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Sunday, January 27, 2019

Purdue, Alivio in Partnership to Advance ALV-107, a Non-Opioid


Purdue Pharma L.P. (“Purdue”) and Alivio Therapeutics today announced that they have entered into a partnership to advance one of Alivio’s product candidates through clinical development with an option exercisable by Purdue to collaborate on a limited number of additional compounds utilizing Alivio’s inflammation-targeting technology. ALV-107 is a non-opioid treatment being developed for interstitial cystitis/bladder pain syndrome (IC/BPS).
Alivio will receive up to $14.75 million in upfront and near-term license exercise payments and is eligible to receive royalties on product sales and over $260 million in research and development milestones. Purdue also has an option to invest in Alivio’s next equity financing.
“This collaboration with Alivio is an important milestone in our continued pursuit of non-opioid treatments for pain and represents yet another step to�further diversify our portfolio,” said Craig Landau M.D., President and CEO of Purdue Pharma LP. “We are impressed with Alivio’s innovative platform technology as we focus on addressing patient needs – especially in areas where there are few efficacious treatment options.”
Alivio’s inflammation-targeting technology is designed to enable therapeutics such as small molecules, biologics and nucleic acids to act exclusively at sites of inflammation based on the degree of inflammation in the tissue, while sparing healthy tissue. This approach is being evaluated by Alivio internally across a variety of inflammatory diseases, including IC/BPS, pouchitis, and inflammatory bowel disease (IBD).
“We are delighted to enter into this partnership to advance ALV-107 for the potential treatment of interstitial cystitis/bladder pain syndrome. Alivio’s non-opioid approach could provide a novel treatment option for a disease where there is a tremendous unmet need,” said Eric Elenko, PhD, PureTech’s Chief Innovation Officer and a Co-founder of Alivio Therapeutics. “The Alivio platform technology is designed to address a range of inflammatory conditions, and we are rapidly progressing its potential application across pouchitis and inflammatory bowel disease as part of our internal R&D.”
The ALV-107 program recently received a $3.3 million U.S. Department of Defense (DoD) Technology/Therapeutic Development Award. The funds are directed to support Alivio’s preclinical research and development activities, including GMP manufacturing, to enable the filing of an investigational new drug (IND) application.
Alivio’s platform technology has demonstrated proof-of-concept in ten different preclinical models of inflammation including a validated preclinical model for the treatment of IC/BPS. ALV-107relieved pain at all study time points post therapy (vs. vehicle-only control: at 2 hr, p=0.002; 4 hr, p=0.002; 24 hr, p=0.0003). In contrast, the conventional lidocaine-treated group showed statistically significant pain relief only 2 hours post-treatment (p=0.030). Safety and efficacy of ALV-107 will be evaluated during a clinical development program. There is no guarantee that this investigational agent will successfully complete clinical development or gain health authority approval.
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Shared Decision-Making ‘May Sway Patients’ Idea of Fault, Liability’


Shared decision-making can significantly lower the probability that patients will file lawsuits and complaints, according to a simulation study.
Multiple benefits have been associated with shared decision-making, such as facilitating patient-centered care and managing overutilization of lab tests as informed patients forego invasive exams.
Shared decision-making provides clinicians with a measure of legal relief, researchers wrote in the Annals of Emergency Medicine. “Although intent as reported on a survey does not always predict behavior, our results suggest that the use of shared decision-making confers medicolegal protection in the event of an adverse outcome,” they stated.
The researchers used a web-based research recruitment platform to enlist 800 study participants. The participants were surveyed after completing decision-making vignettes for an appendicitis scenario.
They reported that study participants who engaged in brief or thorough shared decision-making were 80% less likely to want a lawyer than participants who did not engage in shared decision-making.
“Participants exposed to either level of shared decision-making reported higher trust, rated their physicians more highly, and were less likely to fault their physicians for the adverse outcome compared with those exposed to the no shared decision-making vignette,” the researchers wrote.
Lead author Elizabeth Schoenfeld, MD, an assistant professor in the department of emergency medicine at UMass Medical School-Baystate in Worcester, Massachusetts, said there are three primary barriers to shared decision-making.
Find the Time
“Clinicians feel that shared decision-making takes up too much time,” Schoenfeld said, adding that it takes organizational commitment to include patient preferences in decision making.
“We can’t just create work-arounds, like sending patients decision aids in the mail, or having a non-clinician start the shared decision-making process. We have to actually commit to giving clinicians time to have these conversations,” she stated. “Clinicians, for their part, can get better at having these conversations efficiently, but a conversation will always take longer than a directive.”
Weigh the Options
Clinicians often feel shared decision-making is inappropriate because the options are not equally advisable, she said.
“The clinician thinks that option A is probably better for the patient than option B, and therefore doesn’t want to discuss the options. The problem with this is that many of our ‘medically reasonable’ decisions have consequences to patients that we have either not considered or have not given sufficient weight.”
Clinicians need to commit to shared decision-making even when they think one option makes more sense, Schoenfeld stressed: “We need to remember that decisions that seem straightforward to us may be less so when the patient’s preferences are considered.”
Encourage Patient Participation
Many clinicians assume that some of their patients do not want to be involved in shared decision-making, but patients want to be involved in decisions when they understand the consequences, she said.
“This means that clinicians should err on the side of thoroughly explaining options and consequences before they seek patient feedback,” Schoenfeld said. “It also probably reflects that we could all be better at communicating medical decision-making.”

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Barrington Research Reaffirms Buy Rating for Varian


Barrington Research restated their buy rating on shares of Varian Medical Systems (NYSE:VAR) in a research note released on Thursday.
“We are maintaining our OUTPERFORM investment rating on VAR shares and are increasing our price target to $135 from our previous $132. We arrive at our price target by attaching a 17.5x multiple to our adjusted EBITDA estimate for FY/19. We assume $800 million in net cash 12 months from now.”,” the firm’s analyst commented.
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Dr. Reddy’s, U.S. Unit Promius, OKd for Migraine Nasal Spray


Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and its subsidiary, Promius Pharma, LLC today announced the approval of TOSYMRA (previously known as DFN-02) by the U.S. Food and Drug Administration (FDA). TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is the latest product to join the Promius Pharma acute migraine treatment portfolio. The company is working toward commercialization of this product.
“We are excited about the approval of TOSYMRA. This approval affirms our ability to develop well-differentiated products to meet the unmet needs of patients with migraine and HCPs treating them,” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories.
According to Dr. Anil Namboodiripad, PhD, President, Promius Pharma, “TOSYMRA nasal spray is formulated using a proprietary novel excipient known as Intravail® to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, resulting in rapid onset of action. Independent research shows that 26% to 40% of migraine patients are not optimally controlled with their current treatment.1 For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. At Promius, we are committed to developing new ways of improving patient experiences. TOSYMRA is a mist-like nasal spray that acts rapidly and is well tolerated.”
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FDA Action Alert: Sanofi, Alkermes, Andor


Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA).
Sanofi Pasteur’s Fluzone Quadrivalent Flu Vaccine
Sanofi Pasteur had a target action date of Monday, January 28 for its Fluzone Quadrivalent Influenza Vaccine. It is for a supplemental Biologics License Application (sBLA) to include children 6 through 35 months of age. The agency approved the vaccine in the 0.5 mL dose for that age group on January 23. The company indicates it will also have the 0.25 mL dose available for the 2019-20 flu season for the expanded age range.
During the 2017-2018 flu season, the Centers for Disease Control and Prevention (CDC) confirmed 185 influenza-related pediatric deaths.
“Offering pediatricians the convenience of the same 0.5 mL dose option for children, may help streamline immunization efforts,” stated David P. Greenberg, Regional Medical Head North America, Sanofi Pasteur. “The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering.”

Alkermes and ALKS 5461 for Major Depressive Disorder
Alkermes has a target action date of Thursday, January 31 for its ALKS 5461 for adjunctive treatment of major depressive disorder (MDD) in patients with inadequate response to standard antidepressant treatments. On November 1, 2018, the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted not to recommend the drug. The vote was 2 for and 21 opposed. Although the FDA is not required to follow the recommendations of the Adcoms, they typically do.
ALKS 5461 missed targets in two late-stage trials in 2016, but another Phase III trial later in that year showed the drug significantly reduced symptoms of depression with patients with MDD compared to placebo.
“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the Advisory Committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants,” stated Richard Pops, Alkermes’ chief executive officer. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”
Andor Pharmaceuticals’ Generic to J&J’s Concerta for ADHD
Andor Pharmaceuticals has a target action date of Friday, February 1, for its methylphenidate hydrochloride extended-release tablets, a generic version of Janssen’s Concerta for attention deficit hyperactivity disorder (ADHD). On August 3, 2018, Andor signed a licensing dealwith Lannett Company for Lannett to market the drug, once approved.
“We look forward to returning to this AB-rated Methylphenidate market,” stated Tim Crew, Lannett’s chief executive officer. “Based on Andor’s target action date of February 1, 2019, we are optimistic about launching the product well within calendar 2019. The product adds to the sizable number of products we expect to launch in the near term.”
In the 12-month period ending June 2018, total U.S. sales of Methylphenidate Hydrochloride Extended-Release tablets were about $1.8 billion.
Evolus’ Resubmission of a BLA for Jeuveau for Frown Lines
Evolus has a target action date of February 2 for its resubmission of its BLA for Jeuveau (prabotulinumtoxinA) for frown lines. On November 19, the FDA gave conditional acceptance of the Jeuveau brand name and its partnership with The American Society for Aesthetic Plastic Surgery (ASAPS).
“The unveiling of the Jeuveau brand and our partnership with key medical societies are significant milestones as we advance towards commercialization in anticipation of a Spring 2019 U.S. commercial launch,” stated Michael Jafar, Evolus’ chief marketing officer.
The product is the first 900 kDa botulinum toxin since Botox, and in several Phase III trials has demonstrated non-inferiority to Botox.
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Cal. AG blocks sale of 2 Santa Clara hospitals; officials respond


Santa Clara County officials and health system staff criticized California Attorney General Xavier Becerra’s requested stay of the sale of two at-risk community hospitals.

KEY TAKEAWAYS

Santa Clara County officials argue that if the sale is halted, the two facilities will shutter.
California Attorney General Xavier Becerra said the county has not agreed to certain provisions ensuring protected healthcare access.
The appeal hearing is set for January 30, ahead of the March 4 deadline for the deal to close.
The recent decision by California Attorney General Xavier Becerra to halt the planned $235 million sale of two financially struggling hospitals to Santa Clara County has been met with derision from local leaders and staff at both facilities.
County officials held a press conference Thursday afternoon to discuss the financial and clinical implications of Becerra’s motion to request a stay on the sale of O’Connor and Saint Louise hospitals, located in San Jose and Gilroy, respectively.
Advocates for the deal, which was approved by U.S. Bankruptcy Court in Los Angeles in December, argue that Becerra’s decision to block the sale to Santa Clara could result in the closure of both hospitals.

At the press conference, Miguel Márquez, COO of Santa Clara, stated that the county was the only available buyer for the two hospitals and that the municipality is not “out to make a profit” on the purchase.
Márquez added that if the deal fell through, the county would lose 451 beds between the two hospitals and thousands of clinical staff would become unemployed. He also predicted that pressure on other local health systems to handle additional patients would rise as a result of the closure.
The parent company for both hospitals, Verity Health System, is selling the facilities after filing for bankruptcy in August and openly considering selling four other California hospitals over the summer.
The purchase agreement requires the deal to close by March 4, according to The Mercury News, and a hearing to consider Becerra’s stay request is set for January 30.
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Ochsner reduces patient falls by 51% with telesitters


Remote monitoring with mobile camera units improves patient safety and saves money

How do you reduce patient falls across all medical-surgical units in 11 hospitals by 51%? Ochsner Health System did it by rolling out a remote telesitter program, enabling trained patient safety assistants to monitor up to 57 patients each shift via mobile cameras rolled into the rooms of at-risk patients.
Telesitter programs at hospitals across the country have reported similar reductions in falls, as well as savings over utilizing bedside sitters. Costs vary by institution, but UC San Diego Health reports saving $2.5 million over two years.
According to the Agency for Healthcare Research and Quality, 700,000 to 1 million patients suffer a fall in a U.S. hospital each year. Some 30% to 50% of these falls result in injury, according to a Sentinel Event Alert published by The Joint Commission on September 28, 2015.
A deeper look into Ochsner’s telesitters initiative could be helpful to other health systems seeking ways to improve patient safety and reduce costs. We explore the device behind this solution, as well as other innovative  tech tools in the January/February issue of HealthLeaders magazine.

THE TECHNOLOGY

Ochsner began using the AvaSys TeleSitter Solution by AvaSure in May 2016. This mobile device, a continuous virtual patient safety and engagement platform, includes a two-way camera and speaker on a rolling unit, similar to an IV pole. Trained telesitters can monitor up to 16 patients simultaneously (Ochsner telesitters monitor 12 patients each), replacing the need—and cost—for most bedside sitters, while also expanding the number of patients that can be monitored.
Telesitters can speak directly to patients or nurses, activate an automated message if a patient tries to get out of bed while the sitter is speaking to a different patient, or sound an alarm to alert nurses on the floor to attend to the patient.
The camera has the ability to tilt, zoom, and pan. While some facilities opt for equipment that is permanently installed in a room or portable, wall-mounted units, the mobile option offers flexibility and convenience to quickly transport technology to beds where it’s most needed.
Among the advantages this technology delivers:
  • Reduces the risk of patient falls
  • Reduces labor costs for bedside sitters
  • Conserves nursing resources
  • Prevents patient elopements

OCHSNER’S APPROACH

Ochsner has a total of 26 patient safety assistants who have been trained as remote telesitters. Five telesitters work 12-hour shifts alongside nurses who monitor the health system’s eICU patients. There are 57 camera units available to all med-surg units throughout the 11-hospital system, and the devices have a 95% utilization rate.
Training for patient safety assistants, as well as nurses on the units, was provided by AvaSure and an essential component of the program, says Anita Campbell, director of Ochsner’s critical care telemedicine and telesitter program. “At the heart of all technology,” says Campbell, “you have to have your people engaged on both ends of the camera and the right processes in place.”
Initially, there was some resistance from nurses on the units who were concerned about having a camera in the room. Now, they “fight” over the cameras, Campbell says, because “they see we are preventing their patients from falling. Falling increases their length of stay and could result in injuries with harm. We’re helping reduce that.”
The program also enables Ochsner to “cast a broader net,” she says, covering a more patients than the system would have been able to monitor via bedside sitters.
Ochsner does not charge patients for the telesitter services and is not reimbursed for it by payers. “It’s considered a standard of care,” says Campbell. ” We don’t need a physician order, but they might ask for it. It’s available to all (med-surg) patients if your nurse feels like you need it.” It is also possible to run a report from the electronic health record to determine whether a patient is at risk or which patients are high priority.

OUTCOMES

Numerous health systems, hospitals, and rehabilitation facilities report a reduction in falls, as well as reduced expenses for bedside sitters because telesitters are able to monitor more patients simultaneously:
  • Ochsner Health System reports a 51% reduction in falls on monitored units and a 26% reduction in the overall system fall rate. Based on total patient days, Campbell says that 91% of Ochsner patients are less likely to fall due to the TeleSitter program.
  • Northwell Health’s Northern Westchester Hospitalexperienced a 54% reduction in falls and a 72% reduction in sitter expenses, as reported in the September 6, 2018, issue of Journal of Nursing Care Quality.
  • TIRR Memorial Hermann experienced a 60% reduction in bedsitter costs by using telesitters (who could monitor multiple patients simultaneously), as reported in the July 1, 2015, issue of Healthcare Risk Management. The facility also had a corresponding 54% reduction in staff injuries related to the care of brain-injured patients, which the hospital attributes to the ability to remotely interact with patients rather than intervene in person.
  • By using the device and trained telesitters, UC San Diego Health decreased bedsitter costs by $2.5 million over two years as published in the June/July 2015 issue of Journal of Nursing Administration.
  • Sunnyview Rehabilitation Hospital experienced a 20% reduction in falls and saved $186,000 in bedsitter costs as reported in the March/April 2018 issue of Rehabilitation Nursing Journal .

BEHIND THE INNOVATION

The solution AvaSys TeleSitter Solution has been deployed in hundreds of U.S. hospitals and was created by CEO Brad W. Playford, who founded AvaSure a decade ago to develop a clinical solution for his video surveillance company.

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