Akari Therapeutics up 6% on encouraging nomacopan data

Thinly traded nano cap Akari Therapeutics (AKTX +5.9%) is up on average volume in reaction to preclinical data on a long-acting version of lead drug nomacopan (PAS-nomacopan) that, it says, supports its use for back-of-the-eye diseases with less-frequent injections.

In a mouse model, PAS-nomacopan lowered intraocular levels of VEGF as effectively as an anti-VEGF antibody (74% and 68%, respectively) compared to saline control. It also significantly reduced retinal inflammation versus control.

A Phase 2 study in atopic keratoconjunctivitis is ongoing. Additional preclinical work will include models of AMD.

https://seekingalpha.com/news/3534784-akari-therapeutics-up-6-on-encouraging-nomacopan-data

Numbers of those who can’t afford healthcare still rising

• Passage of the Affordable Care Act in 2010 and its enactment six years ago helped cut the nation’s uninsured by nearly half, from 49.9 million in 2010 to 25.6 million in 2017. Nevertheless, a huge unmet need remains for many to access medical services, according to a study published Monday in JAMA Internal Medicine.
• Between 1998 and 2017, the share of the U.S. population unable to see a doctor due to the associated costs of doing so rose from 11.4% to 15.7%, although the differences were even starker when divided among those with insurance coverage and those without. There were also increases in inability to see a physician among those with chronic conditions, and the proportion of women receiving mammograms dropped.
• The study, authored by physicians and researchers from Harvard Medical School, the Cambridge Health Alliance and Hunter College, suggests that narrowing provider networks as well as increasing co-payments and out-of-pocket costs may be driving the trend.

More people have obtained insurance in recent years, but more are also being saddled with costs that not only burden their pocketbooks but also threaten their health.
The study’s authors analyzed 20 years of data from the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System, starting from January 1998 to the end of 2017. The data focused specifically on any adults ages 18 to 64, about 360,000 in all.
During that time period, the proportion of the economy devoted to expenditures on healthcare rose from 13.3% to 17.9%. Meanwhile, the proportion of uninsured in the survey shrunk from 16.9% in 1998 to 14.8% in 2017. Among African-Americans, it dropped from 22.1% to 16.6%.
Although the proportion of the population who could not afford to see a doctor rose 4.3 percentage points, the differences between those who have coverage and those who do not was striking.
Among those who lacked insurance, those who could not afford to see a doctor rose from 32.9% to 39.6% during the study’s time period. That’s an overall increase of 20.3%. But among those who had insurance, those who could not afford a doctor rose from 7.1% to 11.5% — an increase of nearly 62%.
The study was accompanied by a commentary penned by John Ayanian, director of the Institute for Healthcare Policy and Innovation at the University of Michigan. He noted that although the ACA significantly increased the number of insured, those middle-class and upper middle-class Americans with incomes about 400% of the federal poverty level (about $103,000 for a family of four) are feeling a squeeze. That group “saw no reduction in out-of-pocket spending and a significant 23% increase in health insurance premiums from 2012 to 2015,” he wrote.
The study raised concerns about this rising gap of those unable to see a doctor, particularly those with chronic conditions. “Financial barriers to care have been associated with increased hospitalizations and worse health outcomes in patients with cardiovascular disease and hypertension and increased morbidity among patients with diabetes,” the authors observed.
The study also noted the financial barriers to seeing doctors was far more formidable in the U.S. than in other countries. The Organization for Economic Co-operation and Development concluded only 9.1% of people worldwide skipped seeing doctors due to cost — in the U.S., the rate was 72.5% higher. In neighboring Canada, only 1% of citizens couldn’t afford to see a doctor.
https://www.healthcaredive.com/news/aca-slashed-uninsured-rate-but-number-who-cant-afford-care-still-rising/571105/

Providers warned to be vigilant as coronavirus fear spreads

• Centers for Disease Control and Prevention officials said Sunday clinicians are calling “all day and all night” to report concerns of the 2019 Novel Coronavirus (2019-nCoV). “That’s what we want,” Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, told reporters in a phone briefing. “We want people to have a high index of suspicion and to call if they have a patient they’re concerned about.”
• Five cases of the virus have now been confirmed in the United States, including people in Arizona, California, Illinois and Washington. All of them had direct travel to Wuhan, China, where the outbreak began. CDC officials said they expect to see more cases in the U.S.
• The American Hospital Association told its members in an advisory to “be vigilant and follow CDC’s interim guidance” including screening steps and informing public health authorities when evaluating patients with fever and acute respiratory illness.

Messonnier said Sunday the immediate health risk to the general public from 2019-nCoV “is low at this time, but the threat is serious and our public health response is aggressive.” More than 100 patients from 26 states are under investigation currently, according to the CDC.
Several groups are working on treatments and vaccines but it is not clear whether any will be available to help with this outbreak, she said. The CDC has published the entire genetic sequence of the first U.S. patient to help with those efforts.
Messonnier said the CDC is rapidly working to get laboratory diagnostics available to state and local health departments and is in the process of growing the virus for further study.
The World Health Organization late last week decided not to declare a global health emergency. The disease has killed at least 80 people in China, according to The New York Times.
The new threat also comes as flu cases continue to ramp up in the U.S., straining providers in hard-hit areas. The number of jurisdictions with high flu activity increased from 34 to 37 last week, according to the CDC.
Messonnier said providers should be on the lookout for people with travel history to Wuhan and to anyone caring for such a patient, “Please take care of yourself and follow recommended infection control procedures.”
Epic rolled out an update to its standard travel screening questionnaire last week to remind front-line staff to ask patients about recent international travel. The company said it is also reaching out individually to organizations to make sure their EHR workflow follows CDC guidelines.
Depending on the spread of the outbreak, U.S. hospitals could be put to the test. A 2018 report from the HHS Office of Inspector General found hospital administrators admitted they were not prepared for the 2014 Ebola outbreak and remained concerned about “sustaining preparedness over time.”
OIG did find, however, that hospitals had improved their emergency plans, trained staff, purchased additional supplies and conducted drills focused on emerging infectious diseases. About 14% of hospitals leaders told the agency they are not prepared for an emerging infectious disease threat.
https://www.healthcaredive.com/news/providers-warned-to-be-vigilant-as-coronavirus-fear-spreads/571124/

J&J chief testifies he did not read all documents related to asbestos in talc

Johnson & Johnson Chief Executive Alex Gorsky told a jury Monday that he did not read all the internal company documents related to potential asbestos contamination in Johnson’s Baby Powder.

It was the CEO’s first appearance in a jury trial over allegations that the company’s Baby Powder causes cancer.
Asked by a plaintiffs’ lawyer whether he read all documents linked to a Dec. 14, 2018, Reuters report, Gorsky replied, “I did not read all the documents but I would rely on the experts in these fields.”
Gorsky was subpoenaed by plaintiffs’ lawyers as a witness in a trial playing out in a courtroom near J&J headquarters. The plaintiffs, three men and one woman, all have mesothelioma, a rare and incurable cancer that they allege was caused by their exposure to asbestos in Baby Powder in infancy during their diapering.
During an earlier liability phase of the trial, a jury agreed with plaintiffs that the company’s powders had caused their cancers and awarded $37.2 million in compensatory damages. Now plaintiffs’ lawyers are seeking to persuade a new jury that the company’s behavior was so reckless that it should award additional punitive damages.

J&J fought the subpoena, arguing that its chief executive had no first-hand knowledge about the safety of its powders and that the case involves corporate conduct that occurred long before he joined the company in 2012. Compelling his testimony “would serve no purpose other than to harass Mr. Gorsky and divert him from his executive responsibilities,” J&J said in a motion.
The New Jersey Supreme Court turned down the company’s request to suspend the subpoena last week, clearing the way for plaintiffs’ to call Gorsky.
The stakes are high. J&J faces more than 16,000 lawsuits alleging it sold powders contaminated with asbestos, a known carcinogen, and failed to warn users. It also faces a federal criminal investigation into how forthright it has been about the products’ safety.
In October, J&J disclosed that a contract lab for the U.S. Food and Drug Administration had found asbestos in a bottle of Baby Powder produced in 2018. The company questioned the finding and commissioned tests on samples from the same bottle and talc from the same lot. Less than two weeks later, J&J announced those tests had found no contamination, other than some asbestos it attributed to an air conditioner in the lab.
J&J’s share price has been sensitive to developments related to the litigation. In December 2018, a selloff wiped out $40 billion in market capitalization following a Reuters report that the company knew small amounts of asbestos had been found in its talc on occasion since 1971. J&J dismissed the Reuters’ report as “an absurd conspiracy theory.” To read the Reuters report, see:
Gorsky’s journey to the witness stand can be traced to the lead role he played in company efforts to rebut the Reuters’ report. In the days following publication, the chief executive personally attested to the safety and purity of Johnson’s Baby Powder in a video posted on the company’s website, as well as in an appearance on CNBC’s “Mad Money.”
“We unequivocally believe that our talc, our Baby Powder, does not contain asbestos,” Gorsky told the investment show’s host Jim Cramer.
https://www.reuters.com/article/us-johnson-johnson-talc-ceo/jj-chief-testifies-he-did-not-read-all-documents-related-to-asbestos-in-talc-idUSKBN1ZQ1R4

GeoVax jumps on coronavirus bandwagon with vaccine announcement

In a clear sign of the extreme degree of market lather over all companies related to the coronavirus situation, GeoVax Labs (OTCQB:GOVX), hoping to cash in on the buying frenzy, announces that it has signed a letter-of-intent with Wuhan-based vaccine developer BravoVax to jointly develop a vaccine against 2019-nCoV.

It says it will use its MVA-VLP platform and know-how to design and construct the candidate using genetic sequences from the current outbreak. BravoVax will be responsible for further development and interactions with regulatory authorities.

https://seekingalpha.com/news/3534736-geovax-jumps-on-coronavirus-bandwagon-vaccine-announcement

Beam Therapeutics sets IPO terms

Beam Therapeutics (BEAM) has filed a prospectus for an IPO of 6.25M common shares at $15 – 17 per share.

The gene editor says its proprietary technology is more precise than CRISPR, Zinc Fingers, Arcuses and TAL Nucleases since it targets a single base, thereby avoiding making a double-stranded break in the DNA.

https://seekingalpha.com/news/3534741-beam-therapeutics-sets-ipo-terms

How to handle heparin shortage with supply chain issues in China

If the heparin shortage goes critical, there are some steps that could mitigate the harm, as one group outlined.
“Manufacturing disturbances and an outbreak of African swine fever in China are threatening to cause a severe heparin shortage globally, particularly in the USA, which currently relies solely on porcine-derived heparin,” Cian McCarthy, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues wrote in a viewpoint in The Lancet.

Cow-derived heparin was taken off the U.S. market after the bovine spongiform encephalopathy (“mad cow disease”) outbreak in the 1990s. Now it’s all porcine — 80% from China, where an ongoing outbreak of African swine fever has killed up to 40% of pigs whose intestines supply the heparin.
“[P]hysicians, hospital administrators, manufacturers, regulators, and the community at large should prepare for alternative anticoagulant strategies and secure safe and more durable long-term anticoagulant options,” the authors recommended.
Even though the FDA said in October that there wasn’t a U.S. heparin manufacturing or distribution issue, premixed unfractionated heparin (UFH) is in short supply and heparin flushes for line care and prefilled syringes “could progress to shortage if sources are not optimised.”
Some institutions have started “moving beyond conservation to implement alternative anticoagulation strategies.”
McCarthy’s group proposed a tiered response for temporary shortage:

First would be to triage use of unfractionated heparin in particular, using fondaparinux (Arixtra) or direct oral anticoagulants in appropriately selected patients and low molecular weight heparin or direct thrombin inhibitors for acute coronary syndromes. Parenteral direct thrombin inhibitors like bivalirudin (Angiomax) are pricier but could be used when close titration of anticoagulation is needed, as with cardiopulmonary bypass.
“If the heparin shortage were to progress to a critical status, UFH might be prioritised for only urgent or emergency cardiac surgeries,” McCarthy and colleagues wrote.
At a hospital level, action plans and pathways can have a big impact, they noted. “We have introduced a venous thromboembolism prophylaxis pathway at our institutions, which provides guidance for alternatives to using 5000 unit/mL heparin vials and has resulted in an 84% reduction in use.”
Conservation efforts could include only spiking heparin bags once ready to use and keeping heparin out of contact isolation rooms until needed, as well as encouraging multidose vials in procedural rooms and aseptically capping IV UFH bags if stopped for a procedure.
Manufacturers and regulators have a role as well in mitigating and preventing shortage, McCarthy’s group wrote.

McCarthy disclosed no relevant relationships with industry, although co-authors had extensive disclosures.

• Primary Source

  The Lancet

  Source Reference: McCarthy CP, et al “Running thin: implications of a heparin shortage” Lancet 2020; DOI:10.1016/ S0140-6736(19)33135-6.

https://www.medpagetoday.com/cardiology/acutecoronarysyndrome/84550