Stryker initiated with a Buy at Deutsche Bank. Deutsche Bank analyst Pito Chickering started Stryker with a Buy rating and $179 price target. Deutsche had a Buy rating on the shares under analyst Kristen Stewart before going restricted on the name in June of 2018.
Wednesday, January 2, 2019
Amgen, Teva resolve patent dispute over generic Cinacalet HCl product
Teva Pharmaceutical Industries (TEVA) announced that it has resolved its ongoing dispute with Amgen (AMGN) over Teva’s generic cinacalcet HCl product. Teva and Amgen have been involved in patent infringement litigation, and Teva recently received approval for, and launched its generic product in the US. By virtue of the settlement, the litigation between the parties will be ended and Teva has agreed to stop selling its generic product until its license date in mid-year 2021, or earlier under certain circumstances. Teva will pay Amgen an undisclosed amount as part of the settlement. That amount and other terms of the settlement remain confidential. Cinacalcet is a calcium-sensing receptor agonist indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. It is also used for the treatment of hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
Pain Management Task Force Calls for ‘Integrative’ Treatment Plan
A Congressional task force stressed that non-opioid medications and non-pharmacologic therapies should be used as first-line treatment for pain management.
In a draft report released on Dec. 28, 2018, members of the Pain Management Best Practices Inter-Agency Task Force also recommended developing condition-specific guidelines that incorporate a “biopsychosocial model” of care, and emphasized the importance of careful evaluation of patients and proper risk assessment, particularly in light of the nation’s growing opioid crisis, in patients with chronic and acute pain.
“It is imperative to strike a balance between ensuring that patients with painful conditions can work with their health care providers to develop an integrative pain treatment plan that optimizes function, quality of life… and productivity while also ending the devastating effects of opioid misuse,” they stated.
The task force was established to identify “gaps and inconsistencies” in pain management as part of the Comprehensive Addiction and Recovery Act of 2016. The task force includes representatives from the Department of Health and Human Services (HHS), the Department of Veterans Affairs, the Department of Defense, and the Office of National Drug Control Policy.
Members of the public will have 90 days to provide comments on the proposed recommendations.
Around 47,600 people died from opioid overdoses in 2017, according to the CDC. In addition, there are 50 million adults affected by chronic pain, of which 19.6 million have “high-impact chronic pain” that can make work and daily activities a challenge, the report noted.
Mounting public awareness and government pressure has seen clinicians reducing the number of opioids prescriptions they give patients, the task force said. This heightened concern over inappropriate prescribing of opioids that has, in some cases, led to unintended consequences, including “patient abandonment,” “forced tapering,” and patients moving from prescription drugs to illicit drugs such as fentanyl and heroin, according to the report.
The authors recommended increasing the use of specific clinical practice guidelines (CPG) for individual diagnoses or causes of pain. They also called for increased access to effective pain management treatment, and for pain management to become a part of “routine training” for clinicians, particularly during residency.
Other recommendations include:
- Use non-opioid medications (acetaminophen, nonsteroidal anti-inflammatory drugs or NSAIDS) with non-pharmacologic treatments as first-line therapy in both in-patient and out-patient settings “whenever possible”
- Begin opioid therapy only when “benefits outweigh the risk” and follow evidence-based guidelines
- Use “procedure-specific, multimodal regimens and therapies” before, during, and after an operation including nonopioid medications, nerve blocks, analgesia, and psychological therapies to lessen opioid exposure
- Primary care clinicians and other non-pain specialists should collaborate early with pain specialists for patients with complex pain to mitigate complications
- Establish appropriate reimbursement to enable a “multi-modal approach” to address acute pain in the perioperative setting
- Establish guidelines for managing acute pain for common surgical procedures and trauma
The task force suggested that guidelines emphasize an individualized approach to treatment of acute pain “accounting for patient variability” with respect to comorbidities, severity, and other factors, and focus on improved pain control, quicker recovery, and earlier mobilization, while reducing risk of blood clots, pulmonary embolism, and excess opioid exposure.
They also called for clinician training on prescription drug monitoring programs (PDMP), noting that clinicians should discuss PDMP data with patients to avoid errors that could lead to inappropriate care.
The task force discussed the risks and benefits of non-opioid pharmacotherapies used for chronic pain, such as anticonvulsants and antidepressants, and touched on restorative therapies (physical therapy, occupational therapy). They pointed out that use of the latter is “often challenged by incomplete or inconsistent reimbursement policies.”
As for opioids, the report noted that “although effective for moderate to severe acute pain, the effectiveness of opioids beyond 3 months requires more evidence.” The authors called attention to a 2018 study in JAMA that found that opioid treatment on its own was “not superior” to treatment with different combinations of non-opioid therapies over 12 months. The JAMA study authors concluded that “This study does not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.”
The report cited the debate over establishing a “ceiling dose” for opioids — the CDC’s dose limit of 90 morphine milligram equivalents per day — but determined that “establishing such a ceiling is difficult, and the precise level for such a ceiling has not been established. The risk of overdose increases with the dose, but the therapeutic window is highly variable.”
The task force also echoed a 2018 recommendation from HHS and encouraged “take-home naloxone” for patients and family members when a patient is on long-term opioids.
The task force held two public meetings in 2018 to gather feedback from patients and stakeholders. It also reviewed patient testimonials, best practices, and explored “relevant medical and scientific literature” in addition to consulting with government and nongovernment experts in pain management.
Does Medical Marijuana Relieve Pain? Pain Medicine News Report
A new study found no evidence that medical marijuana reduces pain severity or use of prescription opioids.
In a recent commentary, pain medicine experts voiced concern over forced opioid tapering.
Researchers have found that tetrahydrocannabinol (THC) decreases pain as well as neural connectivity among brain regions associated with pain control in patients with chronic radicular neuropathic pain.
Continuous ketamine infusions appear to reduce chronic pain following acute trauma, preliminary data show.
Researchers recently validated a model for patients undergoing spine surgery that predicts risk factors for postoperative pain.
Boyu Capital aids Celgene-partnered Antengene to fast commercialization
Shanghai-based Antengene has ushered in the first biotech mega-round of the year, designed to fuel a quick commercial turnaround of in-licensed cancer drugs.
The $120 million Series B marks a significant boost for the young biotech, which was founded in April 2017 on a deal with Celgene $CELG, and quite possibly the last financing round before Antengene heads to an IPO — according to previous comments by CEO Jay Mei.
Boyu Capital led the round alongside FountainVest, with help from Series A leader Qiming Venture Partners, founding investor Celgene, as well as WuXi Corporate Venture Fund and Taikang.
“We view in-licensing of first-in-class/best-in-class drug candidates as an effective solution to the unmet clinical needs in China,” said Boyu managing director Yanling Cao in a statement. “In addition, we are very impressed with the progress that Antengene is making and the pipeline they are building.”
Aside from Celgene’s TORC1/2 inhibitor — now dubbed ATG008 — Antengene’s pipeline includes another lead program in-licensed from Karyopharm in a partnership that covered three other early-stage assets. ATG-010, or selinexor, is in Phase III trials for multiple myeloma and liposarcoma.
While the cash infusion will go a long way in funding the later-stage development of these assets, further beefing up the company’s pipeline and preparing for a potential commercial launch, an IPO — with a 50/50 chance of falling in the US and Hong Kong — could be looming in the next 12 months.
“We need to be ready,” Mei told a group of reporters at the BIIS conference organized by Endpoints News and PharmCube last October. “The market doesn’t wait for companies. Companies must catch market opportunities.”
Antengene is also building a 160,000-plus square feet manufacturing site in Shaoxing, China to supply its own clinical and commercial drugs.
Bausch Health Largest Percent Increase Since September
Bausch Health Companies Inc. (BHC.T) closed at C$27.47, up C$2.22 or 8.79%
— Highest close since Dec. 18, 2018, when it closed at C$28.16
— Largest percent increase since Sept. 12, 2018, when it rose 12.76%
— Earlier Wednesday, Piper Jaffray’s David Amsellem upgraded Bausch Health Companies to overweight and raised his price target to $27 from $22. “Though we have been unrelentingly negative on the company for years (at least up until a few months ago), we believe it is time to turn the page following a closer look at the business,” Amsellem said
— Down 92.07% from its all-time closing high of C$346.32 on Aug. 5, 2015
— Down 4.82% from 52 weeks ago (Jan. 3, 2018), when it closed at C$28.86
— Down 24.47% from its 52 week closing high of C$36.37 on Oct. 3, 2018
— Up 43.45% from its 52 week closing low of C$19.15 on March 2, 2018
— Traded as high as C$27.64; highest intraday level since Dec. 19, 2018, when it hit C$28.60
— Up 9.47% at today’s intraday high; largest intraday percent increase since Sept. 12, 2018, when it rose as much as 15.63%
Big claims strain senior living market for U.S. insurers
Last March, a 103-year-old resident of a Sunrise Senior Living facility in Willowbrook, Illinois, went on a field trip to the movies. Ruth Smith, who used a walker, fell down two concrete steps in the theater and died about six weeks later. Now Smith’s estate is suing Sunrise, saying that aides did not properly watch her.
As the U.S. society ages, senior living communities are on the rise. So are claims and lawsuits against them. And when they lose, it is usually down to insurers to pay up.
“It’s a tremendous opportunity that has pretty specific challenges,” said Brendan Gallagher, who heads the senior care business at insurance broker Arthur J. Gallagher & Co.
Some senior living facilities could see insurance rate hikes in 2019 as high as 30 percent, according to insurance broker Willis Towers Watson.
Fewer insurers are offering coverage today than they were five years ago and some Lloyd’s of London members stopped writing the coverage during the past year, said John Atkinson, managing partner at Willis.
Some insurers are dropping coverage of those communities entirely while others are avoiding litigious locations such as Kentucky, Illinois and Florida, said insurers and brokers.
While the pullback threatens to raise costs for families, other insurers are expanding, betting on the industry’s strong growth prospects.
The number of people living in U.S. residential care facilities has grown by over 10 percent to 812,000 between 2010 and 2016, according to the most recent data from the U.S. Centers for Disease Control and Prevention.
As the industry gears up for the arrival of the greying 74-million baby boom generation, senior living facilities have grown even faster. The number of rooms in those centers has risen up by a fifth since 2013, according to the National Investment Center for Seniors Housing & Care (NIC), which collects data for the 99 largest U.S. metro areas.
While aging is a global phenomenon and the U.S. society is relatively younger than those in Europe and north Asia, its greater dependence on senior centers confronts it with challenges other nations may yet have to grapple with.
More so than previous U.S. generations, today’s elderly often live far away from their children. In Europe, seniors tend to live much closer to their relatives or in communities that provide generous government services for the elderly. In many Asian and African communities, multiple generations commonly live together.
Not only do more people move into retirement communities, but they tend to do it later than they used to, resulting in more frequent and severe injuries, insurance professionals say.
“People are living longer and they are more frail,” said Gloria Holland, vice president of finance at Capital Senior Living Corp, a Dallas-based company that runs 129 communities across the country.
A spokeswoman for Sunrise Assisted Living, where Smith lived, said the company had policies and procedures in place to help promote resident safety. “Anytime we lose a member of our community we are deeply saddened,” she said.
Falls are the biggest risk. Allegations of falls account for nearly half of all assisted living claims that insurer CNA Financial Group clo
sed in 2016 and 2017, the company said. (Graphic: https://tmsnrt.rs/2GzYrHM
sed in 2016 and 2017, the company said. (Graphic: https://tmsnrt.rs/2GzYrHM
Another source of insurance claims are “memory care” centers, which cater to people with Alzheimer’s disease and other types of memory problems.
The nascent sector has grown 52 percent since 2013, according to NIC. A big issue there: residents who wander away.
Last year, the body of 77-year-old Audrey Penn was found in a ditch after she left a senior living community in Allentown, Pennsylvania. A lawsuit filed by her family settled for an undisclosed amount.
A CHANGING AMERICA
Capital Senior Living’s Holland said the average age of residents who moved to its facilities was between 78 and 80 when she joined the company in 2004 and has risen to between 82 to 84 by now. That makes individual claims more expensive to settle. The company anticipates a 5 percent rate increase when it renews its insurance in 2019, Holland said.
Higher rates and deductibles are more likely to affect smaller facilities, which may lack robust compliance programs for preventing accidents and other problems, insurers and brokers say. Smaller centers often “struggle to keep up with changing regulations,” said Caroline Clouser, who heads the healthcare industry practice at insurer Chubb Ltd.
Insurance premiums for senior facilities vary by state. Premiums for each assisted living apartment range from $150 to $600 annually, insurers and brokers say.
Insurance for those facilities makes up less than 1 percent of the $558 billion property and casualty insurers collected in net written premiums in 2017. Yet it is likely to grow as aging boomers fill up senior communities, industry insiders say.
Nationwide is among the companies that have been growing their senior living insurance business while being selective, said Jeremy Moore, senior living underwriting manager.
“You have to understand what the exposures are and the controls in place,” he said.
Nationwide has a team of former senior living executives and administrators who visit communities and look at everything from building maintenance to evacuation procedures, Moore said.
Wisconsin-based Church Mutual Insurance Company, which writes coverage for the industry in 49 states, is planning to expand into Florida, the remaining state, in 2019, according to Jim Ketterson, who heads the insurer’s senior living practice.
Brokers are also working to help senior living communities better manage their risk. Willis recently launched a program to help facilities learn how to more safely lift residents.
Willis also runs a webinar on active shooter events, including tips such using beds to block doors that do not lock, a common feature in memory care facilities.
Senior living companies also keep reviewing their facilities and procedures, they say. For example, Capital Senior Living is gradually replacing carpet flooring with laminate, which is less of a trip hazard, Holland said. It is also considering a technology that can help track residents’ movements to determine if they are at risk of a fall.
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