Stifel analyst Annabel Samimy started Evolus (EOLS) with a Buy rating and $27 price target, citing her view of the potential for Jeuveau to be an identical, drop-in, “frictionless” replacement for Allergan’s (AGN) Botox with “a marketing angle and pedigree that no other toxin has claimed before.”
Monday, January 28, 2019
Eiger BioPharmaceuticals initiated at Baird
Eiger BioPharmaceuticals initiated with an Outperform at Baird. Baird analyst Madhu Kumar started Eiger BioPharmaceuticals with an Outperform rating and $47 price target. The company’s hepatitis delta virus pipeline could transform the disease, with lonafarnib monotherapy in progeria can provide near-term, high EBIT margin revenue, Kumar tells investors in a research note.
https://thefly.com/landingPageNews.php?id=2854739
Constellation Pharmaceuticals initiated at Baird
Constellation Pharmaceuticals initiated with an Outperform at Baird. Baird analyst Michael Utz initialed Constellation Pharmaceuticals with an Outperform and $17 price target.
https://thefly.com/landingPageNews.php?id=2854741
Illumina, Pacific Bio deal faces significant FTC scrutiny, Capitol Forum says
Illumina’s (ILMN) deal to acquire Pacific Biosciences (PACB) will face “significant FTC scrutiny” due to questions about both existing and future competition, Capitol Forum said in an article to its subscribers, citing its analysis of gene sequencing market dynamics.
https://thefly.com/landingPageNews.php?id=2854701
NY pharmacists: PBMs mark up generic drugs in state’s Medicaid managed care
As policymakers turn up the heat on pharmacy benefit managers (PBMs) over the role they may play in increasing drug prices, a new analysis is pushing New York officials to audit how they function in the state’s Medicaid program.
The report (PDF), which was sponsored by the Pharmacists Society of the State of New York (PSSNY), a group that represents the state’s pharmacies, found that PBMs contracted by New York’s Medicaid managed care organizations are increasingly boosting prices for generic medications.
The PBMs paid pharmacies an average of $10.85 per generic prescription but charged the payer an average of $14.34 per prescription, according to the report. That’s a 32% markup and up from an 11% markup in 2016.
The practice, called “spread pricing,” is controversial—other states, such as Ohio, have cracked down on PBMs for doing so—but it is one way PBMs generate revenue. The report says PBMs contracting with New York’s Medicaid managed care plans, including CVS Caremark, Optum and Express Scripts, have shifted “hundreds of millions of dollars” away from patient care.
“The anticompetitive business practices of the PBM industry are felt by independent pharmacies, hospital pharmacies and chain pharmacies of all sizes,” PSSNY’s board said in a letter accompanying the study. “Their practices negatively impact the ability of pharmacists and other healthcare professionals to provide patient care.”
The report estimates that New York’s Medicaid managed care program spent the most of any state on generic drugs, a total of nearly $1.3 billion in 2017.
PBMs have become a prime target for blame in the discussion around increasing drug costs because practices like spread pricing are opaque. The Trump administration, in looking to shake up the pharmaceutical supply chain, has been mulling an overhaul to safe harbors for PBM rebates since last summer.
The analysts, a firm called 3 Axis Advisers, calls for state auditors to examine its managed care pharmacy spending, as that would include a more comprehensive data set. The report dove into claims from pharmacies for more than 170,000 generics sold between January 2016 and March 2018.
However, while the report points the finger at PBMs, the Pharmaceutical Care Management Association, which represents PBMs, said that the problem isn’t in their pricing models but instead in the design of New York’s Medicaid program itself.
“It’s no secret that New York’s Medicaid program wastes millions every year by overpaying drugstores,” the group said in a statement to FierceHealthcare. “By operating more like Medicare and commercial market plans, New York’s Medicaid program could reduce pharmacy costs and save money without cutting benefits.
“By defending wasteful spending in a program that’s clearly in trouble, New York’s special interest drugstore lobby wants to rearrange deck chairs on the Titanic without offering ways to keep Medicaid afloat.”
The report also says that the opacity of PBM contracts leaves limited room for them to negotiate terms with these insurers. Walmart and CVS’ recent spat puts a spotlight on this problem, according to the report; if a retailer the size of Walmart had to make a public scene to reach a deal with CVS it believes is fair, smaller pharmacy chains have even less leverage.
“It is far past time that these companies stop hiding behind ‘take it or leave it’ contracts, gag clause, confidentiality agreements, non-disclosure agreements and other practices not allowed in other aspects of American life,” PSSNY said in the letter.
Preventing flu with an antibody-plus-Tamiflu universal vaccine
The problem with the influenza virus is it can rapidly mutate into strains that are resistant to the yearly vaccine. That has made the search for a universal vaccine all the more challenging.
Researchers at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) have found a new clue to providing broad-based protection against the flu—and it rests partly on Roche’s FDA-approved remedy Tamiflu.
Using mouse models of flu, the NIAID team tested an antibody that recognizes a protein called hemagglutinin, which sits on the surface of the virus and helps it spread to healthy cells. Current flu vaccines work by recognizing the head of hemagglutinin and blocking its ability to shuttle the virus into cells. Problem is, that’s the region that can rapidly mutate to escape the vaccine. So the researchers used an antibody that targets the stem domain of the protein instead—a region that’s far more resistant to mutations.
When they combined the antibody with Tamiflu, which works by inhibiting another flu surface protein called neuraminidase, the mice were better able to survive a severe viral infection. The researchers reported their discovery in the Journal of Experimental Medicine.
Although anti-stem antibodies that target hemagglutinin have long been considered a promising approach in the development of next-generation flu vaccines, the NIAID researchers wanted to gain a better understanding of their mechanism of action. As they conducted research in flu cells, they discovered that the antibodies not only work against hemagglutinin but also inhibit neuraminidase. That’s important, because neuraminidase normally promotes the replication of the flu virus.
Hence, the inspiration to add Tamiflu to the mix. Adding the drug to the anti-stem antibody they tested in mice boosted the activation of immune cells that were exposed to the flu, they reported.
“The ability of neuraminidase inhibitors to enhance … immune cell activation [by anti-stem antibodies] bound to viruses or infected cells suggests the possible clinical synergy,” the authors wrote.
There are a handful of universal flu vaccines in late-stage human testing, including hVIVO’s FLU-v. Earlier this month, the company’s shares surged on news that its vaccine reduced symptoms and stimulated an immune response in a phase 2b trial. FLU-v is a “synthetic polypeptide” vaccine that’s designed to provide protection against multiple strains, including emerging mutations of the virus. The company is now preparing to bring the vaccine into phase 3 testing.
Several other approaches to universal flu protection have shown promise in preclinical studies. In November, for example, scientists led by Scripps Research Institute and Johnson & Johnson’s Janssen reported that they developed a new type of antibody from llamas immunized with a flu vaccine. The molecules, called neutralizing single-domain antibodies, were able to protect mice against most strains of influenza A and B, they reported.
Although the current flu vaccine has so far proven more effective than last year’s version, the threat from the virus is still evident. Of the 54 jurisdictions that report flu activity to the Centers for Disease Control and Prevention, 48 said the infection was widespread last week.
NY Docs ‘Back Med Aid in Dying 56-26%; Back NY Med Aid in Dying Bill 67-20%’
Kicking off the 2019 campaign to pass the bipartisan New York Medical Aid in Dying Act in 2019, Compassion & Choices today released the first valid survey of New York State physicians’ views on medical aid in dying. The survey – conducted by WebMD/Medscape – shows that by a 56-26 percent margin, New York doctors support medical aid in dying as an end-of-life care option. By an even larger 67-20 percent margin, New York doctors support proposed legislation to authorize medical aid in dying.
Last year, the Medical Society of the State of New York (MSSNY), at the Assembly’s public hearing on the Medical Aid in Dying Act, testified about incomplete and inaccurate data from a flawed Survey Monkey poll purporting to represent its members’ views on medical aid in dying. The MSSNY survey was so defective that its leadership refused to release the survey and its findings publicly and failed to provide it to the Legislature.
“The medical society did a great disservice to its members, to the vast majority of New York doctors whom are not among its members, to legislators and to the public,” said Corinne Carey, New York campaign director for Compassion & Choices. “That’s why we felt it was so important to hire professionals who’ve conducted national physician surveys on medical aid in dying to conduct an honest, valid survey about how New York physicians really feel about this issue.
“It’s clear that New York doctors strongly support allowing terminally ill state residents to have the option of medical aid in dying, just as a strong majority of New Yorkers do – 63-29 percent, according to the most recent Quinnipiac poll,” Carey said.
Dr. Robert Morrow, associate professor, Albert Einstein College of Medicine, representing the New York State Academy of Family Physicians (NYSAFP), said: “The New York State Academy of Family Physicians (NYSAFP) was honored to participate in the development and analysis of this first-ever publicly-released survey of New York doctors. We are not surprised that a strong majority of New York doctors supports the palliative care option of medical aid in dying for terminally ill adults to peacefully end unbearable suffering and an even stronger majority supports it when they learn about the specifics of the legislation.
“In 2017, NYSAFP voted to support the Medical Aid in Dying Act because – regardless of personal views – patients should have the freedom to make end-of-life decisions according to their own values. The NYSAFP was also instrumental in changing the policy of the American Academy of Family Physicians, which has now adopted a position of engaged neutrality toward medical aid in dying, viewing it as a personal, private, end-of-life decision made in the context of the doctor-patient relationship,” Morrow said.
WebMD/Medscape conducted this research by sending email invitations to randomly selected New York State physicians to participate in an online survey. Medscape database includes 78,000 self-registered, credential-certified physicians from New York State. Medscape hosted the survey on its platform, obtaining 601 responses that met targets for geographic and gender ratios based on the Association of American Medical Colleges Workforce Profile demographics of New York State physicians. Of the 601 respondents, 45 percent were from New York City, 28 percent from the downstate suburbs, and 27 percent from upstate New York. A full copy of the survey report – including the specific wording and order of every question asked – can be found here.
The questions in the survey utilized both the terms “medical aid in dying” favored by supporters and “physician-assisted suicide” favored by opponents to ensure fairness. For example, the first question was: “Medical aid in dying (MAID), also known as physician-assisted suicide (PAS), is a practice in which a terminally ill adult with decision-making capacity asks for and receives a prescription medication that may be self-ingested to hasten death. Do you support or oppose this option?” Every other survey question included both of these terms’ acronyms: “MAID/PAS.”
New York’s Medical Aid in Dying Act (A.2694) was reintroduced for 2019 last week in the Assembly and this week in the Senate by lead sponsors Senator Diane Savino (D-Staten Island) and Assemblymember Amy Paulin (D-Westchester). If enacted, the bill would allow mentally capable, terminally ill adults with six months or less to live to have the option to request a doctor’s prescription for medication they can decide to take to peacefully end their suffering if it becomes unbearable. This end-of-life care option is available in California, Colorado, the District of Columbia, Hawai’i, Montana, Oregon, Vermont, and Washington.
Dr. Timothy Quill, Founding Director of the University of Rochester School of Medicine Palliative Care Program, said: “This survey confirms what I’ve long believed: My colleagues across the state want what’s best for their patients and want to be able to carry out their patients’ wishes. There’s near-universal support for requiring that patients who request medical aid in dying be offered a referral to hospice if they are not already enrolled. The goal for dying patients must be to keep them comfortable and respect their wishes. I’m glad that New York doctors support patient-centered choices and support medical aid in dying.”
Dr. Jay Federman, family physician and Medical Director, High Peaks Hospice, said: “The strong support by New York doctors for allowing qualified patients to have the option of medical aid in dying is not surprising, but is reassuring. This is similar to results of physician surveys in other states. It’s also heartening to see that doctors were consistent in their views about medical aid in dying, whether it was about patients or themselves. By a 63-20 percent margin – better than 3-to-1 – doctors say they would like to have the option of medical aid in dying if they become terminally ill.
“Think about it. New York doctors strongly support medical aid in dying. They even more strongly support the legislation currently being debated in Albany. They support MAID as an option for their patients who want it, and they want this option for themselves,” Federman said.
Senator Diane Savino (D-Staten Island), prime sponsor or the bill, said: “Medical aid in dying is overwhelmingly supported by New Yorkers. Now we know it’s overwhelmingly supported by New York doctors. We will get this law passed in New York because it’s the right thing to do. I don’t know what my decision would be if I were in that situation. But I do know I would want the option for me, my loved ones and all New Yorkers who want that option.”
Assemblymember Amy Paulin (D-Westchester), prime sponsor of the bill, said: “Medical Aid-in-Dying is an important end-of-life option that polls have consistently shown most New Yorkers believe ought to permissible in specific circumstances and with appropriate safeguards. Based on this new honest, legitimate data, it’s clear that a strong majority of doctors concur that lawmakers should allow this option for their patients who are suffering irreversible, terminal conditions.”
Assembly Health Committee Chair Richard N. Gottfried (D-Manhattan), a co-sponsor of the bill, said: “It is important to have a professionally-designed and conducted survey of physicians in New York State. It is encouraging that a majority of our physicians believe that this question, like so many others, is a matter of patient choice, patient-physician decision-making, and the individual physician’s judgment and conscience. The law should get out of the way here.”
Senate Health Committee Chair Gustavo Rivera (D-Bronx), a co-sponsor of the bill, said: “I look forward to working with my Senate colleagues to give terminally-ill New Yorkers the ability to have medical aid in dying as an option to provide comfort and ease suffering. Having the support of the New York Academy of Family Physicians and knowing we have the strong support of doctors across the state will help us in that effort.”
David Leven, Executive Director Emeritus and Senior Consultant, End of Life Choices New York, said: “It is time for the Legislature to pass the Medical Aid in Dying Act. There is increasing public and physician support. Medical aid in dying has been shown to be a safe, ethical and humane medical practice that benefits patients and harms no one. There are no justifiable arguments in opposition. Dying patients who are suffering terribly should have the option of medical aid in dying now.”
Donna Lieberman, Executive Director, New York Civil Liberties Union, said: “Deciding what medical care is best for you is among the most personal decisions you can make. No New Yorker should be forced to suffer, particularly when facing terminal illness. The New York Medical Aid in Dying Act would give patients and their families comfort during the most difficult of times by giving individuals control over how their lives end. The right to make decisions about your body is central to American values of liberty and autonomy, and with this legislation New York is showing what it means to defend those values.”
George Eighmey, Board Chair, Death with Dignity National Center, said: “For more than 20 years these laws functioned flawlessly and gave enormous comfort and peace of mind to countless terminally ill people and to their loved ones. It is reassuring to know legislators recognize a large majority of New Yorkers support the right of terminally ill persons to have the option to live their final days on their terms and die with their dignity.”
National polls conducted by Web MD, using its Medscape platform, have shown strong and growing support for medical aid in dying among doctors (58 percent support), as have surveys of physicians in Arizona (53 percent support), Colorado (56 percent support), Maryland (54 percent support or neutral), and Massachusetts (60 percent support).
NOTE: Full results of the survey are attached as a PDF, or available here: www.compassionandchoices.org/new-york-physicians-support-medical-aid-in-dying/.
Compassion & Choices is the nation’s oldest, largest and most active nonprofit organization committed to improving care and expanding choice at the end of life. Compassion & Choices New York is leading the campaign to give mentally capable, terminally ill New Yorkers the same legal option to request medical aid in dying that people in seven other states – including New York’s neighbor, Vermont – and the District of Columbia currently have.
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