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Friday, June 21, 2019

Ocular up as DEXTENZA gains an indication

The FDA approves the Ocular Therapeutix (NASDAQ:OCUL) sNDA for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication.
DEXTENZA received FDA approval last year for ocular pain after ophthalmic surgery.
OCUL shares are up 7.8% pre-market to $4.45.

Updated Epizyme data from tazemetostat Phase 2 trial ‘positive’

Epizyme (NASDAQ:EPZM+10.9% pre-market after reporting positive interim data from an ongoing Phase 2 trial of its lead candidate, tazemetostat, as a monotherapy for patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
EPZM says the data indicate tazemetostat showed meaningful clinical activity and was generally well tolerated in both patients with EZH2 activating mutations and those with wild-type EZH2.
EPZM says the data will be presented today at the International Conference on Malignant Lymphoma.
The company says it remains on track for submission of a New Drug Application submission for tazemetostat for follicular lymphoma by the end of the year.

Labcorp gains a sell-side bull

Bullish on the outlook for LH‘s Covance Drug Development operation and lower risk in the diagnostic business, Deutsche Bank’s Dan Leonard upgrades Labcorp to Buy from Hold.
His Street-high price target of $220 suggests 31% upside.
The average Sell-Side rating for Labcorp is Buy/Outperform, but the Quant Rating is Neutral.

Fred’s to close more stores

Fred’s (NASDAQ:FRED) says it will close an additional 49 underperforming stores as part of an ongoing effort to optimize the store footprint.
The retailer notes the decision to close the additional stores follows a continued evaluation of the store portfolio, taking into consideration historical and recent store performance as well as the timing of lease expirations.
FRED is +5.56% to $0.40.
Source: Press Release

Thursday, June 20, 2019

American Well, Cisco partner on in-home telehealth option for Medicare Advantage

  • Telehealth vendor American Well and tech conglomerate Cisco are joining up to expand virtual health options for older patients.
  • Initial plans for the partnership include converting in-home television sets into patient portals for telehealth care delivery through American Well for care that’s usually delivered in a hospital or skilled care facility.
  • Though the two companies have yet to launch a product, any joint device will likely be HDMI compatible and allow for remote control by the care team, according to an American Well source.

Technology is among the factors driving care from traditional medical facilities like hospitals to the home and other parts of the community.
CMS finalized a rule in April giving Medicare Advantage plans greater flexibility in telehealth benefits for patients treated in their homes. The expansion of virtual services is meant to foster greater benefits at reduced costs and starts Jan. 1.
Over the past decade, MA membership has roughly doubled from 11.1 million people in 2010 to 22 million in 2019. About one-third of Medicare beneficiaries are in the privately-run Medicare plans.
The Congressional Budget Office estimates steady enrollment growth in MA over the next decade, rising to about 47% of all Medicare enrollees.
Though the two companies have yet to offer a concrete device, the work will take advantage of Cisco’s tech infrastructure and video expertise. Eventual offerings could include a smart camera that identifies where the patient is regardless of lighting, according to an American Well source.
This tech will allow “doctors and nurses to use technology to knock on our door and visit us at home regularly,” American Well CEO Roy Schoenberg said in a statement. “This will allow healthcare that previously warranted hospital admission or facility stay to take place in the home.”
It could be useful in a variety of clinical scenarios, such as chronic care, cancer care or a check-in, the company said.
American Well contracts with more than 130 health systems on their telehealth offerings, and 150 million people have access to American Well services through their health plan, according to the company.
Telehealth adoption among private payers is growing as well. According to FAIR Health, private insurance claims for services rendered via telehealth as a percentage of all medical claim lines grew 53% nationally between 2016 and 2017.
And Comcast and Independence Blue Cross joined in April of last year on a similar pilot to deliver pre- and post-care support through the patient’s TV.

AHIP19: Cigna CEO says ‘society demands more’ from insurance industry

One of the most powerful voices in healthcare is calling on the industry to rethink consumer needs, acknowledging patients’ frustration with costs and industry’s obligation to respond.
“Society demands more value from us sooner, and they should as it relates to more personalized affordable, predictable services,” David Cordani, CEO of Cigna, said speaking at the payer industry’s annual conference.
As the 2020 presidential election nears, Cordani said the industry is faced with an important question on its response to demands for change. After years in the cross-hairs of the politically charged debate over the Affordable Care Act, many Democratic hopefuls are pushing for “Medicare for All,” pitching it as a solution for the current healthcare system’s woes.
Cordani alluded to Medicare for All in his pitch for the industry to deliver its own solutions.
“We all know there is an election coming up and we all know there is a present narrative around this because society demands more value from us today. The question is: are we going to resist, are we going to collaborate, or as we look at the path forward, will we choose to lead by being able to identify the bright spots that are working?” he asked.
For its part, Cigna is promising to bend the cost curve of healthcare by committing to deliver a rate of medical cost growth that will not exceed the consumer price index by 2021.
Industry needs to rethink how it envisions consumers. Leaders need to think about the American earning $50,000 who’s trying to navigate the system and gets a surprise medical bill, he said.
“We need to pivot from solving things on average, or explaining things in aggregate, and come back to the individual consumer level,” Cordani told a ballroom full of health insurance employees and providers during the annual gathering of America’s insurance plans, organized by the powerful lobbying group AHIP.
Consumers are basically saying to healthcare companies: know me, help me and make it easier and simplify it, Cordani said.
“Before anybody can be helpful to a person, you need to know that individual,” he added.
The message fits in with Cigna’s current strategy after acquiring Express Scripts for nearly $70 billion and in line of vertical integration across the industry.
Cigna is betting that the future of health insurance is managing the whole person — not just their medical benefit or their pharmacy benefit, but the totality of their care including behavioral health and dental.
Failing to do this creates more fragmentation in the industry, he said, and causes more frustration for patients.

Sanofi, Regeneron: positive topline Phase 2 results for IL-33 antibody in asthma

  • REGN3500 (SAR440340) monotherapy significantly reduced loss of asthma control and improved lung function compared to placebo
Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. The trial also met a key secondary endpoint, demonstrating REGN3500 monotherapy significantly improved lung function compared to placebo.
In the trial, the greatest improvement was observed in patients with blood eosinophil levels ≥300 cells/microliter. Patients treated with Dupixent® (dupilumab)  monotherapy did numerically better than REGN3500 across all endpoints, although the trial was not powered to show differences between active treatment arms. The combination of REGN3500 and Dupixent also did not demonstrate increased benefit compared to Dupixent monotherapy in this trial. More detailed results will be presented at an upcoming medical meeting
“This trial suggests that REGN3500 may provide an alternative targeted approach for patients suffering from asthma,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. We look forward to working with Sanofi to advance REGN3500 through our asthma clinical trial program, as well as continuing our ongoing trials in atopic dermatitis and chronic obstructive pulmonary disease.”