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Friday, October 4, 2019

New York court blocks state ban on flavored e-cigarettes

A New York court on Thursday temporarily halted a state ban on the sale of flavored e-cigarettes, giving the embattled vaping industry a breather just a day before the state’s prohibition was due to take effect.
The appellate court ruling puts a hold on the ban that was announced by New York state’s Democratic Governor Andrew Cuomo last month in response to widespread growing concern about the rising use of e-cigarettes among teens and a nationwide spate of lung illnesses.
The ban, which was due to start on Friday, will remain on ice until at least Oct. 18 when the Supreme Court in Albany is scheduled to hear the case brought by industry trade group Vapor Technology Association arguing for a preliminary injunction on the ban.
“We are very pleased with the New York State Appellate Division’s decision, which acknowledges the strength of our claims about the State’s executive overreach, and which preserves the ability of hundreds of small businesses to remain open and continue to serve their adult customers,” Tony Abboud, executive director of the association said in an emailed statement.
New York Health Commissioner Howard Zucker said he remained confident the ban would eventually be enforced.
“Make no mistake: this is a public health emergency that demands immediate action to help ensure the wellbeing of our children, and we’re confident that once the court hears our argument they will agree,” Zucker said in a statement.
A handful of states have imposed or are eyeing similar bans as the crisis grows and the U.S. Centers for Disease Control and Prevention recommends people stop using vaping products.
Governors in Michigan and Rhode Island have announced sales restrictions, while Massachusetts imposed an outright ban for four months while it examined potential new regulations. Ohio’s state governor this week urged lawmakers to pass a ban.
U.S. health officials earlier on Thursday reported 18 deaths due to a mysterious lung illness linked to e-cigarettes and other vaping products and said the number of confirmed and probable cases of the condition now exceeds 1,000.
The U.S. Federal Trade Commission also on Thursday ordered several e-cigarette companies, including Juul Labs Inc and Nu Mark, to turn over sales and advertising data, in the first sign of a likely probe of their marketing practices. Tobacco giant Altria Group Inc owns Nu Mark and has a 35% stake in Juul.

Abboud noted that New York state lawmakers had already raised the minimum age for the purchase of vapor products from 18 to 21 from November and imposed a tax increase.
He said the lobby group was ready to work with officials “to achieve the twin goals of restricting youth vaping, which already is illegal, and preserving flavored alternatives for adults desperately trying to quit smoking.”
The New York state Department of Health had pledged to provide retailers with a two-week grace period before conducting site visits to enforce the ban on all flavored e-cigarettes besides tobacco and menthol.
https://www.reuters.com/article/us-health-vaping-new-york/new-york-court-blocks-state-ban-on-flavored-e-cigarettes-idUSKBN1WJ0IK

CVS drug coverage plan based on outside pricing review is off to a slow start

A CVS Health Corp (CVS.N) health plan that uses an outside drug pricing group to help it decide whether to cover certain new medicines has gained little traction with customers, according to its top medical executive, and has drawn fierce criticism from patient advocacy groups.
The company has held back on marketing the pharmacy benefit plan while it talks to these groups, CVS said.
The plan, launched a year ago, is based on analyses by the Institute for Clinical and Economic Review (ICER), a Boston-based group that assesses effectiveness of drugs to determine appropriate prices.
Using ICER’s cost effectiveness assessment, CVS decides whether to include second or third medicines entering the market if there are already similar ones in the plan.
Opposition to the CVS plan is part of much broader concerns cited by drug companies and advocacy groups, many of which receive funding from the pharmaceutical industry. Some say that ICER’s analysis based on additional years of “quality life” gained from a given treatment is arbitrary and disregards the costs of drug development and patient needs.
More than 50 groups, including drugmakers, PhRMA, the industry’s main lobby group, and other advocacy groups, have provided comment during a public input period included in a review by ICER of its assessment methods. Many asked ICER to eliminate price recommendations from its efficacy analyses.
ICER has defended its methods, which are based on a widely-used cost effectiveness analysis.

The soft rollout of CVS’ ICER-related product comes as employer health plan sponsors – its biggest clients – are showing increased concern over their cost for new high-priced drugs, and are considering refusing to pay for them at all, CVS Chief Medical Officer Troy Brennan said in a recent interview.
If corporate customers follow through on that threat, CVS said it could change tactics with the plan.
Rising drug prices, particularly for expensive specialty treatments for severe or deadly conditions, have pushed annual U.S. healthcare spending to $3.65 trillion, and made them unaffordable for many individuals.
Earlier this year, Novartis AG (NOVN.S) launched Zolgensma, a more than $2 million gene therapy for a rare but deadly disease called spinal muscular atrophy.
The new CVS program, cited as an example of ICER’s growing influence on U.S. drug pricing, would not apply to such a breakthrough treatment. It is a tiny plan by CVS standards as the company manages pharmaceutical benefits for more than 102 million people and also owns Aetna insurance and a national pharmacy chain.

NOT WIDELY PROMOTED

The plan’s scope is limited to so-called me too drugs, those where similar effective treatments already exist, and aims to pressure drugmakers to set lower prices. For example, two of three very similar drugs for migraine approved in 2018 could have been excluded, but drugmakers set prices ICER deemed cost effective.

CVS has limited sales and marketing for the plan while it talks to patient groups who oppose it. About 240,000 CVS employees and a few large clients’ employees are enrolled thus far. The company declined to comment on exact membership.
“We are not widely promoting this program,” Brennan said, adding that CVS is working to address patient groups’ concerns.
Meanwhile, Brennan said some employers are considering refusing to pay for million-dollar treatments like gene therapy. They are saying, “I’m not going to cover these kinds of therapies no matter what their comparative effectiveness is if they’ve got a really high cost.”
Large healthcare consultant and brokerage Mercer said it has begun to field similar concerns.
“We have certainly gotten some plan sponsors saying ‘What if we don’t cover specialty drugs?’” said David Dross, who runs Mercer’s managed pharmacy practice. Two years ago, it never received any such questions, he said.
Steve Wojcik, an executive with the National Business Group on Health which represents large employers, said he does not believe many will take that drastic step.
Still, ICER President Steven Pearson said employers tell him they worry about their ability to cover everything and have suggested they might drop some high-cost treatments. He said employers can use cost effectiveness analysis to help them manage their spending.
ICER has responded to outside criticism by meeting with patient advocates and by adding new measurements for a drug’s effectiveness, such as the value of life years gained, which does not focus on quality of life improvements, Pearson said.
Since 2015, ICER has published up to a dozen reviews each year of drugs and classes of medicines.
Most U.S. private insurers now use ICER clinical and cost analyses to inform coverage negotiations with drugmakers. ICER funding primarily comes from a non-profit foundation, but drug companies and health insurers provide some funds for ICER-related activities.
https://www.reuters.com/article/us-cvs-health-drugpricing-focus/cvs-drug-coverage-plan-based-on-outside-pricing-review-is-off-to-a-slow-start-idUSKBN1WI2IO

Arbutus hit as it discontinues hepatitis treatment

Arbutus Biopharma (NASDAQ:ABUS) has tanked after hours, falling 24.5% after a decision to stop development of AB-506.
That is an oral capsid inhibitor for the treatment of chronic hepatitis B.
“We have observed two cases of acute hepatitis in our Phase 1a 28-day clinical trial in healthy volunteers,” says CEO William Collier. “Consequently, the clinical trial and further development of AB-506 have been stopped.”
The two subjects are experiencing resolution of the acute hepatitis, he adds.
“While we are disappointed in these recent clinical findings, we have a number of oral follow-on capsid inhibitor compounds with distinct chemical scaffolds that we believe have the potential to contribute to the inhibition of HBV replication as part of a combination regimen,” says Chief Scientific Officer Michael Sofia. “Our objective is to select one of several lead compounds for IND-enabling studies by December of this year.”
https://seekingalpha.com/news/3503901-arbutus-minus-24_5-percent-discontinues-hepatitis-treatment

Gilead reports new data from Descovy Discover trial

Gilead Sciences (NASDAQ:GILD) announces findings from the DISCOVER trial evaluating Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for HIV pre-exposure prophylaxis (PrEP), showing significant improvements in key measures of bone and renal safety parameters in a subset of study participants who switched from Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP to Descovy for PrEP.
The data will be presented at the IDWeek 2019 conference being held in Washington, D.C. from October 2-6. Two sub-analyses of data will be presented.
The first 48-week study reports statistically significant improvements in key prespecified laboratory measures of kidney function. Improvements were statistically significant as early as Week 4 of the trial.
A second presentation reports 48-week data on bone mineral density (BMD). Of these individuals (n=383), 53 participants were on baseline F/TDF PrEP at enrollment, 26 of whom were randomized to F/TAF.
Participants who switched to F/TAF experienced statistically significant improvements in BMD of the hip and spine compared with those randomized to continue F/TDF.
In addition, participants taking F/TAF for PrEP were significantly less likely to develop osteopenia of the spine.
A new analysis demonstrates the significant impact of PrEP for reducing new HIV diagnoses. Importantly, this effect was independent of the impact of treatment as prevention.
Projecting out five years, the analysis suggests that if PrEP utilization among individuals at high risk of HIV could reach 50% by 2022 in the MSAs analyzed, a 40.7% decline in the rate of new HIV diagnoses is possible.
https://seekingalpha.com/news/3503983-gilead-reports-new-data-discover-trial

Novartis Eyes New Cosentyx OK After Positive Axial Spondyloarthritis Trial

Novartis Cosentyx hit the mark in treating patients with non-radiographic axial spondyloarthritis (nr-axSpA). In a Phase III trial, Cosentyx showed a significant and clinically meaningful reduction in disease activity for patients versus placebo.
Data from the Phase III PREVENT trial showed that Cosentyx (secukinumab) demonstrated a sustained response and maintained a consistent safety profile at 52 weeks. At the end of a year, treatment with Cosentyx met its primary endpoint of ASAS40, a typical measurement for the disease. As Novartis noted, ASAS40 is achieved when there is a measure of an improvement of at least 40% and an improvement of at least 10 units on a 0–100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function according to the Bath Ankylosing Spondylitis Functional Index, and Inflammation.
There are approximately 1.7 million patients with nr-axSpA in the United States and European Union, Novartis said.
No new safety signals were detected, the Swiss pharma giant announced Wednesday. Positive 16-week PREVENT data were announced in the middle of September and submitted to European Medicines Agency for approval in nr-axSpA. The company intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Cosentyx in nr-axSpA. The data from the PREVENT trial add to the five-years of clinical data posted last year supporting the long-term efficacy and safety of Cosentyx across ankylosing spondylitis, psoriatic arthritis and psoriasis, the company said.
Full data from the PREVENT trial will be presented at a future medical conference, Novartis said. Cosentyx is an interleukin-17A (IL-17A) inhibitor. IL-17A is produced by various cells from both the innate immune system (which can be triggered by mechanical stress) and the adaptive immune system. Cosentyx has been approved to treat plaque psoriasis, active psoriatic arthritis and ankylosing spondylitis, a form of arthritis that affects the spine.
John Tsai, Novartis’ chief medical officer and head of global drug development, said the data from the PREVENT trial are encouraging for people living with nr-axSpA, a chronic form of arthritis that typically affects the low back and buttocks, which has limited treatment options.
“It’s a great example of how we’re working to reimagine medicine to help patients realize early relief from this disease,” Tsai said in a brief statement.
Atul Deodhar, medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the secukinumab clinical trial program, said that if left untreated, axial spondyloarthritis can have a significant negative impact on quality of life. The positive results from the PREVENT trial show that Cosentyx could be a potential new treatment option for these patients.
https://www.biospace.com/article/novartis-eyes-new-cosentyx-approval-after-positive-phase-iii-axial-spondyloarthritis-trial/

Sarepta up 5% premarket on positive data from SRP-9003 trial

Sarepta Therapeutics (NASDAQ:SRPT) is up 5% premarket on announcing nine-month functional results from three Limb-girdle muscular dystrophy Type 2E (LGMD2E) clinical trial participants who received SRP-9003, an investigational gene therapy intended to transduce skeletal and cardiac muscle with a gene that codes for the full-length, native beta-sarcoglycan protein.
In Cohort 1 of the study, three participants ages 4-13 were treated with an infusion of SRP-9003 at a dose of 5×1013vg/kg. Improvements in functional outcomes were observed at day 270 (nine months) for all three participants.
At Day 270, mean creatine kinase was significantly reduced compared to baseline. All three participants showed improvements from baseline across all functional measures.
No new safety signals were observed and the safety profile seen to date supports the ability to dose escalate in the next cohort of the study.
https://seekingalpha.com/news/3503968-sarepta-5-percent-premarket-positive-data-srpminus-9003-trial

FDA approves AstraZeneca asthma drug for self-administration

AstraZeneca (NYSE:AZN) says the U.S. Food and Drug Administration approved the self-administration of its Fasenra asthma treatment, which uses a pre-filled, single-use auto-injector pen.
“We can now offer Fasenra in an even more convenient way, giving U.S. healthcare providers and patients the option of administering Fasenra at home or in a doctor’s office, and making treatment more accessible to patients with severe eosinophilic asthma,” the company says.
Fasenra, AZN’s first respiratory biologic, already is approved as an add-on maintenance treatment in severe eosinophilic asthma in the U.S., Europe and Japan; Fasenra self-administration and the Fasenra Pen already are approved in the European Union.
https://seekingalpha.com/news/3503937-fda-approves-astrazeneca-asthma-drug-self-administration