Glaxo grabs new drug development head from Boehringer

GlaxoSmithKline has hired Chris Corsico from German drugmaker Boehringer Ingelheim to fill the new role of senior vice-president development as the company reshapes its research strategy, a spokesman for the British group said on Tuesday.

Corsico, currently chief medical officer at Boehringer, will start at GSK on January 1, reporting to research head Hal Barron.

Barron himself joined GSK at the start of 2018 in a key appointment for new Chief Executive Emma Walmsley, whose top priority is to improve research productivity in pharmaceuticals.

https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/GlaxoSmithKline-GSK-grabs-new-drug-development-head-from-Boehringer-27279038/

Benefit Gains Exceed Wage Growth, New Labor Data Shows

Americans’ compensation is growing, but workers might not notice it in their regular pay.

The value of benefits — including bonuses and vacation time — grew at a faster rate in the 12 months ended in June than wages and salaries, according to data the Labor Department released Tuesday. That extended a long-running but slow shift in compensation toward benefits and away from wages.

The cost of benefits for private-sector employers rose 3% in June from a year earlier, while the cost of wages and salaries advanced 2.7%.

The benefit gain was driven by a nearly 12% increase in bonuses and other forms of supplemental pay. That likely in part reflects bonuses that many large companies, including AT&T Inc. and Comcast Corp., gave to employees after Congress approved a package of tax cuts.

Increased bonus payments could also indicate firms are using one-time payments to recruit or retain workers, rather than raising their base salaries.

While bonus payments were well up from a year earlier, they were unchanged from March, the last time the data was collected. The data aren’t seasonally adjusted, making monthly comparisons potentially misleading, but the lack of movement could suggest that at least some of those payments may not be repeated.

Paid leave, including vacation time, rose 4% in June from a year earlier. The cost of health-care coverage and other insurance rose 2.3% from a year earlier.

Benefits growth outstripping wage gains is consistent with a recent paper from President Trump’s economic advisers that found broader compensation growth was stronger than the gain in average hourly earnings reported in the monthly jobs report.

Most forms of benefits have been growing at a better rate than wages and salaries since the recession ended in mid-2009.

https://www.marketscreener.com/news/Benefit-Gains-Exceed-Wage-Growth-New-Labor-Data-Shows–27279172/

Spire profit sinks on ‘unprecedented’ UK National Health cutbacks

 Core earnings at UK private hospital operator Spire Healthcare Group sank 21 percent in the first half of 2018, driven by belt-tightening at the National Health Service that cut referrals to its big private providers.

Shares of Britain’s largest independent hospital group dropped 12 percent to an all-time low 148.6 pence after the report, which also predicted full-year core earnings would fall by up to a fifth, to 120-125 million pounds.

Spire, BMI Healthcare and Nuffield Health have helped the NHS cope with pressures on services in recent years, but their earnings and revenue have taken a hit as the NHS prioritises emergency cases and makes cuts elsewhere, focusing on essential health services.

Spire shares have now fallen 40 percent this year.

To mitigate the hit from fewer NHS referrals, Spire – founded in 2007 as a network of 25 Bupa hospitals – said it was reducing capital spending further and focusing on self-paying patients and its own general practitioners.

Chief Executive Justin Ash, who took charge last September, told Reuters after the results he was cutting his forecast for full-year investment for the second time in two months, by another 10 million pounds to 80 million pounds.

“We are investing in to what is a relatively difficult market largely because of the NHS,” Ash said, calling the decline in NHS admissions at Spire hospitals and clinics “unprecedented”.

Ash said in the release the company expected other private providers to suffer similarly from the changing environment, and as one of the UK’s big providers saw opportunities in that.

He said revenue from the company’s private business was up 2.5 percent while self-pay revenue at the firm rose 8.3 percent to 87.3 million pounds in the first half.

NHS revenue, by contrast, fell 10 percent to 140.3 million pounds, pulling down overall revenue by 1.1 percent to 445.6 million pounds in the six months ending June 30.

Spire’s first-half earnings before interest, taxes, depreciation and amortisation (EBITDA) dropped to 66.1 million pounds.

The company’s forecast for full-year EBITDA compared to the consensus of 134.8 million pounds estimated by 11 analysts, according to Thomson Reuters I/B/E/S.

In a separate statement, the company named John Forrest, former chief operating officer of pub operator Greene King retail operations, as its new chief operating officer.

The appointment is the latest in a string of top management changes at Spire, as it looks to combat constraints from the NHS-linked business.

Difficult trading conditions and belt-tightening by the NHS led Australian rival Ramsay Health Care to post a 21 percent fall in annual profit last month.

https://www.marketscreener.com/GREENE-KING-9590136/news/Spire-profit-sinks-on-unprecedented-NHS-cutbacks-27274735/?countview=0

Senate Overwhelmingly Passes Bill to Address Prescription Opioids

The U.S. Senate overwhelmingly supported a new bill aimed at opioid abuse and other addictive drugs.

In a 99 to 1 vote, the Senate passed the bill that looks to cut down on the flow of illegal narcotics entering the United States through the mail, as well as taking aim at the abuse of prescription opioid medication – a problem that has grown to an epidemic in the United States. Among the measures the Senate bill does is provides a simpler approach for companies and organizations to research non-addictive pain treatments, according to the Associated Press.Additionally, the U.S. Food and Drug Administration (FDA) would be allowed to “require drugmakers to package smaller quantities of drugs like opioids,” the AP reported. Smaller quantities, which could be sold in three- and seven-day treatment packets, would hopefully cut down on the number of prescription drugs in circulation and reduce the chances of abuse.

Additionally, the bill provides funding through federal grants for treatment centers and for the training of emergency workers who would respond to potential overdose issues.

The AP noted that the U.S. House of Representatives passed its own legislation earlier this year that also attempts to address some of these same issues. The two chambers of Congress will now have to hash out the differences between the bills before voting on the combined package.

Opioid abuse has become a significant problem across the United States. Statistics provided by the U.S. Department of Health and Human Services indicate that approximately 116 Americans die daily from opioid overdoses. That same data showed that 11.5 million people in 2016 misused prescription opioids. Those statistics were based on 2016 numbers, the most recent data that department has compiled. Earlier this year the U.S. Centers for Disease Control and Prevention (CDC) released a report earlier this year that shows opioid-related emergency room visits spiked 30 percent across the states between July 2016 and September 2017. Midwestern states were particularly hard hit with spikes of 70 percent, the CDC report said.

The issues with opioid abuse have become so significant that the White House has weighed in on the matter several times. Last month, during a meeting with his Cabinet, President Donald Trump called on U.S. Attorney General Jeff Sessions to file lawsuits against certain drug manufacturers whose drugs have contributed to the opioid crisis. During that meeting, Trump highlighted some of the lawsuits states and municipalities have brought against a number of opioid drugmakers, including Purdue Pharma, Teva Pharmaceutical, Johnson & Johnson, Endo International, and Allergan. Certain distributors, like Wal-Mart, Walgreens and CVS have also been named in the lawsuits.

The U.S. Department of Justice has already gotten involved in the legal matters between state and local governments and opioid manufacturers. In April the Department of Justice filed a motion to participate in settlement discussions as a “friend of the court.” The friend of the court filing comes about a month after the DOJ formed a task force to target opioid manufacturers and distributors for the roles they have allegedly played in the increase of addiction across the country.

In May the FDA approved the first non-opioid treatment to manage withdrawal symptoms from opioid addiction. Kentucky-based US WorldMeds snagged the greenlight for Lucemyra (lofexidine hydrochloride) for the mitigation of opioid withdrawal symptoms in adults. Approval for the treatment was based on positive trial data that showed the medication significantly reduced the severity of withdrawal symptoms in comparison to placebo.

https://www.biospace.com/article/jc1n-senate-overwhelmingly-passes-bill-to-address-prescription-opioids/

Allergan and Sosei Halt Alzheimer’s Trial Over Safety Concerns

Allergan and its development partner Sosei Group have voluntarily suspended clinical trials of HTL0018318 in Alzheimer’s and other types of dementia because of safety problems.

HTL0018318 is a selective small molecule muscarinic M1 receptor agonist. It is being developed for cognitive issues in patients with Alzheimer’s disease and other dementias, including dementia with Lewy bodies.

The drug was in Phase I clinical trials in the United States, sponsored by Allergan, and in a Phase II clinical trials in Japan sponsored by Sosei. The trial in Japan was for patients with Lewy body dementia. An additional Phase Ib clinical trial in Alzheimer’s disease has finished in Europe and is currently being analyzed. That trial is sponsored by Sosei’s subsidiary Heptares Therapeutics.

The safety concerns arose in a single animal toxicology study in non-human primates. That study was evaluating different dosing levels of the drug over a nine-month period. A rare tumor was observed at doses and durations higher than those used clinically in humans to date. So far, the drug has been investigated in 310 humans in the U.S. and Europe, including health patients and patients with mild to moderate Alzheimer’s disease. In humans, the drug has been well-tolerated with no serious side effects at the tested doses for up to 28 days.

The companies have reported the safety issues to the U.S. Food and Drug Administration (FDA) and the Japan Pharmaceutical & Medical Devices Agency (PMDA). At this point, the companies’ scientists are reviewing all data accumulated so far.

As a result of these findings and the suspension of the trials, the start of a planned Phase II trial in Alzheimer’s and Lewy body dementia will be delayed by at least six months. Sosei notes that because of the delay, its revenue will be impacted next year because it doesn’t believe it will receive a major milestone payment from Allergan in 2019 related to the progress of the program.

The two companies entered the global research-and-development and commercialization partnership in April 2016 under a deal where Allergan licensed exclusive global rights to a portfolio of novel subtype-selective muscarinic receptor agonists. The deal was potentially worth $3.35 billion. Allergan paid $125 million up front and Heptares was eligible for milestone payments of up to $665 million linked to successful Phase I, II and III clinical development, as well as launch of the first three licensing compounds for multiple indications. There was an additional $2.5 billion tied to certain annual sales milestones for several years after launch. Heptares is also eligible for up to double-digit tiered royalties on net sales. Allergan also committed up to $50 million to R&D.

“We were very surprised to see these results given the safety profile HTL0018318 has exhibited across all previous animal and clinical studies,” said Tim Tasker, Sosei’s chief medical officer, in a statement. “We have taken these steps in the best interests of patient safety which is our number one priority. We are committed to working with clinical investigators, R&D teams and our regulatory authorities to understand better the reason for the findings from this animal toxicology study and so enable the human clinical development program with HTL0018318 to continue as soon as possible. We remain confident that this compound has the potential to deliver important benefits to patients with AD and DLB.”

https://www.biospace.com/article/-cp8r-allergan-and-sosei-halt-alzheimer-s-trial-over-safety-concerns/

Ligand rises after Viking’s study of VK2809 hits primary goal

Shares of Ligand Pharmaceuticals (LGND) are higher in early trading after Viking Therapeutics (VKTX) announced top-line results from a Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with non-alcoholic fatty liver disease, or NAFLD, and elevated low-density lipoprotein cholesterol, or LDL-C. The study successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in LDL-C compared with placebo, Viking said. In May of 2014, the companies announced that Ligand licensed the rights to five programs to Viking. The drug candidates and programs covered by the license agreement included VK0612, VK5211, VK0214, a portfolio of orally available small molecule EPOR agonists for the potential treatment of anemia and a portfolio of orally available small molecule inhibitors of the enzyme DGAT-1 for the potential treatment of lipid disorders such as obesity and dyslipidemia. Also as part of that transaction, Ligand agreed to extend a $2.5M convertible loan facility to Viking that can be used to pay Viking’s operating and financing-related expenses. In early trading, shares of Viking Therapeutics have more than doubled to $21.57. Meanwhile, Ligand is up 6% to $268.62 per share.

https://thefly.com/landingPageNews.php?id=2792066

Citron Research calls Tilray news ‘promotional and misleading’

Citron Research just tweeted, “$tlry has now crossed to promotional and misleading They announce that they are supplying cannabis to an already arranged study that does not involve them tinyurl.com/y79y62pp. No collaboration Low float a promo is a dirty combo for.” Shares of Tilray are up 12%, or $14.74, to $134.93 in early trading. The company’s CEO is appearing tonight on Jim Cramer’s Mad Money show.
https://thefly.com/landingPageNews.php?id=2792089