JPMorgan analyst Gary Taylor calls Q1 report “solid,” with a 3.6% EPS beat on 1% revenue upside vs. consensus, telling investors in a research note that the Medical Loss Ratio, or MLR, beat was “unexpected” given upward pressure from the 2019 HIF Holiday and nearly four times faster government vs. commercial premium growth. Taylor questions whether the beat and modest raise will be enough to change the negative public sentiment that has pressured both the stock and the group year-to-date.
Tuesday, April 16, 2019
UnitedHealth CEO: Medicare for All would ‘destabilize’ nation’s health system
David Wichmann, the company’s CEO, warned that Medicare for All would “destabilize” nation’s health system and limit the ability of clinicians to practice medicine “at their best.” He feels Medicare for All would have a “severe” impact on the economy and jobs, “all without fundamentally increasing access to acre.” He said the best path forward is to achieve universal coverage, which he said could be substantially reached through existing public and private platforms. Comments taken from UnitedHealth’s Q1 earnings conference call earlier. Shares of UnitedHealth are down 3.3% to $222.86.
Wave Life Sci presents final safety data on DMD candidate suvodirsen
Wave Life Sciences (NASDAQ:WVE) slips 11% premarket on light volume on the heels of final safety and tolerability data on Duchenne muscular dystrophy (DMD) candidate suvodirsen (WVE-210201) that appears worse than Sarepta’s EXONDYS 51 (eteplirsen). The results are being presented today at the Muscular Dystrophy Association Clinical and Scientific Conference in Orlando, FL.
36 DMD patients received one of five ascending doses of suvodirsen or placebo and were followed for 85 days. No serious adverse events, deaths or discontinuations were reported.
67% (n=16/24) of participants who received suvodirsen and 80% (n=8/10) of those receiving placebo experienced one or more adverse events (AEs). The most common AEs, all mild or moderate, in the suvodirsen group was pyrexia (high temperature), headache, vomiting and tachycardia (rapid heart rate), all consistent with infusion-related reactions. All resolved spontaneously or with symptomatic treatment.
Safety data on EXONDYS 51 showed a 38% rate of balance disorder and vomiting and 25% rate of contact dermatitis at at 1.7x the recommended dosage.
The company will initiate a Phase 2/3 trial, DYSTANCE 51, in DMD boys amenable to exon 51 skipping in July. Participants will receive 4.5 mg/kg or 3 mg/kg of suvodirsen or placebo administered intravenously once per week for 48 weeks. The primary endpoints will be the change in dystrophin protein level and the change in North Star Ambulatory Assessment score.
Interim muscle biopsy data from an ongoing open-label extension study should be available in H2.
Humana Launches Oncology Model of Care Program
Humana Inc. (NYSE: HUM) is engaging with physician groups across the country to launch a national, value-based care oncology program designed to provide more integrated cancer care for Humana Medicare Advantage and commercial members.
Humana’s national Oncology Model of Care (OMOC) program aims to improve the patient experience and health outcomes for patients with new or recurrent cancer diagnoses, through provider delivery of coordinated, cost-effective care. Humana offers analytics to support providers, and will provide compensation for enhanced care navigation based on incremental evaluation of quality and cost within several key care components – including inpatient admissions; emergency room visits; medical and pharmacy drugs; laboratory and pathology services; and radiology – as determined by metrics that address access to care, clinical status assessments, and patient education.
“With the field of oncology rapidly evolving, we’re very pleased to announce the launch of a quality-based program specifically focused on the delivery of cancer care,” said Bryan Loy, MD, MBA, Corporate Medical Director of Humana’s Oncology, Laboratory, and Personalized Medicine Strategies Group. “Humana is committed to providing physician support and working together to improve coordination across the continuum of care for our members with cancer.”
The OMOC program’s inaugural practices are: Southern Cancer Center, a practice in The US Oncology Network (Alabama); Arizona Oncology Associates, a practice in The US Oncology Network (Arizona); Highlands Oncology Group* (Arkansas); Cancer Specialists of North Florida** (Florida); Baptist Health Medical Group and St. Elizabeth Healthcare (Kentucky); Ponchartrain Cancer Center and Slidell Memorial Hospital Physicians Network (Louisiana); Michigan Healthcare Professionals (Michigan); Minnesota Oncology, a practice in The US Oncology Network (Minnesota); Comprehensive Cancer Centers of Nevada, a practice in The US Oncology Network*** (Nevada); TriHealth and University of Cincinnati Physicians Company (Ohio); and The Center for Cancer and Blood Disorders, The START Center for Cancer Care, and Texas Oncology, a practice in The US Oncology Network (Texas).
The OMOC program is Humana’s fourth specialty-care payment model, following its episode-based programs for Humana Medicare Advantage members undergoing total hip or knee joint replacement or spinal fusion procedures, and its maternity episode-of-care bundled payment program for Humana commercial plan members.
Axsome’s AXS-05 Helps Patients Quit Smoking Significantly in Phase II Trial
Axsome Therapeutics, based in New York City, announced that its AXS-05 met its primary endpoint for smoking cessation treatment. The drug significantly reduced daily smoking compared to patients on bupropion.
The trial, as well as the topline analysis, was conducted at Duke University’s Duke Center for Smoking Cessation. Treatment with the drug resulted in a 25% greater decrease in the average number of cigarettes smoked each day over a 3-week period. For patients receiving AXS-05, the average reduction was 8.49 cigarettes per day, while it was 6.79 for patients receiving bupropion.
In addition, patients receiving AXS-05 showed a more than 50% reduction in expired carbon monoxide levels. This is a biochemical marker of smoking intensity. For patients receiving bupropion, the expired carbon monoxide levels decreased by 30.4%.
“The findings in this trial are notable because AXS-05 was compared to bupropion, an approved treatment for smoking cessation,” stated James Davis, medical director of the Duke Center for Smoking Cessation and principal investigator of the trial. “The improvement of AXS-05 over bupropion observed in this trial is similar in magnitude to the improvement over placebo reported for the approved smoking cessation treatment varenicline in studies with a similar design.”
Bupropion is prescribed as a treatment for both smoking cessation and depression. It is marketed under several brand names, including Wellbutrin XL, Zyban, and Forfivo. Varenicline is marketed as Chantix by Pfizer.
AXS-05 is a novel, oral NMDA receptor antagonist. It is being developed for the treatment of central nervous system (CNS) disorders. It is made up of dextromethorphan and bupropion using Axsome’s metabolic inhibition technology.
On March 27, the U.S. Food and Drug Administration (FDA) granted AXS-05 Breakthrough Therapy designation for the treatment of major depressive disorder (MDD). This designation was supported by data from the Phase II ASCEND trial, which looked at 80 patients with confirmed moderate to severe MDD, who received AXS-05 or bupropion. Those receiving AXS-05 showed a fast and statistically significant decrease in depression symptoms compared to those on bupropion.
AXS-05 is also being investigated in the clinic for Alzheimer’s disease and treatment-resistant depression, both of which are in ongoing Phase III clinical trials.
The company also has several other compounds in the clinic. These include AXS-08 for migraine, currently in a Phase III trial; AXS-12 for narcolepsy, now in Phase II; and AXS-09 for CNS disorders, wrapping Phase I.
In the Phase II smoking cessation trial, 48 smokers were randomized 1:1 to either receive AXS-05 or bupropion. They were given the respective drugs twice a day and evaluated over three weeks. The smokers enrolled used 10 or more cigarettes daily. The average number of cigarettes smoked daily at baseline was 20 for the AXS-05 group and 17 for the bupropion group.
Drug adherence between the two groups was similar. AXS-05 was safe and well tolerated and there were no serious adverse events. The most common side effects were headache, dry mouth, and insomnia and vivid dreams. The incidences of these side effects were similar in both treatment groups.
“The topline results of this Phase II trial in smoking cessation add to the growing body of clinical data demonstrating biologic activity for AXS-05 in different areas of unmet medical need including major depressive disorder,” stated Herriot Tauteau, Axsome’s chief executive officer. “We would like to thank the team at the Duke Center for Smoking Cessation for their collaboration with Axsome and for the execution of this important trial. We look forward to continuing to analyze these results with the team at Duke and to determining the next steps for this program.”
Amgen Sets Annual List Price for Osteoporosis Drug Evenity at $21,900
One week after the U.S. Food and Drug Administration approved Amgen’s Evenity, the California-based company has set the list price for the medication at $21,900.
Evenity was approved for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Approximately 10 million people in the United States suffer from osteoporosis. Many people diagnosed with osteoporosis are susceptible to fractures related to the disease. There are about 2 million osteoporosis-related bone breaks annually. Once one of these types of bone breaks occurs, the patient is far more likely to experience another one within a year. Annually in the United States, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions. With an aging population in the U.S., treatment-related costs for osteoporosis are expected to reach approximately $25.3 billion by 2025, Amgen said. Data shows that only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post fracture.
On Monday, Amgen announced its pricing plan for the medication as it prepares to launch the drug in the United States. Evenity will have a list price of 1,825 per dose, or $21,900 for a full course of treatment, which is 12 monthly doses.
Amgen’s Evenity is an inhibitor of a protein called sclerostin, which stops bone production and increases breakdown. Evenity can rapidly increase bone formation and simultaneously reduce bone resorption. Evenity is designed to help rebuild bone rapidly in patients over the course of 12 months. Evenity is intended for short-term treatment options for postmenopausal women. The company’s other osteoporosis treatment, Prolia, is intended for chronic treatment of the disease. Data from late-stage trials showed that Evenity increased bone mineral density in patients and also decreased the risk of fractures. Prolia increases bone mass in the patients.
Murdo Gordon, executive vice president of Global Commercial Operations at Amgen, told Reuters that Amgen set the price for Evenity so it is “clearly a better value than existing agents that build bone.” Other drugs that build bone include Eli Lilly’s Forteo and Radius Health’s Tymlos, take at least 18 months to two years to do so, in comparison to the 12 months for Evenity. Amgen said the list price for Evenity is “34 to 74 percent lower than currently available anabolic agents over their full course of therapy.”
Citing IBES data from Refinitiv, Reuters reported that analysts have pegged annual Evenity revenue at $274 million a year by 2024. Sales of Prolia are forecast to hit $3.3 billion by 2024, Reuters said.
Evenity launches with a boxed warning due to concerns over cardiovascular risks associated with the drug. Because of those risks, analysts predict that will impact sales of the drug.
“Osteoporosis is a silent disease that can lead to devastating consequences. Unfortunately, only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment post-fracture,” Gordon said in a statement. “This is unacceptable for the millions of women who have suffered from an osteoporosis-related fracture. We need to urgently make postmenopausal osteoporosis a women’s health priority.”
Gilead Forges NASH Deal With insitro, Continues to Aim at Liver Disease
Less than one year after it was launched, South San Francisco-based insitro has inked a three-year collaboration with Gilead Sciences to discover and develop therapies for patients with nonalcoholic steatohepatitis (NASH).
NASH is one of the primary indications at which Gilead is aiming its R&D pipeline. Last week, the Foster City, Calif. company joined forces with Novo Nordisk to combine medications within their pipelines for treatment of NASH. Gilead also has its own programs aimed at the liver disease that has become a growing health concern with the increase in levels of obesity across the United States and other parts of the world. Last week, Gilead presented new proof of concept data that showed positive data from a combination treatment of cilofexor and firsocostat resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers.
With insitro, Gilead will use that company’s proprietary insitro Human (ISH) platform to create disease models for NASH and discover targets that have an influence on clinical progression and regression of the disease. The ISH platform applies machine learning, human genetics and functional genomics to generate and optimize unique in vitro models in order to drive the discovery and development of new treatments. Under terms of the deal, Gilead can advance up to five targets identified through this collaboration and will be responsible for chemistry and development against these targets.
As Gilead pushes ahead in NASH, the company is casting a wider net with partnerships in order to help it overcome a setback with its late-stage NASH candidate selonsertib, which failed to hit its primary endpoint in a Phase III trial.
Gilead will provide insitro with $15 million in upfront cash, as well as additional near-term payments of up to $35 million based on milestones. insitro is also eligible for up to $200 million per each of the targets that Gilead aims for. Under terms of the deal, insitro can opt-in on the targets Gilead has selected and will have the rights to co-develop in the United States.
John McHutchison, Gilead’s chief scientific officer and head of R&D, reiterated the company’s commitment to developing treatments for NASH, particularly those with advanced fibrosis who have the greatest unmet need.
“We are excited about the opportunity to partner with insitro to tackle the scientific challenges associated with this complex disease. Through this collaboration we will utilize deep learning to explore the scientific underpinnings of the biology and clinical spectrum of NASH, with the goal of accelerating the development of highly effective treatment options for patients with this disease,” McHutchison said in a statement.
Stanford professor and Coursera founder Daphne Koller, who founded and helms insitro, said NASH will be the primary cause for liver transplants in the U.S. Koller said she and her team are excited to work with Gilead to identify new therapeutics for NASH and help patients across the globe.
NASH is estimated to affect more than 16 million people in the U.S. alone. If untreated, NASH patients face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation Also, they are at a significantly higher risk of liver-related mortality. Current treatment standards for NASH are lifestyle changes, including diet, weight loss and exercise. Because of the lack of approved treatments for NASH, it has become a wildly popular target for companies. There are nearly 200 experimental treatments in the pipeline of drugmakers. With the plethora of companies aiming resources at NASH and the increasing growth of the disease, GlobalData has speculated the NASH market will hit $18.3 billion by 2026.
In addition to its deal with Gilead, insitro also secured $100 million in a Series A funding round led by Arch Venture Partners, Foresite Capital, GV and Third Rock Ventures.
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