Enrollment underway in mid-stage study of Jazz Pharma’s defibrotide

The first participant has been enrolled in an exploratory Phase 2 clinical trial evaluating Jazz Pharmaceuticals’ (NASDAQ:JAZZ) defibrotide for the prevention of neurotoxicity in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) receiving Gilead Sciences’ (NASDAQ:GILD) CAR T therapy Yescarta (axicabtagene ciloleucel).

The first part of the 35-subject two-part study will assess the safety of two doses of defibrotide. The second part will evaluate the safety and efficacy of defibrotide at the recommended dose for preventing CAR T-associated neurotoxicity. The primary endpoint is the incidence of said neurotoxicity. The estimated primary completion date is April 2021.

Defibrotide is mixture of single-stranded oligonucleotides purified from the intestines of pigs that acts locally as an anticoagulant and an anti-inflammatory and anti-ischemic agent.

https://seekingalpha.com/news/3505140-enrollment-underway-mid-stage-study-jazz-pharmas-defibrotide

Amid vaping crisis, U.S. to issue new advice for doctors on lung infections

U.S. health officials are preparing to release new guidance for doctors stressing the need to ask every patient with an apparent respiratory infection about their vaping history.

The updated guidance will also advise physicians on how to diagnose and manage patients who may have both a lung infection and a vaping injury.
Dr. Ram Koppaka, a medical officer with the Centers for Disease Control and Prevention (CDC), said doctors need to be aware that there is an overlap between the early symptoms of vaping injury and common respiratory infections.
The CDC has already recommended doctors start asking patients about their vaping history during routine visits, but gathering that information is especially important as doctors evaluate patients with respiratory symptoms from infectious causes.
“Both diagnoses must be evaluated,” Koppaka said in a phone interview.

The CDC reported on Thursday that as of Oct. 8, 1,299 people in the United States have had confirmed or probable cases of lung injuries linked to vaping, and 26 have died.
Some U.S. doctors have raised concerns that vaping injury cases will be missed in the crush of patients seeking treatment for seasonal flu and other respiratory ailments.
The early symptoms of vaping injury include shortness of breath, cough, chest pain, fever, and in some cases, gastrointestinal symptoms such as nausea, vomiting and diarrhea. “All of those can also be seen with influenza,” Koppaka said.
In the United States, flu activity starts to pick up in October and November and typically peaks between December and February.
“The fact that a given individual that presents for clinical evaluation could have flu, could have lung injury due to e-cigarettes, or both, makes it complicated for providers,” Koppaka said.

As many as 72% of the earliest vaping patients in Illinois and Wisconsin sought medical treatment in outpatient clinics and emergency rooms before doctors admitted them to a hospital with severe lung injuries from vaping, state officials reported last month in the New England Journal of Medicine.
Most of those patients initially were given antibiotics. When those failed, many responded to treatment with supplemental oxygen and steroids.

‘ENDED UP IN AGONY’

In addition to flu, many respiratory infections, including fungal infections, can cause symptoms that could confound doctors and delay a vaping diagnosis.
The University of Utah Hospital in Salt Lake City has treated 22 patients with vaping injuries, including Jeffrey Manzanares, 33, who was also infected with a cold and human metapneumovirus that led to pneumonia.
Manzanares first sought treatment at a local hospital on Sept. 3, where he was given an antibiotic and oxygen for his pneumonia and sent home, his vaping injury undetected, he said in a phone interview.

“I ended up in agony from the lack of oxygen. It felt like someone was stabbing a knife into my whole body,” he said.
He went to the University of Utah Hospital the next day, where he spent 21 days, including 17 in intensive care. During his illness, Manzanares said he lost 50 pounds (22.7 kg), a third of his normal body weight.
“He was wildly sick,” said Dr. Scott Aberegg, a pulmonologist who treated Manzanares. “If that is any harbinger of what is to come in viral pneumonia season, this could be very problematic.”
Aberegg participated in a conference call earlier this month with other doctors advising the CDC on how clinicians should diagnose and manage vaping patients.
He said many doctors who get back a positive flu test may just assume the patient has the flu and not realize they are also a vaper.
State health officials are on alert.
“We want to make sure to investigate all cases that are reported and make sure we don’t miss anything that may be thought of as flu or may be associated with vaping or vice versa,” Dr. Pam Pontones, Indiana’s deputy health commissioner and state epidemiologist, said in a phone interview.
Influenza can be deadly in people who have other underlying illnesses.
“It’s really important that anyone, but especially people who have underlying pulmonary infections of any kind, be vaccinated for influenza,” Pontones said.
The CDC recommends everyone over the age of six get a flu shot.
https://www.reuters.com/article/us-health-vaping-cdc-guidance/amid-vaping-crisis-u-s-to-issue-new-advice-for-doctors-focused-on-lung-infections-idUSKBN1WP2P1

U.S. appeals court will not disqualify judge in opioid cases or delay trial

The 6th U.S. Circuit Court of Appeals in Cincinnati said U.S. District Judge Dan Polster, who oversees nationwide opioid litigation, had not created an appearance of bias against the drug industry through his rulings, public statements, and efforts to encourage settlements.
Companies that sought Polster’s recusal included retailers CVS Health Corp, Rite Aid Corp, Walgreens Boots Alliance Inc and Walmart Inc, and distributors AmerisourceBergen Corp, Cardinal Health Inc, Henry Schein Inc and McKesson Corp.
The appeals court also said Ohio failed to show that letting the trial proceed would undermine its right to litigate on its own. Thirteen other states and Washington, D.C. joined Ohio’s effort to delay the trial.
AmerisourceBergen declined to comment. Lawyers for the other companies had no comment or did not immediately respond to requests for comment.
In a Thursday afternoon filing, Ohio Attorney General Dave Yost, who sought the trial delay, said he may appeal to the U.S. Supreme Court.
Polster oversees more than 2,300 of the roughly 2,600 lawsuits by state, local and tribal governments, hospitals and other entities seeking to hold the drug industry responsible for the toll of opioid abuse.
Opioid addiction claimed roughly 400,000 lives in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention.
The industry wants to avoid a prohibitively costly bill, and the retailers and distributors faulted Polster for saying it was his “personal mission” to address the crisis.
Ohio’s Cuyahoga and Summit countries are the only plaintiffs in the Oct. 21 trial in Cleveland, the first in a federal court over the crisis. Defendants include the four drug distributors, Walgreens and drugmaker Teva Pharmaceutical Industries Ltd.
The counties’ lawyers said in a statement they remained committed “whether through negotiation or litigation” to help communities address the opioid epidemic, and Polster was being “pragmatic” in encouraging a settlement.
In letting Polster stay on, the appeals court said judges in complex cases were encouraged to pursue settlements early.

It admonished the judge to be more careful talking to the press and in court, saying his comments may “in isolation” appear to reflect bias though they did not warrant recusal.
“We do not encourage Judge Polster to continue these actions,” especially in “a case of such enormous public interest and significance,” the court said.
https://www.reuters.com/article/us-usa-opioids-litigation/u-s-appeals-court-will-not-disqualify-judge-in-opioid-cases-or-delay-trial-idUSKBN1WP2F2

Five Prime to restructure, axe 70 jobs

Aimed at extending its cash runway, Five Prime Therapeutics (NASDAQ:FPRX) will restructure its operations, including cutting 70 jobs across all functions, most (70%) by year-end.

Management says the move should save ~$20M per year. It will record a ~$3M pre-tax charge for related costs.

The company reaffirms its 2019 guidance and expects to end the year with $148M – 153M in quick assets.

https://seekingalpha.com/news/3505122-five-prime-restructure-axe-70-jobs

Big Pharma’s shelling out big-time to patient organizations: Quid pro quo?

It’s been eight months since Big Pharma executives faced a grilling by the Senate Finance Committee over their pricing decisions. But the scrutiny is far from over—and now, the committee is digging into pharma funding for patient advocacy groups, which have been known to speak in tunes that are music to the industry’s ears.
AbbVie, Bristol-Myers Squibb, Pfizer, Merck & Co., AstraZeneca and Johnson & Johnson together contributed more than $680 million to hundreds of patient groups and other nonprofits last year, according to a Bloomberg examination of data the companies sent to the Finance Committee.
The total tally more than doubled the $321 million the six companies handed out in 2015 and significantly exceeded what the industry itself spent on lobbying. In 2018, the entire pharmaceutical and health products industry—including pharmaceutical benefit managers—spent $283 million in lobbying U.S. lawmakers, according to the independent research group OpenSecrets.

AbbVie’s spending on patient groups contributed the lion’s share of the jump, according to Bloomberg, from well below $100 million in 2015 to about $350 million in 2018. AbbVie, Bristol-Myers and Pfizer ranked as the three biggest spenders.
AbbVie, in a response to Bloomberg, said it’s looking for information about certain conditions targeted by its products when deciding what groups to fund.

The companies handed over their donation data to the Finance Committee after executives testified in February about rising drug prices. Sanofi’s then-CEO Olivier Brandicourt also appeared at the hearing, but the Bloomberg report doesn’t include donation data from the French pharma. During the testimony, Sen. Ron Wyden, the committee’s ranking member, pointed to the connection between Humira sales and AbbVie CEO Richard Gonzalez’s pay as “problematic.”
It’s unclear whether the torrent of cash has affected the patient groups’ stance on pharma-related issues, but they certainly have supported causes that align with the companies’ own.
Patient advocacy groups are meant to educate and provide support services to patients and caregivers. Drugmakers also count on their insights from patients, which can be important in guiding their decision-making, R&D and marketing.
Some groups also promote messages that are beneficial to drug companies, and the large amount of money they’ve collected from the industry raises questions about potential conflicts of interest and the credibility of their own testimony to Congress.
For example, patient groups routinely appear at FDA Advisory Committee meetings to support a new product’s approval. They also speak at public hearings organized by the Institute for Clinical and Economic Review, often saying a negative review by the drug-cost watchdog could keep patients from getting access to a needed treatment.
The Patient Access Network Foundation, which collected the most in donations from the six companies over the past three years, joined dozens of other nonprofits in warning the Finance Committee about proposed changes to Medicare’s Part D benefit. The proposals might be detrimental to “beneficiaries’ costs and access to prescription drugs,” the groups said, as noted by Bloomberg. A spokeswoman for the organization told the news outlet that its advocacy work isn’t influenced by drugmakers.

Earlier this year, several patient advocacy groups rallied in objection to a Trump administration plan that would introduce step therapy in Medicare, essentially requiring patients to try cheaper drugs before moving to more costly ones. The plan would also allow drugs to be kicked off Part D formularies if price hikes are too steep. A Kaiser Health News analysis found that about half of the groups that objected had received funding from the pharmaceutical industry.
Meanwhile, the Justice Department has been investigating pharma donations to certain assistance organizations that help patients afford their medicines. Celgene, Biogen, Gilead Sciences, Pfizer, Johnson & Johnson and Valeant (now Bausch Health), among others, have been roped into that probe.
The federal prosecutors alleged the companies earmarked their donations, requiring the patient charities to use the money to offer copay assistance for their own drugs. Last May, Pfizer agreed to pay $23.8 million to settle the probe around its cancer drugs Sutent and Inlyta and arrhythmia drug Tikosyn.
https://www.fiercepharma.com/pharma/big-pharma-paid-patient-advocates-big-time-there-any-quid-pro-quo

J&J emerges unscathed in retried California talcum powder suit

Facing a raft of talcum powder lawsuits nationwide, Johnson & Johnson has already been on the wrong side of big penalties in New Jersey and California. Two weeks after losing a case in the latter, J&J can take solace in notching another defense win.
A Torrance, California, jury returned a defense verdict to J&J Wednesday in a lawsuit alleging the drugmaker’s talc products caused 60-year-old schoolteacher Carolyn Weirick to develop mesothelioma. The verdict followed a five-week retrial after an original jury failed to reach a decision, according to the Courtroom View Network.
In a statement, J&J applauded the win, which was the drugmaker’s seventh jury trial victory.
“The jury got it right—Johnson’s Baby Powder does not contain asbestos and was not the cause of the plaintiff’s disease,” the company said.

The latest win for J&J comes on the heels of recent setbacks in California and New Jersey courtrooms, which both slapped hefty penalties on the drugmaker.

Most recently, in a separate California verdict earlier this month, a jury leveled a $40 million penalty against J&J, arguing the company’s baby powder contained asbestos and caused a 70-year-old woman to develop mesothelioma.
Just weeks before, a New Jersey jury had ordered the drugmaker to pay $37.3 million to four plaintiffs on the same grounds. In a unique twist, the judge struck J&J’s entire closing argument after the company’s lawyer called the plaintiffs’ attorneys “sinister.”
A J&J spokeswoman said at the time the company would appeal the decision.

Those recent losses pale in comparison to past verdicts for J&J. In 2018, a St. Louis jury knocked the drugmaker with an eye-popping $4.69 billion penalty after a trial that combined the claims of 22 plaintiffs. Other recent losses include verdicts worth $325 million and $25 million in California and New York, respectively. J&J has said it plans to appeal each loss.
Despite those setbacks, J&J has emerged mostly unscathed from the talc litigation with no negative verdicts surviving appeals so far, the company said.
As recently as August, J&J won another defense verdict in Kentucky after a jury rejected claims that talc products from J&J and Colgate-Palmolive caused plaintiff Donna Hayes to develop mesothelioma. It was the first case to reach a jury verdict in the state, and the panel deliberated for just 30 minutes.
https://www.fiercepharma.com/pharma/j-j-emerges-unscathed-retried-california-talcum-powder-suit

FDA OKs OraSure rapid Ebola test

The FDA approves OraSure’s (OSUR +0.4%) OraQuick Ebola Rapid Antigen Test for the presumptive diagnosis of Ebola virus disease. The agency reviewed the company’s application under its De Novo premarket review pathway since there were no predicate devices.
https://seekingalpha.com/news/3505090-fda-oks-orasure-rapid-ebola-test