drugs that target the gene mutation.
The phase 1 trial of Biogen’s tofersen offers a proof of concept, and based on a positive analysis first disclosed last December, the company has exercised its option to obtain full control of the antisense drug from Ionis. Biogen is now advancing the drug into pivotal trials, with the goal of proving it works in larger groups of patients over longer periods of time.
Deciphera nears its biggest test
The small-molecule oncology player zeroes in on its first commercial opportunity.
One of the amazing things about the immune checkpoint blockade revolution in oncology is the extent to which it has concealed a parallel explosion, namely the growth in targeted small-molecule kinase inhibitors.
Deciphera floated in September 2017 precisely on this promise. Since then its fortunes have waxed and waned, but now the company has a chance to prove itself, as the phase III Invictus study of its lead asset, the Kit-PDGFRα kinase inhibitor ripretinib, is set to read out mid-year; a positive hit could result in regulatory filing, Deciphera reckons.
The extent of some analysts’ bullishness is reflected in ripretinib’s consensus 2024 estimated sales forecast, which according to EvaluatePharma amounts to $700m. Deciphera itself is sufficiently confident of success to have already started building commercial infrastructure to support launch.
| Project | Ripretinib (DCC-2618) |
| Company | Deciphera |
| Market cap | $906m |
| Product NPV | $2.1bn |
| NPV as % of market cap | 229% |
| Event | Results of phase III Invictus study |
| Timing | Mid-2019 |
Still, investors need to remain cautious. Invictus tests ripretinib in all-comer fourth-line gastrointestinal stromal tumour (GIST) patients, which likely amounts to a fairly small population, and there are questions about whether the drug could have use beyond this niche.
Invictus enrolled 129 subjects, and compares ripretinib directly against placebo, with 15-month PFS set as the primary endpoint; remission rate and 15-month overall survival feature among the trial’s secondary measures.
Leerink analysts rate Deciphera “underperform” despite expecting a hit in Invictus. They reckon ripretinib might not be used beyond the 90% of GIST patients with Kit-positive disease, and have negative expectations for the project’s use in PDGFRα-positive GISTs and advanced systemic mastocytosis; the project is also being studied in gliomas and other solid tumours.
In fairness, the baseline in fourth-line GISTs is pretty low. The latest cut of an uncontrolled study of ripretinib in all-comer GIST patients was declared successful having shown overall remission of just 9% in subjects who had failed three or more prior lines of therapy, and a median progression-free survival of 24 weeks. The vast majority of the 111 subjects in this late-line cohort had Kit-driven GISTs, so it is not entirely clear why the response to the Kit-targeted therapy was not higher.
The Blueprint issue
Leerink also says ripretinib is expected to enter the market behind Blueprint’s avapritinib, a rival Kit-PDGFRα inhibitor.
Still, this is no dead cert; avapritinib’s 2020 filing, for advanced systemic mastocytosis, is subject to FDA discussions. And in GISTs, in contrast to Deciphera, Blueprint is employing a biomarker-driven strategy from the outset, focusing on Kit-positive patients.
But the rival companies make for an interesting comparison, both having been created to capitalise on the promise of next-generation kinase inhibition (Vantage point – Life for kinase inhibitors in an immuno-oncology world, January 19, 2017).
Treatment of GISTs was revolutionised by Novartis’s Bcr-Abl tyrosine kinase inhibitor Gleevec, which is approved for first-line GISTs as well as chronic myelogenous leukaemia. Pfizer’s Sutent and Bayer’s Stivarga are second and third-line GIST therapies.
Deciphera has long argued that ripretinib is no ordinary kinase inhibitor, binding to its target kinase’s “switch pocket” and preventing the enzyme from being locked in its “on” state; this could enable it to control all mutant forms of Kit-PDGFRα kinase and reduce the scope for mutation-based escape mechanisms.
A separate Deciphera pivotal trial, Intrigue, testing ripretinib in second-line GISTs, was initiated last December. In the second-line setting a remission rate of around 20% among all-comers is expected.
The low expectations for Invictus reflect the lack of options for fourth-line subjects. All Deciphera has to do with ripentinib now is beat placebo. Convincing the US FDA that a broad label is warranted could be trickier.
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