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Thursday, January 9, 2020

Bayer, Evotec In Agreement to Develop PCOS Treatments

Bayer AG said Thursday that it will partner with Evotec SE to develop therapies for polycystic ovary syndrome, a common hormone disorder that affects women.
Under the terms of the five-year collaboration agreement, German drug discovery company Evotec is eligible for 16.5 million euros ($18.4 million) in research payments as well as more than EUR330 million in milestone payments, plus royalties generated from sales of treatments that enter the market.
Bayer and Evotec will collaborate in the early development stage, while Bayer will be responsible for clinical trials and commercialization, it said.
The two companies have previously signed collaboration deals to develop drugs targeting endometriosis and kidney disease.
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FARE, J&J Fund Research Grant to Discover Food Allergy Biomarkers

Food allergies are fairly common, but for millions of people they are life-threatening. While there are treatments in development for allergies to nuts, milk and others, Johnson & Johnson is launching a program focused on identifying novel food allergy biomarkers.
On Tuesday, Janssen, J&J’s pharma division, received a $250,000 grant from Food Allergy Research & Education (FARE) to help discover and validate those biomarkers in order to boost research into food allergies and potentially develop therapies for them. Johnson & Johnson matched that grant with another $250,000. In a statement to BioSpace, FARE said the biomarker research project, which will be conducted at Janssen’s World Without Disease Accelerator, “has the potential to make a real and significant impact for the 32 million Americans living with food allergies.”
Currently, there are limited treatment options for most people with food allergies. They, and their loved ones, must typically be on guard about what foods are around them and, many walk around with epinephrine auto-injectors and antihistamines in case of accidental exposure, which can lead to anaphylactic shock or, in the worst cases, death. According to recent FARE-supported research, medical claims with diagnoses of life-threatening anaphylactic food reactions rose nearly 400% nationwide between 2007 and 2016. Peanut allergy is the most common food allergy in children and that number has been rising. From 2010 to 2017 the number has increased 21 and almost 2.5% of children in the U.S. are thought to have a peanut allergy, according to the American College of Allergy, Asthma, and Immunology.
Those rising numbers are what makes the biomarker research so critical. It has the potential to change the lives of those millions of Americans, FARE said. Childhood-onset food allergy, a complex disease involving multiple body systems, still requires much more research to fully understand its root causes. Such research will accelerate innovation in food allergy treatment, whether by prevention to stop disease onset, interception to arrest disease development, or with a cure to eliminate food allergy completely and restore health, the organization added. FARE said it will launch a formal request for applications to the Biomarker Research Grant in early 2020.
Janssen’s World Without a Disease Accelerator is an R&D organization that is focused on building collaborative teams to study diseases and point toward an interception of disease, meaning they want to discover ways to arrest the disease before it leads to illness. The research can also lead to better treatment options or a potential cure. The accelerator is focused on areas that include microbiome, immunosciences, predictive analytics and behavioral science.
Lisa Gable, chief executive officer of Virginia-based FARE, said the $500,000 grant to J&J supports the organization’s goal of gaining a better understanding of food allergies. Also though, the grant can help lead to the development of promising new treatments and, hopefully, a potential cure, she said.
“We are proud to work with Janssen on this initiative and look forward to our collaborative effort working towards changing the face of food allergy research,” Gable said in a statement.
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Can a Flu Shot Be Used to Improve Cancer Immunotherapies?

Researchers with Rush University Medical Center injected tumors with flu vaccines, even some FDA-approved seasonal flu shots, and found that this attracted immune cells to attack the tumors. In the language of immuno-oncology, it turned cold tumors, which don’t cause much of an immune reaction, hot. The research was published in the Proceedings of the National Academy of Sciences.
“We wanted to understand how our strong immune responses against pathogens like influenza and their components could improve our much weaker immune response against some tumors,” said Andrew Zloza, assistant professor in Rush Medical College’s Department of Internal Medicine and senior author of the study.
Some immunotherapies against cancer leverage live pathogens, but they haven’t shown lasting effects in most patients or cancer types. Pulling data from a National Cancer Institute database, the research team found that lung cancer patients who had been hospitalized for a lung infection caused by influenza at the same time lived longer than lung cancer patients who had no flu. They ran experiments and found similar results in mice with tumors and flu lung infections.
“However, there are many factors we do not understand about live infections, and this effect does not repeat in tumors where influenza infections do not naturally occur, like skin,” Zloza said.
So they worked with an inactivated flu virus, which is basically a flu vaccine. A direct injection of this vaccine into the skin melanoma of the mice caused the tumors to either shrink or grow slower. It appears to increase the proportion of dendritic cells in the tumor, which are immune-stimulating cells. This resulted in an increase in CD8+ T-cells, which recognize and kill cancer cells.
In addition, injecting the vaccine into the skin melanoma tumor on one side of the body also reduced growth of a second skin tumor on the other side of the mouse’s body that had not been injected. This means that the “vaccine,” although dosed locally, had a systemic effect.
The researchers also observed similar systemic results in a mouse model of metastatic triple-negative breast cancer where it reduced the primary tumor but also the metastasis of the breast tumor to the lungs.
“Based on this result,” Zloza said, “we hope that in patients, injecting one tumor with an influenza vaccine will lead to immune responses in their other tumors as well. Our successes with a flu vaccine that we created made us wonder if seasonal flu vaccines that are already FDA-approved could be repurposed as treatments for cancer.”
He went on to add, “Since these have been used in millions of people and have already been shown to be safe, we thought using flu shots to treat cancer could be brought to patients quickly.”
And their experiments showed that they did. Additional experiments involved a mouse model called AIR-PDX, where they implanted tumor cells and immune cells from a cancer patient into a mouse that didn’t have a functioning immune system of its own. This prevents the mouse from rejecting the implanted cells. They used a human lung tumor and a melanoma metastasis in their AIR-PDX models. What they found was that injecting the flu shot into the patient-derived tumors also caused them to shrink, while the untreated tumors continued to grow.
They also ran experiments using checkpoint inhibitors, a type of immuno-oncology treatment, such as Merck’s Keytruda (pembrolizumab). The flu vaccines reduced cancer growth alone whether the tumor was responsive to checkpoint inhibitors or not. And when they combined the flu vaccine with a checkpoint inhibitor, they showed an even greater decrease in tumor growth.
“These results propose that eventually both patients who respond and who do not respond to other immunotherapies might benefit from the injection of influenza vaccines into the tumor, and it may increase the small proportion of patients that are now long-term responders to immunotherapies,” Zloza said.
The researchers used five different flu shots from the 2017-2018 flu season in their research, and four were effective in fighting tumors.
The next step is to plan clinical trials. Because the flu vaccine is already FDA approved, the study time may be shorter.
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Wednesday, January 8, 2020

The most interesting health tech at CES 2020

Do you want an “intelligent” toilet you can talk to? You can get it—if you’re willing to shell out about $10,000 for it.
Kohler unveiled the Numi 2.0 intelligent toilet at CES 2020, which comes with heated seats and a warm air dryer, ambient lighting, warm water personal cleansing and integration with Amazon Alexa so you can find out the weather while you’re taking your “bathroom time.”
It was among hundreds of products aimed at health at this showcase of the latest gadgets, robots and home technology that could be coming to the market soon.
There were digital health products that address aging issues, sleep health, underwear wearables and even sex tech from companies like Lora DiCarlo. And there were Lamborghini massage chairs that looked very inviting after several hours of walking the show floor.
Kohler’s Numi 2.0 intelligent
toilet at CES 2020 (Heather Landi)
Here’s a look at some of the most interesting technology products—from wellness-focused to just plain wacky—I saw at CES 2020.
Age tech: AARP’s Innovation Labs showcased several health and wellness technologies to empower people 50 and older to choose how they live as they age. The organization launched a developer ecosystem called the Alcove playground that makes it easy for app developers to build or integrate virtual reality experiences into AARP’s VR platform, Alcove.
The organization develops some innovations internally and is focused on leveraging VR to improve consumers’ lives as they age, Andy Miller, senior vice president of innovation and product development at AARP, told FierceHealthcare. Products include VRHealth to allow patients who have had strokes or other disabling events to do physical therapy at home and Rendever, which entertains and engages residents of long-term care facilities with virtual reality experiences.
AARP also collaborates with startups to roll out new products. Solutions showcased at the AARP booth included Sana Health, a wearable that uses pulsed light and sound with the aim of reducing chronic severe pain, and VoiceItt, a speech recognition technology. VoiceItt translates unintelligible speech in real-time, with the goal of enabling people with severe speech impairments to communicate by voice.

Sleep tech: Based on the show floor at CES, better sleep is the next big health and wellness trend. Philips has invested significantly in the sleep health space, and the company rolled out its latest SmartSleep products, including the next-generation Deep Sleep Headband. The product uses sensors to monitor brain activity and detect deep sleep then plays quiet tones to improve sleep. Walgreens is now collaborating with Philips to offer its sleep solutions and digital tools through its digital marketplace as part of its ongoing focus on chronic disease management.
Wearables company Withings debuted a feature of its ScanWatch that monitors for sleep apnea. The device uses a SpO2 sensor that measures oxygen saturation levels and identifies when they’re too low, which is an indicator of the common sleep condition.
Sleep Number also unveiled a smart bed that uses temperature technology to create a personalized microclimate and is designed to work with an individual’s natural sleep cycles.

Baby tech: Pampers worked with Verily Life Sciences to develop a smart diaper that does the dirty work—or, at least some of it.
Lumi by Pampers is a connected infant monitoring system that includes a smart HD video monitor and an activity sensor on the diapers. The information is then combined through an app to enable parents to view their baby’s sleep, feeding and diapering patterns.
The bad news: They haven’t figured out self-changing diapers just yet.
Women’s health: CES 2020 so far has been limited on technology for women, but one company, Willow, is focused on innovating in that space. The company is using technology to update breast pumps, which haven’t changed much in decades.
Willow developed an in-bra wearable breast pump that provides more privacy, the company said.
Heart monitoring: Smartwatches and devices that track heart health are all over the CES 2020 show floor.
OmronHealthcare is trying to personalize heart health monitoring and make blood pressure monitors more consumer-friendly devices. The company showcased its HeartGuide product, what it calls the first wearable blood pressure monitor, and another device that’s a blood pressure monitor with an EKG.
This summer, the company plans to launch a mobile app experience that will act as a personal heart health coach called Omrom Connect 2.0. Users also will be able to sync data with the Apple Health and Google Fit platforms to integrate reports on heart health, activity levels and sleep quality.
Smart scale: There was a smart weight scale that looks more like a toy from South Korean brand Kakao. The company is a mobile messaging giant, and its character licensing and merchandising unit, Kakao Friends, is launching smart home appliances. The smart scale has a more playful design than most scales—it looks like a cloud—and helps users manage their weight by connecting with an app.
Under-there wearables: Tech is everywhere now, including in your underwear. Myant has been developing textile computing products for several years. The company designs clothing embedded with sensors and plans to launch its Skiin smart clothing brand in the first quarter of 2020. The smart clothing, for which the company won a CES 2020 Innovation Award, will feature embedded sensors that monitor biometrics such as a wearer’s heart rate, breathing rate, temperature, movement, posture and sleep.
The first product will be underwear, the company said.
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Medtronic warns spine surgeons its Mazor X robot could come loose and fall

Medtronic alerted customers of its Mazor X robotic surgery system of its potential to come loose and detach itself from an operating room table, and possibly fall upon a patient during a spine procedure.
The manufacturer has tracked the issue to the system’s pneumatic positioning hardware, which lifts, mounts and locks the device to the OR bed frame. Over time, air leakage from certain models can weaken the system’s grip, according to Medtronic.
This only affects positioners labeled as “Type II,” which feature a wired surgeon screen and a locking switch on the back of the device, near the top user handle. These differ from Type I positioners with wireless screens and a locking lever on the lower-right side.
As of mid-November 2019, Medtronic received seven complaints about the system becoming detached and no reports of patient injuries. The company’s field safety notice was published this week by the U.K. Medicines and Healthcare products Regulatory Agency.
Medtronic and its Mazor Robotics division said that it is developing a permanent fix to the pneumatic issue—but that in the interim, leaving the device’s locking switch in the “open” position would help maintain pressure without adversely affecting the system.
The MHRA also published field safety notices from GE and Philips: GE noted certain cases of point-to-point measurement errors arising in its Centricity Universal Viewer picture archiving and communication system, while Philips alerted its customers of the risk of burning out a capacitor within its Velara X-ray generator following a large number of surges in a short amount of time.
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Cigna: Uniting Medical, Drug And Mental Health Saves $850 Per Enrollee

Cigna said efforts to combine medical, pharmacy and behavioral benefits saves more than “$850 per customer,” according to the insurer’s internal analysis.
Cigna, which owns the large pharmacy benefit manager (PBM) Express Scripts, released its fourth annual “value of integration” study documenting various savings for employer clients that have a “connected set of medical, pharmacy, and behavioral benefits.” The insurer looked at more than 2.3 million customer claims during a two-year period.
Though an internal report that would seem to favor a developing Cigna strategy, the analysis captures a broader effort by the health insurance industry to integrate more than just medical benefits into offerings they sell to employers and government clients.
Health insurers see a value-based approach that better coordinates care for the “whole person” as a way to improve health outcomes and ultimately save money. That contrasts with fee-for-service medicine that pays doctors and hospitals based on volume of care delivered.
“More than ever, employers are prioritizing whole person health and offering fully connected benefits, which are key to attracting and retaining talent,” Matt Totterdale, Cigna’s senior vice president of pharmacy said in a statement accompanying its report.
In Cigna’s case, the health plan has more to offer with Express Scripts under the same umbrella since the insurer bought the PBM in December 2018.
Meanwhile, rival health plans are stepping up integration of their insurance products with pharmacy and the provision of medical care. UnitedHealth Group owns an array of medical care providers under its Optum unit and is beginning to package insurance products that feature its providers. And CVS Health, the large drugstore chain that also operates a PBM, owns Aetna, the nation’s third-largest health insurer, and is also working to package more benefits beyond medical into the offerings it sells clients. Humana, too, is using the medical care providers it has acquired in benefits packages for seniors in its Medicare Advantage and other plans.
Health insurance companies are paying for services outside of medical care to address social determinants of health like food insecurity, loneliness and the lack of affordable housing. Thus, health plans are investing more into health coaches, case managers and behavioral health benefits that in the past may have been part of a different company’s services.
“With connected medical, pharmacy, and behavioral health benefits customers are more engaged in their health and well-being, are more likely to stay in-network for their care and are more informed about their care options, which can, not only drive down costs but also often translate to improved outcomes,” Cigna said.
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Focus Needed Not Just On Drugs But Hospital Expenses To Cut Health Costs

Much is made of the cost of drugs in the U. S., a topic that is in the crosshairs of both political parties. Particularly galling for Americans is that drugs are cheaper around the world than they are here. As the 2020 Presidential campaign heats up, we are likely to see more examples of candidates like Sen. Bernie Sanders taking busloads of people to Canada to purchase drugs that are cheaper there than in our country.
The reason that drugs are cheaper elsewhere is that foreign governments have single payer systems. In most countries, biopharmaceutical companies must negotiate prices with each nation in order to be able to market their drug in said country. The U.S. operates in a completely different system where biopharmaceutical companies negotiate with the various different payers that exist in our system, mainly the federal government and insurance companies. Unlike what happens in Europe and elsewhere, the U.S. government is not allowed to negotiate drug prices. Whether this policy continues in the future may depend on the outcome of the 2020 election.
However, drugs make up only a small portion of healthcare spending in the U.S. Data from the Centers for Medicare and Medicaid Services (CMS) show that in terms of per capita health expenditures, less than 14% is spent on drugs. Not unexpectedly, the largest share of costs in our $3.5 trillion health care system rests in the lap of hospitals. As Elisabeth Rosenthal has pointed out in a New York Times op-ed, “hospital prices increased a whopping 42% from 2007 to 2014 for inpatient care and 25% for outpatient care, compared to 18% and 6% for physicians.” This growth in hospital spend shows no sign of slowing down.
Now, an eye-opening report from the New York Times shows that hospital costs are also much more costly in the U.S. than around the world. A typical angioplasty, a procedure that opens a blocked blood vessel to the heart, averages $32,200 in the U.S., compared to $6,00 in the Netherlands and $7,400 in Switzerland. A typical, MRI scan costs $1,420 here versus $450 in Britain. Knee replacements, appendectomies, hip replacements, etc., are all far more expensive here than outside the U.S.
Despite the fact that hospital costs are the biggest part of our health care system and that such costs are growing more rapidly than other health care segments, politicians find it easier to go after biopharma companies. The attacks on drug pricing have indeed had an effect. In 2017, spending on prescription medicines grew a modest 0.6%. In 2018, according to a report from the federal Department of Health and Human Services, spending on drugs DROPPED 1%, a rare result driven by a decline for generics and slow, low growth in the cost of brand-name medications.
There is some irony in all of this. Biopharmaceutical companies have a limited window where they can gain profits. Once patents expire on brand-name drugs, generic competition occurs resulting in price decreases on the order of 90% as happened with Pfizer’s Lipitor when its patent expired. That will never happen with the cost of an angioplasty. Yet, generic drugs like statins actually reduce cardiovascular disease thereby reducing the need for patients to require angioplasties. It is well established that drugs can in fact reduce hospital costs.
By all means, let’s explore ways to reduce drug costs. But, if politicians really want to reduce health care expenditures, they should focus on hospital costs.
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