Stellar Achieves Robust Viral Clearance for Manufacturing Process

 Stellar Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a key protein utilized in multiple immunotherapy development pipelines targeting Alzheimer’s, lupus and cancer, among other diseases, today announced that third-party trial results have demonstrated that the company’s KLH manufacturing methods achieve robust viral clearance. This clearance step is a key quality assurance milestone under Stellar’s initiatives to increase the scalability and throughput capacity of its manufacturing processes.

Results from testing completed by Texcell, a contract testing organization for viral safety, demonstrated that Stellar’s manufacturing process for its most widely used formulation effectively removes three representative viruses, and meets suggested regulatory criteria for robustness. While routine quality testing has never detected the presence of viruses in Stellar KLH, one of the principal approaches to control the potential presence of viruses in biological products is to purposely introduce viruses in a test environment and demonstrate the capacity of the production process to remove them.

Stellar Executive Vice President of Corporate Development, Gregory T. Baxter, PhD, said that the company aims to roll out manufacturing optimizations ahead of the next phase of its customers’ clinical studies, and will continue to routinely test for viruses and validate the viral removal of its manufacturing processes as needed.

“KLH is a key component for the success of multiple immunotherapies under development and Stellar is committed to expanding our manufacturing capacity and validating our quality systems as our customers advance toward pivotal Phase 3 clinical studies,” said Dr. Baxter.

To produce Stellar KLH, hemocyanin protein is extracted from its native source using Stellar’s patented process and then purified and manufactured into various grades and formulations. Due in part to its controlled aquaculture source and manufacturing methods, Stellar KLH has been shown to produce a vigorous primary and secondary immune responses. Researchers interested in obtaining Stellar KLH, or obtaining technical specifications for research or GMP-grade KLH, may contact Stellar business development department at (805)488-2800 or KLHinfo@stellarbiotech.com.

https://bit.ly/2s8R27R

Novartis gets EU OK for 6th biosimilar

Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.

Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, Novartis said in a statement on Thursday.

Zessly is the sixth approved biosimilar medicine for Sandoz, with several more major oncology and immunology launches expected globally by 2020, Novartis said.

https://reut.rs/2s48HgO

Antidepressants Carry Weight Gain Risk Years Into Treatment

Weight gain was tied to use of antidepressants, a long-term study in Britain found.

Men and women prescribed antidepressants were more likely to experience a 5% or greater weight gain compared to people not taking antidepressants (adjusted rate ratio 1.21, 95% CI 1.19-1.22, P<0.001), reported Rafael Gafoor, PhD, of the School of Population Health and Environmental Sciences at King’s College London, and colleagues.

This elevated risk for weight gain was maintained over six years of antidepressant prescribing, they wrote in The BMJ.

Moreover, use of antidepressants was also tied to a graduation in weight class:

• Normal weight to overweight: adjusted RR 1.29 (95% CI 1.25-1.34)
• Overweight to obesity: adjusted RR 1.29 (95% CI 1.25-1.33)

“The risk of weight gain was substantially increased during the second and third years of treatment,” Gafoor’s group wrote, highlighting that the risk of 5% or greater weight gain was 46% higher during the second year of treatment compared to those not on antidepressants.

Less than one year of antidepressant use, however, was not tied to weight gain.

“This level of risk might look modest, but the effect at population level could be substantial,” commented Alessandro Serretti, MD, PhD, and Stefano Porcelli, MD, of the University of Bologna in Italy, in an accompanying editorial. “If roughly 13% of the U.K. population take an antidepressant, many thousands of people will gain weight each year because of their treatment.”

In praising Gafoor’s group for their study, the editorialists agreed with the recommendation that providers provide lifestyle and weight management advice to patients on these agents and to utilize these findings when selecting patients’ antidepressant prescriptions.

“Currently, we are still unable to identify patients at higher risk of weight gain with antidepressants. Hopefully it will be possible in the not too distant future to identify a genetic predisposition and recognise those at higher risk before treatment is started,” Serretti and Porcelli wrote.

The population-based study drew on the U.K. Clinical Practice Research Datalink, using a sample of 136,762 men and 157,957 women who had at least three recordings of body mass index in their primary care electronic health records. Of this group, 17,803 (13.0%) men and 35 307 (22.4%) women were prescribed antidepressants in 2004.

Use of antidepressants was more common among patients with comorbidities, including stroke and diabetes, as well as co-prescriptions, including antiepileptics and antipsychotics.

Antidepressant use was initially classified into type for the analysis, which included tricyclic and related antidepressants, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, serotonin/noradrenaline reuptake inhibitors, and other antidepressant drugs. The authors further analyzed use according to specific drugs, including mirtazapine, duloxetine, sertraline, venlafaxine, citalopram, fluoxetine, escitalopram, trazodone, amitriptyline, paroxetine, nortriptyline, and dosulepin (also known as dothiepin).

Among the individual drugs assessed, mirtazapine was tied to the highest risk of weight gain (aRR 1.50, 95% CI 1.45-1.56). Other antidepressants that were tied to the highest associated risks for weight gain compared to other antidepressants included duloxetine (1.23, 95% CI 1.15-1.31), escitalopram (1.23, 95% CI 1.17-1.29), and citalopram (1.26, 95% CI 1.23-1.28).

In general, the researchers found that older generation drugs, such as monoamine oxidase inhibitors and tricyclic antidepressants, tended to be associated with a higher risk for weight gain versus newer drug classes, like SSRIs.

Study authors and editorialists declared they had no relevant financial interests.

LAST UPDATED 05.24.2018

• Primary Source

  The BMJ

  Source Reference: Gafoor R, et al “Antidepressant utilisation and incidence of weight gain during 10 years’ follow-up: population based cohort study” BMJ 2018; DOI: 10.1136/bmj.k1951.

• Secondary Source

  The BMJ

  Source Reference: Serretti A, et al “Antidepressant induced weight gain” BMJ 2018; DOI: 10.1136/bmj.k2151.

https://bit.ly/2J7Teqz

Business Model Makes All the Difference in Healthcare

Whose fault is it that electronic health records (EHRs) still aren’t fully interoperable? Not the government’s, Farzad Mostashari, MD, said Thursday.

“People say, ‘Surely it’s [the fault of] the government — they didn’t put enough standards in,'” said Mostashari, co-founder and CEO of Aledade, a company that helps primary care physicians start up accountable care organizations (ACOs). “No, that’s not the problem with interoperability. The problem is, people don’t have a business model where they make more money sharing data.” Mostashari spoke at a summit on healthcare costs sponsored by the Alliance for Health Policy.

“The reason we don’t have interoperability is not because we don’t have the technical standards to do it — it’s because we don’t have the business case to do it, or people are feeling like in furtherance of their business model, they can block the flow of information,” said Mostashari, who served as National Coordinator for Health Information Technology under President Obama.

He noted that in many states, hospitals aren’t notifying physicians when their patients are discharged from the hospital. “One hospital [I know of] said to a primary care doctor, ‘If you join our ACO, you can get access to this information.'” In fact, having an interoperable EHR should be a condition of a hospital’s Medicare participation, Mostashari suggested.

Health IT also hasn’t helped cut healthcare costs, despite all its promise in that area, he continued. “Health IT is not going to do anything [to control costs] unless the people doing health IT are using it to achieve that goal. If you don’t have the right goal, the right tools aren’t going to help you.”

Another reason healthcare costs haven’t come down is that no one has really figured out how to make lots of money off of prevention, he said. “How can you make money preventing people from [for example] going into the hospital and needing dialysis? We know how you can make money giving dialysis; how do you make money saving lives? That’s the question.”

One thing that will help is payment incentives, said Mostashari: “Set the right payment policies and the market will emerge.” He noted that although providers seem hesitant to take two-sided risk — that is, they aren’t willing to risk losing money — when they form an ACO, they have no problems doing so in the Medicare Advantage program. “I know of physician groups that are taking full capitation risk on Medicare Advantage,” he said.

Why the hesitation with ACOs? “It’s because of the unpredictability of the benchmarks” being used to determine financial rewards and penalties for ACOs, he continued. “If you made [that program] more [predictable] like Medicare Advantage, it would massively open up the amount of potential disruption.”

Another way to control healthcare costs, at least in federal programs like Medicare, “is to put programs on a budget and no longer give them an unrestricted draw on the U.S. Treasury,” said Douglas Holtz-Eakin, PhD, president of the American Action Forum, a right-leaning think tank here. “Doing that would have a beneficial impact of saying to entire provider/beneficiary sector that ‘There is only so much money for this senior; take good care of them with it, and focus your attention on doing that instead of taking more money from the treasury.'”

Topher Spiro, JD, vice president of health policy at the Center for American Progress, a left-leaning think tank here, agreed that healthcare should be put on a budget, “but it should be structured very carefully.”

Reducing healthcare costs involves reconstructing the healthcare cost drivers, said Spiro. “In Medicare, it’s very clear — [the cost driver is] the variation in spending on post-acute care … For that problem, there is an easy solution: we need to have bundled payments that bundle together the cost of hospital care with costs up to 90 days after discharge. I would phase in the bundles so they’d [eventually] apply to up to half of Medicare spending.”

As for healthcare that’s reimbursed by private insurers, “a recent JAMA study compared the U.S. with other developed countries and found that price, not utilization, was the major difference” that explained why the U.S. spent so much more, said Spiro. “To address this issue, we’re ultimately going to need some kind of regulation of healthcare prices or provider payment rates — such as a system like Maryland’s that has all-payer rate setting. I think that’s going to be necessary in the long run.”

https://bit.ly/2knkN12

Supernus target hiked by Stifel

to $60 from $50; buy maintained; sees more expansion opportunity than competitive risk.

https://bit.ly/2GNhf0M

Kiniksa Pharmaceuticals (KNSA) IPO Opens 36% Higher

Today’s IPO for Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA) opened for trading at $24.45 after pricing 8,477,777 Class A common shares at a public offering price of $18.00 per share, before underwriting discounts and commissions.

In addition, Kiniksa has granted the underwriters a 30-day option to purchase up to 1,271,666 additional Class A common shares at the initial public offering price, less underwriting discounts and commissions.

Goldman Sachs & Co. LLC and J.P. Morgan Securities, LLC are acting as joint book-running managers for the offering. JMP Securities LLC and Wedbush Securities Inc. are acting as co-managers for the offering.

Kiniksa is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa has a pipeline of product candidates across various stages of development, currently focused on autoinflammatory and autoimmune conditions.

https://bit.ly/2kpt2d7

Medtronic tops views, offers outlook

Medtronic (NYSE: MDT) reported Q4 EPS of $1.42, $0.03 better than the analyst estimate of $1.39. Revenue for the quarter came in at $8.1 billion versus the consensus estimate of $8 billion.

GUIDANCE:

Medtronic sees FY2019 EPS of $5.10-$5.15, versus the consensus of $5.15.

In fiscal year 2019, the company expects organic revenue growth to be in the range of 4.0 to 4.5 percent.

https://bit.ly/2GMRvlf