Reports total group sales GBP7.66B. Pharmaceuticals sales GBP 4.2 billion, +4% AER, +2% CER; Vaccines GBP 1.5 billion, +23% AER, +20% CER; Consumer Healthcare GBP 2.0 billion, flat AER, +1% CER. Total Group operating margin 18.6%. Adjusted Group operating margin 28.2%, +1.6 percentage points AER, +1.0 percentage point CER. Emma Walmsley, CEO, GSK said: “We have made a strong start to 2019, which is an important year of execution for GSK, with growth in sales, operating margins and earnings per share in Q1, in line with our expectations. Strengthening our pipeline remains our number one priority and we reported positive data for several potential new medicines in HIV and Oncology during the quarter. I am also pleased to report that integration planning for our new proposed Consumer Healthcare business is going well and, subject to relevant approvals, we continue to expect to complete this transaction in the second half of the year. We look forward to building on the progress made this quarter.”
Wednesday, May 1, 2019
GlaxoSmithKline backs 2019 adjusted EPS view down 5%-9% CER
The company said: “In 2019, we continue to expect Adjusted EPS to decline in the range of -5% to -9% at CER. This guidance reflects the recent approval of a substitutable generic competitor to Advair in the US and the expected impact of the Tesaro acquisition and assumes that the proposed Consumer Healthcare nutrition disposal closesby the end of 2019 and the proposed Consumer Healthcare Joint Venture with Pfizer closes during H2 2019. GSK expects to maintain the dividend for 2019 at the current level of 80p per share.”
VBI Vaccines reports Q1 EPS (15c), one estimate (22c)
Reports Q1 revenue $360,000, one estimate $200,000. “2019 has the potential to be a transformative year for VBI, marked by clinical milestones across all four of our lead programs, and as such, the first quarter of 2019 was characterized by intense focus on the execution of our ongoing clinical programs,” said Jeff Baxter, President and CEO, VBI Vaccines Inc. “In April 2019, all subjects in the Sci-B-Vac pivotal Phase 3 PROTECT study completed clinical visits, including follow-up visits for safety, which confirms the timeline to top-line data. This data read-out is the most significant clinical milestone in the history of VBI and we remain diligently focused and excited as we advance towards the data read-out, expected mid-year this year, 2019.”
Heron Therapeutics receives CRL from FDA regarding NDA for HTX-011
Heron Therapeutics announced that it received a Complete Response Letter from the U.S. FDA on April 30 regarding its New Drug Application for HTX-011 for the management of postoperative pain. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional CMC and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses. “We plan to request a meeting with the FDA to obtain its agreement on our approach to resolve the issues outlined in the CRL and resubmit the NDA as soon as possible,” said Barry Quart, Pharm.D., President and CEO of Heron Therapeutics.
Xeris Pharmaceuticals announces results from Phase 1 diazepam study
Xeris Pharmaceuticals announced findings from a Phase 1 study of its formulation of diazepam. The Phase 1, open-label, three-treatment, three-way crossover, randomized controlled study was conducted among 24 healthy volunteers to assess the bioavailability and pharmacokinetics, or PK, of Xeris’ novel formulation of diazepam after intramuscular, or IM, and subcutaneous, or SC, administration compared to an administration of commercial diazepam rectal gel. Secondary objectives were to assess the safety and tolerability of Xeris’ diazepam after SC and IM administration. Xeris’ IM and SC administration of 10 mg diazepam yielded higher exposure as compared to an equivalent dose of diazepam rectal gel as assessed by AUC 0-8. In individual comparisons, Xeris’ IM administration resembled diazepam rectal gel for both Cmax and Tmax. Additionally, both Xeris arms were safe and well-tolerated as a single dose. The study found no safety trends in any treatment group. Based on these results, Xeris anticipates initiating a Phase 2 open-label, single-arm, weight-based dosing study with IM administration of diazepam in patients with seizure disorders in the second half of 2019.
CVS Health says sees run-rate savings of $1.5B-$2B in 2022
Management said, “CVS and Aetna have a strong history of executing successful cost reduction and productivity initiatives and, through our integration, we are seeing the opportunity to make productivity gains across the enterprise. We expect to generate run-rate savings of $1.5 billion to $2.0 billion in 2022, savings over and above deal synergy targets.”
ARCA Biopharma announces GENETIC-AF trial data published
ARCA Biopharma announced that GENETIC-AF data was published in JACC: Heart Failure, a journal of the American College of Cardiology. Bucindolol is a beta-blocker whose unique pharmacologic properties provide greater benefit in HF patients who have the beta-one adrenergic receptor, or ADRB1, Arg389Arg genotype. GENETIC-AF compared the effectiveness of bucindolol and metoprolol succinate for the maintenance of sinus rhythm in a genetically-defined HF population with AF. The trial enrolled 267 HF patients with a left ventricular ejection fraction, or LVEF, less than 0.50, symptomatic AF, and the ADRB1 Arg389Arg genotype. The primary endpoint of AF/atrial flutter, or AFL, or all-cause mortality, or ACM, was evaluated by electrocardiogram during a 24-week period. The hazard ratio, or HR, for the primary endpoint was neutral, but trends for bucindolol benefit were observed in several subpopulations. Precision therapeutic phenotyping revealed that a differential response to bucindolol was associated with: the interval of time from the initial diagnosis of HF and AF to randomization, and: the onset of AF relative to initial HF diagnosis. In a cohort whose first HF and AF diagnoses were less than 12 years prior to randomization, in which AF onset did not precede HF by more than 2 years, the HR was 0.54. Moreover, in the HF with mid-range LVEF subpopulation, which comprised approximately 50% of randomized patients, the HR was 0.42. As expected based on its unique pharmacology, bucindolol reduced plasma venous norepinephrine levels while metoprolol did not. Plasma NT-proBNP, a biomarker of both AF and HF, was reduced in the bucindolol group at 4 weeks, 12 weeks and 24 weeks while in the metoprolol group a reduction was observed only at 24 weeks.
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