Piper Jaffray analyst Michael Lavery writes that his discussions with a medical pain specialist in New York affirm his expectations of continued growth for medical cannabis, particularly as practitioners search for opioid alternatives. With over 30 U.S. states now in favor of medical use of marijuana, the analyst believes that the national prohibition will end in the next few years with the “STATES Act or federal legalization”. Lavery is positive on Tilray (TLRY) and its partnership with Novartis (NVS) to develop and distribute medical cannabis products, keeping his Overweight rating and $90 price target on the shares. The analyst also calls GW Pharma (GWPH) a “trailblazer for developing cannabis-derived products for medical use”, with its FDA-approved epidiolex cannabidiol product, keeping his Overweight rating and $195 price target on the stock. Lavery further maintains his Overweight rating and $60 price target on Canopy Growth (CGC) given its current valuation.
https://thefly.com/landingPageNews.php?id=2874085
Monday, March 4, 2019
Cigna’s CEO Expressed Regret About the Anthem Merger That Later Failed
While publicly backing Cigna Corp.’s 2015 merger with rival health insurer Anthem Inc. as good for investors, Cigna’s CEO privately expressed regret about signing on to a deal that left him with a reduced role, lawyers for Anthem said in court Monday.
Cigna shareholders were slated to get nearly a 30 percent premium for their stock in Anthem’s $48.9 billion buyout. But David Cordani, Cigna’s chief executive officer, lost out to Anthem CEO Joseph Swedish in a corporate duel over who would lead the combined company, set to be the largest health insurer by membership in the U.S.
Anthem officials contend that prompted Cordani to write in June 2015 emails that his “soul was still unsettled’’ by the merger and that he had “remorse about making the decision’’ to agree to the combination, according to evidence introduced in a trial over the failed deal. The merger imploded a year later when a judge found it was anticompetitive.
Now Cigna and Anthem are battling in Delaware Chancery Court over whether one owes the other billions of dollars in damages over its collapse. Cigna is seeking more than $16 billion in damages and termination fees. Anthem, which runs Blue Cross and Blue Shield plans in more than a dozen states, claims it’s owed $20 billion.
Anthem officials accuse Cordani of sabotaging the deal by refusing to turn over crucial information that could have convinced government regulators of the deal’s value. Cigna executives countered that Anthem managers botched getting antitrust clearance and used the proposed merger to hurt its rival.
Cordani testified he was unhappy with Swedish’s plan for integrating the two health insurers, saying the buyer wasn’t making any provision for the target’s businesses to thrive. He complained that Anthem officials refused to allow Cigna units to benefit from discounts the rival insurer had secured from health-care providers, which could put them in a “death spiral.’’
Cordani also wasn’t pleased when he learned Swedish would be the merged company’s CEO, while he would serve as president and chief operating officer. He proposed the new board recognize him as Swedish’s successor after the merged company operated for two years. His Anthem colleagues rejected that request.
“Did you think that Mr. Swedish didn’t know you were coming for his job?’’ Glenn Kurtz, one of Anthem’s lawyers asked.
“I don’t know what he knew,’’ Cordani replied.
Shortly after the merger was announced, Cordani said in an email that “he was steeled for a fight,’’ according to evidence introduced in the case. On the witness stand, Cordani denied that indicated he had decided to torpedo the merger.
Once Cordani learned he wouldn’t be leading the new company or in charge of the integration of the two insurers, Cigna hired lawyers and consultants to poke holes in the merger, including the law firm Wachtell Lipton, Kurtz said in court. Anthem officials didn’t know about Wachtell’s hiring, according to court filings.
Ariane Finkel, a Wachtell spokeswoman, didn’t immediately respond to a call for comment.
Consultants were tapped to plant stories in the press critical of the merger, Anthem alleges. Kurtz produced memos to show the CEO was briefed on that effort. Cordani said he wasn’t aware that such a plan was “activated.”
The case is In Re Anthem-Cigna Merger Litigation, 2017-114, Delaware Chancery Court (Wilmington).
Readmission for Patients With Sepsis Common and Costly
Readmission after sepsis hospitalization is common and is associated with considerable costs, according to a study published in the March issue of CHEST.
Shruti K. Gadre, M.D., from the Cleveland Clinic, and colleagues derived a cohort of patients admitted with sepsis from the Healthcare Cost and Utilization Project National Readmission Data 2013 to 2014. The authors examined the associated etiology and risk factors for readmission.
The researchers found that 87.2 percent of the 1,030,335 index admissions survived to discharge. Overall, 17.5 percent of patients had a 30-day readmission, with a median of five days to readmission. The most commonly associated cause for 30-day readmission was infectious etiology (42.16 percent, including sepsis [22.86 percent]), followed by gastrointestinal, cardiovascular, pulmonary, and renal causes (9.6, 8.73, 7.82, and 4.99 percent, respectively). Diabetes (odds ratio, 1.07), chronic kidney disease (odds ratio, 1.12), congestive heart failure (odds ratio, 1.16), discharge to short-term/long-term facility (odds ratio, 1.13), Charlson comorbidity index ≥2, and length of stay at least three days during the index admission were significant predictors associated with increased 30-day readmission. Per readmission, the mean cost was $16,852, with an annual cost of >$3.5 billion in the United States.
“Our findings serve to create awareness among clinicians, administrators and policy makers alike regarding patient populations that are vulnerable to sepsis readmission and thus increased utilization of resources,” the authors write.
Acne Drug Accutane May Not Depress Mood as Earlier Thought
For years, doctors have debated the safety of the acne drug most commonly known as Accutane, but new research suggests the medication does not boost depression risk among its users.
“The existing literature to date is quite mixed with regards to the issue of whether there is or is not an association between isotretinoin [Accutane] use and increased risk of depression,” explained study author Dr. Bethanee Schlosser.
“Our retrospective, population-based study shows no increased risk of depression in patients taking isotretinoin, compared to patients with acne but not taking isotretinoin,” she said.
Still, while she found the results reassuring and a mirror of what she sees in her clinical practice, it remains “critical that patients maintain open communication with their dermatologists,” Schlosser added.
“It is vital that dermatologists query patients about the impact of their acne on their mood, as well as any underlying medical or mental health history, which may influence selection of treatment,” she said.
“Patients who are prescribed systemic treatment for acne, including isotretinoin, should be monitored closely for potential adverse effects during their entire treatment course,” according to Schlosser, who is an associate professor in the department of dermatology at the Northwestern University Feinberg School of Medicine, in Chicago.
In the study, her team reviewed medical records on more than 38,000 patients between the ages of 18 and 65. All patients resided in the Midwestern region of the United States, and all had been diagnosed with an acne condition at some point between 2001 and 2017.
Almost 1,100 of the patients had been prescribed isotretinoin as part of their treatment program; nearly 37,000 had not. Among those taking the drug, treatment lasted for about five months, on average.
In the end, the research team found that depression onset was actually slightly less among isotretinoin patients (under 4 percent) compared with the non-drug group (nearly 5 percent).
Schlosser argued that the finding should be interpreted in concert with what clinicians do know for sure — “that acne [itself] is associated with increased risk of mood changes, low self-esteem and depression.”
And, she added, “the more severe the acne, the potentially greater impact on quality of life and mood.” Schlosser suggested that, as a practical matter, treating the problem with isotretinoin might actually lower depression risk rather than aggravate it.
The study findings were presented Friday at the annual meeting of the American Academy of Dermatology, in Washington, D.C. The research should be considered preliminary until published in a peer-reviewed journal.
Dr. Marc Glashofer is a dermatologist in private practice with The Dermatology Group in New Jersey. He was “not surprised by the findings of this study, as this further confirms previous data dispelling this myth,” he said.
“A correlation between isotretinoin use and depression/anxiety symptoms has been suggested in the past, but an evidence-based causal relationship has never been established. This suggests that isotretinoin exposure is not an independent risk factor for depression in patients with acne,” Glashofer added.
“My advice to parents that are anxious about their children starting this medication is to understand that there is no definitive link, and to minimize the social media chatter that is not backed up by data,” he said.
“I would [also] advise parents that they should not deprive their children suffering with moderate to severe acne the opportunity to take a medication that can be so positively life-altering,” Glashofer said.
“Past studies provide evidence that treatment of acne with isotretinoin was accompanied by improvement of both depressive and anxiety symptoms,” he explained, “as well as improved quality of life of patients with acne.”
More information
There’s more on acne and acne treatment at the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases.
SOURCES: Bethanee Schlosser, M.D., Ph.D., associate professor, department of dermatology, Northwestern University Feinberg School of Medicine, Chicago; Marc Glashofer, M.D., board-certified dermatologist, private practice, The Dermatology Group, New Jersey; March 1, 2019, American Academy of Dermatology annual meeting, Washington, D.C.
Promising new pancreatic cancer treatment moves forward
Even among cancers, pancreatic cancer is an especially sinister form of disease. The one-year survival rate is extremely low, and treatment progress has lagged behind that of many other malignancies.
A study published today in the journal Nature Medicine led by researchers at Huntsman Cancer Institute (HCI) at the University of Utah (U of U) describes a new therapeutic approach with potential for patients with pancreatic cancer. These researchers discovered a combination drug therapy that may effectively combat the disease. HCI researchers first observed anti-cancer impacts in a laboratory setting and, subsequently, in its first use in a human patient.
The study has already progressed to a clinical trial that is now open at HCI and will soon be open at other sites in the United States. Details about the clinical trial, called THREAD, are available under National Clinical Trial Number 03825289. The combination therapy uses two drugs already approved for use by the Food and Drug Administration for other diseases, including cancer. The new drug combination is administered through pills taken orally.
Pancreatic tumors are characterized by mutations in a gene called KRAS. When KRAS is mutated in this way, it sends constant signals that promote abnormal cell division and growth in cancer cells. As a result, tumors grow out of control. At the same time, like all cells, pancreatic cancer cells must recycle their components to provide building blocks for new growth in an essential cell function known as autophagy. Previous studies to combat pancreatic cancer that were focused either on the role of KRAS or on impacting autophagy were not effective.
The new HCI study, using an approach that simultaneously targets both abnormal KRAS signaling and the autophagy process, shows a strong response in mouse models and may be a promising therapy for patients with pancreatic cancer. Conan Kinsey, MD, PhD, a physician-scientist at Huntsman Cancer Institute and the Department of Internal Medicine at the U of U and Martin McMahon, PhD, a cancer researcher at HCI and Professor of Dermatology at the U of U, led the study.
“We were able to observe that the combination of these two drugs — which, when used individually, don’t have much of an impact on the disease — appears to have a very potent impact on the growth of pancreatic cancer,” says McMahon. “We have observed this in the lab in petri dishes, then in mouse models, and now in a pancreatic cancer patient on a compassionate use basis. Indeed, we proceeded from a petri dish to a patient in less than two years — a timeline that is rarely seen in medical science.”
The HCI-led research is bolstered by a separate study published in the same issue of the journal. This study outlines complementary findings regarding the effects of autophagy in pancreatic cancer in the laboratory setting and was led by Channing Der, PhD, Sarah Graham Kenan, PhD, and Kirsten Bryant, PhD, at the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center. McMahon and Der learned about the parallel nature of their research programs at a scientific meeting one year ago. Given the critical need for advances in pancreatic cancer therapies and the promise of their collective findings, they worked together to push their studies forward on a companion basis.
“In our paper, we show the response of a pancreatic cancer patient who had received surgery and multiple lines of chemotherapy prior to this combination,” said Kinsey, who was also the patient’s physician. “This patient, who has since succumbed to the disease, nevertheless had a remarkable response to these drugs for several months. We need to carefully evaluate this new combination therapy in the context of clinical trials to better understand if good responses might be seen in multiple patients. We also need to identify the specific features of any patient who may benefit, before any recommendation can be made about use on a larger scale.”
These preliminary findings are being rigorously scrutinized in clinical trials to observe and understand whether the combination of these drugs is safe and effective for pancreatic cancer patients. The trial is underway at HCI and is underway or planned at the University of California, San Francisco, and Columbia University in New York.
Story Source:
Materials provided by Huntsman Cancer Institute. Note: Content may be edited for style and length.
Journal Reference:
- Conan G. Kinsey, Soledad A. Camolotto, Amelie M. Boespflug, Katrin P. Gullien, Mona Foth, Amanda Truong, Sophia S. Schuman, Jill E. Shea, Michael T. Seipp, Jeffrey T. Yap, Lance D. Burrell, David H. Lum, Jonathan R. Whisenant, G. Weldon Gilcrease, Courtney C. Cavalieri, Kaitrin M. Rehbein, Stephanie L. Cutler, Kajsa E. Affolter, Alana L. Welm, Bryan E. Welm, Courtney L. Scaife, Eric L. Snyder, Martin McMahon. Protective autophagy elicited by RAF→MEK→ERK inhibition suggests a treatment strategy for RAS-driven cancers. Nature Medicine, 2019; DOI: 10.1038/s41591-019-0367-9
Napp launches Neulasta biosimilar in UK
Napp’s Pelmeg, a biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), has been launched in the UK following approval late last year.
This is Napp’s first launch of a product developed by Cinfa Biotech, which was acquired by its parent network Mundipharma in October. Aside from Pelmeg, Cinfa has one other undisclosed biosimilar in its pipeline.
It is not the first pegfilgrastim biosimilar to be launched in Europe, though, as Coherus BioSciences’ Udenyca and Accord Healthcare’s Pelgraz were approved earlier last year.
Meanwhile, Mylan also has a biosimilar approved in the US market.
Neulasta is an easy target for companies marketing biosimilars as patents on the original drug have expired. The drug brought in $4.5 billion for Amgen in 2017, and the market for the drug outside the US is worth around $603 million.
It is used to reduce the duration of neutropenia and the incidence of febrile neutropenia (FN) for adult patients undergoing cytotoxic chemotherapy. Neutropenia is an abnormally low number of neutrophils – white blood cells that usually fight off bacterial infections and fungi. Patients undergoing chemotherapy are particularly prone to developing neutropenia while their cell counts replenish.
Although there have been improvements in the prognosis of FN, it is still responsible for considerable morbidity and mortality, with 20%-30% of patients requiring costly in-hospital management and an overall mortality rate of approximately 10%. People who experience neutropenia and FN are at higher risk of infection, treatment dose reductions and dose delays.
“We are proud to be delivering treatments that address patient need in the oncologytreatment pathway and that could potentially improve patient experience at such a critical time,” said Paul Clark, director of biosimilars at Napp Pharmaceuticals. “We hope that Pelmeg will not only help to alleviate some of the resource pressures on the NHS by providing a more affordable long-acting treatment option, but that it may also help improve patient access to these vital medicines.”
Mundipharma already markets two biosimilars through a partnership with South Korea’s Celltrion – Remsima, a biosimilar of MSD’s Remicade (infliximab), and Truxima (rituximab-abbs), a biosimilar of Roche’s Rituxan (rituximab).
Short-Term Health Insurance Especially Attract Older Consumers: eHealth Survey
A new survey of consumers who purchased short-term health insurance policies through eHealth, Inc. (NASDAQ: EHTH) (eHealth.com) finds that older enrollees are more likely than younger ones to consider short-term insurance as an affordable alternative to Affordable Care Act (ACA) plans.
Key findings from eHealth’s survey:
- Affordability is key for many older enrollees: 70 percent of respondents ages 55 to 64 cite affordability as their primary reason for choosing short-term coverage, compared to 53 percent of young adults ages 18 to 24.
- Most consider low premiums more important than comprehensive benefits: 88 percent of people ages 55 to 64 say they value affordable monthly premiums more than comprehensive coverage, compared to 78 percent of those ages 18 to 24.
- Older enrollees want short-term coverage for the long haul: 64 percent of people ages 55 to 64 say they would like to retain short-term coverage for 7 months or longer; by comparison 56 percent of those between the ages of 18 and 24 say they intend to keep their short-term coverage for no more than 6 months
“At eHealth we believe comprehensive coverage is always best, but the fact is that many middle-class Americans don’t qualify for subsidies and cannot afford comprehensive ACA plans,” said eHealth CEO Scott Flanders. “As demonstrated by our survey results, affordability may be a greater concern for older Americans who face significantly higher monthly premiums than younger adults when buying ACA coverage. Short-term plans may offer many their only alternative to going uninsured.”
While older consumers showed special interest in short-term coverage, eHealth found a change in consumer attitudes across all age bands since the maximum term of short-term policies was extended beyond 90 days, and significant satisfaction with short-term coverage even among those who received medical care while covered by a short-term policy:
- Overall, 61 percent of eHealth’s survey respondents say they chose short-term coverage primarily because it was more affordable than their other coverage options; 28 percent say they chose short-term because they only need temporary coverage. A year ago, when short-term plans carried a maximum policy term of 90 days, 27 percent cited affordability while 61 percent said they only needed temporary coverage.
- More than 9 in 10 enrollees are very satisfied (41 percent) or somewhat satisfied (51 percent) with their short-term plan. 86 percent of those who have received medical care while covered by their short-term plan are very or somewhat satisfied with their coverage, despite the fact that short-term plans do not provide the comprehensive coverage available under ACA-compliant plans.
eHealth believes that consumers interested in purchasing short-term health insurance should understand what they’re buying and how short-term coverage differs from coverage provided through ACA-compliant health insurance plans. Educational materials are found on the eHealth website and a brief guide to short-term coverage may be found here.
Read eHealth’s full survey report for additional findings and analysis.
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