Amarin to Present on Reducing Cardiovascular Risks in Diabetes

Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that three Amarin-supported posters will be presented at the American Diabetes Association 79^th Scientific Sessions in San Francisco, June 7 – 11, 2019.  All three posters highlight important findings regarding the challenges of current treatment options for diabetes patients with cardiovascular risks.  More than 30 million adults in the United States have diabetes, 10 million of whom are considered at elevated risk for cardiovascular events, despite being on cholesterol-management medicines.^1,2

“We have learned through research that cholesterol and diabetes management is not enough to effectively treat cardiovascular disease in patients with diabetes and other risk factors,” said Craig Granowitz, M.D., Ph.D., chief medical officer of Amarin.  “Cardiovascular disease is the No. 1 cause of death in people with diabetes. We applaud the ADA for highlighting the need to better understand and address increased cardiovascular risk in patients with diabetes.”

https://www.globenewswire.com/news-release/2019/06/07/1865933/0/en/CORRECTING-and-REPLACING-Amarin-to-Present-Findings-Regarding-Challenges-of-Current-Treatment-Options-in-Reducing-Cardiovascular-Risks-for-Diabetes-Patients-Even-for-Those-With-Con.html

American Diabetes Association 79th Scientific Sessions

The American Diabetes Association (ADA) will host its 79th Annual Scientific Sessions in San Francisco, California, from Friday, June 7, through Tuesday, June 11, 2019.¹

Attendees can look forward to over 2000 original research presentations and 180 sessions at ADA 2019. Amongst the new trial data being presented, some of the most highly anticipated findings are from cardiovascular disease risk prevention trials, including the REWIND trial (Researching CV Events with a Weekly Incretin in Diabetes), being presented Sunday, June 9 at 4:30 _PM, and the CAROLINA trial(Cardiovascular Safety of Linagliptin), being presented Monday, June 10 at 4:30 _PM.¹

Other notable presentations to look for at 79th Scientific Sessions:¹

The D2d study, launched in 2013, is the largest ever clinical trial designed to explore the effects of vitamin D supplementation on delay of diabetes onset. Results will be unveiled at ADA 2019 for the first time.

(Friday, June 7, 11:30 _AM -12:30 _PM)

The TODAY2 Study, documenting the course of type 2 diabetes and its comorbidities (renal, cardiac, eye, nerve) in the transition from youth to young adulthood.

(Saturday, June 8, 1:45-3:45 _PM)

The PREVIEW study, a global trial that used meal replacements, diets of varying compositions, and 2 physical activity strategies to gain insights into weight loss maintenance and diabetes prevention.

(Saturday, June 8, 4:00-6:00 _PM)

TrialNet results, which will cover findings from the Teplizumab Prevention Trial of individuals with type 1 diabetes with multiple antibodies and abnormal glucose tolerance. In addition, data from 2 other TrialNet studies will be presented.

(Sunday, June 9, 8:00-10:00 _AM)

The RISE Clinical Trials, investigating the loss of beta-cell function in type 2 diabetes. Presenters will discuss the pathogenesis of the disease by comparing results from the Adult Medication Study with data from youth with the same glucose tolerance abnormalities.

(Sunday, June 9, 12:00-1:30 _PM)

The DECLARE-TIMI 58 trial, which assessed patients with diabetes and risk factors for atherosclerotic cardiovascular disease receiving dapagliflozin. The session at ADA 2019 will cover renal end points and other safety aspects.

(Sunday, June 9, 2:15-4:15 _PM)

The CREDENCE and CARMELINA trials, for which key findings will be reviewed and new data analyses presented. These major trials explored the effects of canagliflozin and linagliptin, respectively, in patients with type 2 diabetes at high risk for renal and cardiovascular complications.

(Tuesday, June 11, 7:30-9:30 _AM)

The PIONEER trial program, comparing the efficacy and safety of orally administered peptide drugs with other antihyperglycemic agents.

(Tuesday, June 11, 9:45-11:45 _AM)

Of note, the ADA is now offering a mobile application available from Google Play or the App Store to help create personalized itineraries and stay connected throughout the conference.¹ Attendees are encouraged to wear red on Sunday, June 9th, to support the ADA’s mission to prevent and cure diabetes.²

Visit Endocrinology Advisor’s conference section for continuous coverage from ADA 2019.

American Diabetes Association 79th Scientific Sessions: What to Expect

Sanofi bets on new CEO to drive sluggish drug sales

In veteran drug salesman Paul Hudson, Sanofi’s 100,000-plus employees are getting a new chief executive who relishes a good commercial fight.

The French firm said on Friday it had poached 51-year-old Hudson from Novartis, betting on him to rejuvenate a business hit by sluggish cholesterol drug sales and a diabetes unit facing growing competition for its top seller.

Hudson, the latest of several Novartis executives to exit the Swiss firm, has nearly 30 years of industry experience, including a stint as AstraZeneca’s top U.S. manager.

The Englishman, a skilled public speaker and fan of his hometown soccer team Manchester United, will replace Olivier Brandicourt, 63, who is retiring in September.

At Novartis, Hudson kick-started sales of heart failure medicine Entresto that the firm expected to generate $5 billion but whose sales began at a glacial pace after its 2015 launch.

After heavy marketing investment and a sales push, Hudson turned the drug into a Novartis blockbuster.

“We’re now starting to see the fruits of all the effort we put in,” Hudson told analysts on a Novartis call in April. “Will it continue? We believe it does continue.”

At Sanofi, one of Hudson’s challenges will be to turn around the fortunes of Praluent, a cholesterol medicine that has failed to meet original expectations due to concerns about its price and a bitter patent dispute with rival Amgen.

“The departure of Paul Hudson is regrettable for Novartis, due to his industry experience in the United States,” said Michael Nawrath from Zuercher Kantonalbank.

But his knowledge of the world’s biggest drugs market will be Sanofi’s gain.

Hudson, awarded an honorary doctorate at his alma mater Manchester Metropolitan University, also has to defend Sanofi’s patent-expired insulin Lantus, a top earner at 3.6 billion euros ($4 billion) even after a 20 percent drop in sales.

Competition will come from Mylan’s generics and even Novartis, which in 2018 signed a deal with China’s Gan & Lee to make Lantus copies.

Hudson has proved a tenacious salesman at Novartis, winning approval for the world’s costliest medicine, gene therapy Zolgensma for spinal muscular atrophy, at $2.1 million per patient.

Novartis said Hudson’s replacement would be Marie-France Tschudin, 48, who has led the Swiss firm’s European cancer unit after joining the company in 2017. She previously worked at Celgene’s cancer business.

It marks another change at the top of Novartis, where most of its executive committee was appointed in the last two years.

“The turn-over at the Novartis executive committee continues at high speed,” Bank Vontobel analyst Stefan Schneider said.

This week, Samit Hirawat, head of oncology drug development, left for Bristol-Myers Squibb, while Novartis’s cancer chief, Susanne Schaffert, has only been in her post since January. In March, the Swiss firm hired a new generics head, Richard Saynor, from GlaxoSmithKline.

A Novartis spokesman said Novartis had a deep bench of global experts to fill talent gaps left by Hudson and others.

https://www.marketscreener.com/ASTRAZENECA-4000930/news/France-s-Sanofi-bets-on-new-CEO-to-drive-sluggish-drug-sales-28723174/

Staph Bacteria Tied To Food Allergies in Kids

Target Audience and Goal Statement: Allergists, pediatricians, dermatologists, nutritionists, emergency department physicians, family medicine physicians

The goal was to explore the association of Staphylococcus aureus colonization with specific immunoglobulin E (sIgE) production to common food allergens and allergies in early childhood independent of eczema severity.

Questions Addressed:

• What was the association between S. aureus and food allergy?
• Was any association of S. aureus colonization with sIgE production to common food allergens and food allergy in early childhood independent of eczema severity?

Synopsis and Perspective:

Nearly one in twenty five school-age children have food allergies. Some common foods — including peanuts, eggs, milk, tree nuts, fish, shellfish, soy, and wheat — trigger over 90% of the allergic reactions in affected individuals.

Parent-reported childhood food allergies are on the rise, according to a U.S. household surveyconducted from 2015 through 2016. About 42% reported at least one or more lifetime food-allergy related emergency department visits. IgE-mediated food allergy is a prime reason for anaphylaxis warranting such a visit. Many survey respondents (40.7%) had a current epinephrine auto-injector prescription.

Lead researcher, Olympia Tsilochristou, MD, of Kings College London, and colleagues recently reported in the Journal of Allergy and Clinical Immunology that S. aureus bacteria on the skin of young children with severe eczema may be one of the factors contributing to the chance of developing food allergies.

S. aureus is found in the nose and on the skin of healthy individuals. However, it tends to be more common in eczema sufferers.

Most of the study participants with skin S. aureus had concurrent moderate and severe eczema at all time points. Evaluations at the 12- to 30- and 60- to 72-month intervals showed that eczema significantly worsened in participants with immediately preceding skin S. aureuscolonization compared to uninfected counterparts. Study participants with skin S. aureuspositivity at any time during the study period also produced sIgE to hen’s egg white, peanut, and cow’s milk. This indicated that the participants were allergic to those foods.

“Participants with S. aureus were more likely to have persistent egg allergy and peanut allergy at 60 and 72 months of age independent of eczema severity,” the researchers wrote.

Results were derived from a secondary analysis of the Learning Early About Peanut Allergy (LEAP) study and a 12-month extension of the LEAP study, known as the Persistence of Oral Tolerance to Peanut (LEAP-On) trial. The LEAP study enrolled infants ages 4-11 months with severe eczema, egg allergy, or both. The babies were randomized to therapeutic peanut consumption or peanut avoidance, and all had eczema clinical evaluation and culture of skin and nasal swabs at baseline.

The follow-up LEAP-On study assessed the children at age 72 months, after 12 months of peanut avoidance in both groups.

Skin and nasal swabs were obtained at baseline and at ages 12, 30, and 60 months. A total of 48.8% of the participants had some form of S. aureus colonization (32.2% skin and 32.3% nasal) on at least one LEAP study visit, with most having just one positive test result. The greatest rates of colonization were recorded at 4-11 months of age.

Early introduction of peanuts in infants at high risk for allergy was shown to prevent peanut allergy. Reduction in the prevalence of peanut allergy following eating peanuts until the age of five years, persisted at the age of six years (after 12 months of not eating peanuts).

However, this related study showed that, even if they ate peanuts at a young age, infants whose skin and noses were colonized with S. aureus were more likely to develop a food allergy.

“These findings indicate that S. aureus may have reduced the chance of young infants gaining tolerance to peanut, even if peanut was eaten in early childhood,” said co-author, Dr. George Du Toit, a King’s College professor.

While the team used bacteriological culture techniques and not DNA-based testing, they pointed out that they were able to enumerate live microorganisms and did not have to rely on possibly identifying remnant non-viable genetic material from a prior infection. They acknowledged that they did not genotype the isolated strains and that it was not possible to match organisms over time and between skin and nasal swabs. Other study limitations cited by the team were only collecting swabs on four occasions in the LEAP study and none in the LEAP-ON study. Diagnostic food challenges were only undertaken for peanuts and they also cautioned that associations were based on “small numbers of LEAP study consumers with peanut allergy as it is reflected in the wide CIs [confidence intervals] around the ORs [odds ratios].” Tsilochristou’s group could also not rule out the possibility of confounders.

Source Reference: Journal of Allergy and Clinical Immunology 2019; DOI: 10.1016/j.jaci.2019.04.025

Study Highlights: Explanation of Findings

This secondary analysis of the LEAP and LEAP-on studies was conducted to better understand the relationship between S.aureus and food sensitization/allergy by correcting the analyses for eczema severity. About half of the LEAP participants were colonized with S. aureus. Eczema severity, persistence, and deterioration could be correlated to skin colonization with S. aureus. Interestingly, hen’s egg white and peanut sIgE levels at each visit in the LEAP and LEAP-On studies were significantly linked with skin S. aureus positivity at any LEAP study time point, even after correcting for eczema severity. High-level hen’s egg white and peanut sIgE production reflected a stronger relationship. Similarly, a high-level sIgE response to milk at 30, 60, and 72 months of age was related to any skin S. aureus colonization. Tsilochristou’s group interpreted the collective results as meaning that S. aureus was associated with allergies to a hen’s egg, peanuts, and cow’s milk.

It is worth noting that 42.7% and 38.1% of baseline participants with an egg allergy had persistent egg allergy at 60 and 72 months of age, respectively. This finding contrasted with previous literature evidence suggesting that allergy to a hen’s egg typically resolves during early childhood. Researchers concluded that S. aureus can prevent the acquisition of natural tolerance to a hen’s egg.

“Our study reveals that aside from eczema severity, this bacterium that patients with eczema commonly become colonized with could be an added risk factor for food sensitization and allergy,” Tsilochristou said in a related report.

“S aureus has been associated with more severe forms of atopic diseases, and our data extend these observations in patients with food allergy,” Tsilochristou’s group concluded.

Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College

Primary Source

Journal of Allergy and Clinical Immunology

Source Reference: Tsilochristou O, et al “Association of Staphylococcus aureus colonization with food allergy occurs independently of eczema severity” J Allergy Clin Immun 2019; DOI: 10.1016/j.jaci.2019.04.025.

Secondary Source

MedPage Today

Source Reference: Boyles S “Common Skin Bacterium Linked to Food Allergy Risk in Kids” 2019.

https://www.medpagetoday.org/allergyimmunology/allergy/80323?_ga=2.41751074.1830602290.1559775994-1125047970.1528569052

Why Alexa’s bedside manner is bad for healthcare

It remains an open question whether virtual medicine will prove a valuable, convenient adjunct to healthcare.

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KEY TAKEAWAYS

If virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make healthcare worse.

Children who have a telemedicine visit for an upper-respiratory infection are far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work.

Alexa still can’t provide many things patients want, such as a reliable price estimate for surgery, the infection rates at the local hospital, or the location of the cheapest cholesterol test nearby.

Amazon has opened a new healthcare frontier: Now Alexa can be used to transmit patient data. Using this new feature — which Amazon labeled as a “skill” — a company named Livongo will allow diabetes patients — which it calls “members” — to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”

Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize healthcare, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.

In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.

But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.

Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced healthcare system.

But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to healthcare. Or, instead, will it be a way for the U.S. profit-driven healthcare system to make big bucks by outsourcing core duties — while providing a paler version of actual medical treatment?

After all, my doctors have long answered my questions and dispensed phone and email advice for free — as part of our doctor-patient relationship — though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies — maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.

Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.

And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make healthcare worse.

My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.

A study published recently in Pediatrics found that children who had a telemedicine visit for an upper-respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.

More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need — and deserve — human contact.

Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?

So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.

But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring healthcare into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

https://www.healthleadersmedia.com/clinical-care/analysis-why-alexas-bedside-manner-bad-healthcare

HCA redeems, sells secured notes at favorable rate differentials

On June 5, 2019, HCA Healthcare, Inc. (the “Registrant” or the “Parent Guarantor”), HCA Inc., a wholly owned subsidiary of the Registrant (the “Issuer”), and certain subsidiary guarantors of the Issuer entered into an underwriting agreement (the “Underwriting Agreement”) with BofA Securities, Inc., Citigroup Global Markets Inc., and J.P. Morgan Securities LLC as representatives of the several underwriters named therein, for the issuance and sale by the Issuer of $5,000,000,000 aggregate principal amount of senior secured notes (collectively, the “Notes”) in the following tranches:

     •   $2,000,000,000 aggregate principal amount of 41/8% Senior Secured Notes
         due 2029;




     •   $1,000,000,000 aggregate principal amount of 51/8% Senior Secured Notes
         due 2039; and




     •   $2,000,000,000 aggregate principal amount of 51/4% Senior Secured Notes
         due 2049.

The Notes will be guaranteed on a senior unsecured basis by the Parent Guarantor and on a senior secured basis by certain of the Issuer’s subsidiaries, and will be issued and sold pursuant to the Registrant’s Registration Statement on Form S-3 (File No. 333-226709) and a related preliminary prospectus supplement dated June 5, 2019.

The description of the Underwriting Agreement is qualified in its entirety by the terms of such agreement, which is incorporated herein by reference and attached to this report as Exhibit 1.1.

On June 5, 2019, the Issuer provided notice of its election to redeem (the “Redemption”) all $600 million aggregate principal amount outstanding of its existing 4.25% Senior Secured Notes due 2019, all $3.000 billion aggregate principal amount of its existing 6.50% Senior Secured Notes due 2020 and all $1.350 billion aggregate principal amount of its existing 5.875% Senior Secured Notes due 2022 (collectively, the “Redeemed Notes”). The Redeemed Notes will be redeemed on July 5, 2019 (the “Redemption Date”). The Issuer’s obligation to complete the Redemption is conditioned upon the receipt prior to the Redemption Date by the Issuer of at least $4.500 billionin net proceeds from the sale and issuance of the Notes pursuant to the Underwriting Agreement. This Current Report on Form 8-K does not constitute a notice of redemption of the Redeemed Notes.

https://www.marketscreener.com/HCA-HOLDINGS-HOSPITAL-CO-7534808/news/HCA-HEALTHCARE-INC-Other-Events-Financial-Statements-and-Exhibits-form-8-K-28724541/

Cancer genomics platform Personalis sets terms for $100 million IPO

Personalis, which provides a genome sequencing platform for cancer research, announced terms for its IPO on Friday.

The Menlo Park, CA-based company plans to raise $100 million by offering 6.7 million shares at a price range of $14 to $16. At the midpoint of the proposed range, Personalis would command a fully diluted market value of $479 million.

Personalis was founded in 2011 and booked $48 million in sales for the 12 months ended March 31, 2019. It plans to list on the Nasdaq under the symbol PSNL. Morgan Stanley, BofA Merrill Lynch and Cowen are the joint bookrunners on the deal. It is expected to price during the week of June 17, 2019.

Relevant Profile: PSNL

https://www.renaissancecapital.com/IPO-Center/News/63561/Cancer-genomics-platform-Personalis-sets-terms-for-$100-million-IPO