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Friday, November 15, 2019

Google ended NIH project on privacy concerns

Google (GOOG +1.6%)(GOOGL +1.6%) abruptly canceled a project with the NIH in 2017, according to The Washington Post sources.
The project ended right before Google was set to publicly post 100K NIH-provided images of chest X-rays. The NIH called and said some of the images still contained information that could identify the patients.
Sources say that Google researchers, while planning the project, didn’t obtain legal agreements covering patient privacy.
In other Google news, a WSJ investigation found the company has “increasingly re-engineered and interfered with search results to a far greater degree than the company and its executives have acknowledged.”
The WSJ says the actions are often due to pressure from businesses, interest groups, and governments.
More than 100 interviews and WSJ testing showed algorithmic changes to favor big businesses, engineer adjustments to information in auto-complete boxes and news results, and blacklisting certain sites separate from those required by law or efforts to curb spam sites.

After Bristol says no, Roche bids $1.4B on Promedior to boost fibrotic pipeline

Roche is spending up to $1.4 billion to snap up a scarring-focused biotech, nabbing an FDA breakthrough-tagged therapy in the process.
The Swiss major, known for its work in cancer research, has in recent years been branching out into new areas, notably into idiopathic pulmonary fibrosis (IPF) with the approval of its drug Esbriet for the lung-scarring disease.
Now, it’s looking to boost its pipeline with Lexington, Massachusetts-based Promedior and its group of experimental meds designed to treat fibrosis (scarring). These all come out of its pentraxin-2 platform that works as an endogenous human protein specifically active at the site of tissue damage.

The private biotech’s clinical lead asset is its midstage PRM-151, a first-in-class recombinant human pentraxin-2, for IPF, and it already has an FDA breakthrough badge while also showing some “promising early clinical trial data,” according to the biotech, in myelofibrosis (MF), with “other fibrotic diseases” also in the crosshairs.
Roche is putting down $390 million in cash upfront with biobucks worth up to $1 billion also in the cards for the company.
But we’ve seen this before: Back in 2015, a similar deal was set up by Bristol-Myers Squibb, which landed the rights to buy out Promedior, paying $150 million upfront and committing a total of $1.25 billion to the deal if PRM-151 was shown to work.
But BMS, now busy with its much larger Celgene acquisition, chose last year not to use its rights to acquire the company; this is usually a death touch for a small biotech, but Roche has clearly seen something it likes and has swooped in with its own deal.
Jason Lettmann, CEO of Promedior and general partner of Lightstone Ventures, said: “With over a decade of research, development and investment, Promedior has demonstrated the unique ability of its pentraxin-2 platform to deliver disease-modifying potential in fibrotic disorders. Due to Roche’s strong expertise in IPF, hematological cancer and other fibrotic disorders, we believe Roche is ideally positioned to bring the potential of our platform to patients and provide new treatment options within these areas of urgent unmet medical need.”
Pentraxin-2 works as an agonist that acts as a macrophage polarization factor to initiate a resolution process for prevention and potential reversal of fibrosis, thereby acting as a master regulator upstream in the fibrosis cascade.
“We are excited to combine Promedior’s portfolio with our drug development capabilities to further advance PRM-151 in fibrotic diseases, including IPF and MF,” added James Sabry, M.D., Ph.D., global head of Roche Pharma Partnering. “With our proven track record in IPF with Esbriet  as well as in hematological cancers, we are well-positioned to leverage our clinical and commercial expertise to bring PRM-151 to patients as fast as possible.”

Sensyne to market AI tools in the U.S. through Cognizant and Agorai

Oxford, U.K.-based Sensyne Health plans to bring its artificial intelligence tools to America, and it’s enlisting IT services giant Cognizant and data infrastructure specialist Agorai to help do it.
The digital health products making the jump will include GDm-Health, therapeutic software prescribed to help manage gestational diabetes; EDGE, a program for monitoring chronic obstructive pulmonary disorder at home; and Support-HF, to track daily vital signs at home following heart failure.
In the U.K., Sensyne also maintains the air pollution monitoring program CleanSpace, and SEND, an early warning system and vital-sign recording platform designed for hospitals.
GDm-Health, currently used in 15 National Health System (NHS) trusts and by about 6,100 patients, will be the first of the group to make its U.S. debut. No U.K. patient data will be shared through the agreements, the company said. The products were first developed within the NHS, in collaboration with the University of Oxford before being licensed to Sensyne.
“Cognizant and Agorai are excellent partners that will enable us to ensure that the full potential of these innovative products, first invented in the U.K.’s NHS, is realised in the U.S. market,” said Lord Paul Drayson, CEO of Sensyne.
“Following the appropriate regulatory approvals, Cognizant will provide these digital health applications to U.S. health care providers and the commercial return made by Sensyne will be shared with the NHS.”
This year, Sensyne partnered up with Bayer to mine anonymized patient data from the NHS to help design trials and develop treatments for cardiovascular disease. This includes genomic sequencing data and real-world evidence.
In the deal, Sensyne describes itself as a “docking station” that oversees the flow of data and insights between the NHS and commercial interests, keeping protected patient information from being sold or transferred to a third party.
A few months later, Bayer spun its AI collaboration with Sensyne into a full-fledged project among its international LifeHubs, which includes innovation centers in France, Germany, the U.S., Singapore and Japan.

Valeritas up on additional positive V-Go data

Thinly traded nano cap Valeritas Holdings (NASDAQ:VLRX) is up 9% premarket on modest volume in reaction to new data on its V-Go Wearable Insulin Delivery device. The results were presented at the Annual Diabetes Technology Meeting in Maryland.
Real-world data from 122 patients with uncontrolled type 2 diabetes (T2D) with HbA1c levels above 7.0% (key threshold for diabetics to manage their condition) showed mean reductions of 1.3% after median duration of five months of V-Go use.
V-Go is a disposable insulin delivery device (patch) that is placed on the skin where it delivers basal/bolus insulin over a 24-hour period.

GlaxoSmithKline’s Shingrix supply will vault upward, CEO says—in 2024

GlaxoSmithKline has been laboring to boost supplies of next-gen shingles vaccine Shingrix, thanks to a speedy launch that bested all expectations. While it’s planning a slight increase next year, the real “step change” will come in 2024 with a brand-new facility.
That’s the word from CEO Emma Walmsley, who said on a recent conference call that the new operation will dramatically boost output. As it stands, company execs have said they plan to produce doses in the “high teens millions” through the end of this year to support the current rollout.
By contrast, the drugmaker expects the new site to deliver a dose increase in the “tens of millions,” GSK vaccine president Roger Connor told Reuters. GSK is building the site in an undisclosed location to complement an existing bioreactor in Belgium, according to the report.
In the meantime, GSK plans a slight increase in production next year.
GSK has good reason to invest in added manufacturing capacity. Since its 2017 approval, the vaccine has been a top growth engine for the company, hitting sales of $1.6 billion in the first 9 months of 2019.
And that performance came despite supply constraints. Late last year, the company said an ongoing U.S. shortage of the vaccine would last “throughout 2019″ as strong demand had been outstripping supply. To deal with the limitations, the company has limited orders and delayed TV ads.
Looking ahead, GSK continues to win new market approval, and it’ll have to support those future rollouts with added capacity. The drugmaker just won an approval in the massive Chinese market in May.
Aside from the U.S., GSK has already launched in Germany and Canada and plans “phased launches” in China and Japan next year, execs said on the call. GSK global pharma head Luke Miels said the Chinese rollout would be a “very targeted initial launch because of the supply” constraints.

Y-mAbs’ omburtamab shows positive effect in rare abdominal cancer

Y-mAbs Therapeutics (YMAB -0.1%announces encouraging data on omburtamab, a humanized B7-H3-targeting monoclonal antibody, in patients with desmoplastic small round cell tumors (DSRCT), a rare type of aggressive sarcoma that typically starts in the abdomen of pelvis. The results were presented at the Connective Tissue Oncology Society Annual Meeting in Tokyo.
A total of 33 patients underwent gross total resection (GTR) at Memorial Sloan Kettering in New York. 24 received whole abdominalpelvic intensity-modulated radiotherapy (WA-IMRT) plus omburtamab interperitoneal radio immunotherapy (IP-RIT) while nine patients received WA-IMRT alone.
Median overall survival (OS) in the omburtamab cohort was 59 months compared to 41 months in the other. Adding omburtamab IP-RIT to GTR improved the five-year Kaplan Meier estimated OS from a historical rate of ~20% to ~40%.
Development is ongoing.

Trump Administration Releases Transparency Rule in Hospital Pricing

The Trump administration on Friday released a far-reaching plan that would for the first time force hospitals and insurers to disclose their secret negotiated rates.
Administration officials said the final rule will compel hospitals in 2021 to publicize the rates they negotiate with individual insurers for all services, including drugs, supplies, facility fees and care by doctors who work for the facility.
The administration will propose extending the disclosure requirement to the $670 billion health-insurance industry. Insurance companies and group health plans that cover employees would have to disclose negotiated rates, as well as previously paid rates for out-of-network treatment, in file formats that are computer-searchable, officials said.
The insurers, including Anthem Inc. and Cigna Corp., would have to provide a transparency tool to give cost information to consumers in advance, senior administration officials said.
The requirements are more far-reaching than many industry leaders had expected and could upend commercial health-care markets, which are rife with complex systems of hidden charges and secret discounts. The price-disclosure initiative has become a cornerstone of the president’s 2020 re-election health strategy, despite threats of legal action from industry.
“Right now there is too much arbitrage in the system,” a senior administration official said in an interview Thursday with The Wall Street Journal. “There are a ton of vested interests who will oppose this. We expect to get sued. We’re really goring people’s oxes.”
Hospitals and insurers typically treat specific prices for medical services as closely held secrets, with contracts between the insurers and hospital systems generally bound by confidentiality agreements. Policy makers, employers and patients are often unable to see clearly which hospital systems and doctor practices are driving high costs.
The proposal covering insurers is the newest part of the price-disclosure initiative, and it would include the private-employer market, where about 158 million people get their health insurance. Insurers and group health plans would have to put the negotiated rates into a file that third-party developers could incorporate into shopping tools.
Insurers would also have to create a web-based tool for beneficiaries that discloses the list price, the negotiated rate, cost sharing, and the amount left on a plan deductible, as well as allowable out-of-network rates, officials said. There will be a 60-day public comment period on the proposal.
Studies show consumers are often required to pay more out of pocket when they don’t have the price information they need to comparison shop. Employer health-plan deductibles are outpacing wage growth and have risen to an average $1,655 for a single plan, according to a September survey by the Kaiser Family Foundation. Workers on average pay $6,015 toward the cost of their coverage.
On the final rule covering hospitals, facilities would have two obligations. First, they will have to provide insurer-specific negotiated rates in a computer-readable file.
Second, hospitals will have to post negotiated charges online for 300 specific services that patients typically shop around for. Seventy of those services, including vaginal birth, colonoscopy, and joint-replacement surgery, are stipulated in the rule, according to senior administration officials. Hospitals can select the other 230 services they post online.
Hospitals face fines of up to $300 a day if they don’t comply with sharing negotiated rates.
Taken together, the price-disclosure initiatives could reshape the $3.5 trillion health-care industry.
Prices charged for health care vary widely depending on whether a provider is in or out of the patient’s insurance network and on the insurer’s undisclosed price agreements with hospitals. A magnetic resonance image of the lower back costs $141 at an imaging center in Jefferson, La., but $7,646 at a hospital in Torrance, Calif, according to data from Clear Health Costs, which publishes information on health costs.
Hospitals, insurers and others in the industry have spent the past nine months since the idea was floated by the White House denouncing the proposal and gearing up for a pitched legal battle.
The industry is also likely to argue in any legal challenge that negotiated rates are proprietary and include confidential contractual agreements. Industry groups have also said it runs counter to the First Amendment.
Pharmaceutical companies prevailed with a similar argument when the Trump administration said they had to disclose list prices for drugs in television ads. A federal judge in July ruled that the requirement overstepped regulatory authority.
“It will have a negative impact on competition,” said Tom Nickels, executive vice president of the American Hospital Association, though he hadn’t yet seen the final rule.
If rates are public, health-care companies say, some hospital systems might push for payment rates that match their crosstown rivals’.
Proponents argue it would bring costs down. Out-of-network doctors could try to compete with in-network negotiated rates. Health systems that charge higher negotiated rates could lose business if they don’t match competitors’ rates or justify the reasons for their steeper costs. And employers could press their insurers to include hospitals with lower negotiated rates in their networks.
Employers and patients are often unable to see which hospital systems and doctor’s offices are driving prices upward. Some health-care economists argue that the secrecy is a factor in why the U.S. spends more per resident on health care than any other developed nation.
The administration’s vision is to arm patients with information needed to make health-care decisions much like shopping for other consumer services. Rates potentially could be posted on public websites, where consumers would check the negotiated price of a service before they pick a provider.
The White House push on price disclosure comes as President Trump seeks to close the gap with Democrats, who hold an advantage on health care in public polling.
President Trump has stated that under his health-care plan, Americans will get better care at a lower cost than they currently pay. About three in 10 adults are very or somewhat confident the president will deliver on his promise, while 62% say they aren’t too confident or not at all confident, according to an October poll by the Kaiser Family Foundation.
The White House is prepared to defend the rule and the proposal covering insurers from lawsuits, a senior administration official said. Officials said authority for the requirements stem from the Public Health Service Act.
“You’ll be able to negotiate all over the place,” Mr. Trump said in an October speech in Florida. “And you’ll be able to pick everything you want, from the hospital to the doctor. And it’s going to save you a tremendous amount of money.”