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Thursday, October 17, 2019

Protalix up on longer-term PRX-102 data

Thinly traded nano cap Protalix BioTherapeutics (NYSEMKT:PLX) is up 18% premarket on modest volume in reaction to 12-month data on pegunigalsidase alfa (PRX-102) from the first 16 Fabry subjects in the open-label Phase 3 BRIDGE switchover study.
At month 12, 16 of 22 enrolled patients who were on a stable regimen of agalsidase alfa [Takeda’s (NYSE:TAK) Replagal] who switched to pegunigalsidase alfa experienced a mean improvement in kidney function with a favorable safety profile.
The results were consistent with six-month data announced in about a year ago.
Development is ongoing.
https://seekingalpha.com/news/3506474-protalix-18-percent-premarket-longer-term-prxminus-102-data

FDA accepts Foamix application for rosacea topical FMX103

Foamix Pharmaceuticals (NASDAQ:FOMX) is up 1% premarket on average volume in response to its announcement that the FDA has accepted for review its marketing application for FMX103 (minocycline topical foam 1.5%) for the treatment of adults with moderate-to-severe papulopustular rosacea.
The agency’s action date is June 2, 2020.
https://seekingalpha.com/news/3506484-fda-accepts-foamix-application-rosacea-topical-fmx103-shares-1-percent

Horizon Therapeutics launches gout med trial

Horizon Therapeutics (NASDAQ:HZNP) has initiated PROspective sTudy of pEglotiCase in Transplant patients (PROTECT), an open-label trial evaluating the use of KRYSTEXXA (pegloticase injection) in 20 adults with chronic gout refractory to conventional therapies, also known as uncontrolled gout who have undergone a kidney transplant.
The study’s primary endpoint is response rate, as measured by sustained serum uric acid reduction to <6 mg/dL at Month 6 of treatment.
It will also evaluate secondary outcomes such as complete resolution of at least one tophus, and scores related to pain and disability.
https://seekingalpha.com/news/3506485-horizon-therapeutics-launches-protect-trial-evaluating-krystexxa-uncontrolled-gout

Stealth Bio up on elamipretide data

Thinly traded micro cap Stealth BioTherapeutics (MITO +2.2%) perks up, albeit on volume of only 5,300 shares, on the heels of new data from the open-label extension portion of its Phase 2/3 TAZPOWER study evaluating Fast Track-tagged elamipretide in patients with a rare inherited disorder called Barth syndrome, characterized by an enlarged and weakened heart. The results were presented at the American Society of Human Genetics Annual Meeting in Houston, TX.
Patients receiving elamipretide, an inner mitochondrial membrane-targeting peptide compound that binds to a molecule called cardiolipin that plays a key role in mitochondrial function, experienced a 27% increase in average cardiac stroke volume.
In April, the company announced that TAZPOWER failed to achieve the primary endpoint of a statistically significant improvement in the 6-minute walk test at week 12 versus placebo, but data from the extension phase showed a 40% decrease in the ratio of abnormal to normal cardiolipin, suggesting that a longer duration of treatment may produce a greater treatment effect.
https://seekingalpha.com/news/3506536-stealth-bio-2-percent-elamipretide-data

Wednesday, October 16, 2019

GE Healthcare, Premier Inc. Team on One-Stop Breast Cancer Center Mod

GE Healthcare and Premier Inc. (PINC) said Wednesday they planned to develop a model for a one-stop breast cancer diagnostic center similar to a model currently in use in France.
The French Gustave Roussy Cancer Campus saw 75% of patients leave after a one-day visit with an accurate diagnosis and a treatment care plan on the same day, the companies said.
Premier conducted a Rapid Evidence Review and, based on the results of the first phase of the collaboration, GE Healthcare and Premier intend to evaluate the potential and merits of adopting the model in the U.S.
“Premier is eager to explore the U.S. adoption of the One-Stop Clinic model, which decreases anxiety, aims to improve accuracy and speeds up the time it takes to diagnose breast cancer and establish a treatment plan,” said Denise Juliano, Group Vice President for Premier Applied Sciences.

https://www.marketscreener.com/PREMIER-INC-14383011/news/Premier-GE-Healthcare-Premier-Inc-Team-on-One-Stop-Breast-Cancer-Center-Model-29385995/

Drug firms offer to settle U.S. opioid suits with $50 billion package

Five drugmakers and distributors are offering $22 billion in cash as well as drugs and services they value at $28 billion to resolve lawsuits alleging the industry fuelled the U.S. opioid crisis, two sources familiar with the matter said on Wednesday.

The drug industry faces roughly 2,600 lawsuits brought by state and local governments, hospitals and other entities seeking to hold drugmakers and distributors responsible for the toll of opioid abuse. Local governments seek funds to cover costs of services in their communities.
Distributors McKesson Corp, AmerisourceBergen Corp and Cardinal Health have offered to pay $18 billion in cash over 18 years, while drugmaker Johnson & Johnson would pay $4 billion in cash, two people familiar with the matter told Reuters.
Teva Pharmaceutical Industries Ltd has offered to give away medications it values at $15 billion as part of the deal and provide distribution services it values in the billions, one of the people said.
Both said that Teva’s proposed agreement would run over 10 years and had a total estimated value of around $28 billion. However, it is not clear how the valuation was reached, and one source said some states are asking whether Teva should pay cash as well.
The negotiations are being led by the attorneys general for Texas, Tennessee, North Carolina and Pennsylvania, one person said.
Teva and the three distributors are all defendants in a landmark trial set to begin in federal court in Cleveland, Ohio, on Monday. U.S. District Judge Dan Polster, who has long pushed for a global settlement of the litigation, will preside over the trial.
The distributors, accused of failing to halt and report suspicious drug orders, are pushing for a settlement to be agreed to before the trial begins on Monday, one source said. The second source added that a sticking point was compensation for lawyers who typically are paid a percentage of settlements and represent many of the state and local plaintiffs.
The sources cautioned that there was no guarantee a deal would be struck. One source said lawyers for the thousands of cities and counties with cases pending in federal court have not yet agreed to back the proposal the states are negotiating.
In a joint statement late on Wednesday, the lead attorneys for the cities and counties pursuing federal lawsuits – Joe Rice, Paul Farrell and Paul Hanly – called media reports that they were tentatively supporting the settlement proposal “inaccurate.”
“We await the fine print of the settlement framework so that we can work alongside the 2,600 communities we represent to determine the best path forward,” they said.
Jury selection went ahead on Wednesday in anticipation of opening statements on Monday. Other defendants in the trial are Walgreens Boots Alliance Inc and Henry Schein Inc.
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 companies did not respond to requests for comment on Wednesday. J&J had said on Tuesday it was open to a settlement.
https://www.marketscreener.com/HENRY-SCHEIN-INC-9582/news/Drug-firms-offer-to-settle-U-S-opioid-suits-with-50-billion-package-sources-29385820/

Vaping industry group launches Fox News ad blitz

The Vapor Technology Association (VTA) is launching an advertising blitz to try and convince President Trump not to move ahead with his proposal to ban flavored e-cigarettes.
The organization is placing a one-week, six-figure buy that covers Fox News programming throughout the day, including “Fox & Friends,” which the president has been known to watch and tweet about.
Last month, Trump announced from the Oval Office that he was instituting a total ban on all e-cigarette flavors except tobacco until the companies can clear the Food and Drug Administration’s (FDA) strict regulatory requirements.
VTA’s ads, however, don’t fault Trump at all. Instead, they praise Trump for keeping his promises on making sure government agencies follow the law, and blame faceless “bureaucrats” for the proposal.“Despite President Trump’s efforts, bureaucrats are considering a huge new overreach: they’re considering banning flavored vapor,” a narrator says in the 30-second ad. “Vaping is at least 95 percent safer than smoking. But if the government bans flavored vapor, 150,000 jobs — gone. Millions will resort to cigarettes or the black market.”
The ads, which will also run online, are expected to begin Thursday.
The VTA represents many e-cigarette manufacturers but split with Juul over the summer after the group filed a lawsuit against the FDA.
The ads are the latest attempt to sway Trump into changing his mind about the policy, which has yet to be formally implemented. The ads echo the language used by conservatives, who say the flavor ban will harm small businesses and is a violation of core Republican free-market principles.
https://thehill.com/policy/healthcare/466176-vaping-industry-group-launches-fox-news-ad-blitz