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Sunday, September 2, 2018

AstraZeneca improves diabetes pen to maintain its market share


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The European Commission (EC) has approved AstraZeneca’s Bydureon BCise, a new weekly formulation of established GLP-1 diabetes drug with the added benefit of glucose reduction, better weight loss results and a new injection pen.  
AstraZeneca announced that the EC green-lighted the new formulation of the once-weekly type-2 diabetes injection, which will be marketed as Bydureon BCise (exenatide 2mg prolonged-release suspension).
The new authorisation has been granted for a single-dose, pre-filled pen device that requires no titration and is approved for use in combination with other glucose-lowering medicines, including basal insulin, to help improve glycaemic control together with diet and exercise.
The EC made its decision based on data from DURATION-NEO-1 clinical trial comparing Bydureon BCise and AZ'[s twice-daily exenatide formulation, Byetta. After 28 weeks of treatment, patients administered with the new formulation demonstrated an HbA1c reduction of 1.4% and 1% respectively.
Additionally, Bydureon BCise demonstrated a mean weight reduction of 1.5 Kg as monotherapy comparing to 1.9 Kg with certain oral antidiabetic medicines.
Elisabeth Björk
Elisabeth Björk, vice president, head of cardiovascular, renal and metabolism, global medicines development at AstraZeneca, said: “Building on the already well-established efficacy and safety profile of once-weekly Bydureon, today’s approval of Bydureon BCise will enable us to offer an additional treatment option for patients with type-2 diabetes whose blood sugar levels are inadequately controlled by other glucose-lowering medicines together with diet and exercise.”
This new formulation of once-weekly Bydureon BCise has been already approved in the US by the Food and Drug Administration (FDA) in October 2017 and hit the market in the first quarter of this year.
Despite improvements Bydureon’s will still face stiff competition to sustain its established drug share on the GLP-1 market.
Novo Nordisk recently published the first promising PIONEER 5 trial results for oral semaglutide, and also claim that its current Ozempic shows the greater levels of blood sugar and weight reduction when compared with Bydureon and Eli Lilly’s Trulicity.
Market analysts suggest that Novo Nordisk will be able to add another blockbuster to its portfolio and further billions to its revenue should semaglutide get approved in a daily pill form.
Also, the small Israeli biotech Oramed is developing an oral version of exenatide – the active ingredient in AstraZeneca’s Byetta, but this drug is still in mid-stage trials.

Roche reveals hemophilia drug data ahead of label expansion decision


Roche has revealed new trial data that make the case for use of its haemophilia A drug Hemlibra in an expanded patient group, ahead of a decision by the FDA in the autumn.
Hemlibra (emicizumab) is already approved for patients with inhibitors, which are produced by the body and prevent factor VIII replacement therapy from working properly.
But the new phase 3 HAVEN 3 study shows Hemlibra also works in patients aged 12 years or older who have not produced inhibitors, unlocking a large portion of the market in patients treated with standard care of recombinant factor VIII therapy.
The FDA is set to decide on whether Hemlibra can be used in the larger patient group by October 4.
Findings published in the New England Journal of Medicine showed Hemlibra prophylaxis administered subcutaneously every week or every two weeks significantly reduced treated bleeds by 96% and 97% respectively compared with no prophylaxis.
Results also showed that 55.6% of people treated with Hemlibra every week and 60% of people treated with Hemlibra every two weeks experienced zero treated bleeds, compared to 0% of people treated with no prophylaxis.
In a comparison of people who previously received factor VIII prophylaxis in a prospective non-interventional study and switched to Hemlibra prophylaxis, Roche’s drug demonstrated a statistically significant reduction of 68% in treated bleeds, making it the first medicine to show superior efficacy to prior factor VIII prophylaxis treatment, the current standard of care.
Roche said there were no unexpected or serious adverse events related to the drug in the HAVEN 3 study, and the most common adverse events were consistent with previous studies.
The FDA has already granted the drug a faster, six-month priority review in this new indication and was granted Breakthrough Therapy Designation, to expedite the development and review of medicines for serious conditions that could represent a step forward over standard care
Sandra Horning, chief medical officer at Roche, said: “Current prophylactic treatment options for people with hemophilia A can require frequent intravenous infusions, and despite treatment, many continue to have bleeds that can lead to long-term joint damage.”
“Given the challenges many people face managing their hemophilia, we believe Hemlibra could make a meaningful difference, and we are working with health authorities to hopefully make this treatment available to people with hemophilia A without factor VIII inhibitors as soon as possible.”

Major medical construction projects



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Monkey Trials Raise Hope for Non-Addictive Opioid Alternative


The ongoing opioid addiction crisis means the search for powerful but non-addictive painkillers is more urgent than ever before. Now, a team of scientists says it may be nearing that goal.
Research in monkeys suggests that an experimental painkiller — called AT-121 — is not only very effective in easing pain, but it may also blunt the addictive effects of opioids.
AT-121 provided the same level of pain relief as a typical opioid, but at a 100-times lower dose than morphine, according to the research team from Wake Forest Baptist Medical Center, in Winston-Salem, N.C.
“In our study, we found AT-121 to be safe and non-addictive, as well as an effective pain medication,” said Mei-Chuan Ko, a professor of physiology and pharmacology at the hospital.
“In addition, this compound also was effective at blocking abuse potential of prescription opioids, much like buprenorphine does for heroin, so we hope it could be used to treat [both] pain and opioid abuse,” Ko added in a Wake Forest news release.
The research showed that — in monkeys, at least — AT-121 suppressed the addictive potential of oxycodone (Oxycontin), a commonly abused opioid prescription drug.
In the experiments, monkeys were able to “self-administer” potentially addictive drugs such as cocaine or oxycodone, but when given AT-121, they were no more likely to do so than when they’d received simple saline solutions.
According to Ko’s team, this suggests that AT-121 lacks the addictive potential of typical opioids.
And unlike typical opioids, withdrawal symptoms weren’t observed when the monkeys ceased using AT-121 after three days, the researchers said.
AT-121 also seemed to ease pain without some of the typical side effects of opioids, such as itch, motor impairment, respiratory and other issues.
Of course, trials conducted in animals sometimes fail to pan out in people. But Ko noted that monkeys are a very close model to humans.
“The fact that this data was in non-human primates, a closely related species to humans,” suggests that the findings have a good chance of being replicated in clinical trials in people, he said.
Still, further research — including safety studies — is needed before applying to the U.S. Food and Drug Administration for approval to conduct those clinical trials, Ko said.
The study was published Aug. 29 in the journal Science Translational Medicine.
More information
The U.S. National Institute on Drug Abuse has more about prescription opioids.
SOURCES: Wake Forest Baptist Medical Center, news release, Aug. 29, 2018; Science Translational Medicine, news release, Aug. 29, 2018

Which ER patients should be restrained?


Most patients restrained in emergency departments (EDs) fall into two categories — a relatively young and predominantly male group presenting with alcohol or drug use, and an older group with medical complaints, recent research shows.
“Our data found strong association of alcohol or drug use with physical restraints and identified a unique elderly population with behavioral disturbances in the ED,” the researchers wrote in Annals of Emergency Medicine.
They explained that knowing which agitated patients in the ED could require restraint is valuable information because of a steadily growing number of behavioral emergencies and grave risks associated with restraint.
Behavioral emergencies in EDs have skyrocketed in recent years, with national estimates of a 50% increase in ED visits for behavioral disorders between 2006 and 2011 compared with an 8.6% increase in the total number of visits. Agitation is often associated with behavioral ED visits, with 1.7 million events occurring annually.
Although the use of patient restraint is common in the ED setting, negative health outcomes and potential liability can be severe, the researchers noted. “Adverse events have been cited in the restraint process, including blunt chest trauma, aspiration, respiratory depression, and asphyxiation leading to cardiac arrest. In addition, a survey of ED patients found that 66% reported experiencing severe psychological distress and lasting consequences in regard to care-seeking behavior after physical restraint.”
The study was the first large-scale investigation designed to characterize the kinds of patients who are restrained in the ED setting. Included were 3,739 patients who were restrained in the emergency rooms of five hospitals.
For the vast majority of patients in the study, the researchers found there were two groupings of restrained patients with significantly different characteristics:
  • The larger grouping accounted for two-thirds of restrained patients, with a median age of 39, compared with 64 for the smaller grouping
  • About 70% of the larger grouping were men, compared with about 60% in the small grouping
  • About 30% of patients in the larger grouping were black, compared with 20% in the smaller grouping
  • About 60% of patients in the larger grouping had Medicaid coverage, while 49% in the smaller grouping had Medicare coverage
  • Homelessness was much higher in the larger grouping, at 8.9%, compared with 0.9% in the smaller grouping
  • Chief complaints varied widely between the two patient categories, with about 50% of the larger grouping complaining of drug or alcohol use and about 80% of the smaller grouping presenting with medical complaints
The researchers wrote that ED staff should take a cautious approach when deciding whether to restrain both kinds of patients.
An earlier study showed that ED staff had strong sentiments of frustration and resentment toward patients with alcohol or drug use, psychiatric illness, homelessness, and frequent ED visits — all qualities associated with the larger grouping of patients identified in the new research.
“These negative sentiments highlight a potential pitfall for implicit bias and stigmatization by ED health workers of an already marginalized population because of their underlying health conditions,” the authors wrote.
They added that there is significant risk associated with restraining older adults, noting that two previous retrospective studies of elderly ED patients with behavioral emergencies reported significant rates of cognitive impairment and multiple comorbidities that may be affected by sedation and restraint use.
Best Practices
The Joint Commission has highlighted the following 10 primary standards for restraint and seclusion of patients:
  • Restraint and seclusion should be used only when clinically justified or when patient behavior poses a physical danger to the patient or others
  • Patient restraint or seclusion should be implemented safely based on hospital policy as well as laws and regulations
  • Restraint or seclusion should be based on an individual order for specific patients, not standing orders; if the attending physician did not make the restraint or seclusion order, he or she should be consulted as soon as possible
  • Medical staff should monitor restrained or secluded patients
  • Hospitals should have written guidelines for restraint and seclusion
  • Patients who are restrained or secluded should be evaluated repeatedly
  • Patients who are both restrained and secluded should be monitored continually
  • Use of restraint or seclusion should be documented
  • Staff should be trained in the safe use of restraint and seclusion
  • Deaths linked to restraint or seclusion should be reported to the Centers for Medicare & Medicaid Services
This report is brought to you by HealthLeaders Media.

Clal Biotechnology Industries: Gamida Cell files for Nasdaq IPO


Clal Biotechnology Industries Ltd. (TASE: CBI) and Elbit Medical Technologies(TASE: EMTC) have announced that Gamida Cell, their joint subsidiary, had submitted a prospectus to the US Securities and Exchange Commission (SEC) for an IPO on Nasdaq. Gamida Cell previously announced its intention of holding an IPO this year, but the plan is now being officially implemented. The prospectus is still confidential, and Gamida Cell’s controlling shareholders said that it is still possible that the plan will not go through, but after several months during which Gamida Cell assessed the US capital market and considered its options, it appears that the decision is coming at the right time for an IPO. It is believed that Gamida Cell will seek to raise $50-75 million at a company value of $300 million, before money.
Gamida Cell is developing stem cell-based products. Its first product, NiCord, designed for treatment of blood cancer, has successfully passed Phase I/II clinical trials, in which it was found to improve the speed at which implants are absorbed by patients whose immune systems have been destroyed and reconstructed through implants cells generated by umbilical cord blood. Besides Clal Biotechnology and Elbit Medical, each of which has an 18% stake in Gamida Cell, the other shareholders include drug company Novartis (10%), which previous considering acquiring Gamida Cell, but has meanwhile retained its stake in the company; the IBF venture capital fund; and the Shavit Capital fund, which invests in Israeli pre-IPO life sciences companies. Hong Kong fund VMS also took part in Gamida Cell’s most recent financing round.
Gamida Cell has raised over $100 million to date. Its most recent financing round was in June 2017, when it raised $40 million at a company value of $150 million.
Implants in adults
Gamida Cell has developed a unique stem cell technology that makes it possible to multiply stem cells and improve their density in cell units without detracting from their characteristics. Current treatment for blood cancer can destroy the patient’s immune system, which is then reconstructed through what is known to the public as bone marrow transplants. These consist of stem cells developing for a new immune system for the patient. The quantity of stem cells in an umbilical blood unit is currently suitable only for treatment of children or adults weighing up to 45 kilograms, because stem cell density in each unit is too low for a normal adult. Adult patients therefore search for a bone marrow donation from an adult donor, rather than from umbilical cord blood. Frequently, however, no such donation is found.
Gamida Cell’s technology is also suitable and is being tested for treatment of genetic diseases of the blood system, such as sickle cell anemia, and can also be appropriate for multiplying cells in other areas, such as improvement of a new cell therapy technology for treatment of cancer — CAR-T.
Gamida Cell is managed by CEO Dr. Julian Adams, a member of a wealthy Canadian real estate family. Adams has brought a number of drugs to market, including Velcade, a bestseller cancer drug.
Gamida Cell
Founded: 1998
Field of business: Stem cell-based drugs for treatment of cancer and genetic diseases
CEO: Dr. Julian Adams
Most recent financing round: $40 million at a $150 million company value.

Sherwin Williams Lands in Trouble Over 114-Year-Old Paint Ad


When companies get in trouble over their advertisements, it usually happens quickly. In the case of Sherwin-Williams Co., it took more than a century.
The paint maker is fighting a California court ruling that ordered it and two other companies to collectively pay hundreds of millions of dollars in damages for promoting lead paint over several decades, when they allegedly knew or should have known it was hazardous. The litigation has highlighted Sherwin-Williams ads dating back to 1904.
Sherwin-Williams and its co-defendants in July petitioned the U.S. Supreme Court to take up the case, arguing that they were unaware of the health risks of lead before it became accepted science and are being improperly punished for truthful advertising about a product that was legal at the time. The federal government banned the use of lead paint in homes in 1978.
Companies already put their advertisements through a range of stress tests to ensure legal and regulatory compliance, adding careful wording and disclosures. But some advertising executives say the Sherwin-Williams ruling, if upheld, would raise the stakes, forcing marketers to consider whether advertising a product may open them to liability many years down the road.
That, in turn, could lead creative teams on Madison Avenue — which wasn’t implicated in the lead-paint litigation — to exercise even more caution when dreaming up ads and bulk up on disclaimers.
“You can’t demand companies to have clairvoyance,” said Dan Jaffe, executive vice president of government relations for the Association of National Advertisers, a trade group of marketers that filed a brief in support of Sherwin-Williams. “It’s the precedent we’re concerned about. We believe that what they’re doing in regard to Sherwin-Williams certainly would apply to many other categories.”
The ruling could potentially affect advertising of a range of products that are subject to frequent studies about their health effects, including everyday food items and consumer products, some ad executives said. “We’re constantly learning things about products we didn’t think were of any concern,” said Mr. Jaffe.
Harris Diamond, chief executive of McCann Worldgroup, a network of creative agencies owned by ad giant Interpublic Group of Cos., said while companies are always mindful of potential liability from ads, “I do think this is a reach that’s further and more than we’ve seen in the past.”
In some ways, the fight echoes the legal battle over tobacco marketing in the 1990s. In that case, government officials said there was clear evidence tobacco companies knew of the health risks of cigarettes and deceived the public. A massive settlement between state attorneys general and the tobacco firms resulted in significant restrictions on advertising and huge payments to states by the firms.
The health effects of lead are now well known. Exposure to it can affect physical and mental development in a variety of ways, especially in children, from behavioral and learning problems to slowed growth, according to the U.S. Environmental Protection Agency.
The state of California argued in its suit that several paint companies were aware of lead paint’s toxicity for years while they marketed it. In the case of Cleveland-based Sherwin-Williams, the plaintiff referred to an internal communication in 1900 that described white lead — which was used in paint — as a “deadly cumulative poison.” The defendants said they didn’t have knowledge of risks now known to be associated with lead-based paint.
A California trial court ruled for the state in 2014, ordering Sherwin-Williams and two other companies involved in manufacturing and marketing lead paint in California, ConAgra Grocery Products Co. and NL Industries Inc., to pay $1.15 billion into a state fund that would go toward removing health hazards posed by lead paint in California homes.
An appeals court last year said the companies should only be liable for lead-paint usage before 1951 because there was “insufficient evidence” the defendants had promoted lead paint for interior use after 1950. This could reduce the damages to between $409 million and $730 million, according to a Sherwin-Williams filing.
But the appeals court upheld the substance of the ruling. It pointed to a Sherwin-Williams ad from 1904 that ran in the Los Angeles Times and San Diego Union. It contained images of paint cans with the company’s SWP logo, along with the message, “Put S.W.P. on your house and you will get satisfaction and save money every time.”
A spokeswoman for the law firm representing Sherwin-Williams said the company stopped making white-lead interior paint in 1943.
In their Supreme Court petitions, the defendants say the state ruling violates their rights to free speech and due process. The high court only takes up a fraction of cases. A lawyer for the California plaintiff said in a statement that there are no constitutional grounds for the high court to take up the case.
An executive at one packaged-goods company said the paint ruling could cause some marketers to shy away from advertising products with a long shelf life, or those that involve health claims like “allergen free.” “That science could change over time,” said the executive.
Advertisers may need to think more carefully about how every word in their ad is interpreted 50 years from now, said Gene Grabowski, a partner at crisis firm kglobal who has worked on lead-paint litigation for Sherwin-Williams and other paint companies in the past.
Companies could be “held accountable not just for making a product available, but for touting that product, for encouraging its use,” he said.