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Saturday, March 16, 2019

Amarin: Cardio events based on triglyceride levels forecast

Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today the presentation of data and analysis which concluded that over nine million atherosclerotic cardiovascular disease (ASCVD) events are projected to occur in the United States within the next ten years in adults aged 40-79 for whom ASCVD is not established. Over three million of these events are projected to occur in persons with elevated triglyceride (TG) levels of ≥150 mg/dL, including approximately one million events in statin users. The research used a risk calculator to estimate 10-year risk and reported that increased cardiovascular (CV) risk was proportionally greater among persons with higher TG levels. This research highlights that millions of CV events will occur in people that haven’t had a CV event and supports the need for expanded education about the use of TG levels as an identifier of cardiovascular risk. It also highlights that there is an urgent need to address this immense risk and examine the capacity of lifestyle modification and other therapies to attenuate ASCVD risk beyond cholesterol management in patients with elevated TG levels.
These data and analysis were presented in a poster entitled “Burden of Atherosclerotic Cardiovascular Disease Risk in Persons with Elevated Triglyceride Levels According to Statin Use” at the American College of Cardiology’s (ACC) 68th Annual Scientific Session in New Orleans, LA. The research used the ACC/AHA risk calculator and NHANES data with corresponding projected population sizes to estimate a 10-year risk of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), or fatal/nonfatal stroke in people without established atherosclerotic cardiovascular disease (ASCVD). The analysis did not include other major adverse cardiovascular events such as by-pass surgery, stents or hospitalization for angina.
“This presentation underscores that people with elevated triglycerides without established cardiovascular disease are at a high risk for cardiovascular events,” stated John F. Thero, president and CEO of Amarin. “While lowering triglyceride levels alone without reducing other cardiovascular risks may be insufficient to significantly lower cardiovascular risk, elevated triglyceride levels provide a means of identifying patients with increased cardiovascular risk beyond cholesterol levels. We encourage people to recognize this risk and to discuss elevated triglyceride levels with their medical professionals.”
This poster was authored by Nathan D. Wong, Wenjun Fan, Sephy Philip, Craig Granowitz, and Peter Toth.
Amarin Investor/Analyst Conference Call
Amarin plans to webcast live a physician panel discussion for investors and analysts on Monday, March 18 at 4:00 p.m. CT / 5:00 p.m. ET. During the panel discussion leading physicians are anticipated to review data pertaining to Vascepa presented at ACC’s 68thAnnual Scientific Session, including the scheduled presentation on Monday, March 18 at 9 a.m. CT / 10 a.m. ET in the late-breaker session regarding additional data from the REDUCE-IT cardiovascular outcomes study. The panel discussion may also cover data from the above described poster and from other posters presented at ACC.
This physician panel discussion will commence at the time shown above and will be accessible via webcast through the investor relations section of the company’s website at http://www.amarincorp.com. The panel discussion can also be heard via telephone by dialing 877-407-8033. A replay of the panel discussion will be made available for a period of two weeks following the webcast. To hear a replay of the call, dial 877-481-4010 (inside the United States) or 919-882-2331 (outside the United States). A replay of the panel discussion will also be available through the company’s website shortly after the webcast. For both dial-in numbers please use conference ID 44518.
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Study will gauge impact of smartphone on memory and focus

Scientists are to use an app to conduct the first crowdsourcing study on the impact of smartphone use on working memory, mental focus and attention.
The app created by Datacubed Health will also allow scientists from the University of Southern Denmark to study the effects of mindfulness techniques and music listening patterns on concentration, stress, and working memory.
Datacubed Health is a Brooklyn-based tech company specialising in data capture using devices such as smartphone apps, wearables, and environmental sensors.
The two studies, focusing on smartphone use and mindfulness respectively, begin next month and will use the app for electronic consent and data collection.
The app employs an interface that will take participants on journeys through several interactive maps and virtual worlds as they ‘journey’ through the research study.
There has been much popular discussion about smartphone use on cognition in recent years, but Ulrich Kirk, associate professor at the Institute of Psychology at the University of Southern Denmark said few objective studies have attempted to measure their effects in large numbers of participants.
The smartphone study aims to include more than a thousand participants. The mindfulness study will be conducted in dozens of Danish workplaces to reach thousands of workers.
Kirk said: “These studies will allow us to bring cognitive neuroscience to people’s everyday lives.
“With Datacubed’s involvement in creating an app for iPhone and Android devices, thousands of people will be able to participate using their own phones.”
Paul Glimcher, CEO of Datacubed Health, said: “We are excited to partner with the University of Southern Denmark on this unique and innovative research project.
“We have found that by adapting techniques and technologies used by the video game industry, we can create research tools that are compelling to participants and that often achieve adherence rates above 95% in clinical trials.
“In these studies, our apps are being used to reach large numbers of people and gather valid neuroscientific data for academic publications and policy research.”
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Edwards Lifesciences SAPIEN 3 Valve Beats Surgery In Partner 3 Trial

Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the results of the randomized PARTNER 3 Trial demonstrated superiority for the SAPIEN 3 transcatheter aortic valve over outcomes with surgery.
The trial, which compared treatment with the SAPIEN 3 valve to surgery in patients with severe symptomatic aortic stenosis (AS) at low risk of death from surgery, achieved superiority of its primary endpoint at one year. The results of the trial will be presented on Sunday as part of the late-breaking clinical trials at the American College of Cardiology’s 68th Annual Scientific Session (ACC.19) in New Orleans, and have been published online in the New England Journal of Medicine.
The PARTNER 3 Trial was an independently evaluated, randomized clinical trial comparing outcomes between transcatheter aortic valve replacement (TAVR) and open-heart surgery in this patient group. TAVR with the SAPIEN 3 valve achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and rehospitalization at one year.
‘From the first TAVR case more than 17 years ago, to the extensive series of rigorous clinical trials to date, the PARTNER studies have shown increasingly robust outcomes with TAVR and have supported the treatment of hundreds of thousands of patients globally. This demonstrates that TAVR is a proven therapy for severe aortic stenosis, a deadly and debilitating disease that has a worse outlook than many cancers,’ said Martin B. Leon, M.D., director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia UniversityMedical Center and professor of medicine at the Columbia UniversityCollege of Physicians and Surgeons. Leon is the national co-principal investigator of the PARTNER 3 Trial. ‘In the PARTNER 3 Trial, TAVR with the SAPIEN 3 valve showed a remarkably low death and disabling stroke rate of 1.0 percent at one year versus 2.9 percent for surgery. Based upon these clinical trial findings at one year, TAVR should be considered the preferred therapy in low surgical risk aortic stenosis patients.’
The PARTNER 3 Trial randomized 1,000 patients at 71 centers between March 2016and October 2017. Patients were assigned to undergo either TAVR with the SAPIEN 3 valve or surgery with any commercially available surgical valve. All patients were followed for at least one year, and 10-year clinical and echocardiographic follow-up is planned for all patients.
‘These data demonstrate that TAVR with the SAPIEN 3 valve gives low surgical risk patients with severe AS a treatment with better outcomes, less time in the hospital and the ability to resume their everyday lives more quickly,’ said Larry Wood, corporate vice president, transcatheter aortic valve replacement. ‘It is also highly encouraging to see that 96 percent of TAVR patients were discharged to home as opposed to remaining in a hospital or specialized care setting.’
More than 600,000 patients around the world have benefitted from TAVR. The SAPIEN 3 valve is approved in the United Statesfor the treatment of intermediate and higher risk patients with severe, symptomatic AS; it is not yet approved for the treatment of low-risk patients. Edwards continues to anticipate U.S. Food and Drug Administration approval of a low-risk indication for the SAPIEN 3 valve late this year.
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Biotech week ahead, March 18

Biotech stocks had an upweek, with the release of clinical trial results and the positive broader market sentiment offering ample support.
Here are some key catalysts that can move biotech stocks in the unfolding week.

Conferences

  • 2019 American College of Cardiology meeting – March 16-18, in New Orleans, Louisiana
  • The Society of Gynecologic Oncology’s 2019 annual meeting – March 16-19, in Honolulu, Hawaii
  • 3rd World Congress on Embryology and In Vitro Fertilization – March 18-19, in New York
  • 16th World Hematology Congress – March 18-19, in Rome, Italy
  • 7th International Conference on HIV/AIDS, STDs and STIs – March 18-19, in New York
  • 23rd International Conference on Neurology & Neurophysiology – March 18-19, in Edinburgh, U.K.
  • 20th Annual World Congress on Pediatrics – March 18-19, in Chicago
  • Oppenheimer 29th Annual Healthcare Conference – March 19-20, in New York
  • 10th Euro Breast Cancer Summit – March 20-21, in Paris, France
  • 6th World Congress on Mental Health, Psychiatry and Well-being – March 20-21, in New York
  • 9th International Conference and Exhibition on Advanced Cell and Gene Therapy – March 21-22, in Rome
  • ENDO 2019 – March 23-26 in New Orleans, Louisiana

PDUFA Dates

The FDA is set to rule Monday on Roche Holdings AG Basel ADR RHHBY 0.82%‘s sBLA for Tecentriq, in combination with carboplatin and etoposide (chemotherapy) for first-line treatment of people with extensive-stage small cell lung cancer, or SCLC.
SAGE Therapeutics Inc SAGE 2.18% and Ligand Pharmaceuticals Inc. LGND 0.74% await FDA decision on their NDA for Brexanolone in the treatment of postpartum depression. The -day is set for Tuesday.
On Wednesday, the FDA will rule on Jazz Pharmaceuticals PLC JAZZ 1.42%‘s NDA for JZP-110, its treatment candidate for excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.
Sanofi SA SNY 1.71% and Lexicon Pharmaceuticals, Inc. LXRX 1.36% await FDA verdict on their oral diabetic drug Zynquista, chemically Sotagliflozin on Friday.

Clinical Trial Results

PhaseBio Pharmaceuticals Inc PHAS 6.06% is scheduled to present Phase 1 data for PB2452, its reversal agent for tricagrelor, at the American College of Cardiology meeting.
AstraZeneca plc AZN 0.57% on Monday is due to present Phase 3 data for its Type-2 diabetes candidate Farxiga.
Amarin Corporation plc AMRN 1.17% on Monday will release new Phase 3 data for Vascepa, its treatment candidate for high triglycerides with mixed dyslipidemia, at the American College of Cardiology meeting.
Leap Therapeutics Inc LPTX 21.62% on Monday is due to present Phase 2 data for its endometrial cancer treatment candidate DKN-01 and Paclitaxel at the Society of Gynecologic Oncology meeting.
Strongbridge Biopharma plc SBBP 0.75% on Saturday is expected to present already-released Phase 3 data for COR-003 that is being evaluated for endogenous Cushing’s syndrome at ENDO 2019.

Earnings

Monday, March 18

  • Aclaris Therapeutics Inc ACRS 4.57% (before the market open)
  • Akebia Therapeutics Inc AKBA 2.64% (after the market close)
  • Innovate Biopharmaceuticals Inc INNT (after the market close)
  • Novavax, Inc. NVAX 3.3% (after the market close)

Tuesday, March 19

  • Catalyst Pharmaceuticals Inc CPRX 0.67% (before the market open)
  • Provention Bio Inc PRVB 3.02% (after the market close)

Thursday, March 21

  • Aptinyx Inc APTX 1.72% (before the market open)
  • Orchard Therapeutics PLC – ADR ORTX 5.03% (before the market open)
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Irreparable rotator cuff tears may have another surgical option

The arthroscopic superior capsule reconstruction (SCR) surgical technique offers patients with irreparable rotator cuff tears restored shoulder function and the opportunity to return to sports and physically-demanding work, according to research presented today at the AOSSM/AANA Specialty Day in Las Vegas, Nevada. The study, which examined patient outcomes up to five years after surgery, built upon earlier research which examined short-term patient results.
“We studied 30  who were treated with arthroscopic SCR, and consistently saw improvements in outcomes related to  and the daily lives of those treated,” noted lead researcher Teruhisa Mihata, MD, Ph.D., from Osaka Medical College in Osaka, Japan. “The technique allowed 11 of 12 patients who had previously worked to return full-time at five-year follow-up, and all eight who had participated in sports to return to play.”
The study measured both American Shoulder and Elbow Surgeons (ASES) and Japanese Orthopaedic Association (JOA) scores in patients, which improved significantly at both one and five years after . The average ASES scores rose from 29.0 before surgery to 83.0 at one year and 92.3 at five years after surgery, with JOA scores rising from 51.5 before surgery to 85.9 and 91.4, respectively. Active elevation increased from 85 degrees prior to surgery to 151 degrees 5 years after the operation. Out of 30 patients followed for five years, only three (10%) experienced graft tears. Those who demonstrated graft healing also showed no sign of glenohumeral osteoarthritis during the five-year period.
“Our latest research shows continued promise for the arthroscopic SCR technique, particularly to restore a patient’s  function and allow them to return to work or sports if they so choose,” said Mihata. “We plan to continue studying longer-term outcomes for patients, focusing on continued function and the appearance of osteoarthritis.”
Explore further
More information: www.sportsmed.org/aossmimis/me … search-Abstracts.pdf
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FDA to review implant biocompatibility, after patient reactions to some materials

The FDA has begun to re-evaluate the state of the science around the materials used in long-term medical implants, pointing to a growing body of evidence that suggests a subset of patients may be predisposed to painful responses to the devices.
While the vast majority of patients have no adverse reactions to implants constructed of metal, plastic or silicone, the agency said some may still develop inflammatory responses and tissue changes several years following the initial procedure, with symptoms that might not occur until long after a clinical study.
Those symptoms, both local and generalized, can include fatigue, rash and muscle and joint pain, mimicking more well-known immune system conditions.
Symptoms have not been reported with most materials, including most metals—however, some patients with a history of pre-existing allergies have developed skin lesions while using certain devices, the agency said, and cautioned that not all device-related reactions are allergic in nature.
“It’s clear more work needs to be done,” wrote FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren in an agency statement. “Enhancing our collective understanding of materials science could lead to identifying materials that may cause an exaggerated response in sensitive individuals and advance the development of safer materials.”
This could include working to develop new tests to identify at-risk patients, modernizing the FDA’s review of medical device materials, issuing safety notices, and working with companies to recall and correct issues after devices are on the market, Gottlieb and Shuren said.
Certain classes of devices may also undergo deeper scientific evaluations. Last month, the FDA reported that it has seen a jump in the number of cases of a rare type of cancer linked to silicone breast implants, which the agency has been tracking for years.
Specifically, the FDA said more cases of anaplastic large cell lymphoma, a rare type of non-Hodgkin’s lymphoma that develops in the scar tissue surrounding a breast implant, have been confirmed in patients with textured implants compared to smooth ones, however the agency said it does not yet have enough definitive evidence of an association. The FDA is hosting a two-day advisory committee panel meeting later this month on its ongoing assessment of breast implants and long-term health effects.
In addition, Gottlieb and Shuren said they believe there’s a need to evaluate particular metal devices, including now-infamous metal-on-metal hip replacements—which have been the focus of thousands of international lawsuits against manufacturer Johnson & Johnson and its subsidiaries—as well as Bayer’s discontinued permanent birth control device Essure, made of coiled wire consisting of multiple metals, including nitinol and stainless steel.
Bayer and the FDA recently extended a postmarket study of Essure from three up to five years, and the agency called for additional blood testing to detect signs of immune responses.
Meanwhile, the use of the nickel-titanium alloy nitinol has increased, particularly in the construction of stents, guidewires and other devices used in minimally invasive procedures, due to its flexible properties, according to the FDA. The agency said it plans to publish a new draft guidance on the use of nitinol in the next few months.
And while there are no longer any approved metal-on-metal hip replacements marketed, they still remain implanted in people’s bodies. New interim results from FDA surveillance studies show significantly higher blood levels of metal ions, including cobalt and chromium, which can leach out of the implants over time as the parts rub together.
While not unexpected, some patients had higher blood levels with no symptoms, compared to some with severe symptoms with lower ion levels, the agency said.
An additional advisory panel meeting this fall will explore hypersensitivity to nitinol and other metals in devices, and the FDA also plans to publish a white paper summarizing the current scientific knowledge in the biocompatibility field.
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Cryotherapy, -200 degree chamber top athletes use for fast recovery

Weston Blasi
CryoCentral in Hoboken, N.J.

What separates world class athletes from their challengers isn’t just how they train, but also how they recover. That’s why top athletes like Steph Curry and Cristiano Ronaldo, among others, in recent years have been using a new tool for full body recovery called cryotherapy.
Cryotherapy is the use of extremely cold temperatures for overall recovery, most notably in large gaseous chambers. The chamber fills up with nitrogen gas and encapsulates your body with temperatures hitting as low as -230° F.
A cryotherapy session is like a much more intense ice bath (the latter are typically used by top athletes and are around 40° F) but they’re dry and only last about three minutes, the length of the Beach Boys’ “Sloop John B.”
“An ice bath may help you recover in terms of flushing something out of your legs, but the way this works, tiredness and soreness everywhere in your body is much less,” Alberto Salazar said in 2012. Salazar has coached several world-class runners, including Mo Farah, who won a Gold medal at the 2012 Olympics.
However, while some of the best athletes in the world use the therapy, it has not been approved by the FDA. “The FDA has not cleared or approved any of these devices for medical treatment of any specific medical conditions.” It also urges people to talk with their doctor before trying the therapy. Robert H. Shmerling, an associate professor in medicine at Harvard Medical School, adds that people with certain conditions, such as high blood pressure and heart or lung disease, should probably avoid cryotherapy.
In fact, two Missouri State basketball players were injured in 2018 during a cryotherapy session when they developed blisters on their feet. Their coach described it at the time as “rather serious but nothing long-term.”
But clearly some professional athletes believe it helps them. Players in MLB, the NBA and the NFL trust the therapy to help them recover. And soccer star Cristiano Ronaldo reportedly purchased a chamber to keep in his house.
Even some forward-thinking sports teams have implemented cryotherapy chambers into their facilities, including some in Europe’s Premier League.
The head athletic trainer for the NBA’s Phoenix Suns, Aaron Nelson, said to NBA.com about cryotherapy, “If a person has an injury, whether it’s a contusion or a strain, the blood running to the core and then coming back to the limbs with oxygenated blood redevelops injured cells and helps you heal faster.”
While the technology has been around for decades, it started to gain momentum when athletes and celebrities took to social media to show off their new recovery routines.
What it’s like to try cryotherapy
Considering that top athletes use it, I decided to try it out for myself to see if this therapy could help a 23-year-old weekend warrior who plays hoops a few times a month (still money from 16-feet out).
When I arrived for my session, I was surprised at how nonchalant the employees were about throwing me into a freezing cold chamber, and that there was no waiver to sign. While other customers also seemed restless, it was just another day in the office for the machine operator.
Weston Blasi
Stiven Espinoza-Hunter, the author’s friend, is ready to try cryotherapy for the first time.
Patrons must disrobe of everything but their underwear for maximum effectiveness. The only things joining you in the chamber are a pair of socks and gloves. These are to protect your toes and fingers, the most susceptible to freezing damage because it takes longer for blood to circulate to the body’s extremities.
As you stand inside watching the big digital meter go from -30° to -80° to -150°, the cold really hits you and you start shivering. It takes about 20 seconds to reach -230° F. The best way to get through your session is to bring a buddy to talk to, as I did. The last thing you want to focus on is how cold you actually feel. The same way you shouldn’t look down when climbing something tall.
Weston Blasi
The moment you step out of the chamber, your body begins to heat itself back up. It doesn’t take long to get back to your normal temperature.
“A lot of our clients are older people, non-athletes who have a condition like arthritis or joint pain,” Jeff Esquillo, the owner of CryoCentral in Hoboken, N.J., told MarketWatch. “The whole body chamber is essentially an ice pack for your body.”
Esquillo went on to say that in the past couple of years, the number of locations offering cryotherapy boomed in major cities like San Francisco and New York.
The soreness in my lower back from sleeping on my stomach every night was nonexistent. I felt bouncy — and had more pep in my step.
As soon as you get dressed you can go. The process takes less than 10 minutes, and it costs roughly $30 to $50.
And when I walked outside that chilly Sunday morning, the -5° F didn’t feel so bad.
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