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Thursday, October 4, 2018

Want a glimpse into pharma’s future? Look to cable television, Merck CEO says


If all the scrutiny on drug prices has taught us anything, it’s that there are a lot of intermediate players in today’s pharma supply chain. But expect that to change, Merck CEO Ken Frazier said Wednesday.
In comments made at the Economic Club of New York, Frazier foreshadowed pharma’s “disintermediation”—a.k.a., stops on that chain between drugmakers and patients—pointing to the cable television industry as an example.
“You could actually look at the cable industry at one point where the content providers—if you were Disney, you had to pay a lot of money to get your content to the other side,” Frazier said, as quoted by Yahoo Finance, adding, “I think that’s going to happen in this area.”
The way he sees it, nixing some of the middlemen can bring down costs, and the Trump administration—which is examining the role of various participants in the supply chain—is focused on it, too.
“I think at the end of the day, I’ll just be blunt here, I just don’t understand why we live in a world where 50% of the value goes into the supply chain,” Frazier said.

As drug pricing has come into the national spotlight—aided by high-profile scandals featuring Martin Shkreli and Mylan’s Epipen, as well as commercials from once-presidential candidate Hillary Clinton and ominous tweets from Trump—drugmakers and others have been quick to point the finger at one another for costs that have soared in recent years.
Lead PBM Express Scripts has been particularly vocal about pharma’s price hikes, and it’s patted itself on the back repeatedly for introducing formulary tactics that incentives pharma to hand over discounts.
“Despite promises to limit price increases, drugmakers are trying to game the market by delaying generic competition, blocking access to safe and effective biosimilars, and coyly deferring—not cancelling—list-price increases. This is why our work to expand access and maximize value is more important now than ever,” Express Scripts said in August.

But as PBM industry critics have been quick to point out, such moves help their bottom lines without reducing costs for consumers. Industry association PhRMA has spent big bucks the past couple of years on awareness ads that seek to both educate patients on the role of different players in forcing prices up—and to encourage them to probe deeper.
“I mean no disrespect to anyone else in the supply chain, but I know how hard it is to make my 50 cents on the dollar,” Frazier said. “I have to invent something that’s never existed in the history of the world. And I have to ask my shareholders to be patient with their capital. I think that the system has got to change.”

Horizon Presents Follow-Up to Phase 2 of Thyroid Med Trial


Horizon Pharma plc HZNP, +1.16% announced new data from the Phase 2 clinical trial of teprotumumab for people living with moderate-to-severe active thyroid eye disease (TED) showing a majority of patients that had reductions in proptosis at week 24 maintained these reductions 48 weeks following the study completion, or nearly a year off therapy. The results of this investigational medicine were presented during an oral session at the American Thyroid Association (ATA) Annual Meeting, Oct. 3 – 7, 2018, in Washington, D.C.
TED is a rare autoimmune disease that is active for up to three years. During active TED the insulin-like growth factor 1 receptor (IGF-1R) is overexpressed on orbital fibroblasts, resulting in local inflammation and tissue expansion, which can in turn lead to proptosis, or bulging of the eye. This can result in stiffness of the muscles, displacement of the eyes so they are no longer in line with each other, and/or the eyelids are unable to close. The inability for people living with active TED to close their eyelids can lead to corneal ulcerations and potential blindness, and many also endure challenges with double vision, known as diplopia. Once TED is no longer active, the orbital muscles and tissues become fibrotic and, for some, changes due to local inflammation and tissue expansion can only be corrected with surgery.
“Proptosis creates numerous challenges for people living with thyroid eye disease and is the most important measure from a clinical perspective,” said George J. Kahaly, M.D., Ph.D., lead author and professor of medicine and endocrinology and metabolism, Johannes Gutenberg University Medical Center. “In addition to challenges with visual function and appearance, proptosis can lead to permanent structural changes around the eyes and is what drives the decision for surgery following active thyroid eye disease.”
The analysis of the Phase 2 data, 48-Week Follow-Up Of A Multicenter, Randomized, Double-Masked, Placebo Controlled Treatment Trial Of Teprotumumab In Thyroid-Associated Ophthalmopathy, shows that at four weeks following the initial 24 week treatment period, proptosis response was 73.8 percent for patients receiving teprotumumab versus 13.3 percent for patients receiving placebo (p<0.001). In addition, 53 percent of week 24 teprotumumab proptosis responders maintained at least a 2 mm improvement relative to baseline at week 72 (48 weeks following treatment period). Teprotumumab is an investigational medicine and its safety and efficacy have not been established.
“Teprotumumab has the potential to be an impactful treatment for people living TED and the first therapy to demonstrate reduction in proptosis,” said Elizabeth Thompson, Ph.D., vice president clinical development, rare disease, Horizon Pharma plc. “We are encouraged by these data, which suggest proptosis reductions could be maintained in a majority of responders for nearly a year off therapy. Through our ongoing confirmatory Phase 3 trial and extension study, we expect to gain a deeper understanding of the effect of additional treatment for those considered non-responders as well as those who may benefit from retreatment.”
Horizon Pharma will host an investor call at 10:30 a.m. ET to discuss these data, as well as provide an overview of TED and the current treatment landscape.
Additional data from the 48 week off-therapy follow-up will be presented during an oral session on Oct. 25, 2018, at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) and on Oct. 29, 2018, at the American Academy of Ophthalmology (AAO 2018) meeting in Chicago, IL. The presentation is titled Diplopia Response in a Controlled Trial with Teprotumumab, an IGF-1 Receptor Antagonist Antibody for Thyroid Eye Disease.

New Display Design May Create Lightweight, Compact Smart Glasses


Researchers have developed a fundamentally new approach to a see-through display for augmented reality, or smart glasses. By projecting images from the glass directly onto the eye, the new design could one day make it possible for a user to see information such as directions or restaurant ratings while wearing a device almost indistinguishable from traditional glasses.
“Rather than starting with a display technology and trying to make it as small as possible, we started with the idea that smart glasses should look and feel like normal glasses,” said research team leader Christopher Martinez of the Laboratoire d’électronique des technologies de l’information (Leti) in France. “Developing our concept required a great deal of imagination because we eliminated the bulky optical components typically required and instead use the eye itself to form the image.”
In Optica, The Optical Society’s journal for high-impact research, the authors detail their new retinal projection display concept and report positive results from initial optical simulations. Although glasses using this new approach wouldn’t be useful for showing videos, they could provide information in the form of text or simple icons.
“Although we are focused on augmented reality applications, the new display concept may also be useful for people with vision problems,” said Martinez. “The disturbance present in the eye could be integrated into the projection, giving visually impaired people a way to see information such as text.”
Forming an image in the eye
The unconventional display design rapidly projects individual pixels, which the brain puts together to form letters and words. “We don’t bring an image to the surface of the glass, but instead bring information that is emitted in the form of photons to make the image in the eye,” explained Martinez.
According to the design concept this feat would be accomplished by sending photons from a laser or other light source through a light-guiding component into a holographic optical element created within the lens of the glasses. Holographic optical elements that are significantly smaller than their traditional counterparts can be made in light-sensitive plastics using the same laser light interactions that make holograms such as those that protect credit cards from forgery.
For the concept to work, it is critical that all the projected photons have synchronized phases and match in coherence. Otherwise, a noisy image is formed, akin to what you would hear if the members of a choral group were singing the same song but starting and stopping at different times. The researchers used the holographic element to synchronize the phase, like a cue that helps the singers start at the same moment.
“It is very complicated to use traditional methods such as a mask with an optical structure to adjust the phase of photon emitters that are separated from each other by just hundreds of microns,” said Martinez. “Our design uses a unique holographic element to synchronize the photons by matching the phase with a reference beam.”
The design also includes a grid of lightguides that makes the photons coherent, akin to making sure the singers all sing at the same speed. This component was made using an integrated photonics approach that incorporates the same semiconductor fabrication techniques used to make computer chips and fabricate optical components in silicon.
The researchers say that their display concept is an important example of the new opportunities for retinal projection that will now be possible thanks to recent developments in integrated photonics, which have moved from applications using telecommunication wavelengths into visible wavelengths that can be used in displays.
Seeing outside the box
Because of the limited space available in glasses’ lenses, the first prototype will likely have a resolution of 300 by 300 pixels, which the researchers say could be improved by stacking two displays on top of each other. Importantly, the design enables completely new ways to use the pixels available, which are not constrained to a square shape like traditional displays.
“Using a holographic element to form a retinal display is quite different from the traditional grid of pixels used for traditional displays,” said Martinez. “For example, information could be projected to the left and right portions of the field of view with no information in between, without increasing the complexity of the display.”
A detailed optical simulation of the new design validated the new approach and revealed that a clearer image would be created if the points where light is emitted were arranged randomly rather than with a periodic pattern. The researchers are now figuring out how to best accomplish this random arrangement. They also point out that although the device should be safe because very little light will be needed to form the image on the eye, safety studies will be needed as development progresses.
The researchers plan to make and test the individual components before creating a working prototype. The first prototype will display static monochromatic images, but the researchers are confident that the retinal projection approach can be used for a dynamic multi-color display.
Paper: C. Martinez, V. Krotov, B. Meynard, D. Fowler, “See-Through Holographic Retinal Projection Display Concept,” Optica, 5, 10, 1200-1209 (2018).

Richmond Vascular Center 1st to Use Non-Surgical Dialysis Fistula System


Richmond Vascular Center, Central Virginia’s state-of-the-art treatment center for Radiology Associates of Richmond and Surgical Associates of Richmond, is the first US site to offer the Ellipsys® Vascular Access System, a game-changing innovation for patients with End-Stage Renal Disease (ESRD).
The newly FDA-approved Ellipsys System is a minimally-invasive, single catheter-based system designed for ESRD patients requiring hemodialysis. Pioneered by local interventional radiologist and the Director of Richmond Vascular Center (RVC), Dr. Jeffrey Hull, the new procedure and technology bring patients a unique non-surgical option for arteriovenous fistula (AVF) creation, a procedure that had previously not changed in over 50 years.
A significant advancement for dialysis patients and clinicians, the Ellipsys System, developed by Avenu Medical (San Juan Capistrano, CA), transforms an open surgery connecting an artery to a vein into a minimally invasive procedure using a needle and a catheter. Using a percutaneous approach, the Ellipsys procedure replaces an incision with a needle puncture, ultrasound imaging replaces surgical dissection, and sutures are replaced with tissue fusion. The procedure can be performed in the physician office, but will also be used in hospitals and ambulatory surgery centers. After the procedure, the patient leaves with just a band aid.
Since 1966, the AV fistula was surgically created in an operating room by sewing a major arm vein and artery together in the arm. When this is done, blood from the artery will pass through the vein increasing its flow rate and diameter. This makes the vein suitable for the insertion of the needles required for hemodialysis treatment. The AVF is the best method for vascular access reducing hospitalization and mortality with the additional benefits of longer term patency, improved flow rates and fewer complications than other methods of vascular access.
“We are very encouraged by the consistent positive results we’ve been seeing in patients,” said Dr. Hull. “And it is rewarding to be able to offer a faster, more efficient and less-invasive option for patients requiring vascular access. We’re proud to be the first in the nation to provide this quality of life improvement opportunity for ESRD patients.”
Located at 173 Wadsworth Drive, in the Midlothian Center in North Chesterfield, Richmond Vascular Center (RVC) is committed to serving its community with the utmost compassion and respect. Offering a state-of-the art facility, our outpatient center and its entire staff recognize the importance of compassion, privacy, and dignity in the delivery of these services. RVC can be reached at 804-864-8346.

Roche’s Genentech announces FDA approval of Hemlibra for Hemophilia A


Genentech, a member of the Roche Group, announced that the U.S. FDA has approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously and at multiple dosing options. This approval is based on positive results from the Phase III HAVEN 3 and HAVEN 4 studies. Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis and across all other bleed-related endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4 study. Hemlibra is now available to people in the U.S. who have hemophilia A without factor VIII inhibitors.
https://thefly.com/landingPageNews.php?id=2799953

Novocure Announces 55 Presentations at European Association of Neuro-Oncology


Highlights include a data analysis of EF-14 that demonstrated an increased dose of Tumor Treating Fields to the tumor bed improved overall survival in GBM patients as well as safety data from a surveillance study
Novocure (NASDAQ: NVCR) announced today 55 presentations on Tumor Treating Fields at the European Association of Neuro-Oncology (EANO) Meeting 2018, Oct. 10 through Oct. 14, in Stockholm. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. The volume of Tumor Treating Fields presentations marks a record number of abstracts for Novocure at this conference.
Highlights include a retrospective data analysis from Novocure’s EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma (GBM) that demonstrated an increased dose of Tumor Treating Fields to the tumor bed improved overall survival in GBM patients; and safety data on the use of Tumor Treating Fields as a treatment for GBM from a surveillance study, supporting EF-14 trial results.
Novocure also will host a scientific lunchtime symposium on Tumor Treating Fields at the meeting.
“We continue to evaluate the data from our EF-14 trial and apply what we learn to the development of Tumor Treating Fields,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “The focus on Tumor Treating Fields at scientific conferences continues to grow each year, demonstrating an increased interest in our therapy among the scientific community. We are proud of the work we have done to generate increased awareness of the potential benefits of Tumor Treating Fields with the scientific community and look forward to presenting at the EANO Meeting.”
Oral Presentation
(OS5.5) Surveillance data demonstrates the tolerability of tumor treating fields in pediatric glioma patients. A. Kinzel. 12:03 to 12:15 p.m. CEST Saturday, Oct. 13.
Invited Oral Presentation
Optune when to use and when not? A. Hottinger. 8:34 to 08:51 a.m. CEST Friday, Oct. 12.
Scientific Lunchtime Symposium
Glioblastoma therapy with Tumor Treating Fields (Optune®). 12:50 to 2:20 p.m. CEST Friday, Oct. 12.
+ Poster Presentations

Resmed Launches Brightree CARE App for Home Health and Hospice Aides


App enables aides to document care visits from aides’ mobile devices
Brightree®, the leading provider of cloud-based software to help post-acute care companies improve business performance and patient outcomes, announced today the release of its new BrightreeCARE app.
BrightreeCARE, free on the Apple App Store and Google Play store, enables home health and hospice aides to easily document their visits on their smart device, without having to carry additional equipment.
“The BrightreeCARE app has made our staff more mobile, flexible and efficient – plus significantly improved our patients’ satisfaction rates,” said Tarrah Lowry-Schreiner, CEO of Sangre de Cristo Hospice and Palliative Care in Colorado. “Our aides are able to easily maneuver in a patient’s location without being tied down to an iPad or other larger device. Their phone can easily be placed in their pocket to give the patient the care indicated on their Care Plan.”
“Our staff is also thankful for the instant updates when visits are changed or added to their schedule, just by glancing at their BrightreeCARE app,” Lowry-Schreiner said.
“This powerful app is comprehensive, easy-to-use and tailored to the individual aides’ needs,” said Bob Dean, vice president and general manager of Brightree’s Home Health, Hospice & Private Duty business. “Supporting a bring your own device strategy, the application helps agencies incorporate aides into the EMR making them more productive and compliant to the patient’s care plan.”
Availability
All Brightree customers can download and use the BrightreeCARE app today. Aides can also experience the app with a hands-on demo at the National Association of Home Care & Hospice (NAHC) in Grapevine, Texas, October 7–10, 2018.
About Brightree
Brightree LLC, a wholly owned subsidiary of ResMed (NYSE: RMD) (ASX: RMD), is the leading provider of cloud-based software to improve clinical and business performance of post-acute care companies. Ranked one of the top 100 health care IT companies in the U.S., Brightree serves more than 2,500 organizations in the HME, home health, hospice, orthotic and prosthetic, HME pharmacy, home infusion, and rehabilitation home care segments.