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Monday, October 21, 2019

Premarket analyst action, Oct. 21

Axonics Modulation Technologies (NASDAQ:AXNX) initiated with Overweight rating and $43 (110% upside) price target at Barclays.
GW Pharmaceuticals (NASDAQ:GWPH) initiated with Buy rating and $200 (69% upside) price target at Needham & Co. Shares up 1% premarket.
ShockWave Medical (NASDAQ:SWAV) initiated with Overweight rating and $39 (21% upside) price target at Piper Jaffray.
Zogenix (NASDAQ:ZGNX) initiated with Buy rating and $58 (36% upside) price target at Needham.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) initiated with Buy rating and $18 (124% upside) price target at Needham. Shares up 4% premarket.
Baxter International (NYSE:BAX) resumed with Buy rating and $109 (24% upside) price target at Deutsche Bank.
Omega Healthcare Investors (NYSE:OHI) downgraded to Market Perform at Raymond James. Shares down 1% premarket.
https://seekingalpha.com/news/3507220-needham-likes-gw-pharma-premarket-analyst-action

Immunome teams up with pH Pharma in cancer

Immunome (IMMU +2.4%) inks an agreement with South Korea-based pH Pharma Co., Ltd. aimed at the discovery of novel antibody-drug conjugates (ADCs) for cancer.
Under the terms of the partnership, Immunome will be responsible for initial antibody discovery and prioritization work with its proprietary platform while pH Pharma will conjugate the antibody candidates to its proprietary ADC payloads and test the ADC candidates for safety and efficacy.
PH Pharma will have the right to develop and commercialize the first candidate. The rights to subsequent candidates will be determined via a selection process. The rightholder will pay the other party up to $100M in milestones per product plus royalties. The companies will share revenues from sublicensing deals.
https://seekingalpha.com/news/3507298-immunome-teams-ph-pharma-cancer-shares-2-percent

Soliton up 10% ahead of key data readout

Soliton (SOLY +10%) is up on average volume in apparent reaction to today’s announcement that preliminary data from a proof-of-concept study evaluating its acoustic shock wave technology for the treatment of keloid and hypertrophic scars will be presented on Thursday, October 24, at the American Society of Dermatologic Surgery Annual Meeting in Chicago followed by a webcast on Friday, October 25 at 5:30 pm ET.
https://seekingalpha.com/news/3507312-soliton-10-percent-ahead-key-data-readout

Patient voice overcomes EU ‘no’ for UCB/Amgen’s osteoporosis drug

UCB/Amgen’s osteoporosis drug Evenity (romosozumab) looks set for approval in Europe after regulators finally recommended it, following a successful appeal against a rejection with help from doctors and patients.
The positive opinion by the CHMP follows the FDA’s approval of the drug in April, after a rejection in 2017.
It’s notoriously difficult to overturn a negative opinion from Europe’s CHMP scientific committee, which makes regulatory recommendations that the European Commission nearly always rubber stamps after a few months.
UCB reckons that only 20-25% of appeals against CHMP rejections are successful, and last year only one out of five appeals against negative opinions for new drug applications succeeded.
Dr Pascale Richetta, executive vice president and head of the Bone Patient Value Unit at UCB, said the CHMP’s initial concern was about the cardiovascular safety signal that emerged in the ARCH trial.
In the US, Amgen and UCB got around the initial rejection with a request for a narrower indication in women at high risk of fracture, instead of in the population of all postmenopausal women.
In Europe, the companies have also gone for the more focused indication, but needed testimony from two patients and doctors who highlighted the pressing need for a new therapy to win over the initially sceptical CHMP.
Under the European Medicines Agency’s rules, appeals must not include any new data, and as such companies can only present new analyses and new arguments in favour of approval.
Richetta told pharmaphorum in a telephone interview that the safety issue from ARCH was “based on small numbers”, and that the company may “not have articulated the unmet medical need and how much the benefit was unprecedented.”
“They (the CHMP) looked at further analysis of the data, and also took additional advice from patient representatives and experts on osteoporosis and cardiovascular disease.”
“The patients articulated the unmet medical need, and that one fracture brings risk of another fracture.”
“We are enjoying the remarkable achievement of the regulatory team. We are really proud to have done that for Europe.”
UCB and Amgen will get an equal share of profits from the drug worldwide, and the focus now shifts to launches in Europe following a likely approval later this year.
Aside from the US, the drug is also approved in markets including Japan, Australia, Canada, and South Korea, with other countries likely to follow.
Evenity is important to Amgen as a successor to its blockbuster osteoporosis drug Prolia/Xgeva (denosumab).
Prolia, a RANK inhibitor, is one of Amgen’s top-selling drugs with sales of $2.3 billion last year, but will start losing patent protection in Europe in 2022 and in the US in 2025.
Patient voice overcomes EU ‘no’ for UCB/Amgen’s osteoporosis drug

When Pharmacies Close, Low Income Neighborhoods Lose

The escalating closure of U.S. pharmacies tends to hit independent drugstores and low-income neighborhoods, a new analysis in JAMA Internal Medicine says.
One in eight pharmacies had closed between 2009 and 2015, which “disproportionately affected independent pharmacies and low-income neighborhoods,” the analysis led by researchers from the University of Illinois at Chicago wrote in JAMA Internal Medicine.
“From 2009 to 2015, the total number of U.S. pharmacies increased by 7.8% from 62,815 to 67,721,” the analysis shows. “Of the 74,883 pharmacies in operation at any point during this period, 9,564 (12.8%) had closed by 2015.”
The study comes amid a period of time when large drugstore chains are increasingly adding more healthcare services led by CVS Health, Walgreens Boots Alliance and Walmart. These chains also offer retail clinics at many of their stores that are staffed by nurse practitioners and other clinicians.
But the added services of the large chains and their closer ties with health insurers could be hurting independent chains and some Americans in low income neighborhoods.
When these larger chains form narrow or “preferred networks” that offer financial incentives to stick with one of the larger chains, independent drugstores have been harmed, the research indicates. But the JAMA research also suggests more could also be done that would allow pharmacies to provide more care and access to U.S. patients, particularly in urban areas. And that argument lays some of the blame for independent drugstore closures on U.S. policymakers and lawmakers.
“These findings suggest that policies aimed at reducing pharmacy closures should consider payment reforms, including increases in pharmacy reimbursement rates for Medicaid and Medicare prescriptions,” researchers wrote in their three-page analysis in a “research letter” published online Monday.
“The findings also suggest the importance of understanding the influence of preferred pharmacy networks in order to protect independent pharmacies most at risk for closure, especially in urban areas,” the researchers wrote. “Such efforts are important because pharmacy closures are associated with non-adherence to prescription medications, and declines in adherence are worse in patients using independent pharmacies that subsequently closed.”
Though the report didn’t address closures since 2015, hundreds of drugstores have closed since that time.
Walgreens has closed several hundred drugstores after it bought a portion of Rite Aid’s pharmacies and there have also been retail pharmacies that have filed for bankruptcy protection like Fred’s and Shopko, which also have led to hundreds of store closures and acquisitions by larger and regional chains of the prescription files of these bankrupt chains. CVS, Walgreens, Rite Aid and other larger chains bought or won access to these pharmacies’ prescription files at auctions and other sales.
https://www.forbes.com/sites/brucejapsen/2019/10/21/study-when-pharmacies-close-low-income-neighborhoods-lose-access/amp/

Knee Osteoarthritis: Pain Meds, Including Narcotics, on Upswing

Target Audience and Goal Statement:
Orthopedists, geriatricians, pain management specialists/anesthesiologists, primary care physicians, internists, family medicine physicians
The goal of this study was to compare rates of physicians’ recommendations for physical therapy (PT), lifestyle counseling, and pain medication prescriptions for osteoarthritis (OA) of the knee, and to identify patient-, physician-, and practice-level factors associated with each treatment recommendation.
Questions Addressed:
  • What were the rates of physician recommendations for PT, lifestyle counseling, and pain medication prescriptions for patients with knee OA over the years 2007-2015?
  • How closely did practice coincide with recommendations from professional societies?

Action Points

  • Physical therapy and lifestyle interventions remain underutilized in the management of knee osteoarthritis (OA), while reliance on drug treatment, including opioids, continues to rise, according to a nationwide survey.
  • Understand that these trends suggest that knee OA is primarily managed by controlling symptoms and not by improving physical function, fitness, and overall well-being; the rise in narcotic prescriptions is concerning and warrants attention.
Study Synopsis and Perspective:
According to a nationwide survey, PT and lifestyle interventions remain underutilized in the management of knee OA, while reliance on drug treatment, including opioids, continues to rise.
The rate of referrals to PT by orthopedic specialists fell from 158 per 1,000 visits in the years 2007-2009 to 86 per 1,000 visits in 2013-2015 (β = -0.012, P=0.013), and lifestyle counseling was offered in 184 per 1,000 visits in 2007-2009, but in only 88 per 1,000 in 2013-2015 (β = -0.020, P=0.018), said Samannaaz S. Khoja, PT, PhD, of the University of Pittsburgh, and colleagues.
At those same time points, rates of prescriptions for nonsteroidal anti-inflammatory drugs (NSAIDs) during visits to orthopedic specialists more than doubled, from 132 per 1,000 visits to 278 per 1,000 (β = 0.19, P=0.017), while prescriptions for narcotics tripled, from 77 per 1,000 visits to 236 per 1,000 (β = 0.021, P=0.001), they reported in Arthritis Care & Research.
These trends suggest “that knee OA is primarily managed from a perspective of symptom control and not from the perspective of improving physical function, fitness, and overall well-being,” the researchers wrote.
OA, which is the most common type of arthritis, affects over 30 million American adults. Characterized by the breakdown of cartilage within joints and changes in the underlying bone, it usually develops slowly and worsens over time. OA can inhibit proper function and is a major cause of disability among adults, leaving them less able to perform daily tasks and work activities, creating a major source of financial burden.
Evidence-based clinical practice guidelines have been developed by several professional organizations, which promote nonpharmacological, nonsurgical approaches such as PT and lifestyle modifications (weight loss and exercise) as first-line treatment. These approaches can delay or reduce need for pain medication, knee surgery, and other invasive procedures such as intra-articular injections.
The prevalence of knee OA in the U.S. has risen dramatically in recent years, from 9 million in 2005 to 15 million in 2012, and costs have increased accordingly.
Patients who seek treatment from either orthopedic specialists or primary care physicians may be treated largely pharmacologically — despite the realization that pain medications are not likely to affect disability but only treat symptoms. Little has been known, however, about actual patterns of physician referral, advice, and prescription use for these patients.
To study these questions, the research team analyzed data from the National Ambulatory Medical Care Survey database, which conducts an annual survey of office-based physicians on patient characteristics, reasons for visits, diagnoses, therapeutic choices, and practice types and locations. The data were analyzed in 3-year intervals, from 2007 to 2015.
During that period, the survey included 2,297 visits for knee OA, which represented approximately 67 million weighted physician visits, or about 8 million per year. Two-thirds were to orthopedic surgeons, 21% were to primary care physicians, and the remainder were to other types of specialists.
The majority of patients were white women, with an average age of 64.
Different patterns of treatment were seen for primary care physicians. Unlike with orthopedic specialists, referrals for PT in primary care were low, and did not significantly change from 2007-2009 to 2013-2015 (26 vs 46 per 1,000 visits, β < 0.001, P=0.988). Lifestyle counseling also did not change significantly, from 243 to 221 per 1,000 visits (β = 0.003, P=0.837).
However, significant increases were seen for NSAID prescriptions, from 221 per 1,000 visits to 498 per 1,000 (β = 0.039, P=0.005), along with nonsignificant increases in prescriptions for narcotics, from 233 to 316 per 1,000 visits (β = 0.016, P=0.243).
The observed increases in use of narcotics for pain relief “seems counterintuitive, especially because of the increased awareness of the hazards of chronic narcotic (opioid) use, and because clinical practice guidelines for knee OA either have uncertain or inconclusive recommendations for opioid analgesics or recommend using them very sparingly and in selected cases (e.g., if other treatments failed or patients cannot undergo replacement surgery),” the researchers wrote.
They noted that orthopedic specialists in rural locations were less likely to refer for PT or offer lifestyle advice, which may be due to lack of resources and time pressures. Those practicing in the South were also more likely than those in the Northeast to rely on medications. Demographic factors such as patient age and sex did not appear to influence treatment choices.
One study limitation was its cross-sectional design.
Source Reference: Arthritis Care & Research 2019; DOI: 10.1002/acr.24064
Study Highlights and Explanation of Findings:
In this cross‐sectional analysis examining data from 2007 to 2015 from the National Ambulatory Medical Care Survey, researchers noted that PT and lifestyle counseling were underutilized for managing patients with OA of the knee, “with no trends in improvement over time, while pain medication use has significantly increased” in this patient population, they wrote.
Although PT and lifestyle interventions for knee OA have been part of guideline-based care since 1995, the utilization of these recommendations remains low.
“Physicians seem more focused on helping their patients manage their pain with medications, which includes both NSAIDs and narcotic medications,” Khoja told MedPage Today. “However, it is important to consider the long-term benefits of lifestyle interventions, such as weight management, exercise, and PT, for mitigating declines in physical health and reducing dependence on medications.”
“Management of knee OA through physical therapy or lifestyle counseling may reduce overall healthcare utilization by minimizing the continuous need for pain medication and delay the need for knee surgery and other invasive procedures (e.g., intra-articular injections),” Khoja and colleagues wrote.
“Future research to develop strategies to overcome barriers to patient care and to effectively implement guideline-based care for patients with knee OA is warranted,” they concluded.
Last Updated October 18, 2019
Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

Emergent BioSolutions to Host 2019 Analyst & Investor Day

Emergent BioSolutions Inc. (NYSE: EBS) today announced that the company will host an analyst and investor day on November 21, 2019 in New York City. This event, which is designed for sellside research analysts and institutional investors, will begin at 8:00 AM EST and end at 2:00 PM EST.
Institutional and analyst attendees who choose to participate onsite must register, as space is limited. To register for onsite participation at the event or for more information, please contact Robert Burrows, IRO for Emergent BioSolutions at burrowsr@ebsi.com or (240) 631-3280.
Event Agenda
Emergent’s senior management will provide a detailed overview of the company’s 2020-2024 Growth Strategy. Presenters include President and CEO, Robert G. Kramer; EVP, Business Operations, Adam Havey; EVP Corporate Development and General Counsel, Atul Saran; EVP and CFO, Richard Lindahl; and the heads of Emergent’s four business units.
Lunch will be provided following the completion of the formal portion of the event.
Webcast Information
A live audio-only webcast of the formal portion of the event as well as presentation materials will be available on the Investor Relations homepage of the company’s website at https://investors.emergentbiosolutions.com/. The audio and accompanying presentations will be archived on the company’s website after completion of the event.
https://www.biospace.com/article/releases/emergent-biosolutions-to-host-2019-analyst-and-investor-day/