Teva up 1% premarket on positive fremanezumab data

Teva Pharmaceutical Industries (NYSE:TEVA) perks up 1% premarket on light volume on the heels of additional data from a Phase 3 clinical trial, FOCUS, evaluating Ajovy (fremanezumab) for the prevention of migraine in adults who failed to respond adequately to two to four classes of preventative treatments. The results were presented at European Academy of Neurology Annual Congress in Oslo.

Treatment with fremanezumab, a calcitonin gene-related peptide (CGRP) antagonist, reduced the average monthly migraine days and sustained 50+% response rates over three months compared to placebo and reduced the use of acute headache medications.

Improvements in migraine symptoms (nausea, vomiting, photophobia, phonophobia), quality of life measures, depression and productivity were also noted.

Complete results will be submitted for publication later this year.

The FDA approved Ajovy in September 2018. The European Commission approved it in April of this year.

https://seekingalpha.com/news/3475196-teva-1-percent-premarket-positive-fremanezumab-data

Amarin up 8% premarket on guidance boost

Citing increased demand for Vascepa (icosapent ethyl), Amarin (NASDAQ:AMRN) has raised its 2019 revenue guidance to $380M – 420M from $350M.

Q2 sales should be $97M – 101M while H1’s tally should be $170M – 174M.

It also plans to double the size of its U.S. salesforce. Recruiting is underway.

The FDA’s action date for its review of the company’s supplemental marketing application for a CV benefit claim for Vascepa is September 28.

Shares are up 8% premarket on light volume.

https://seekingalpha.com/news/3475189-amarin-8-percent-premarket-guidance-boost

Gilead Intends to Submit Application for Rheumatoid Arthritis Med This Year

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib. The company discussed with the agency the Phase 3 FINCH studies, as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.

Filgotinib is an investigational agent and not approved anywhere globally. Its efficacy and safety have not been established.

https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-Announces-Intent-to-Submit-New-Drug-Application-for-Filgotinib-to-U-S-Food-and-Dr-28840102/

Smart glasses follow our eyes, focus automatically

Though it may not have the sting of death and taxes, presbyopia is another of life’s guarantees. This vision defect plagues most of us starting about age 45, as the lenses in our eyes lose the elasticity needed to focus on nearby objects. For some people reading glasses suffice to overcome the difficulty, but for many people the only fix, short of surgery, is to wear progressive lenses.

“More than a billion people have presbyopia and we’ve created a pair of autofocal lenses that might one day correct their vision far more effectively than traditional glasses,” said Stanford electrical engineer Gordon Wetzstein. For now, the prototype looks like virtual reality goggles but the team hopes to streamline later versions.

Wetzstein’s prototype glasses — dubbed autofocals — are intended to solve the main problem with today’s progressive lenses: These traditional glasses require the wearer to align their head to focus properly. Imagine driving a car and looking in a side mirror to change lanes. With progressive lenses, there’s little or no peripheral focus. The driver must switch from looking at the road ahead through the top of the glasses, then turn almost 90 degrees to see the nearby mirror through the lower part of the lens.

This visual shift can also make it difficult to navigate the world. “People wearing progressive lenses have a higher risk of falling and injuring themselves,” said graduate student Robert Konrad, a co-author on a paper describing the autofocal glasses published June 28 in the journal Science Advances.

The Stanford prototype works much like the lens of the eye, with fluid-filled lenses that bulge and thin as the field of vision changes. It also includes eye-tracking sensors that triangulate where a person is looking and determine the precise distance to the object of interest. The team did not invent these lenses or eye-trackers, but they did develop the software system that harnesses this eye-tracking data to keep the fluid-filled lenses in constant and perfect focus.

Nitish Padmanaban, a graduate student and first author on the paper, said other teams had previously tried to apply autofocus lenses to presbyopia. But without guidance from the eye-tracking hardware and system software, those earlier efforts were no better than wearing traditional progressive lenses.

To validate its approach, the Stanford team tested the prototype on 56 people with presbyopia. Test subjects said the autofocus lenses performed better and faster at reading and other tasks. Wearers also tended to prefer the autofocal glasses to the experience of progressive lenses — bulk and weight aside.

If the approach sounds a bit like virtual reality, that isn’t far off. Wetzstein’s lab is at the forefront of vision systems for virtual and augmented reality. It was in the course of such work that the researchers became aware of the new autofocus lenses and eye-trackers and had the insight to combine these elements to create a potentially transformative product.

The next step will be to downsize the technology. Wetzstein thinks it may take a few years to develop autofocal glasses that are lightweight, energy efficient and stylish. But he is convinced that autofocals are the future of vision correction.

“This technology could affect billions of people’s lives in a meaningful way that most techno-gadgets never will,” he said.

This research was funded in part by Intel Corporation, NVIDIA, an Okawa Research Grant, a Sloan Fellowship and the National Science Foundation.

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Story Source:

Materials provided by Stanford University. Note: Content may be edited for style and length.

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Journal Reference:

1. Nitish Padmanaban, Robert Konrad, Gordon Wetzstein. Autofocals: Evaluating gaze-contingent eyeglasses for presbyopes. Science Advances, 2019; 5 (6): eaav6187 DOI: 10.1126/sciadv.aav6187

https://www.sciencedaily.com/releases/2019/07/190701144250.htm

Kaiser, Centene and Molina must pay big risk-adjustment charges

Kaiser Permanente, Centene Corp. and Molina Healthcare are among the health insurers that racked up massive charges under an Affordable Care Act program meant to steady the premiums in the individual insurance market and discourage insurers from cherry-picking healthy, less costly plan members.

According to Modern Healthcare’s analysis of data released by the CMS late last week, Kaiser Permanente, which is integrated with Kaiser Foundation Health Plan, must pay $891.7 million into the ACA risk-adjustment program for the individual market for 2018, which will be transferred to insurers who enrolled riskier patients. Kaiser must pay another $414.3 million into the risk-adjustment program for the small-group market. Modern Healthcare excluded catastrophic plans and high-risk pools from the analysis.

St. Louis-based Centene Corp., which is the dominant ACA marketplace insurerwith nearly 2 million exchange enrollees, racked up charges of $629.7 million in the individual market. Molina Healthcare must pay $373.2 million for individual market risk-adjustment purposes.

Most of the companies set to receive the biggest payments from the risk-adjustment program were Blue Cross and Blue Shield affiliates, as has been the case in previous years. Combined, the Blues companies, including Anthem, will get $2.5 billion in risk-adjustment payments for the individual market and another $567.4 million for the small-group market.

ACA risk-adjustment is a permanent program that shuffles money from plans that enroll relatively healthy members to plans with sicker, riskier patients. The zero-sum program is based on a patient’s risk score. Payments and charges are calculated by comparing each health plan’s average patient risk score to the average premium in the state. In 2018, 572 health insurers participated in the program and transfers between them totaled $10.4 billion.

Various factors can contribute to whether a plan receives payments or must pay into the program, but, “At the end of the day, it comes down to the risk of your membership and the premiums you’re charging,” said Deep Banerjee, insurance analyst at S&P Global.

Larger health insurers that have been serving their populations long enough that they have a wealth of data on their members and understand and can code them accurately are more likely to receive risk-adjustment payments, which explains why the Blues companies tend to receive funds, Banerjee explained.

The three insurers set to receive the largest payments included Blue Shield of California, whose payments tallied $784.8 million in the individual market; Health Care Service Corp., which will receive $574.7 million; and Blue Cross and Blue Shield of Florida, with payments of $512.3 million. Those insurers will each receive smaller risk-adjustment payments for the small-group market as well.

Other insurers that have expanded rapidly into new markets where they don’t have a lot of information on their patients’ health conditions are more likely to pay into the program, as are smaller or younger insurers.

That might explain why Oscar Health, a smaller insurer that expanded in five states in 2018, must pay $201.9 million to the individual market’s risk-adjustment program.

But there are other more technical factors. David Anderson, a research associate at Duke University’s Margolis Center for Health Policy, explained that in Tennessee, for example, new-to-the-area Oscar enrolled a bunch of members in a bronze plan in 2018. Meanwhile, its competitor Blue Cross and Blue Shield of Tennessee enrolled most members in silver and gold plans. Silver and gold plans have higher risk scores under the risk-adjustment methodology, while bronze plans, which tend to attract young and healthier than average members, have a lower risk score, Anderson said.

By concentrating on selling bronze plans, Oscar was already going to have risk-adjustment charges. But with a membership heavy in silver and gold plans, Blue Cross and Blue Shield of Tennessee pushed the statewide average risk higher, making Oscar’s membership look even healthier.

For Centene and Molina, the big charges are a product of the patients covered and the insurers’ narrow networks and low premiums, Anderson said.

Centene prices its health plans to capture low-income patients who don’t anticipate having a lot of health problems; Molina does something similar, he said. Their plan designs help them avoid patients with high cost conditions who are more likely to go to sign up with an insurer with a broader network. Centene and Molina end up with healthier populations and so, pay into the risk-adjustment program.

Anderson noted that risk-adjustment charges and payments are not necessarily indicators of profitability. Centene has turned a profit on the exchanges and its business as a whole despite having big charges under the program.

The risk-adjustment program is a controversial one. Small health plans and ACA co-ops have long argued that the formula used to calculate payments favors large plans with more claims experience. In early 2018, insurance co-op New Mexico Health Connections won a partial victory in a lawsuit challenging the program. In response, the Trump administration froze payments to insurers for the 2017 benefit year but then restored the program not long after. Litigation in the case is ongoing.

https://www.modernhealthcare.com/insurance/kaiser-centene-and-molina-must-pay-big-risk-adjustment-charges

Evercore boosts Dova Pharmaceuticals to Outperform

Evercore ISI has upgraded Dova Pharmaceuticals (NASDAQ:DOVA) to Outperform, from In-Line.

That joins a mostly bullish set of covering analysts.

Sell-side analysts rate the stock an Outperform on average, while it has a Quant Rating of Neutral.

At last check shares were up 2.1% postmarket.

https://seekingalpha.com/news/3475150-evercore-boosts-dova-pharmaceuticals-outperform

More effective flu vaccine begins clinical trials across the U.S.

A more effective seasonal flu vaccine is about to be tested in clinical trials across the US.

The flu shot was working well early in the season with effectiveness around 47% in February. But this decreased substantially during a second wave of a tougher flu strain, with effectiveness at just 9%, as reported by the U.S. Centers for Disease Control and Prevention.

Dr Nikolai Petrovsky, Flinders University Professor and Research Director of Vaxine Pty Ltd , says current flu vaccines do provide some protection, but his team have demonstrated a lot can be done to improve their effectiveness.

“Despite currently available vaccines, flu remains a very major global health problem,”

“During the 2017-18 Northern hemisphere flu season, the Centers for Disease Control and Prevention estimated that the US had 49 million cases of flu, 960,000 hospitalizations due to influenza complications and 79,000 deaths.”

Dr Petrovsky developed the technology behind this vaccine using adjuvants- substances which act as a turbocharger to enhance their ability to protect against infection.

The technology behind this improved flu shot is believed to be the first human drug in the world to be completely designed by artificial intelligence (AI).

This represents the start of a new era where artificial intelligence is going to play an increasingly dominant role in drug discovery and design. ”

Professor Nikolai Petrovsky, Flinders University

Although computers have been used in the past to help in drug design, this vaccine technology was independently designed by an AI program called SAM (Search Algorithm for Ligands), created by the Flinders-based team.

Associate Professor Dr Dimitar Sajkov, says a number of influenza patients seen this year had received the 2019 vaccine, highlighting the need to develop a better flu shot

“It is tremendous to see such a promising vaccine that we developed with the very first human trials being done at Flinders, progressing onto the world stage,”

“In 2009 the team at Flinders were the first in the world to develop a new swine flu vaccine to combat the 2009 pandemic. The Flinders trials confirmed both the effectiveness and speed with which this new vaccine could be delivered, resulting in many awards including the AMP National Innovation Award at the Telstra Business Awards.

The US clinical trial will take about 12 months to complete and aims to recruit 240 healthy volunteers.

The trial is sponsored by the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

Dr Petrovsky expressed gratitude to the US government for providing long term funding for research that led to this breakthrough.

“It takes decades to develop a new human vaccine and this is extremely hard to achieve under Australian funding models which tend to be short term.”

https://www.news-medical.net/news/20190701/More-effective-flu-vaccine-begins-clinical-trials-across-the-US.aspx