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Tuesday, July 2, 2019

Cholesterol that is too low may boost risk for hemorrhagic stroke

Current guidelines recommend lowering cholesterol for heart disease risk reduction. New findings indicate that if cholesterol dips too low, it may boost the risk of hemorrhagic stroke, according to researchers.
Over a period of nine years, a Penn State-led study examined the relationship between —LDL, commonly known as “bad” —and hemorrhagic stroke. This type of stroke occurs when a blood vessel bursts in the brain.
The researchers found that participants with LDL cholesterol levels below 70 mg/dL had a higher risk of hemorrhagic stroke.
Xiang Gao, associate professor of nutritional sciences and director of the Nutritional Epidemiology Lab at Penn State, said the results—published today (date) in Neurology—may help refine and personalize recommendations for ideal target cholesterol levels.
“As is true with many things in nutrition, moderation and balance is key when deciding the optimal target level of LDL cholesterol,” Gao said. “You can’t go to either extreme—too high or too low. And if you’re at a high risk for hemorrhagic stroke due to family history or risk factors like  and heavy alcohol drinking, you may want to be extra careful about LDL cholesterol levels.”
According to the researchers, low LDL cholesterol is recommended as a way to reduce the risk of a heart attack or ischemic stroke—the latter when a blood vessel in the brain becomes blocked by a clot. But previous research has suggested a link between very low LDL cholesterol levels and hemorrhagic stroke.
Chaoran Ma, a nutritional sciences graduate student at Penn State, said that while previous studies suggested this connection, there was a need for additional validation in a separate cohort.
“For our study, we wanted to expand the scope of knowledge in this area by investigating the issue prospectively in a large cohort with multiple LDL cholesterol measurements to capture variation over time,” Ma said.
The study included 96,043 participants with no history of stroke, heart attack or cancer when the study began. LDL cholesterol levels were measured when the study began and yearly thereafter for nine years. Reported incidents of hemorrhagic stroke were confirmed by medical records.
The researchers found that participants who had LDL cholesterol levels between 70 and 99 mg/dL had a similar risk of hemorrhagic stroke. But, when LDL cholesterol levels dipped below 70 mg/dL, the risk of hemorrhagic  increased significantly. For example, the risk increased by 169 percent for participants with LDL levels less than 50mg/dL relative to those with LDL levels between 70 and 99 mg/dL. These findings were consistent after controlling for age, sex, blood pressure and medication.
“Traditionally, an LDL cholesterol level of more than 100 mg/dL had been considered as optimal for the general population and lower in individuals at elevated risk of heart disease,” Gao said. “We observed that the risk of  increased in individuals with LDL cholesterol levels below 70 mg/dL. This observation, if confirmed, has important implications for treatment targets.”
Ma said the findings may be able to help health care professionals continue to refine guidelines.
“The results were based on a large community-based study, which is an advantage because it focused on healthy people in a non-clinical setting,” Ma said.

States agree to pause lawsuits against bankrupt opioid maker Insys

Five states have agreed to facilitate settlement talks by dropping objections to a bid by Insys Therapeutics Inc (INSYQ.PK) in bankruptcy court to put on hold their lawsuits alleging the drugmaker helped fuel the opioid epidemic.
The agreement was announced on Tuesday by a lawyer for Chandler, Arizona-based Insys during a hearing before a federal bankruptcy judge in Wilmington Delaware, who was set to consider whether to block the states from moving forward with their cases.
Insys requested the injunction when it filed for Chapter 11 bankruptcy protection on June 10, becoming the first drugmaker accused in lawsuits by state and local governments of contributing to the deadly opioid epidemic to do so.
Insys filed for bankruptcy days after striking a $225 million settlement with the Justice Department resolving claims it paid doctors bribes to prescribe Subsys, the company’s addictive fentanyl spray.
A federal jury in Boston in May found Insys founder John Kapoor and four other former executives guilty of engaging in a racketeering conspiracy involving Subsys marketing practices.

Filing for bankruptcy normally halts active litigation against a company while it reorganizes. But a longstanding exception in U.S. bankruptcy law allows for lawsuits to proceed enforcing government officials’ “police powers.”
Lawyers for Maryland and Minnesota, where Insys faced upcoming administrative trials in August and September, last week opposed Insys’ motion to stay their cases, citing that exception. New York, New Jersey and Arizona joined them.
A ruling on Insys’ motion could have influenced whether OxyContin maker Purdue Pharma LP – another opioid manufacturer facing some 2,000 lawsuits – decides to file for bankruptcy protection, according to a person familiar with the matter and legal experts.
But at Tuesday’s hearing, Ronit Berkovich, a lawyer for Insys, told U.S. Bankruptcy Judge Kevin Gross that the five states, as well as North Carolina, had agreed to stay their cases in order to support a settlement negotiation protocol.
After hearing arguments over the proposal’s merits, Gross agreed to approve it, saying it initiates negotiations that need to take place to avoid draining cash-strapped Insys of money.

“We don’t want to reduce that money by litigating and the like,” he said.
Cities and counties pursuing hundreds of similar cases against Insys are not part of the deal, nor are several states that had already agreed to put their lawsuits on hold.
But Berkovich said they would be invited to participate in the negotiation process, which she said envisions putting Insys in a position to file a restructuring plan for the court’s approval by Sept. 2.

Invacare cuts 75 jobs, names new sales roles

In a progress update on its transformation plan, Invacare (NYSE:IVC) says it’s cut 75 jobs and changed some leadership in its sales organization.
The company named Joost Beltman VP – Sales and Marketing, North America. Most recently, he served as managing director of the Benelux and Italy regions.
It’s also named Keith Brantly director of CRT sales; he’s rejoining the company from Amoena USA.
Meanwhile, it’s shed 75 associates in North America and Europe. The company expects pretax cash restructuring charges of about $0.6M in Q2 and $2.5M in Q3.
Once the workforce reduction is done, it expects $6.4M in annualized pretax savings: $3.3M in Europe, and the rest in North America.

Mizuho starts Merck at Buy


Karuna closes $103M IPO

Karuna Therapeutics (NASDAQ:KRTX) has closed its IPO of ~6.4M common shares at $16 per share, including the full exercise of underwriters’ over-allotment. Gross proceeds were ~$102.6M.

USANA Health Sciences cuts 2019 outlook

USANA Health Sciences (NYSE:USNAanticipates Q2 sales in the range between $253M – $256M, compared to $301M last year, and EPS of ~$0.91 – $0.95, compared with $1.36 in the prior-year period.
The company lowered its FY19 outlook, amid challenging consumer environment in China due to negative media coverage of the health products and direct selling industries
Forecasts sales of ~$1.02B – $1.06B as compared to prior guidance of $1.21B-$1.26B, with EPS of $3.70 – $4.10 down from prior guidance of $5-5.35
Q2 results will be released on July 23, 2019.

Arbutus sells portion of Onpattro royalties to Canadian pension plan

Arbutus Biopharma (NASDAQ:ABUS) has sold a part of its royalty interest in future global sales of Alnylam Pharmaceuticals’ ONPATTRO (patisiran), approved by the U.S. and Europe in August 2018 for polyneuropathy caused by hATTR, to an Ontario, Canada-based pension plan called OMERS.
Under the terms of the agreement, Arbutus will receive $20M gross, to be retained by OMERS until it has received a total of $30M in royalties.
Under the terms of its license with Alnylam, Arbutus will receive tiered royalties of 1.00 – 2.33% after offsets. The royalties that it will receive under its license deal with Acuitas Therapeutics are unaffected.