Piper Jaffray analyst Joseph Catanzaro says he spoke with a KOL as the commercial launch of Catalyst Pharmaceuticals’ Firdapse gets underway, who believed that all 12 of his LEMS patients, previously part of the Jacobus IND, have transitioned to Firdapse through the Catalyst Pathways program. Ultimately, he believed that the clinical data package supporting the approval of Firdapse would be difficult for both physicians and insurers to ignore, and expected broad payer coverage over time, the analyst notes. Catanzaro believes this KOL’s experience speaks positively to the work Catalyst has done to identify LEMS patients, transition them to Firdapse and obtain payer coverage. He reiterates an Overweight rating and $7.50 price target on Catalyst Pharmaceuticals’ shares.
Sunday, March 3, 2019
Highwoods provides information on Laser Spine Institute
Highwoods Properties provided information on Laser Spine Institute, which leases a 176,000 square-foot, six-story building with structured parking in Tampa’s Westshore submarket, a best business district. The building, which was developed by Highwoods, has been used by Laser Spine Institute, a long-term customer of Highwoods, for its company headquarters and an ambulatory surgery center. After the market closed on March 1, 2019, Laser Spine Institute announced it would immediately discontinue its operations. This unexpected announcement affects all of its locations nationwide. As a result of Laser Spine Institute’s sudden closure, the company expects to write-off accounts and notes receivable, lease incentives and straight-line rents receivable associated with the building, which aggregated $11.8M at December 31, 2018 and approximately $12.2M at March 1, 2019, including non-cash items of approximately $6.8M as of both dates. The March 1, 2019 balance will be written-off in the first quarter of 2019. These charges, which will affect Funds from Operations, were not included in the company’s initial 2019 per share FFO outlook published on February 5, 2019. The company will provide an updated FFO outlook as part of its first quarter earnings release on April 23, 2019. During the first quarter of 2019, the company also expects to write-off deferred leasing costs associated with the building, which aggregated $11.8M at December 31, 2018 and approximately $11.6M at March 1, 2019. The write-off of deferred leasing costs will affect net income but not FFO.
https://thefly.com/landingPageNews.php?id=2873413
https://thefly.com/landingPageNews.php?id=2873413
Eager to think bigger than China, Ascletis woos top Merck exec to run R&D
Having paved the way in developing and commercializing China’s first home-cultivated hepatitis C drug — with some help from a multinational pharma partner — Ascletis has now set its sight on a higher goal: To move from first-in-China to global first-in-class drugs.
Highlighting its ambition, the Hangzhou-based biotech has scooped Zhengqing Li, who has run Merck’s drug development in China for the past eight years, to become its chief medical officer and president of R&D in the country.
At Merck $MRK, Li built and led a team of 600 that altogether nabbed more than 20 drug approvals — half of them in the past two years, a sign of the National Medical Products Administration’s willingness to speed up the regulatory process as part of ongoing reforms. In its announcement, Ascletis CEO Jinzi Wu not only nodded toward Li’s role in bringing to market antivirals like Zepatier, Isentress and Gardasil, but also the launch of Keytruda under his purview — signalling a new focus on immuno-oncology.
That’s not been a key area for Ascletis, which has branded itself a leader in antiviral and liver diseases, recently launching Roche’s danoprevir as Ganovo in China and boasting other HCV, HBV, HIV and NASH programs in its pipeline. When the company spelled out how it would use its IPO proceeds in a listing application last May, there was no specific mention of its sole experimental cancer treatment, though other oncology drugs could be incoming as part of the 15% it has set aside to in-license new, unspecified drug candidates.
Despite raising $400 million on the Hong Kong stock exchange and making history as the first pre-revenue biotech listed there, though, Ascletis has been plunging considerably since its debut and is still trading at less than half its IPO price.
That’s all in the background today as the company gets ready to prove its value.
“I am impressed by Ascletis’ R&D strategy and accomplishments in the last few years,” Li said in a statement. “I share Ascletis’ vision to be one of the best R&D driven biotechs on a global scale.”
Omeros up on Q4 beat
Omeros (OMER) Q4 results: Revenues: $22M (+59.4%).
Net Loss: ($23.5M) (-41.6%); Loss Per Share: ($0.48) (-41.2%); Quick Assets: $60.5M (-27.7%).
The consensus Revenue and GAAP EPS estimate was $15.85M and ($0.74), respectively.
XBiotech up on positive dermatitis data
Thinly traded micro cap XBiotech (XBIT +13.4%) is up on over triple normal volume, albeit on turnover of only 484K shares, on the heels of positive results from a Phase 2 clinical trial evaluating bermekimab in patients with moderate-to-severe atopic dermatitis (AD). The data will be presented tomorrow at the American Academy of Dermatology Annual Meeting in Washington, DC.
After seven weeks of receiving 400 mg of bermekimab once per week, 71% of treated patients achieved EASI 75 (75% reduction in AD symptoms). Patients in this cohort also experienced a 71% reduction in itching and 84% reduction in pain.
By comparison, the proportions of AD patients in two Phase 3 studies who received Regeneron Pharmaceuticals (REGN +2.1%) and Sanofi’s (SNY+1.5%) Dupixent (dupilumab) (300 mg every other week for 16 weeks) achieving EASI 75 were 51% and 44%, respectively.
Bermekimab (MABp1) is a monoclonal antibody that binds to (inhibits) the pro-inflammatory protein interleukin-1alpha (IL-1α).
New device can detect cancer in just a drop of blood
Some types of cancer, such as ovarian cancer, tend to remain undetected until they are too advanced for treatment to be effective. Now, an innovative tool may be able to detect cancer easily, quickly, and in minuscule amounts of blood.
In a bid to find a simple, effective way of identifying hard-to-diagnose cancers, researchers from the University of Kansas (KU) in Lawrence and the KU Cancer Center and KU Medical Center in Kansas City have now developed an ultrasensitive cancer-detecting device.
The device, which is called a “3-D-nanopatterned microfluidic chip,” could successfully detect cancer markers in the tiniest drop of blood or in a component of the blood called plasma.
Lead author Yong Zeng, an associate professor of chemistry at KU, and his team describe how the novel tool works in a paper that the journal Nature Biomedical Engineering has published.
This device, the scientists explain, identifies and diagnoses cancer by “filtering” for exosomes, which are tiny vesicles that some eukaryotic cells produce.
In the case of cancer cells, exosomes contain biological information that can direct tumor growth and spread.
“Historically, people thought exosomes were like ‘trash bags’ that cells could use to dump unwanted cellular contents,” Zeng explains. “But, in the past decade,” he adds, “scientists realized they were quite useful for sending messages to recipient cells and communicating molecular information important in many biological functions.”
“Basically, tumors send out exosomes packaging active molecules that mirror the biological features of the parental cells. While all cells produce exosomes, tumor cells are really active compared to normal cells,” Zeng notes.
A high-sensitivity diagnostic tool
The novel device is a 3-D nanoengineering tool with a herringbone pattern that “combs” for exosomes, pushing them to come into contact with the surface of the tool’s chip for analysis. This process is called “mass transfer.”
“People have developed smart ideas to improve mass transfer in microscale channels, but when particles are moving closer to the sensor surface, they’re separated by a small gap of liquid that creates increasing hydrodynamic resistance,” notes Zeng.
“Here, we developed a 3-D nanoporous herringbone structure that can drain the liquid in that gap to bring the particles in hard contact with the surface where probes can recognize and capture them,” he further explains.
In order to develop this state-of-the-art device, Zeng and team collaborated with Andrew Godwin, who is an expert in tumor biomarkers and the current deputy director of KU Cancer Center.
To test the chip’s effectiveness, the researchers used clinical samples from individuals with ovarian cancer, a type of cancer that is notoriously hard to detect.
In doing so, the team found that the chip was able to detect the presence of this cancer in even the tiniest amount of plasma.
“Our collaborative studies continue to bear fruit and advance an area crucial in cancer research and patient care — namely, innovative tools for early detection,” says Godwin, pointing out that, “This area of study is especially important for cancers such as ovarian, given the vast majority of women are diagnosed at an advanced stage when, sadly, the disease is for the most part incurable.”
Multiple clinical applications
The researchers are also thrilled that the new device is easy to make, as well as being cheap to produce, meaning that wide distribution could be possible without increasing patient costs.
“What we created here is a 3-D nanopatterning method without the need for any fancy nanofabrication equipment — an undergraduate or even a high school student can do it in my lab,” notes Zeng.
“This is so simple and low-cost it has great potential to translate into clinical settings,” he emphasizes, explaining that the team “[has] been collaborating with Dr. Godwin and other research labs at the KU Cancer Center and the molecular biosciences department to further explore the translational applications of the technology.”
Even more importantly, Zeng and colleagues argue that this innovative device is, in principle, very adaptable. They believe that in the future, doctors could use it to diagnose many different forms of cancer, as well as other diseases.
“Now, we’re looking at cell-culture models, animal models, and also clinical patient samples, so we are truly doing some translational research to move the device from the lab setting to more clinical applications,” the lead researcher says.
When Mentor Becomes Aggressor: Why Victims Stay Silent
The #MeToo movement in Hollywood saw a wave of actresses (and some actors) sharing stories of powerful men taking advantage of their privileged positions to demean, bully, and sexually exploit them.
It made top-of-the-news headlines because, of course, many of the victims and perpetrators were already world-famous. But the entertainment industry is hardly alone in having a power hierarchy in which junior people are vulnerable to exploitation.
Medicine has such a hierarchy too, and — like in Hollywood — harassment has festered in the field unchecked for years.
While medicine’s version of #MeToo, the campaign to empower targets of sexual harassment, may prove to be less dramatic, preventing the behavior is no less critical to the future of the field. Yet a climate of stigma, intimidation, retaliation, and fear threaten to derail the movement.
Most targets do not report their harassers.
Those who dare to come forward may find themselves terminated, forced to transfer to another academic program, or blacklisted by entire hospital systems, researchers and other clinicians told MedPage Today.
Roberta Gebhard, DO, president-elect of the American Medical Women’s Association (AMWA) and co-chair of its gender equity task force, said there have been repercussions for the victim in every instance of harassment shared with her.
“It’s become their problem,” she said, adding, “This has been going on since the first woman got to medical school.”
As a whole, many hospitals, health systems, and medical organizations have failed to keep clinicians safe from harassment, and failed to hold perpetrators accountable for their actions.
Action — comprehensive and systemic — is needed immediately to set the field on a better course.
With #MeToo and its action-oriented arm, the Time’s Up movement, Gebhard told MedPage Today that she is hopeful.
“Things are on the cusp of changing,” she said.
Making Waves
One reason harassment persists is because everyone feels like he or she is the only one, said Melissa Garretson, MD, a pediatric emergency physician based in Texas, and an American Medical Association delegate.
As a medical student in 1991, Garretson was groped by a physician, but never reported the incident, she said.
At the time, she was trying to get elected to the AMA’s board of trustees, and “didn’t want to make any waves,” she said.
Garretson said she felt guilty for not reporting the incident, but at the time, while she knew it was “ridiculous,” she blamed herself.
“You think you’re a very strong person … but you wonder, ‘What did I do [to cause this]?'”
The memory of the harassment and the harasser leave a mark that can last a lifetime, Garretson said: “I kept track of this man until the day he died.”
Nearly 3 decades later, Garretson co-authored an “emergency resolution” with Samantha Rosman, MD, at last fall’s AMA interim meeting, calling for an independent review of the organization’s sexual harassment protocol and policies.
“As we have seen nationally, it takes one, two, or a handful of women who are willing to stand up to power … and share what happened to them to make everyone realize that they’re not the only one,” she said.
It’s Coming from Inside the House — of Medicine
At that AMA meeting, Rosman shared her own experience of being groped by a fellow AMA delegate at a meeting two years earlier.
Rosman wasn’t planning to report the incident but she told a few colleagues and suddenly a series of younger female physicians started coming to her and telling their stories.
“I felt like I kind of had a responsibility to speak up.”
When Rosman did report her harasser to the association, a woman within the AMA’s ranks told Rosman that something similar had happened to her.
“It’s just kind of part of being a woman,” Rosman said she was told.
Rosman bristled at this.
While the AMA struggled to find the appropriate body to adjudicate her claim, Rosman said more women confided stories of AMA staff harassing staff, of staff being harassed by delegates, of delegates being “fearful” of making reports, and of one AMA delegate offering to trade sex with another delegate’s spouse in exchange for his vote in an election.
Two years after reporting the incident, Rosman said the AMA still hadn’t adequately addressed the issue. So, Rosman and Garrison introduced their “emergency resolution” calling for a review of the AMA’s sexual harassment policies.
The resolution passed in a standing vote to hearty applause.
“It’s really important for future generations, as more and more women are coming into Medicine, that [harassment] is something that we don’t pretend doesn’t happen,” Rosman said.
Since the meeting, the AMA said it has hired both legal counsel and outside consultants to examine its policies, Rosman told MedPage Today in late December.
“I’m cautiously optimistic,” she said.
Fear of Speaking Out
Most targets of harassment never report the incident and that’s especially true in medicine.
In an as-yet-unpublished survey, 58% of female surgeons said they experienced sexual harassment at work — and among those, only 16% said they reported the incident to their institution.
And trainees were more than twice as likely as attendings to say they’d been harassed, according to the study led by Apoorve Nayyar, MBBS, and Kristalyn Gallagher, DO, at the University of North Carolina School of Medicine.
When asked why they did not report the incidents, respondents’ answers centered on fear, Nayyar told MedPage Today.
“Fear of a negative impact [on their career], fear of retribution, fear of being dismissed, fear of inaction, fear of … appearing weak,” he said.
Just over 40% of female surgeons who stayed silent about harassment said they worried about a negative impact on their career, and 32% suspected nothing would happen if they did speak up.
(About one-quarter of male surgeons also said they had been been harassed, and many of them said they too had not reported the incidents. Their most common reason they cited for keeping quiet was belief that “it was an isolated incident.”)
Arguably the most alarming finding in the study was that, of women who did file complaints about harassment, 53% said no action was taken.
This kind of inaction sends a message that harassment is tolerated, which is very discouraging to other women who may be weighing whether to report their own claim, Nayyar told MedPage Today.
“We have a rampant problem and … while we have policies on paper … current systems don’t make it safe to report sexual harassment,” Nayyar concluded.
Adverse Events: Retaliation
Reshma Jagsi, MD, DPhil, of the University of Michigan in Ann Arbor, received a rush of emails after she and colleagues published their own survey on sexual harassment in 2016.
One of these came from a young physician who was harassed during her training:
“If any woman ever tells you that they had any experience like mine, please tell them to get out of there. Please tell them not to worry about the red flag it might be to transfer residencies, not to worry about potential damage to their reputation, not to worry about ‘who would believe [them] anyway,’ not to worry about appearing weak, not to worry about the old boys’ club that lets men cover for each other and makes the woman ‘sound crazy,’ the opportunities that they may miss in going to a smaller program, and unwanted attention that would impinge on their privacy.”
But the writer herself didn’t report the harassment. “They judge me based on my work. I don’t want them to change the way they perceive me,” she told Jagsi.
AMWA’s Gebhard said she’s heard of women having to repeat a year in school after reporting a harasser, and not being promoted because they refused to have sex with a superior.
Another woman in her 50s who reported “sexual violence” was fired for bringing up the incident, Gebhard said.
“What we hear all the time is, ‘We don’t want to lose our jobs,'” said Seun Ross, RN, director of Nursing Practice and Work Environment for the American Nurses Association (ANA).
As more and more hospitals consolidate, “you go from not being able to get a job at one hospital to not being able to get a job at 10 hospitals, which would mean a nurse would have to move or travel a great distance to get a job,” she said.
Retaliation can take many forms, Ross noted. It can mean being fired, switched from the day-shift to the night-shift, bullied, whispered about in hallways, or simply the “silent treatment.” All of this can affect a person emotionally, she added.
It can also be subtle and difficult to prove, explained Sharon Stein, MD, president-elect of the Association of Women Surgeons and associate professor of surgery at University Hospitals of Cleveland.
“People rely on their colleagues, their bosses, their program directors to promote them,” Stein said. “If they don’t have good things to say about you it’s as bad as saying something bad.”
Pinning Down Harassment
There are three types of sexual harassment: gender harassment, unwanted sexual attention, and sexual coercion.
Sexual coercion, “the prototypical sleep with me or you’re fired situation,” is what most people think of when they think of sexual harassment, said Lilia Cortina, PhD, professor of psychology and women’s studies at the University of Michigan, Ann Arbor, and a co-author of a 2018 National Academies of Sciences, Engineering and Medicine report on harassment.
But sexual coercion is the rarest form of sexual harassment, she said. Instead, harassment based on sex/gender is usually a “put-down” and not a “come-on.”
The NASEM report defines gender harassment as “conduct that conveys hostility, objectification, exclusion, or second-class status to members of one gender.” It can also include “degrading words or image” like pornographic cartoons, crass graffiti, and sexual slurs written on white boards, for instance.
“This behavior is not about romance gone awry. It’s not about trying to pull women into sexual relationships. Instead gender harassment is about pushing women out — out of careers where they’re seen not to fit, not to belong, encroaching on men’s territory,” Cortina said.
Coming to Grips
AMWA’s current president Connie Newman, MD, said that harassment in medicine has been an open secret for a long time. Yet, nothing concrete was done about it.
As a medical student, “we just took care of it ourselves … we managed to avoid the people,” said Newman, who is now 65. But “that is not a solution today,” she stressed.
Some older physicians were previously resigned to harassment as a “rite of passage,” Garretson said.
Now, “even our older guards are starting to realize, ‘What happened to you wasn’t okay. … It happened a number of years ago, and there’s nothing I can do about it now, but we can make sure that it doesn’t happen anymore.'”
Barbara McAneny, MD, president of the American Medical Association, included sexual harassment in her keynote speech in November.
She was “disappointed” by the 2018 NASEM report, which highlighted harassment’s prevalence in STEM fields: “We cannot point fingers at others if our own house is not in order.”
In a phone interview with MedPage Today, McAneny rejected the notion that older female physicians have normalized harassment.
“Women in positions of responsibility understand this is not a ‘rite of passage’ [and] is not part of the ‘good ole boys’ culture,” she said. “Most of the women that I discuss these things with understand that this is not to be tolerated.”
“Sometimes the behavior completely crosses the line [but] the tougher parts are the gray zones,” McAneny continued. “Sometimes it’s difficult for an individual woman to say, ‘Was that just a too-close hug that I didn’t want, or is that harassment?'”
The AMA has used its “collective wisdom” to create policies and processes to ensure that those reporting a claim of harassment will be taken seriously and that the investigative process will be fair to both the person making the complaint and the person complained about, McAneny said.
“We have to get a firm set of behavioral norms, so that everybody understands what is permissible, what it not permissible, and allay the fears that men may have … that they’ll be accused unjustly.”
In her own practice, McAneny has fired a physician for sexual harassment, she said.
Physical, Psychological, Emotional Impact
“What we know about any type of harassment, including sexual harassment, is once you’re harassed it becomes this repeating record in one’s brain. [Targets] keep rehashing the incident and thinking ‘What could I have done to prevent it? Is there anything I can do to prevent it from happening again?'” the ANA’s Ross told MedPage Today.
One study found that one-fifth of women who are self-reported targets of sexual harassment met criteria for major depressive disorder, and one-tenth met criteria for post-traumatic stress disorder, said Frasier Benya, PhD, senior program officer for the Committee on Women in Science, Engineering, and Medicine at NASEM.
The literature has shown that gender harassment can be as harmful as sexual coercion and unwanted sexual attention, said Benya, who was study director for the 2018 NASEM report.
When Cortina presented the report last June, she stressed this finding that sexual jokes aren’t merely unfunny.
“According to research, even when sexual harassment entails nothing but sexist insult without any unwanted sexual pursuit, it takes a toll on victims,” Cortina said. When gender harassment is “frequent” and “severe” it can inflict the same damage as “isolated incidences of sexual coercion,” she noted.
According to the report, “Women who experienced coercive sexual harassment reported feeling a loss of personal autonomy and control, humiliation, shame, guilt, anger and alienation as a result of the harassment,” citing a paper by Renee Binder, MD, in the Bulletin of the American Academy of Psychiatry & the Law.
Gender harassment alone can trigger cardiovascular reactivity, putting targets at greater risk of coronary heart disease, and depressed immune functioning, Benya noted.
And any type of sexual harassment, physical or verbal, can have a negative impact on patient care, Ross explained, because it diverts the clinician’s attention.
“That includes touching, verbal comments, making lewd jokes, posting pictures, physically on hospital premises or through social media,” Ross said.
“When you [are exposed to that] and you’re taking care of a patient, that doesn’t leave much space for … double-checking a medication dose [or] making sure a patient gets down for a CAT scan at the right time,” she said. “What we don’t want is anything to take away from a nurse focusing solely on her patient.”
Narrowing the Pipeline
Harassment can also lessen a target’s commitment to the profession, noted the 2018 NASEM report.
A Canadian study published in the Journal of the American Academy of Psychiatry and the Law Online in 1996, found that female physicians who had experienced sexual harassment while still students had “diminished interest in their studies … recurrent intrusive memories of the abuse … [and] severe depression.” Nearly one in three considered quitting medicine completely.
All of the literature shows that sexual harassment can lead to mental and physical health problems, and to targets thinking they can’t stay in the same environment with their abusers, said Timothy Johnson, MD, a co-author of the 2018 NASEM report and a professor at the University of Michigan.
Take the intern whose mentor begins pushing his body against hers during surgery, for example.
“You’ve got this woman, who all of her life wanted to be a doctor, wanted to be a surgeon, and all of a sudden her mentor becomes an aggressor,” Johnson explained.
“She always identified with that person and suddenly, she sees him treating her as if she doesn’t have value,” he said. That intern will question whether she wants to work in such an environment.
“Good people, high-quality people, who can make important contributions to the profession are being lost from the workplace,” Johnson said.
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