L.A. homeless use EMS nearly 20 times more frequently than other residents

The Los Angeles homeless population made up 0.8% of the city’s residents in 2018, but they accounted for 10.2% of all 911-emergency medical services (911-EMS) incidents, and 13.3% of all 911-EMS transports, a researcher reported here.

The rate of calls to 911-EMS was 1,135 per 1,000 among people without homes versus 81 per 1,000 people with housing, reported Joel Lombardi, MD, of the Los Angeles County-University of Southern California Keck School of Medicine.

Additionally, the rate of homeless individuals transported to hospitals was 18.9 times higher than people with housing, at 909 per 1,000 individuals versus 48 per 1,000, respectively, he said in a presentation at the American College of Emergency Physicians (ACEP) annual meeting.

“Homeless individuals in Los Angeles constituted a disproportionately high number of both 911-EMS incidents and transports in 2018,” Lombardi and colleagues wrote. He added the problem will most likely get worse before it gets better as “Urban areas [in general] have seen a recent increase in homelessness.”

L.A. city is 480 square miles with a population of about 4 million, of which 31,825 were estimated to be homeless in 2018 by the L.A. Homeless Services Authority. More recent estimates put that figure at 60,000, Lombardi said.

“There is a large concentration of homeless individuals in the downtown [Skid Row] area, which is the location of several homeless shelters and missions,” Lombardi’s group noted.

“Rescue 9 is the primary fire department station that handles the Skid Row area,” Lombardi said. “It is not unusual for Rescue 9 to make 20 runs a day in response to calls from the area.”

The study was a 12-month retrospective review from January to December 2018 of electronic health records for 911-EMS incidents attended by the Los Angeles Fire Department (LAFD), which is the sole EMS provider for the city of Los Angeles, the authors explained.

Housing status is a mandatory field on EHR patient care reports completed by out-of-hospital responders on scene for all incidents, they added.

During the study period, LAFD recorded 355,421 911-EMS incidents, of which 10.2% were for homeless individuals and 89.8% were for housed individuals.

The battalion covering the Skid Row area produced 3% of all 911-EMS incidents citywide, with 31.4% of incidents in this battalion being for homeless patients, the authors reported. Of the 217,977 calls resulting in treatment and transport, 13.3% were for homeless individuals and 86.7% were for housed individuals.

Lombardi’s group also found that treatment with no transport against medical advice rates were higher for housed individuals at 5.4% than for homeless patients at 2.3%.

The situation in Los Angeles is not unique, said ACEP session moderator Ayanna Walker, MD, of the University of Central Florida College of Medicine in Orlando.

“We see a similar problem in Central Florida too” she said, “One of the things I would like to know is, whether there are super users? Of those people who are activating 911, are they the same few homeless people? Are these calls being activated by the homeless people, or by bystanders who are concerned about the health of someone who may be sleeping on the sidewalk? I think our situation in central Florida might be even worse because we don’t have shelters for these people in our county.”

Lombardi said that anecdotally he is aware of some homeless people in his area who call 911-EMS >100 times in a year. Also, some patients are taken directly to sober homes or to psychiatric services, depending on the circumstances.

“The emergency departments [ED] are becoming overcrowded and overwhelmed, so if we can do things to divert certain populations away from the ED resources … do these people really need ED care or do they need something else,” Walker stated.

Lombardi and Walker had no relevant relationships with industry.

• Primary Source

  American College of Emergency Physicians

  Source Reference: Abramson T, et al “Disproportionate Use of EMS Resources by Homeless Patients” ACEP 2019; Abstract 166.

https://www.medpagetoday.com/meetingcoverage/acep/83057

Medtronic thoracic stent graft OK’d in Japan

Japan’s Ministry of Health, Labor and Welfare approves Medtronic’s (MDT -0.1%) Valiant Navion thoracic stent graft system for the minimally invasive repair of thoracic descending aortic aneurysms and complicated type B aortic dissections (tear in the descending part of the aorta).

Commercial launch is underway.

The device was approved in the U.S. and Europe in late 2018.

https://seekingalpha.com/news/3512503-medtronic-thoracic-stent-graft-okd-japan

Recro Pharma up 11% on appeal of IV meloxicam CRL

Recro Pharma (REPH +11%) is up on more than double normal volume in response to the FDA granting its appeal of the Complete Response Letter (CRL) it received in March related to its marketing application for IV meloxicam.

The company is working on a comprehensive response to the agency including proposed labeling that is consistent with guidance.

Its previously announced spin out of Recro Pharma Acute Care into an independent company should be completed this quarter.

https://seekingalpha.com/news/3512557-recro-pharma-11-percent-appeal-iv-meloxicam-crl

Hemophilia rivalry eats away at post-Shire Takeda; Natpara recall bites too

Before Takeda scored its $59 billion Shire takeover, critics pointed out threats to the Irish drugmaker’s bread-and-butter hemophilia franchise. Their fear has become reality.

In the six months ended in September, the first half of Takeda’s fiscal year, its rare disease business was the only one of its five key areas that declined. Underlying revenue from that unit—which includes the hemophilia drugs—dropped 11% year over year.

“There is one area which is under competitive pressure, and that is the hemophilia area,” Takeda CEO Christophe Weber said during a media briefing Thursday.

Sales of Advate, once Shire’s flagship hemophilia A drug and the new Takeda’s third-best-selling product, plummeted 16% at constant currencies in the first half to JPY 83.2 billion ($766 million).

That’s likely the work of Roche’s fast-growing Hemlibra. The drug’s CHF 921 million ($933 million) haul in the first nine months of 2019 came at the price of almost all hemophilia A players in the market, including Takeda, Bayer and Sanofi.

To hear execs tell it, Takeda had fully expected the decline and factored it into its Shire purchase price. Weber did admit the downward trend will continue because of competition, but Chief Financial Officer Costa Saroukos stressed, “the erosion is in line to our expectations.” And because it knew what was coming, Takeda shouldn’t need to write down the value of Shire’s assets down the road, he said.

Still, it can’t be enjoyable to report the double whammy Takeda’s rare disease franchise suffered in its fiscal second quarter. In September, the company had to recall its hypoparathyroidism drug Natpara in the U.S. after rubber particles turned up in some vials. The drug’s sales dropped to JPY 4.5 billion ($41.5 million), from JPY 7.9 ($72.9 million) in the three months ended in June. Weber said the company is working closely with the FDA to resume supply as soon as possible.

“Eventually hemophilia impact will be behind us, and [rare disease] is a segment we’ll grow in the future,” the CEO said.

One drug that will carry the weight moving forward is hereditary angioedema (HAE) therapy Takhzyro. A follow-up to Shire’s old Firazyr, which has gone generic, Takhzyro was hailed as a best-in-class prospect—and a blockbuster in the making—when it snagged an FDA nod last August.

In Takeda’s second quarter, it racked up JPY 16.2 billion ($150 million). And now Takhzyro is driving growth of the entire U.S. HAE prophylaxis market, the company said, with about a third of Takhzyro patients new to a preventive treatment. And the drug just nabbed a recommendation from England’s drug cost watchdog, the National institute for Health and Care Excellence, for coverage on the National Health Service.

Natpara and Takhzyro are among 14 drugs Weber has laid out as key growth drivers for Takeda. Others include inflammatory bowel disease therapy Entyvio, six-month sales of which jumped 34% and amounted to JPY 168.4 billion ($1.56 billion). Legacy Shire’s short bowel syndrome therapy Gattex and ADHD med Vyvanse “are benefiting from the combination of the two companies because they get more promotional support,” Weber said.

Meanwhile, Takeda has been ramping up its global expansion. During a recent speech at the Nikkei Global Management Forum, Weber said Takeda is preparing to launch more than 10 new medicines in China over the next three years, according to Nikkei Asian Review.

The Japanese pharma has also made further progress in reducing its debt, partly by selling drugs outside of its focus areas of oncology, gastroenterology, neuroscience, rare disease and plasma-derived therapies. It has paid down JPY 584.5 billion ($5.4 billion) of debt this fiscal year and lowered its net debt/EBITDA ratio to 3.9x, down from 4.4x at the end of June.

Overall, Takeda registered JPY 1,660 billion ($15.3 billion) in revenue, down 0.2% on a pro forma basis. For the full year ending March 2020, it’s expecting reported revenue to stand at JPY 3,260 billion ($30.1 billion), lower than its previous forecast, mainly because of a strong yen and the surprising Natpara recall.

https://www.fiercepharma.com/pharma/hemophilia-rivalry-pressures-post-shire-takeda-but-ceo-weber-points-to-14-drugs-for-growth

Bristol-Myers warns I-O blockbuster Opdivo will be ‘under pressure’ in 2020

Bristol-Myers Squibb’s Opdivo had been riding high even amid intense competition, particularly from Merck & Co.’s fast-growing Keytruda. But the immuno-oncology med hit something of a wall in the third quarter, and execs are warning that it’ll face a tough 2020.

Opdivo posted just 1% sales growth for the quarter, reaching $1.8 billion as I-O rivals like Merck’s Keytruda and Roche’s Tecentriq push the Bristol superstar on all sides.

That stagnant sales pace is worrisome in and of itself, but analysts are concerned that the drug’s dwindling second-line lung cancer sales and a significant gap before major data readouts in 2020 could put the drug in a tough position next year.

Bristol can take heart that anticoagulant Eliquis continues to swim in cash and its hoped-for merger partner Celgene also posted strong growth for the quarter. Still, Opdivo remains a sales linchpin, and Chris Boerner, Bristol-Myers’ chief commercialization officer, said Thursday that the lung cancer bite and trial-data timing could put a damper on Opdivo’s sales next year.

The company is also awaiting a potential payoff from two recently-reported studies of Opdivo and its fellow BMS immunotherapy Yervoy in previously untreated lung cancer.

“Given the competitive dynamics in the U.S. and the timing of those regulatory interactions, we still see Opdivo under pressure,” Boerner said during the company’s Q3 earnings call with analysts.

Bristol execs were tight-lipped on the regulatory submission process for both Checkmate studies, including CM-9LA, which showed last week that the Opdivo-Yervoy duo—plus two cycles of chemo—lengthened patients’ lives compared with chemo plus placebo.

The other Opdivo-Yervoy combo study––Checkmate-227––has faced a troubled road itself after Bristol pulled its FDA application in October 2018 to wait for longer-term survival data. BMS unveiled those results last month at the European Society for Medical Oncology meeting.

It’s not all bad news for Opdivo, in Bristol’s eyes: Boerner told analysts the drugmaker expected Opdivo to retake the initiative in sales after the lung cancer filings and trial readouts coming up in 2020 and 2021.

Luckily, there’s anticoagulant Eliquis, which kept up its world-beating performance in the third quarter as it continues to rake in market share and keep a stranglehold on its anticoagulant rivals.

Eliquis nabbed $1.9 billion in worldwide sales for the period, posting 22% sales growth––well above all but one drug in Bristol’s portfolio. Bristol CFO Charles Bancroft said Eliquis’ prescription numbers jumped 30% from the same quarter last year, putting the drug well ahead of its warfarin-alternative rivals—and warfarin itself.

On the whole, Bristol’s pharma stable raked in $6 billion in revenue on the quarter––a 6% bump from the same quarter last year.

As Bristol’s blockbusters turned in varying degrees of growth, Celgene posted increases across the board with a 16% revenue bump to $4.5 billion. Driving that increase were strong performances from blockbuster chemotherapies Revlimid and Pomalyst, which grew 13% to $2.77 billion in sales and 29% to $664 million, respectively.

But the strong sales are painful in one respect: Otezla, which the drugmaker agreed to sell ahead of its pending merger with Bristol, hit $547 million in sales on 27% growth year-over-year.

Celgene reached an agreement with FTC in August to divest the drug, eventually selling it to Amgen for a whopping $13.4 billion. On Thursday’s earnings call, Bristol execs said the proceeds would be used to offset the new company’s debt load, which the drugmaker said would be around $45 billion when the deal closes.

https://www.fiercepharma.com/pharma/eliquis-rise-bristol-myers-squibb-says-blockbuster-opdivo-will-be-under-pressure

J&J HIV Med Edurant, Other Similar Drugs May Be Effective in Treating Zika

Every year or two, another potentially deadly virus hits the U.S. A few years ago, it was Zika virus, which is transmitted by the Aedes mosquitoes. Symptoms include fever, rash, conjunctivitis, muscle and joint pain, and headache. In pregnant women, Zika infection has been associated with microcephaly in the children. It has also been associated with Guillain-Barre syndrome, which can lead to muscle paralysis.

Zika was first observed in humans in 1952 in Uganda and Tanzania, then seen in the U.S. and other parts of the world in 2015.

Researchers with Temple University Health System have found that the Zika virus responds to an HIV drug called rilpivirine, which is marketed by Janssen, a Johnson & Johnson company, as Edurant. In addition, the enzymes targeted by rilpivirine are also found in other viruses similar to Zika, including the viruses that cause dengue fever, yellow fever, West Nile fever, and hepatitis C.

The researchers published their research in the journal Molecular Therapy.

“HIV and Zika virus are distinct types of RNA viruses,” said Kamel Khalili, the Laura H. Carnell Professor and chair of the Department of Neuroscience, director of the Center for Neurovirology, and director of the Comprehensive NeuroAIDS Center at the Lewis Katz School of Medicine at Temple University (LKSOM).

He went on to say, “By discovering that rilpivirine blocks Zika virus replication by binding to an RNA polymerase enzyme common to a family of RNA viruses, we’ve opened the way to potentially being able to treat multiple RNA virus infections using the same strategy.”

The Zika virus requires an enzyme known as non-structural protein 5 RNA-dependent RNA polymerase (NS5 RdRp). The researchers showed that rilpivirine prevents viral replication by binding to the NS5 domain. They carried out experiments in mice that were infected with Zika virus. Usually Zika-infected mice become very sick within a week and eventually die.

“We found, however, that when treated with rilpivirine, the animals survived,” said Jennifer Gordon, associate professor of Neuroscience at Temple’s Center for Neurovirology. “Our conclusion is that rilpivirine disrupted the virus’s usual course of infection.”

Rilpivirine is a non-nucleoside reverses transcriptase inhibitor (NNRTI). The researchers tested two other NNRTIs in Zika-infected cells and found similar effects.

“We now have a clear path forward,” said Khalilli. “We have a starting point from which we can find ways to make these drugs even more potent and more effective against flaviviruses.”

According to the U.S. Centers for Disease Control and Prevention (CDC), the biggest outbreaks of Zika virus in the Americas, particularly Puerto Rico, the U.S. Virgin Islands, and Florida and Texas, occurred in 2015 and 2016. The U.S. reported cases declined in 2017 and in 2018 and 2019 there were no reports of Zika virus transmission in the continental United States.

In 2015, 62 symptomatic cases of Zika virus were reported in the U.S., with all cases in travelers returning from affected areas. In U.S. territories, there were 10 symptomatic Zika virus case reported, with one in a traveler and nine acquired via mosquito bite. The following year, in 2016, there were 5,168 symptomatic Zika virus cases reported in the U.S., with 36,512 cases reported in U.S. territories. In 2017, that dropped significantly to 452 in the U.S. and 666 in the U.S. territories.

https://www.biospace.com/article/hiv-drug-may-fight-zika-virus/

J&J Experimental Ebola Vaccine to be Deployed in Congo to Help Stem Outbreak

While the number of new Ebola cases in the Democratic Republic of the Congo (DRC) declines, the situation has remained troublesome as the outbreak could quickly ramp back up the World Health Organization said earlier this month. To help with the situation, Johnson & Johnson is donating 500,000 vaccine regimens of its experimental treatment aimed at the Zaire strain of the virus, the cause of the current outbreak.

This morning, J&J announced it had committed the doses of the vaccine under development from subsidiary Janssen Pharmaceutical in support of a new clinical study in the African nation. In the Congo, there have been more than 3,000 cases and 2,000 related deaths to the Ebola virus outbreak.

Alex Gorsky, J&J’s chairman and chief executive officer, called Ebola one of the most urgent challenges facing the global healthcare community.

“The fact that we’re in a position to help the people of the DRC protect their communities from such a serious threat—just a few years after we pledged to accelerate vaccine development efforts—is a testament to both the ingenuity of Janssen’s scientists, and the power of close collaboration between partners committed to working for the greater good of all,” Gorsky said in a statement.

In July, the WHO declared the Ebola outbreak in the DRC a public health emergency of international concern. In that announcement, the World Health Organization called for “optimal vaccine strategies” to curtail the outbreak, which prompted J&J’s response. The vaccine will be provided to individuals in the DRC who live in areas close to the current outbreak zone, with the goal of preventing the further geographic spread of the virus.

Janssen’s Ebola vaccine, which is being developed with Bavarian Nordic, consists of two doses leveraging different vaccines. The regimen uses a viral vector strategy in which viruses, adenovirus serotype 26 (Ad26) and Modified Vaccinia Ankara (MVA), are genetically modified so that they cannot replicate in human cells. This safely induces the production of Ebola virus proteins in order to trigger an immune response, the company said. Janssen accelerated development of the vaccine in response to the Ebola outbreak of 2014 to 2016.

The DRC Minister of Public Health Eteni Longondo announced his country’s decision to introduce Janssen’s investigational vaccine alongside other tools as part of an expanded public health response to fight the Ebola outbreak, J&J said this morning. Additionally, the country plans to begin using the vaccine in the border city of Goma, which is a trading hub for the DRC and neighboring Rwanda, the company added.

The DRC isn’t the first African country to authorize the use of experimental Ebola vaccines to stem spread of the virus. In June, authorities in Uganda approved the use of three experimental viruses, Mapp Biopharmaceutical’s ZMapp, Regeneron Pharmaceuticals’ REGN-EB3, and Gilead Sciences’ Remdesivir. In July, trial data showed the efficacy of both ZMapp and Remdesivir. Both successfully inhibited the growth of the virus in human cells in laboratory studies. In August, Regeneron’s PALM trial studying REGN-EB3 was stopped early after it showed superiority to ZMapp.

“No single entity can solve this outbreak which has continued for more than a year,” Paul Stoffels, chief scientific officer of Johnson & Johnson said in a statement. “The global health community has come together in support of this initiative using Janssen’s investigational Ebola vaccine regimen to help prevent its further spread. This collaboration is essential, and a great demonstration of how the public and private sectors can work together to help tackle a public health crisis.”

https://www.biospace.com/article/j-and-j-donates-500-000-experimental-ebola-vaccine-regimens-to-support-outbreak-response-in-the-congo/