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Sunday, December 16, 2018

Amazon targets unprofitable ‘CRaP’ consumer products


Amazon.com Inc. has trained people to buy everything from major appliances to daily staples online. Now it is having second thoughts about some of those sales because they don’t make money — and is pushing big brands to change how they use its site.
Inside Amazon, the items are known as CRaP, short for “Can’t Realize a Profit.” Think bottled beverages or snack foods. The products tend to be priced at $15 or less, are sold directly by Amazon, and are heavy or bulky and therefore costly to ship — characteristics that make for thin or nonexistent margins.
Now, as Amazon focuses more on its bottom line in addition to its rapid growth, it is increasingly taking aim at CRaP products, according to major brand executives and people familiar with the company’s thinking. In recent months, it has been eliminating unprofitable items and pressing manufacturers to change their packaging to better sell online, according to brands that sell on Amazon and consultants who work with them.
One example: bottled water from Coca-Cola Co. Amazon used to have a $6.99 six-pack of Smartwater as the default order on some of its Dash buttons, a small device that allows for automatic reordering with a single press. But in August, after working with Coca-Cola to change how it ships and sells the water, Amazon notified Dash customers it was changing that default item to a 24-pack for $37.20.
That raised the price per bottle to $1.55 from $1.17. And Coca-Cola will start shipping those orders directly to consumers, sparing Amazon the expense of shipping from its warehouses. Manufacturers shipping from their warehouses is something Amazon has asked more brands to do to cut its own costs.
Amazon told Coca-Cola that it was losing money on the smaller, cheaper shipments, according to people familiar with the matter.
Coca-Cola responds that it works with partners to learn together and constantly evolves its offerings.
Moves like that can increase costs for brands. Amazon can get away with it because manufacturers of food and household products are hooked on the online retailer’s size — it accounts for a majority of total e-commerce revenue growth — say consultants who work with brands on their online strategy.
For big consumer brands, not being on Amazon “is not an option anymore,” said Guru Hariharan, chief executive of Boomerang Commerce, which makes e-commerce software. “They have the power; they have the shoppers.”
Amazon also has greater leeway to curb CRaP items because of the rise of independent sellers on its site. They have added hundreds of millions of items, helping ensure that Amazon’s virtual shelves are stocked with the variety shoppers expect. And those sales tend to be more profitable for Amazon, which typically collects a 15% cut plus fees for warehousing.
Chief Financial Officer Brian Olsavsky said earlier this year that eliminating CRaP items is “something that we do and work with our vendors on all the time,” adding that it hasn’t caused a change in profitability for the company in 2018.
Amazon, like other retailers, has made changes to inventory when an item isn’t selling well and is unprofitable. It also has moved some products- — such as its smaller package of Smartwater — into its Prime Pantry category, in which consumers fill up a box with items to reduce the cost of shipping.
Amazon is trying to boost profitability in its core retail business after years of focusing on growth, according to the people. The company’s profit has risen sharply in the past couple of years, helping its stock price soar, although its market value has fallen again recently. But most of that profitability has stemmed from its growing cloud business and advertising unit.
Brand executives privately say Amazon’s push for profitability can be a double-edged sword. Amazon has pressured them to lower prices and change packaging, both of which can be costly. And eliminating or changing what they sell on Amazon can hurt sales.
Some executives, however, say it can help both companies.
Seventh Generation, a Unilever PLC unit that makes plant-based household products, has altered its Amazon selling strategy in recent months after talking with Amazon about improving the profitability of products for sale on the platform, said CEO Joey Bergstein.
Mr. Bergstein said his company has developed new product formats that are more profitable to sell online — on Amazon or elsewhere. Amazon is “really clear that they have a profitability threshold,” he said. “We’ve been clear about saying, ‘Let’s make sure what we’re selling is profitable, and we’re not just lining Amazon’s pockets.'”
That has meant selling smaller, lighter laundry products like detergent pods and skipping cheaper paper towels. Instead of promoting a three-pack of dish soap, Seventh Generation recently started advertising a 6-pack for $17.70, and it created a larger, 504-count package of baby wipes for $19.91 for sale on Amazon and elsewhere.
Mars Wrigley Confectionery and Kellogg Co. executives said they have seen an uptick in products Amazon has dubbed unprofitable over the past year, although they wouldn’t say which items. But they are taking steps to change. Mars, for example, has seen better success on Amazon in selling bigger bags of Life Savers or Dove Promises, a spokeswoman said, and it has better figured out how to offer products online that shoppers want for different occasions.
Campbell Soup Co., which like Coca-Cola ships some products directly to consumers who buy online, is revamping packaging for Amazon for items such as Campbell’s Chunky Soup and Pepperidge Farm Goldfish crackers, which are typically cheap at the store but relatively heavy to ship.
Campbell now uses predictive technology to monitor pricing dynamics so that it can adjust sizes, change the variety or redesign packaging to ensure the products will be profitable enough to stay on Amazon.

FDA Fast Tracks Asana Treatment of Atopic Dermatitis


Asana BioSciences, a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Asana’s investigational oral Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor ASN002 for the treatment of moderate-to-severe atopic dermatitis. “We are pleased that the FDA has granted Fast Track designation to ASN002. This designation recognizes the importance of accelerating the development of new medicines for the treatment of challenging dermatological/inflammatory diseases that have a major impact on patients’ daily quality of life,” said Sandeep Gupta, Founder and CEO of Asana. “We look forward to taking advantage of the opportunity for frequent interactions with the FDA throughout the development of ASN002 and the potential expedited review offered by their Fast Track program.”
ASN002 is currently being evaluated in moderate-to-severe atopic dermatitis in the Phase 2b RADIANT Study (Relief from Atopic DermatitIs with JAK and SYK INhibiTion – NCT03654755). It is also being evaluated in a Phase 2 trial in patients with severe chronic hand eczema (NCT03728504).
ASN002 is the first oral drug to demonstrate improvement in atopic dermatitis lesional skin phenotype correlating with clinical efficacy. ASN002 data demonstrating improvements in skin pathology, disease related genes and inflammation biomarkers, correlating with clinical efficacy in patients with moderate-to-severe atopic dermatitis, will be presented at the Inflammatory Skin Disease Summit (ISDS) meeting to be held in Vienna, Austria, December 12-15, 2018.

Novan Phase 1b Atopic Dermatitis Data at Inflammatory Skin Disease Summit


  • Clinical efficacy, as measured by EASI (Eczema Area and Severity Index) changes, was numerically greater for SB414 treated groups compared to vehicle  
  • Strong anti-pruritic (itch) effect as measured by improvement on the pruritus (itch) numeric rating scale (NRS) compared to vehicle
  • Clinical data additive to established non-clinical results supporting nitric oxide’s role in affecting the underlying immunology of atopic dermatitis
Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced that clinical results from the Company’s Phase 1b trial with SB414 cream for the treatment of atopic dermatitis will be presented at the 3rd Inflammatory Skin Disease Summit in Vienna, Austria.
Tomoko Maeda-Chubachi, M.D., Novan’s Vice President of Medical Dermatology, is scheduled to present “A Topical Nitric Oxide-Releasing Cream SB414: Results of a Phase 1b Double-Blind, Randomized, Vehicle-Controlled Study in Patients with Mild-to-Moderate Atopic Dermatitis” during a poster session on December 12, 2018 and an oral presentation on December 15, 2018.
“We are excited by the data we are presenting with SB414 as it demonstrated trends suggestive of clinical efficacy within only 2 weeks of treatment,” said Tomoko Maeda-Chubachi, M.D., Novan’s Vice President of Medical Dermatology. “Nitric oxide has the potential to impact multiple mechanisms of atopic dermatitis and the results from this trial give us the confidence to move forward with a more robust Phase 2 program.”
Top line results from Novan’s Phase 1b clinical trial with SB414 for the treatment of atopic dermatitis were previously announced in August and the Company intends to conduct a Phase 2 trial.
About the Presentations
Title: “A Topical Nitric Oxide-Releasing Cream SB414: Results of a Phase 1b Double-Blind, Randomized, Vehicle-Controlled Study in Patients with Mild-to-Moderate Atopic Dermatitis”
Authors: Tomoko Maeda-Chubachi, Todd Durham, Stephen Schleicher, Phoebe Rich, Emma Guttman-Yassky
Presenting Author: Tomoko Maeda-Chubachi, M.D., Novan’s Vice President of Medical Dermatology
Poster Presentation: Wednesday, December 12, 2018 at the “Säulenhalle” (Level 1) and the “Science Café” (Level 0) between 6:00 p.m. – 9:00 p.m. Central European Standard Time
Oral Presentation: Saturday, December 15, 2018 from 1:00 p.m. – 1:30 p.m. Central European Standard Time

DBV Data Backs Through-Skin Immunotolerance at Skin Disease Summit


First-of-its-kind study evaluated immune profile of healthy human skin in different body sites
Findings support application of epicutaneous immunotherapy (EPIT) to inter-scapular region of peanut-allergic patients for greater allergen exposure
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that an oral abstract evaluating differences in the immune profile of healthy human skin across different body areas was presented by Dr. Ester Del Duca, Icahn School of Medicine at Mount Sinai, at the 3rd Inflammatory Skin Disease Summit (ISDS) in Vienna, Austria, December 12-15, 2018.
The study results have important implications for treating immunological disorders, such as food allergies, with epicutaneous immunotherapy (EPIT). For food allergies, EPIT is designed to target specific skin immune cells in order to desensitize patients to allergens. In the study presented, of the four body sites studied, the upper back region showed the highest up-regulation of Th2/Th17 pathway genes and regulatory T cells, which are important targets for preventing allergic reactions. The findings support the use of the Company’s investigational Viaskin Peanut treatment for peanut allergy at the inter-scapular region of the upper back due to the local immune profile of the skin.
We are proud to support leading research that helps characterize the significant potential of the skin as the largest immune organ and contributes to our growing understanding of how to best treat food allergies and other immunological diseases,” said Dr. Hugh Sampson,Chief Scientific Officer of DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai.The data presented at ISDS 2018 suggest that the specific immune environment of the skin on the back has the greatest potential to induce immunotolerance in patients with food allergies compared with other areas of the body explored in this study.  Such data help ensure that novel treatments are optimized in the real-world and further support the therapeutic benefit that children with peanut allergy may receive from treatment with Viaskin Peanut, which is applied directly to the upper back.”
In an oral presentation entitled, Major Differences in Expression of Inflammatory Products in Skin from Different Body Sites of Healthy Individuals” (#A67), Dr. Ester Del Duca, from the laboratory of Dr. Emma Guttman at Icahn School of Medicine at Mount Sinai, New York, NY, presented findings showing significant differences in the distribution of cell types and immune profile of the skin across different body areas from healthy individuals. Out of the four locations studied – inner upper arm, upper back, outer upper thigh and lower abdomen – the upper back region showed the highest up-regulation of Th2/Th17 pathway genes and regulatory T cells, important targets for preventing an allergic reaction. The back also had the highest number of dendritic cells and Langerhans cells, as well as the lowest expression of negative immune regulators, which together can support better immune recognition of antigens when treated with EPIT.
In October 2018, DBV Technologies submitted a Biologics License Application to the U.S. Food and Drug Administration for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. Viaskin Peanut is the Company’s lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that delivers biologically active compounds to the immune system through the skin. Viaskin Peanut previously received Breakthrough and Fast Track Designation from the FDA. The submission was supported by a global development in children four to 11 years of age, in which treatment with Viaskin Peanut 250 µg was observed to demonstrate a significant desensitization to peanut as compared to placebo.

Health stocks ‘preparing for market jolt after Obamacare ruling’


U.S. health-care stocks are poised for a potentially ugly trading session Monday as investors weigh in on a judge’s ruling that Obamacare is unconstitutional, according to Bloomberg. A judge sided with Texas late Friday in a lawsuit alleging that Congress’s decision in 2017 to kill a related tax penalty essentially voided the entire Affordable Care Act, the report notes. Publicly traded companies in the space include Aetna (AET), Anthem (ANTM), Centene (CNC), Cigna (CI), Health Net (HNT), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH) and WellCare (WCG)
https://thefly.com/landingPageNews.php?id=2837633

Using remote surveillance, interventions to treat sepsis patients early


Hospitals have a hard time meeting the CMS’ sepsis treatment requirements.
The national average compliance rate for the Severe Sepsis and Septic Shock Early Management Bundle is barely 50%, according to the most recent data on Hospital Compare. The measure was adopted in July 2015 to improve hospitals’ identification and treatment of the life-threatening condition. More than 200,000 people die each year from sepsis.
WellSpan Health, an integrated delivery system based in York, Pa., has blown past that average, recently boasting an 85% compliance rate for the bundle. WellSpan executives credit a year-old quality improvement initiative that involves leveraging the electronic health record and a remote patient monitoring team to identify and treat patients with sepsis early.

Strategies

Create an algorithm in the electronic health record that identifies patients at risk for sepsis.
Establish a remote team of nurses who monitor sepsis alerts and communicate with bedside clinicians.
Enable nurses to continuously monitor patients to ensure all steps of sepsis treatment are followed in a timely manner.
The initiative launched in May 2017 after WellSpan began its transition to an Epic EHR system.
“We knew we had new tools by having a common EHR, (so we started to brainstorm) how we take these tools and leverage the workforce to deliver better care and improve outcomes,” said Dr. Steven Delaveris, vice president of medical services at WellSpan.
Delaveris, along with Jodi Cichetti, senior director of quality and clinical improvement, created an algorithm in the EHR that alerts clinicians to patients at risk for sepsis. The algorithm evaluates a patient’s vital signs including their temperature, heart rate and lab results.
But WellSpan executives were also keenly aware that clinicians are already inundated with lots of alerts and alarms.
To address alert fatigue, WellSpan established a remote surveillance team to monitor sepsis alerts and patients’ vital signs 24/7. The Central Alert Team operates much like air traffic controllers do, with the nurses monitoring patients at five hospitals, allowing them to review and intervene when necessary.
“The idea of the alert team is to facilitate early recognition and communication with the care team at the bedside, so they launch appropriate interventions,” Delaveris said.
Alerts go to the Clinical Alert Team rather than nurses at the bedside. Using patient record data on hand, nurses on the alert team will determine if an alert should be elevated to the next level. If so, they contact the patient’s physician or nurse directly to let them know the sepsis bundle should be activated.
Because the nurses only reach out to the bedside team when they see something amiss, the clinicians take their alerts seriously, Delaveris said. WellSpan also introduced the nurses to the clinicians they’d be working with so “it’s not just someone calling from the sky. We wanted to build a relationship and trust,” he added.
At least one registered nurse with intensive-care and emergency department experience is on duty at any given time monitoring patients for sepsis.
The nurses also continuously monitor the patients they see as at risk for sepsis to ensure the clinical team is following all of the bundle’s steps. WellSpan opted to use the bundle from the Surviving Sepsis Campaign, which is closely aligned with the CMS requirements. The bundle has multiple steps that need to be accomplished within designated time periods.
Before this year, the bundle required hospitals to check patients’ lactate levels, obtain blood cultures and administer antibiotics within a three-hour time frame. And then within six hours, reassess if the patient requires more fluids and check lactate levels again. The Surviving Sepsis Campaign now requires hospitals to complete all those steps within one hour. The CMS hasn’t yet changed its bundle to match those new guidelines, but WellSpan has rolled it out in its EDs.
“There is continuous monitoring for each element of the treatment that needs to be provided for the patient because timing is extremely critical,” Cichetti said.
During the 12 months after the Central Alert Team was established, about 11,520 patients were monitored.
The average sepsis treatment bundle compliance rate improved to 85% in May 2018 from 34% in July 2016. Additionally, mortality rates for sepsis decreased across all the system’s hospitals. At WellSpan Gettysburg Hospital, the mortality rate was 3.48% for the first 10 months of 2018, lower than the 5.2% baseline rate for 2017.

Medicaid overspends billions on supplemental payments


A federal advisory panel for Medicaid wants HHS to better monitor Medicaid’s biggest supplemental payment program for hospitals after finding that states have been overspending by billions.
The Medicaid and CHIP Payment and Access Commission found that 17 states overspent on so-called upper payment limit, or UPL, funds by $2.2 billion in fiscal 2016. These supplemental payments primarily go to hospitals, although they can also be made to nursing homes, physicians and other clinicians.
The overpayments accounted for nearly 17% of the total spending. In fiscal 2017, the government paid out $13.1 billion in these supplemental funds but MACPAC analysts said there is no data on how that money was spent.
Commissioner Dr. Kit Gorton called the finding a “compelling chapter for why things should change in a fairly major way” and said it shows some states are likely using the program as an “unneeded piggy bank.”
“Given the size of this spend, and the lack of accountability, what I come to is: we should recommend very heady stuff,” Gorton said.
States base the upper-payment-limit supplement for Medicaid fee-for-service rates on what Medicare would have paid for same treatment. If the base payments for hospitals fall below the Medicare base, they can make up for it with these supplemental funds.
But MACPAC’s analysis found that HHS doesn’t have a system to check that states’ estimates and payments are accurate, so the commission is weighing draft recommendations to remedy that.
Draft proposals, which will be finalized next month, included a new system for HHS to check states’ financial activity and make sure the hospital payment data is accurate. The CMS could then claw back any overpayments. HHS should also release the hospital payment data, the draft recommendation said.
In their comments, the commissioners unanimously agreed that the CMS needs to get a better handle on the program.
“The recommendations are a good start and won’t be where we end,” said Commissioner Darin Gordon, who questioned whether hospitals may double up on disproportionate-share payments and these supplemental funds.
Commissioner Alan Weil described the issue as being, “like many in Medicaid,” a practical aberration of a good concept.
“I would like to be sober and cautious because I don’t think we know what’s going on here,” Weil said. “I don’t want to sound an alarm, I want to figure out what’s going on. It may drive us to suggest a different way of thinking about UPL.”