GW Rallies On Strong Q2 Epidiolex Sales, Says European Approval Expected In Oct.

GW Pharmaceuticals PLC-ADR (NASDAQ: GWPH), the British manufacturer of the CBD drug Epidiolex, said Tuesday that the medication posted net sales of $68.4 million during the quarter and $101.9 million in the first half of 2019.

GW Pharma posted $72 million in revenue in the quarter versus $3.3 million in the same period last year.

Epidiolex has been prescribed to more than 12,000 patients since its launch, the company said. Patients are now being recruited for a Phase 3 trial in Rett Syndrome.

GW’s second-quarter EPS of 21 cents was higher than a 25-cent loss in the same quarter last year, and sales of $72.038 million beat a $47.05-million Street estimate.

European Commission approval of the drug is expected in early October, and Epidiolex is set for fourth-quarter launches in France, Germany and the U.K., according to GW Pharma. The drug is set to launch in Spain and Italy in 2020.

GW is pleased by strong Epidiolex sales in the U.S., CEO Justin Gover said in a statement.

“With the recent positive Phase 3 trial in Tuberous Sclerosis Complex, we expect to submit an sNDA by the end of 2019 with the goal of expanding the Epidiolex label and market opportunity to include both children and adult patients with TSC, a highly treatment-resistant condition.”

https://www.benzinga.com/general/biotech/19/08/14213402/gw-pharma-rallies-on-strong-q2-epidiolex-sales-says-european-approval-expected-in-october

Newly developed approach shows promise in silencing HIV infection

Researchers from The University of Texas Medical Branch at Galveston have discovered a new potential medication that works with an HIV-infected person’s own body to further suppress the ever present but silent virus that available HIV treatments are unable to combat.

Although the potential new drug could complement the current HIV anti-retroviral therapy (ART) medications, it may also be possible that it could lead to HIV remission without a lifetime of taking ART medications. The findings are published in the Journal of Clinical Investigation.

The HIV virus gets integrated into the infected person’s genetic coding and establishes a constant dormant infection, creating a big treatment challenge. Because of this, current ART medications fail to cure the virus and when someone stops the drug, the virus almost always begins to multiply and wreak havoc. Drug resistance is also a public health issue with the ART medications. Being able to induce a sustained HIV remission free of ART is an important goal for HIV treatment.

“We are the first to show that human BRD4 protein and its associated machinery can be harnessed to suppress dormant HIV,” said senior author Haitao Hu, UTMB assistant professor in the department of microbiology and immunology. “Our findings are exciting because they not only improve our understanding of the biology of HIV epigenetic regulation, they also present a promising approach for the development of probes and/or therapeutic agents for HIV silencing, hopefully leading to cure of the virus eventually.”

In the laboratory study, the researchers found that the protein BRD4 plays an important role in regulating the production of new copies of the HIV gene. The team successfully designed, synthesized and evaluated a series of small molecules to selectively program BRD4 to suppress HIV and identified a lead compound called ZL0580. They tested the lead molecule in HIV infection models and found that it significantly delayed dormant HIV reactivation after ART cessation in blood cells of ART-treated, HIV infected people.

“We will continue to optimize the chemical structure and effectiveness of this class of molecules and conduct safety testing in cellular and animal studies,” said co-senior author Jia Zhou, UTMB professor in the department of pharmacology and toxicology. “We look forward to the time when we can begin clinical trials so that this approach can begin to help HIV-infected individuals.”

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Other authors include UTMB’s Qingli Niu, Zhiqing Liu, Edrous Alamer, Xiuzhen Fan, Haiying Chen, Janice Endsley, Benjamin Gelman and Bing Tian as well as Jintanat Ananworanich, Nelson Michael, Jerome Kim and Merlin Robb from the U.S. Military HIV Research Program.

https://www.eurekalert.org/pub_releases/2019-08/uotm-nda080619.php

Robotic cane shown to improve stability in walking

By adding electronics and computation technology to a simple cane that has been around since ancient times, a team of researchers at Columbia Engineering have transformed it into a 21st century robotic device that can provide light-touch assistance in walking to the aged and others with impaired mobility.

A team led by Sunil Agrawal, professor of mechanical engineering and of rehabilitation and regenerative medicine at Columbia Engineering, has demonstrated, for the first time, the benefit of using an autonomous robot that “walks” alongside a person to provide light-touch support, much as one might lightly touch a companion’s arm or sleeve to maintain balance while walking. Their study is published today in the IEEE Robotics and Automation Letters.

“Often, elderly people benefit from light hand-holding for support,” explained Agrawal, who is also a member of Columbia University’s Data Science Institute. “We have developed a robotic cane attached to a mobile robot that automatically tracks a walking person and moves alongside” he continued. “The subjects walk on a mat instrumented with sensors while the mat records step length and walking rhythm, essentially the space and time parameters of walking, so that we can analyze a person’s gait and the effects of light touch on it.”

The light-touch robotic cane, called CANINE, acts as a cane-like mobile assistant. The device improves the individual’s proprioception, or self-awareness in space, during walking, which in turn improves stability and balance.

“This is a novel approach to providing assistance and feedback for individuals as they navigate their environment,” said Joel Stein, Simon Baruch Professor of Physical Medicine and Rehabilitation and chair of the department of rehabilitation and regenerative medicine at Columbia University Irving Medical Center, who co-authored the study with Agrawal. “This strategy has potential applications for a variety of conditions, especially individuals with gait disorders.”

To test this new device, the team fitted 12 healthy young people with virtual reality glasses that created a visual environment that shakes around the user–both side-to-side and forward-backward–to unbalance their walking gait. The subjects each walked 10 laps on the instrumented mat, both with and without the robotic cane, in conditions that tested walking with these visual perturbations. In all virtual environments, having the light-touch support of the robotic cane caused all subjects to narrow their strides. The narrower strides, which represent a decrease in the base of support and a smaller oscillation of the center of mass, indicate an increase in gait stability due to the light-touch contact.

“The next phase in our research will be to test this device on elderly individuals and those with balance and gait deficits to study how the robotic cane can improve their gait,” said Agrawal, who directs the Robotics and Rehabilitation (ROAR) Laboratory. “In addition, we will conduct new experiments with healthy individuals, where we will perturb their head-neck motion in addition to their vision to simulate vestibular deficits in people.”

While mobility impairments affect 4% of people aged 18 to 49, this number rises to 35% of those aged 75 to 80 years, diminishing self-sufficiency, independence, and quality of life. By 2050, it is estimated that there will be only five young people for every old person, as compared with seven or eight today.

“We will need other avenues of support for an aging population,” Agrawal noted. “This is one technology that has the potential to fill the gap in care fairly inexpensively.”

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About the Study

The study is titled, “Effects of a person-following light-touch device during overground walking with visual perturbations in a virtual reality environment.” The other contributors are Danielle M. Stramel (Columbia Engineering); Robert M. Carrera (Columbia University Irving Medical Center), Sam A. Rahok (Oyama National College of Technology/visiting CUIMC); Joel Stein (Columbia University Irving Medical Center) and Sunil Agrawal (Columbia Engineering).

The authors declare they have no competing financial interests.

LINKS:

Paper: https://ieeexplore.ieee.org/document/8772176

https://www.eurekalert.org/pub_releases/2019-08/cuso-rcs080619.php

CDC: Too Little Naloxone Being Dispensed

Even though prescriptions of the overdose-reversing drug naloxone soared 106% in one year, the drug still isn’t being dispensed often enough, a CDC analysis concluded.

Only one naloxone prescription was dispensed for every 69 high-dose opioid prescriptions in 2018, reported Gery Guy, Jr., PhD, of the agency’s National Center for Injury Prevention and Control, and co-authors in the Morbidity and Mortality Weekly Report.

Naloxone prescriptions doubled from 2017 to 2018, from 270,710 to 556,847, said CDC Principal Deputy Director Anne Schuchat, MD, in a press briefing. And the number of high-dose opioid prescriptions — defined as 50 or more morphine milligram equivalents per day — fell 21% in that period, from 48.6 million to 38.4 million.

But that still fell short, Schuchat said: “If each person with a high-dose opioid prescription were offered naloxone, nearly 9 million prescriptions for naloxone could have been dispensed in 2018.”

And naloxone dispensing was uneven: it was 25 times greater in the highest-dispensing counties than in the lowest-dispensing ones, with rural areas nearly 3 times more likely to be a low-dispensing county than metropolitan locations.

High rates of dispensing also were seen in states such as Arizona and Virginia that require physicians to prescribe naloxone when risk factors for opioid overdose are present, Schuchat pointed out.

In their analysis, the CDC used IQVIA data from approximately 50,400 retail pharmacies to track how the drug was prescribed and dispensed. Overall, naloxone prescribing rates were markedly lower among primary care providers, pain medicine specialists, surgeons, physician assistants, and nurse practitioners. Primary care providers, for example, wrote only 1.5 naloxone prescriptions per 100 high-dose opioid prescriptions.

Providers with higher rates of prescribing naloxone were addiction medicine specialists, psychiatrists, and pediatricians.

Co-pays were needed for 71% of Medicare and 42% of commercial insurance prescriptions for naloxone.

The CDC recommends that healthcare providers consider offering naloxone to all patients at risk for overdose, including people who take high daily dosages of prescription opioids, use benzodiazepines concurrently with opioids, and have a history of substance use disorder, Schuchat noted.

The Department of Health and Human Services also recommends that naloxone should be prescribed with opioids for patients at risk for overdosing. And last year, the U.S. Surgeon General issued a public health advisory urging more Americans to carry and learn the drug. Most states allow naloxone to be sold without a prescription.

The researchers reported no conflicts of interest.

• Primary Source

  Morbidity and Mortality Weekly Report

  Source Reference: Guy G, et al “Vital Signs: Pharmacy-Based Naloxone Dispensing — United States, 2012–2018” MMWR 2019; DOI: 10.15585/mmwr.mm6831e1.

https://www.medpagetoday.com/publichealthpolicy/opioids/81455

Novavax, FDA Agree on Pivotal Phase 3 Trial Design for NanoFlu

Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it received input from the U.S. Food and Drug Administration (FDA) on its End-of Phase 2 questions and has reached agreement on its Phase 3 trial design for NanoFlu™, its adjuvanted recombinant quadrivalent seasonal influenza vaccine candidate for older adults aged 65 and over.

Novavax plans to initiate the pivotal Phase 3 clinical trial of NanoFlu in the fall of 2019, with top-line clinical data expected in the first quarter of 2020. The resulting data would be used to support a future biologics license application (BLA) and licensure of NanoFlu using the accelerated approval pathway. This pathway enables Novavax to conduct a non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure.

“With CDC-reported overall influenza vaccine effectiveness of just 12 percent among older adults during the 2018-2019 season, the pressing need for a more effective vaccine in this population is clear,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are committed to quickly demonstrating that our recombinant nanoparticle approach can help close the gap that exists between circulating flu strains and vaccines produced by traditional methods that frequently result in a mismatch, and ultimately, leave millions vulnerable to the serious consequences of influenza disease.”

https://www.globenewswire.com/news-release/2019/08/05/1897129/0/en/Novavax-Reaches-Agreement-with-the-FDA-on-Pivotal-Phase-3-Trial-Design-for-NanoFlu.html

Short-term health plans spend little on medical care: NAIC

For every dollar in premiums that UnitedHealthcare collected from people enrolled in short-term health plans last year, it spent less than 40 cents on patients’ medical claims.

Short-term plans sold by Cambia Health Solutions, which operates Blue Cross and Blue Shield plans in four states, spent even less on medical care, paying out just 9 cents for every dollar in premiums.

These low “loss ratios”—which show the percentage of premiums spent on medical claims and were published last week in the National Association of Insurance Commissioners’ 2018 Accident and Health Policy Report—are a stark reminder that short-term plans benefit insurance companies more than the patients who purchase them. The data bring into question what kind of value people receive from enrolling in a short-term health plan, insurance experts said. The Trump administration expanded access to such plans last year.

“Compared to comprehensive plans that have to comply with the ACA’s rules, short-term plans’ coverage limitations often result in carriers paying out far fewer claims, or paying pennies on the dollar,” said Rachel Schwab, a research associate at Georgetown University’s Center on Health Insurance Reforms.

The average loss ratio of the five health insurers that bring in the most premiums from short-term insurance policies was 39.2% in 2018. That means that 39 cents of every $1 collected in premiums was spent on medical care, while the rest was spent on administrative expenses or kept as profit.

In contrast, the average loss ratio among comprehensive major medical plans purchased by individuals in 2018 was about 73%, according to the NAIC report.

Short-term health plans’ loss ratios are lower because they don’t cover nearly as many benefits. Unlike Affordable Care Act-compliant plans, short-term plans can deny coverage to people with pre-existing health conditions and charge more based on health status. They are not required to and often don’t cover the 10 essential health benefits, including maternity care and prescription drugs. Their limited coverage also makes them much cheaper than ACA plans.

While ACA-compliant plans must meet a minimum medical-loss ratio of at least 80% or else pay rebates to enrollees, short-term plans are not subject to a minimum MLR requirement.

“There’s no requirement that they spend most premiums on medical care,” said Cheryl Fish-Parcham, director of access initiatives at Families USA. “They can take in lots of premiums and pay very little for consumers’ care.”

The loss ratio for UnitedHealthcare, the leader in the short-term plan market, decreased each year to 37.3% from 50.9% in 2016, according to the NAIC annual reports. Over the same period, the company, which sells short-term plans through its Golden Rule Insurance subsidiary, has grown its premiums from those plans to $41.7 million from $26.5 million.

“Short-term, limited-duration insurance helps increase choice and coverage by providing a broad portfolio of low-cost options that meet the unique needs of individuals,” UnitedHealthcare said in response to a question about why its loss ratio is decreasing. “These policies are not right for everyone and we work to ensure consumers have the information they need to make the right decision based on their circumstances.”

A company spokeswoman added in an email that loss ratios can vary significantly year to year because of the shorter plan duration and changes in who buys the plans.

According to the NAIC’s latest report, about 86,600 people enrolled in short-term plans in 2018, but that figure likely doesn’t capture the entire market since many short-term plans are being sold through out-of-state associations exempt from regulation.

Enrollment in short-term plans is expected to grow this year in the wake of Trump administration’s August 2018 rule, upheld by a federal judge last month, that allowed insurers to extend the duration of short-term policies from a maximum of three months to up to a year. That rule, coupled with the Trump administration’s move to zero-out the individual mandate penalty, made short-term plans a more attractive option for healthy individuals.

The CMS expected about 600,000 additional people to enroll in short-term plans in 2019, with that figure reaching 1.6 million people by 2021 or 2022. At the time, the Trump administration said expanding access to short-term plans would allow more coverage options for people who had been “priced out” of ACA exchange coverage. But critics sounded the alarm that individuals may enroll in the cheaper, skimpier plans without understanding the risks.

“If the MLRs were higher, that would suggest people are still getting value (from the short-term plans). But when loss ratios are very low that means there’s a lot of overhead built into your premium and a relatively small amount of your premium is actually going to be paid out in claims. It does raise the question of what kind of value people are getting from these plans,” said Cynthia Cox, a vice president at the Kaiser Family Foundation.

https://www.modernhealthcare.com/insurance/short-term-health-plans-spend-little-medical-care

Bayer, Lanxess to sell chemical park operator in $3.9B deal

Bayer (OTCPK:BAYRY) and Lanxess (OTCPK:LNXSF) agree to sell their stakes in chemical park operator Currenta to Macquarie Infrastructure and Real Assets for an enterprise value of €3.5B ($3.9B), including net debt and pension obligations as well as a related real estate portfolio.

Bayer’s stake in Currenta fetched an equity value of €1.17B after deducting net debt and pension obligations, and the company agreed to sell real estate on which Currenta operates for €180M.

Bayer initially had planned to sell the Currenta stake – a legacy asset with little benefit for its core drugs and agriculture businesses – to its former industrial chemicals subsidiary Covestro, but the two could not agree on a valuation.

https://seekingalpha.com/news/3488120-bayer-lanxess-sell-chemical-park-operator-3_9b-deal