Tuesday, January 8, 2019
Illumina sees FY19 adjusted EPS $6.50-$6.60, consensus $6.37
Sees FY19 revenue $3.76B-$3.8B, $3.81B. While presenting last night at the JPMorgan Healthcare Conference, Illumina President & CEO Francis deSouza said, according to a transcript: “Looking to 2019, we’re expecting revenue growth in the range of 13% to 14%. We expect our sequencing business to grow in the mid teens with sequencing consumables expected to grow above 20% reflecting the strength of our product portfolio and expanding market opportunities. We’re forecasting low single digit growth in our arrays business in 2019. Our outlook reflects a cautious view of the consumer opportunity as we start the year. Although we expect this business to re accelerate, as consumer health and international opportunities ramp up. Overall, we expect 2019 revenue of between $3.76B-$3.8B, representing an increase of approximately $450 million at the midpoint. Following record system revenue in the fourth quarter, and reflecting expected seasonality, we expect total revenue to be more back end loaded in 2019 than it was in 2018. We expect GAAP EPS in the range of $6.07 and $6.17 and non-GAAP EPS in the range of $6.50 and $6.60. This excludes the expected impact of our acquisition of Pacific Biosciences, which we continue to expect to close in the middle of the year.”
https://thefly.com/landingPageNews.php?id=2845547
Axsome Therapeutics price target raised to $20 from $16 at BTIG
BTIG analyst Robert Hazlett raised his price target on Axsome Therapeutics to $20 and kept his Buy rating after the release of its AXS-05 data findings showing “rapid, sustained efficacy” in Phase 2 trial for patients with major depressive disorder. The analyst says his new price target reflects the net present value update in the company’s major depressive disorder, adding that the expected 2019 readouts by Axsome Therapeutics – including the phase 3 data for AXS-05 for treatment resistant depression and Phase 2/3 ADVANCE-1 trial data in agitation in Alzheimer’s – could be potential catalysts for the stock. https://thefly.com/landingPageNews.php?id=2845549
vTv Therapeutics awarded U.S. patent for Bach1 Inhibitors and Nrf2 Activators
The patent granted to vTv Therapeutics relates to use of Bach1 Inhibitors and Nrf2 Activators for “methods of treating diseases such as psoriasis, multiple sclerosis, and COPD,” according to a post to the USPTO website.
https://thefly.com/landingPageNews.php?id=2845557
https://thefly.com/landingPageNews.php?id=2845557
Monday, January 7, 2019
Study Raises Questions on Nuedexta Prescribing
Dextromethorphan-quinidine (Nuedexta), approved by the FDA for pseudobulbar affect based on studies in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS), appeared to be prescribed primarily for patients with other underlying disorders, an analysis of insurance records found.
Few patients who received the drug had a diagnosis of MS (8.4%) or ALS (6.8%); most (57%) had a diagnosis of dementia or Parkinson’s disease, reported Aaron Kesselheim, MD, JD, MPH, of Brigham and Women’s Hospital in Boston, and co-authors in JAMA Internal Medicine.
“Our study identified that this medication is primarily prescribed to patients with dementia or Parkinson’s disease. This is concerning, since very few studies have evaluated the effectiveness or safety in this patient population,” said lead author Michael Fralick, MD, of the University of Toronto.
It is important physicians realize this medication was studied primarily in patients with ALS and MS, Fralick told MedPage Today: “There are very little data to support its use in patients who do not have either condition. The medication is associated with significant side effects including falls, urinary tract infection, and confusion.”
In 2010, the FDA approved the combination of dextromethorphan hydrobromide and quinidine sulfate to treat pseudobulbar affect — a condition marked by sudden, uncontrollable laughing or crying — based on studies of patients with ALS or MS. The drug’s pivotal trial was a 12-week study of 326 ALS and MS patients who were an average age of about 52.
Prescribing the drug for PBA associated with other conditions is not technically off-label, however, since the approval does not restrict the indications solely to MS/ALS patients.
After FDA approval, drugmaker Avanir Pharmaceuticals rolled out extensive ad campaigns, including television commercials featuring actor Danny Glover to generate awareness of pseudobulbar affect and subsequent ads calling on consumers to ask their doctor about possible treatment.
Pseudobulbar affect is diagnosed clinically, sometimes with the aid of a patient-reported questionnaire. Last June, CNNreported that Medicare asked insurance companies to monitor suspicious prescribing of dextromethorphan-quinidine after concerns that the drug was being marketed aggressively for dementia patients.
“Real pseudobulbar affect is rare,” said Adriane Fugh-Berman, MD, director of the Georgetown University Medical Center-based PharmedOut project, who was not involved with the study. “Financially, it makes sense that a company might try to expand the diagnosis to include populations for whom treatment is inappropriate, but such promotion is unethical,” she told MedPage Today.
Dextromethorphan, found in many cough syrups, is the active ingredient in the drug, noted Fugh-Berman. “Quinidine was added to prolong the effect. Unfortunately, quinidine, an anti-arrhythmic and anti-malarial drug, can also cause cardiac arrhythmias and other problems.”
In 2015, a 10-week phase II trial of 220 patients with Alzheimer’s disease showed the drug reduced agitation scores by 1 to 2 points over placebo on a 0 (no symptoms) to 12 (daily severe symptoms) scale. Patients who received dextromethorphan-quinidine also experienced higher rates of falls (8.6% vs 3.9%), urinary tract infections (5.3% vs 3.9%), and serious adverse events (7.9% vs 4.7%) than placebo. In 2015, the prescribing information was updated to remove a statement saying data in dementia patients were lacking.
In the new analysis, Kesselheim and his group looked at patients prescribed dextromethorphan-quinidine in two commercial insurance databases from October 2010 through March 2017 (Optum Clinformatics Data Mart records) or December 2015 (Truven Health MarketScan database). Because commercial health insurance records include mainly patients younger than age 65, the researchers also included an analysis of Medicare Part D data from 2011 to 2016.
In the commercial health care records, 12,858 patients filled a prescription for the drug. Their mean age was 66 years and 13.3% had a history of heart failure — a contraindication for dextromethorphan-quinidine. About 38% also filled a prescription for QT-prolonging medication within 30 days.
Combining results from both databases, 8.4% of patients had a diagnosis of MS, 6.8% had a diagnosis of ALS, and 57.0% had a diagnosis of dementia and/or Parkinson’s disease. The researchers found a similar pattern before the drug label update in 2015.
In the Medicare Part D database:
- Prescriptions for dextromethorphan-quinidine jumped 51.2-fold, from 9,346 in 2011 to 478,481 in 2016
- The number of patients prescribed the drug rose 15.3 times, from 3,296 in 2011 to 50,402 in 2016
- Nearly three-quarters — 74.3%, or $102.2 million — of 2015 Part D spending for the drug was for patients 65 years and older
While behavioral symptoms are common in dementia patients, the cause often is not pseudobulbar affect, noted Kesselheim and co-authors. “Current therapies to treat behavioral symptoms of dementia are largely ineffective, and thus clinicians may want to prescribe dextromethorphan-quinidine to see if it helps their patients, despite the dearth of trial evidence on its efficacy in this context,” they wrote. “Yet the absence of data showing efficacy, coupled with the demonstrated risks of falls and possible cardiac effects, calls this strategy into question.”
Critics have likened this prescribing to an “uncontrolled experiment,” according to a CNNinvestigation that showed dozens of cases since 2013 in which state nursing home inspectors have questioned the use of the drug.
Further studies should be required to evaluate the safety and effectiveness of this medication as it is currently being used, Kesselheim and colleagues concluded.
The analysis has several limitations, they added. Reasons why dextromethorphan-quinidine was prescribed were unknown. Older adults and patients living in long-term care facilities typically are under-represented in commercial insurance claims databases, and the researchers therefore may have underestimated the extent of prescribing to dementia or Parkinson’s disease patients.
This study was supported by the Laura and John Arnold Foundation, the Harvard Program in Therapeutic Science, the Engelberg Foundation, and the University of Toronto Clinician Scientist Training Program.
Researchers reported relationships with the FDA Office of Generic Drugs and Division of Health Communication unrelated to the topic of this study.
Primary Source
JAMA Internal Medicine
Senescent cell research moves into human trials
Mayo Clinic researchers, along with collaborators from Wake Forest School of Medicine and the The University of Texas Health Sciences Center at San Antonio, have published findings from a safety and feasibility clinical trial on the removal of senescent cells from a small group of patients with pulmonary fibrosis. The findings appear in EBioMedicine.
While lung function, clinical test outcomes, frailty levels and overall health among the patients did not change, all 14 participants showed clinically meaningful improvement in physical function in nine doses over three weeks. That ability was measured in four tests: gait speed, walking speed in six minutes, a chair rise test and a score related to a bank of physical function tests.
“This was a short safety trial to determine if we should move ahead with actual large-scale human trials,” says senior author James Kirkland, M.D., Ph.D., head of the Robert and Arlene Kogod Center on Aging. “It’s important to emphasize that, while some measurable improvement was noted in all the participants, this is simply the start of human studies. We don’t know what lies ahead.” Senescent or semidormant cells (sometimes called “zombie cells”) form in many areas of the body and cause aspects of aging and frailty, ranging from osteoporosis to diabetes and muscle weakness. In this case, researchers are focusing on idiopathic pulmonary fibrosis, a progressive and fatal condition that is related to senescent cells. The researchers used a drug called a senolytic — dasatinib plus quercetin, an open-label drug, to clear the senescent cells.
“We are studying the effectiveness of this and other senolytic drugs, but that does not mean that these should be used by patients or prescribed by physicians for any off-label conditions,” says Dr. Kirkland. “I want to emphasize that no one should take these drugs. This research is only beginning.”
Story Source:
Materials provided by Mayo Clinic. Note: Content may be edited for style and length.
Journal Reference:
- Jamie N. Justice, Anoop M. Nambiar, Tamar Tchkonia, Nathan K. LeBrasseur, Rodolfo Pascual, Shahrukh K. Hashmi, Larissa Prata, Michal M. Masternak, Stephen B. Kritchevsky, Nicolas Musi, James L. Kirkland. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study. EBioMedicine, 2019; DOI: 10.1016/j.ebiom.2018.12.052
ContraFect hit on mid-stage exebacase data
Thinly traded nano cap ContraFect (CFRX -36.6%) is down on almost a 5x surge in volume following its announcement of Phase 2 data on exebacase (CF-301) for the treatment Staphylococcus aureus (S. aureus) bacteremia including endocarditis.
Treatment with exebacase, a recombinant form of an enzyme called lysin, added to standard-of-care antibiotics resulted in a clinically meaningful improvement in response rate at day 14 compared to antibiotics alone, but the separation appeared to fall short of statistical significance. Specifically, the response rate in the exebacase cohort was 70.4% versus 60.0% for antibiotics alone.
The company says exebacase produced statistically significant treatment effects in methicillin-resistant S. aureus patients and in those with bacteremia alone.
On the safety front, the rate of treatment-emergent adverse events (TEAEs) was 88.9% for exebacase compared to 85.1% for antibiotics alone. The rates of serious TEAEs were 47.2% and 51.1%, respectively.
Exebacase acts by targeting a certain area of the cell wall that is essential to the bacterium, making it less likely to develop resistance.
A Phase 3 trial is next up.
Natural Health Trends hit by China allegations
Natural Health Trends came under scrutiny in a segment aired by China Central Television (CCTV) last weekend. Specifically, the report alleged that the e-commerce brand is operating illegally in China.
The company denies these claims, saying that they believe short sellers negotiated with CCTV associates in creating what Natural Health is calling “a deceptive expose… attempting to misleadingly portray the business as a pyramid scheme.”
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