Cara Gains On Licensing Deal For Pruritis Treatment

Shares of Cara Therapeutics Inc (NASDAQ: CARA) are surging to a three-month high in reaction to a licensing agreement the biotech company announced with Vifor Fresenius Medical Care Renal Pharma.

What Happened

Cara said it has licensed worldwide rights — except in the U.S., Japan and South Korea — to commercialize Korsuva injection with VFMCRP, a joint venture between Vifor Pharma and Fresenius Medical Care AG & Co. (ADR) (NYSE: FMS).

Korsuva, chemically difelikefalin, is being evaluated for treating chronic kidney disease-associated pruritis in dialysis patients. It was given breakthrough designation status by the FDA; there are no approved therapies for the condition in the U.S. or European Union.

Cara retains all rights to Korsuva for all other indications.

Why It’s Important

The deal provides for a $50-million upfront cash payment to Cara and an equity investment of $20 million via share sales at $17 apiece. Cara also stands to receive additional payments of up to $470 million, including $30 million in regulatory and up to $440 million in tiered commercial milestones.

The deal provides significant momentum for adoption of Korsuva injections if the drug is approved in the U.S., as it can leverage VFMCRP’s nephrology-focused commercial expertise in its co-promotion partnership for U.S. Fresenius Medical Care dialysis facilities.

What’s Next

Cara has initiated the first pivotal Phase 3 trial of Korsuva in hemodialysis patients suffering from moderate-to-severe pruritis in the U.S. The company expects to initiate a global Phase 3 clinical trial in multiple countries later this year.

Data from these studies would support regulatory filings in the U.S. and other markets, the company said.

https://yhoo.it/2IJz2vJ

Stop & Shop recalls frozen broccoli over bacteria concerns

Major supermarket chain Stop & Shophas issued a frozen broccoli recall for all its stores after health inspectors found potentially dangerous bacteria in one of the packages.

The supermarket chain released an alert on May 21 saying that it’s voluntarily recalling 16-ounce packages of “Private Brands Frozen Broccoli Cuts.” A routine sampling by Connecticut inspectors found listeria monocytogenes, a potentially deadly bacteria, in a sample from a store in South Windsor, CT.

Frozen broccoli with the UPC code “068826700926” and a label stating “BEST BY MAR 15 2020” are being pulled from store shelves. Stop & Shop has over 400 stores in states including New York, New Jersey, Connecticut, and Massachusetts.

There have been no illnesses connected to the recall, however the CDC warns that listeria can seriously affect pregnant women, newborns, and the elderly. Approximately 1,600 people in the U.S. contract a listeria infection each year from eating contaminated food. About 260 people die from the bacteria.

https://cbsloc.al/2LlvJZj

Medtronic has initial positive blood pressure reduction system results

Medtronic announced first-ever-data from the SPYRAL HTN-ON MED Study. Initial study results found statistically significant and clinically important blood pressure reductions in hypertensive patients prescribed anti-hypertension medications treated with the Symplicity Spyral renal denervation, or RDN, system with no major adverse safety events out to six months. The Late-Breaking Trial data, presented at the 2018 EuroPCR Annual Meeting in Paris, was published simultaneously in The Lancet. The Symplicity Spyral system is investigational in the United States and Japan. At six months, patients randomized to the renal denervation procedure experienced an average 9 mm Hg drop in 24-hour mean systolic ambulatory blood pressure, or ABPM, resulting in a 7.4 mm Hg difference compared to patients in the sham control arm. For RDN patients, 24-hour mean diastolic ABPM also declined 6 mm Hg, which is 4.1 mm Hg lower than the sham control arm. Likewise, average office systolic blood pressure, or OBP, in patients in the RDN arm declined 9.4 mm Hg – a 6.8 mm Hg difference from the sham control arm, and the diastolic OBP declined 5.2 mm Hg, a 3.5 mm Hg difference from the sham control arm

https://bit.ly/2ICKHfH

American women’s $1 trillion burden

Student debt is on its way to becoming a universally American problem, but there’s more evidence to indicate that it’s a particularly acute challenge for women.

The gap between the amount of debt shouldered by male and female graduates has nearly doubled in the past four years, according to a report released Monday by the American Association for University Women. On average, female bachelor’s degree recipients graduated with $2,700 more in debt in 2016 than their male counterparts. That’s up from about a $1,400 gap in 2012.

If trends continue on their current trajectory, Kevin Miller, a senior researcher at AAUW and the author of the report, estimates that the outstanding student debt held by women alone could reach $1 trillion over the next year. If the ratio of debt owed by women versus men stays the same, then men hold about $550 billion at that time. “We’ll be keeping a watch on it,” he said.

Terrence Horan/MarketWatch

The data adds to the growing body of evidence — much of which has been published by AAUW — that student debt is a women’s issue. Although they make up just 56% of American college students, women hold nearly two-thirds of America’s outstanding student debt, or about $890 billion, and take longer to pay it off.

There are a variety of reasons why this is the case, according to Miller. For one, women typically have to rely more on loans to finance college because they earn less from their work before they enter college (if they have a job before they start) and while they’re in school.

And once women graduate college, the gender pay gap continues to play a role. Women working full-time with college degrees earn 26% less than their male colleagues, according to AAUW, delaying their efforts to repay their loans. On average, men paid off roughly 38% of their student between one and four years of graduating college, while women only paid off 31%.

All of this means that women aren’t reaping as much financially from their degrees as men, though they’re attending college in higher numbers. That dynamic is the result of a complicated mix of factors, Miller said. Women are getting more degrees because they recognize that they need more education to match men’s earnings, Miller said. But they need to go into debt, and more debt than men, on average, to do so.

https://on.mktw.net/2x4Klcw

India’s Sun gets FDA OK for prostate cancer med combo

YONSA^® was shown in clinical studies to be an effective form of abiraterone acetate, and can be taken with or without food, in combination with methylprednisolone

Sun Pharma had acquired YONSA^® from Churchill Pharmaceuticals and will commercialize YONSA^® in the U.S.

Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) today announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration (FDA) for YONSA^® (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Churchill is eligible to receive upfront and sales-linked milestone payments, and royalties on sales from Sun Pharma pursuant to an agreement between the two companies to commercialize YONSA^® in the U.S.

“We are pleased to add YONSA^® to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” said Abhay Gandhi, CEO – North America, Sun Pharma.

YONSA^® in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the U.S.

https://bit.ly/2J0mZtm

Consumer Reports to retest Tesla Model 3 after brake ‘firmware’ fix

Consumer Reports said Tuesday it will retest brakes on Tesla Inc’s new Model 3 sedans after Chief Executive Elon Musk promised a software update, but the potential hit to sales from the magazine’s negative review weighed on Tesla shares.

A review by the influential magazine on Monday said the car, despite many positives, had “big flaws,” including braking slower than a full-sized pickup truck. That criticism adds to headaches for Musk, already facing pressure over a series of crashes, production issues, and the company’s finances.

“If Tesla can update the brakes over the air – an industry first – we’d be happy to retest our Model 3,” said Jake Fisher, Consumer Reports’ director of automotive testing.

In mass-market, mid-sized cars, vehicles recommended by Consumer Reports account for over 80 percent of the category’s sales volume, Barclays analyst Brian Johnson wrote in a client note.

Musk in a tweet late on Monday acknowledged the brake issue and said that the magazine’s tests had used two early versions of the car before improvements had been made.

“Looks like this can be fixed with a firmware update,” Musk tweeted, saying Tesla aimed to roll out a solution a few days. “With further refinement, we can improve braking distance beyond initial specs.”

Musk said he would ask Consumer Reports to retest using a more recently built car.

The Silicon Valley company uses so-called “over-the-air updates” (OTAs) to send software fixes and improvements to its cars.

Tesla stock, down more than $100 a share since September, fell 3.3 percent to $275.01 on Tuesday. The shares had finished almost 3 percent higher on Monday, helped by news of plans to deliver higher-priced, more profitable versions of the Model 3.

The Model 3 began production in July, but the rollout has been hampered by production bottlenecks. The company now plans to build 5,000 vehicles per week by the end of June.

Musk said the variability in stopping distance was due to a braking system calibration algorithm and could indicate some Model 3s took longer to stop than others.

“If so, we will address this at our expense. May just be a question of firmware tuning, in which case can be solved by an OTA software update.”

Tesla has had a fraught relationship with Consumer Reports in the past. A year ago, the magazine pulled its top ranking for Tesla’s flagship Model S sedan due to the automaker’s failure to install an emergency braking feature, but later reinstated it after Tesla performed an OTA to add that feature.

The magazine also did not recommend Tesla’s Model X SUV, calling it “more showy than practical.”

https://bit.ly/2J0SenX

House passes ‘right-to-try’ bill, sending it to President Trump’s desk

The House voted 250-169 to pass a “right-to-try” bill that would allow terminally ill patients access to experimental drugs. The bill, approved by the Senate last August, is headed to the desk of President Donald Trump, who is expected to sign it into law.

The legislation would allow patients with life-threatening conditions to ask drugmakers for medicines that have not yet been FDA-approved but that have at least completed phase 1 testing. The patient must have run out of approved treatment options and must be unable to participate in a clinical trial of the experimental drug in question. The FDA’s oversight would be rolled back as the patient would only need a physician and the drugmaker to sign off on the request.

Drugmakers are not obligated to provide the treatments: “No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug,” the bill says.

“The administration believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physician,” the White House said in a statement Monday.

The House debated—and failed—a different version of the bill in March, with 138 Democrats and two Republicans voting against it and preventing it from reaching the two-thirds majority it needed to move on.

Objections to that bill, as well as to the version that passed, were underpinned by the belief that it would have little effect on access to medicines, while making patients vulnerable to exploitation by unscrupulous doctors and drugmakers, who would have total control if the FDA were to be cut out of the process.

As it stands, the FDA already approves 99% of requests to access unapproved treatments under its expanded access policies, sometimes called “compassionate use.”

https://bit.ly/2Ln5QIL