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Thursday, January 23, 2020

B. Riley FBR defends Genfit amid drop

In a note, B. Riley FBR analyst Mayank Mamtani (Buy/$43) says today’s selloff in Genfit SA (GNFT -4.6%), apparently over concerns with a potential delay in the development timeline for elafibranor in NASH, is misguided considering that the expected data readout remains on track for this quarter.
He believes the stock could double if the NASH resolution benefit is 15 – 20%.
https://seekingalpha.com/news/3534023-b-riley-fbr-defends-genfit-amid-drop

Edwards Lifesciences down 5% on recent drop in heart valve replacements

Edwards Lifesciences (EW -5.4%) slips on average volume in apparent response to a Jefferies report of a “sharp step down” last month in the growth of heart valve replacements.
Hospital purchasing data for December showed growth ranging from -2% to +3% for transcatheter aortic valve replacement (TAVR) procedures compared to 27-28% growth in October and November. Jefferies cautions over reading too much into one month due to lags in data reporting and the lack of new sites in the same-store sales model.
The company is scheduled to report Q4 results after the close on Thursday, January 30.
https://seekingalpha.com/news/3534028-edwards-lifesciences-down-5-on-recent-drop-in-heart-valve-replacements

Newly Discovered Alzheimer’s Gene Hints at Possible Breakthrough for the Disease

Investigators at the Case Western Reserve University School of Medicine identified a previously unknown gene and the resultant protein that may potentially slow the progress of Alzheimer’s disease. The team has named the protein aggregatin and they believe that if the gene or protein could be suppressed, it could possibly slow the development of the disease.
“Based on the data we have, this protein can be an unrecognized new risk factor for Alzheimer’s disease (AD),” said Xinglong Wang, associate professor of pathology at Case Western. “We also see this as a potential novel therapeutic target for this devastating disease.”
Which is all very early in any development phase. The research team, led by Wang and Xiaofeng Zhu, a professor of Population and Quantitative Health Sciences at Case Western, has filed a patent via the university’s Office of Research and Technology Management for “novel Alzheimer’s disease treatments and diagnosis based on this and related study,” according to Wang. The research was published in the journal Nature Communications.
Alzheimer’s disease is marked by the accumulation of amyloid plaques in the brain. Another abnormal protein, tau, is also associated with the disease, which results in loss of memory and cognition.
The newly identified gene is FAM222A, which the researchers associated with imaging genetics to AD-related regional brain atrophy. The protein, aggregatin, that the gene codes for is mostly expressed in the central nervous system and is increased in the brains of AD patients as well as in an AD mouse model.
Aggregatin accumulates inside amyloid deposits, and with the way it physically interacts with beta-amyloid, helps the accumulation of beta-amyloid.
“This protein characteristically accumulates, or aggregates, within the center of plaque in AD patients, like the yolk of an egg—which is part of the reason we named it ‘aggregatin,’” Wang said.
The research was supported with grants from the National Institutes of Health (NIH) and the Alzheimer’s Association. The Alzheimer’s Disease Neuroimaging Initiative supplied genomic and brain imaging data, which is also supported by the NIH.
The so-called amyloid theory of Alzheimer’s disease has been under fire in recent years. Although it’s clear that an accumulation of amyloid in the brain is related to the disease, dozens of drugs that cleared or prevented amyloid accumulation failed to improve cognitive symptoms of the disease muddied the waters. Currently, the theory has regained at least some support with Biogen’s aducanumab. The drug failed a clinical trial in March 2019, but further analysis of the data at a higher dose suggested it actually worked, and will soon be submitted to the U.S. Food and Drug Administration (FDA), although there is still quite a bit of skepticism among scientists about the effectiveness of the drug.
Perhaps more realistically, many researchers believe that amyloid and tau are only part of the story, and that other factors, some unknown, and others likely related to neuroinflammation, are important.
Although it’s not completely understood how amyloid-beta leads to plaque formation, this new research appears to shed some light on the subject.
“We’re very excited about this because our study is likely the first systematic work combining the identification from a genome-wide association study of high dimensional brain-imaging data and experimental validation so perfectly in Alzheimer’s disease,” Zhu said.
The research team correlated about one million genetic markers with brain images. This allowed them to identify a specific single-nucleotide polymorphism in the FAM222 gene that was associated with patterns of regional brain atrophy. They then injected mouse models with the aggregatin protein, which caused amyloid plaque formation to accelerate in the animals’ brains, causing more neuroinflammation and cognitive problems. When they suppressed the protein, the plaques shrank and neuroinflammation and cognitive impairment lessened.
https://www.biospace.com/article/new-gene-identified-linked-to-alzheimer-s/

China Locks Down 3 Cities at Epicenter of Virus Outbreak

China put on lockdown on Jan. 23 three cities at the epicenter of a new coronavirus outbreak that has killed 17 people and infected nearly 600, as health authorities around the world scramble to prevent a global pandemic.
Health officials fear the transmission rate will accelerate as hundreds of millions of Chinese travel at home and abroad during week-long holidays for the Lunar New Year, which begins on Saturday.
The previously unknown virus strain is believed to have emerged late last year from illegally traded wildlife at an animal market in the central Chinese city of Wuhan.
Most transport in Wuhan, a city of 11 million people, was suspended on Thursday morning and people were told not to leave. Hours later, state media in neighboring Huanggang and Ezhou are reported to be imposing a similar lockdown.
Chinese authorities gave no new details on the numbers of virus infections but it has been reported in Beijing, Shanghai and Hong Kong, and several other countries including the United States, stoking fears it is already spreading worldwide.
Wuhan’s city government said it would shut down all urban transport networks and suspend outgoing flights from 10 a.m. Domestic media said some airlines were operating after the deadline, however.
State media broadcast images of one of Wuhan’s transport hubs, the Hankou rail station, nearly deserted, with gates blocked or barred. The government is urging citizens not to leave the city.
Epoch Times Photo
Chinese paramilitary officers wearing masks stand guard at an entrance of the closed Hankou Railway Station after the city was locked down following the outbreak of a new coronavirus in Wuhan, Hubei province, China, on Jan. 23, 2020. (China Daily via Reuters)
State media reported highway toll booths around Wuhan were closing down, which would effectively cut off road exits. Guards were patrolling major highways, one resident told Reuters.
As the city slipped into isolation, residents thronged into hospitals for checks and scrambled for supplies, clearing out supermarket shelves and queuing for petrol.
Authorities in Huanggang ordered indoor entertainment venues including cinemas and internet cafes to close and were asking citizens not to leave other than under special circumstances, state media said.
Authorities had confirmed 571 cases and 17 deaths by the end of Wednesday, China’s National Health Commission said. Earlier, it said another 393 suspected cases had been reported.
Of eight known cases worldwide, Thailand has confirmed four, while Japan, South Korea, Taiwan and the United States have reported one each.
In a report on Wednesday, Imperial College London said it estimated a total of 4,000 cases of the coronavirus in Wuhan alone as of Jan. 18, an infection rate based on the number of cases reported in China and elsewhere.

Virus Spreading

In contrast with its secrecy over the 2002-03 Severe Acute Respiratory Syndrome (SARS) that killed nearly 800 people, China’s communist government has provided regular updates to avoid panic ahead of the holidays.
During a visit to Wuhan, Vice Premier Sun Chunlan said authorities needed to be open about the virus and efforts to contain it, the official Xinhua news agency said.
The World Health Organization (WHO) has said it will decide on Thursday whether to declare the outbreak a global health emergency, which would step up the international response.
If it does so, it will be the sixth international public health emergency to be declared in the last decade.
Some experts believe the new virus is not as dangerous as previous coronaviruses such as SARS and Middle East Respiratory Syndrome (MERS), which has killed more than 700 people since 2012.
“The early evidence at this stage would suggest it’s not as severe,” Australia’s Chief Medical Officer Brendan Murphy told reporters.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters in Geneva that China’s actions were “very strong” but called on it to take “more and significant measures to limit or minimize the international spread”.
“We stressed to them that by having a strong action not only they will control the outbreak in their country but they will also minimize the chances of this outbreak spreading internationally. So they recognize that,” he said.
Despite China’s response, stock markets across Asia were on the back foot on Thursday, led by drops of roughly 1.5 percent in Hong Kong and Shanghai while China’s yuan fell to a two-week low.

Flights, Rail Suspended

There is no vaccine for the virus, which can spread through respiratory transmission. Symptoms include fever, difficulty in breathing and cough, similar to many other respiratory illnesses.
Preliminary research suggested the virus was passed on to humans from snakes, but government medical adviser Zhong Nanshan has also identified badgers and rats as possible sources. Confirmed sufferers include 15 medical workers.
Many Chinese were cancelling trips, buying face masks and avoiding cinemas and shopping centers, and even turning to an online plague simulation game as a way to cope.
Epoch Times Photo
Passengers wear masks to prevent an outbreak of a new coronavirus at the Hong Kong West Kowloon High Speed Train Station, in Hong Kong, China, on Jan. 23, 2020. Tyrone Siu/Reuters)
The release of seven movies over the Lunar New Year has been postponed. The holiday is the high season for distributors and cinemas attract huge crowds.
Airports globally stepped up screening of passengers from China and the European Centre for Disease Control and Prevention said the further global spread of the virus was likely.
“Obviously this is a huge concern for the world,” Britain’s business minister, Andrea Leadsom, told Sky.
https://www.theepochtimes.com/china-locks-down-two-cities-at-epicenter-of-virus-outbreak_3213547.html

Tivity Health inks deal with Walmart

Tivity Health (TVTY +0.1%) is now offering its Prime Fitness program to Walmart’s (WMT -0.2%) 1.5M associates and their dependents in the U.S. Members will have access to more than 9,000 fitness locations for a little as $9 per paycheck.
Tivity says it now offers Prime Fitness to 43M people between the ages of 18-64. Health clubs 24 Hour Fitness and Planet Fitness are national partners.
https://seekingalpha.com/news/3533968-tivity-health-inks-deal-walmart

Costs of prior authorizations increase for physicians’ practices at an ‘alarming’ rate

The cost of prior authorization requirements on physicians’ practices has continued to increase—up 60% in 2019 to manually generate a request to insurers.
The just released CAQH 2019 Index, which concluded that the healthcare industry can save $13.3 billion on administrative waste through automation of eight transactions including prior authorizations, said the medical industry could see potential annual savings of $454 million by transitioning to electronic prior authorizations.

The Medical Group Management Association (MGMA) said the CAQH report confirms its own concern about the burden prior authorizations place on physician practices.
“The just-released CAQH 2019 Index confirms MGMA’s findings that the financial burden of prior authorization requirements on physician practices is increasing at an alarming rate,” said Anders Gilberg, senior vice president of government affairs at MGMA, in a statement.

The CAQH index, put together by the nonprofit alliance, revealed that the cost for providers to manually generate a prior authorization increased from $6.61 in 2018 to $10.92 in 2019, Gilberg said. Payer cost for the same transaction decreased from $3.50 in 2018 to $3.32 in 2019.
At the same time, the cost for providers to generate an electronic prior authorization transaction dropped from $2.80 in 2018 to just $1.88 in 2019, and the cost for payers stayed steady.
However, overall industry use of electronic transactions increased only slightly from 12% in 2018 to 13% in 2019, the CAQH report said.

“In 2020, practices should not be forced to rely on fax machines to complete manual prior authorizations when health plans could modernize the process,” said Gilberg. The federal government needs to streamline prior authorization by requiring a national automated approach to minimize administrative costs and delays in patient care, he said.
Insurers, however, are pledging to do more and just last month launched a new initiative aimed at expanding the use of electronic prior authorization, hoping to address an issue most providers say is the most burdensome they face.
The Fast Prior Authorization Technology Highway initiative aims to use technology from Availity and Surescripts in physicians’ offices to speed up requests and responses for prior authorization, where a provider must get permission from an insurer before prescribing a pricey drug or performing a certain surgical procedure.
The initiative is led by insurance industry group America’s Health Insurance Plans and several member insurers including Anthem, Cigna and WellCare. It will have physicians’ offices volunteer to work with insurers to incorporate the new processes into existing technology.

Having to seek prior authorization from payers is the most burdensome regulatory issue for practice leaders, and it’s only getting worse, according to an MGMA survey taken last year.
The CAQH report said prior authorization is the most costly, time-consuming administrative transaction for providers. On average, providers spent almost $11 per transaction to conduct a prior authorization manually and nearly $4 using a web portal. The cost of an electronic transaction is $1.88.
Adoption of electronic prior authorization by medical plans remained low relative to other administrative transactions, with only that one percentage point increase in electronic adoption from 2018 to 2019, the report said.
The use of partially electronic transactions through payer’s web portals rose by almost 20 percentage points after a 21 percentage point decline, while manual use decreased 18 percentage points. Medical plans have reported that this shift to partially electronic versus manual utilization is the result of concerted efforts to encourage providers to submit prior authorization requests through plan specific portals, the report said.

The process is time-consuming for practices. On average, a manual prior authorization required 21 minutes of provider staff time, while electronic prior authorization transactions can be completed in four minutes.
Prior authorizations were just one of the changes the CAHQ report highlighted. The U.S. healthcare industry spends $40.6 billion annually on just eight healthcare administrative transactions related to verifying patient insurance coverage and cost-sharing, obtaining authorization for care, submitting claims and supplemental information and sending and receiving payments, according to CAQH researchers.

CAQH found that by adopting fully electronic processes for just these eight transactions the industry can reduce waste by $13.3 billion annually—33% of administrative spending. Those eight transactions are:
1. Eligibility and benefit verification
2. Prior authorization
3. Claim submission
4. Attachments
5. Coordination of benefits
6. Claim status inquiry
7. Claim payment
8. Remittance advice
Of the $13.3 billion in potential savings through automation, $9.9 billion can be saved by medical plans and providers, while $3.4 billion can be saved by the dental industry, according to the report. In both industries, the greatest savings exist for providers as compared to plans.
The report also found that while the industry has made progress in automating fee-for-service processes, the industry is transitioning to value-based payment models. And there is a need now for more interoperable administrative and clinical systems.
While the industry has already avoided $102 billion annually by automating administrative transactions, significant opportunities for additional savings remain for both the medical and dental industries, CAQH said.
“While a greater percentage of business transactions are now conducted electronically, the U.S. continues to spend more on healthcare administration than any other nation,” said Kristine Burnaska, director of research and measurement at CAQH. “The Index offers a roadmap for those areas where further automation can drive down costs and burdens for both providers and plans.”
CAQH called for greater collaboration across industry stakeholders to harmonize and accelerate approaches that can accommodate emerging market needs. For example, standards and operating rules must be updated more quickly to support changing technology, payment models and patient care delivery strategies.
“While the industry has reduced administrative complexity by automating fee-for-service processes, our healthcare system is evolving,” said April Todd, senior vice president, CORE and Explorations at CAQH. “As the industry transitions to value-based payment models and the need for interoperable administrative and clinical systems becomes more acute, we need to adapt in order to maintain and improve upon the progress made to date.”
https://www.fiercehealthcare.com/practices/costs-prior-authorizations-increase-for-physician-practices-at-alarming-rate

Amgen wades deeper into Asia with full control of an Astellas Japanese JV

Seven years into a strategic alliance in Japan with Astellas Pharma, Amgen is taking on full control of the local business as the Big Biotech bets more on the rapidly growing Asian market.
Amgen will purchase the remaining 49% shares it doesn’t yet have in Amgen Astellas BioPharma—a Japanese joint venture it formed with Astellas in 2013—on April 1, 2020, the pair announced (PDF) Thursday. After that, the entity will become Amgen K.K., a wholly owned Amgen affiliate, and will move its headquarters to Tokyo Midtown.
The move comes on the heels of a $2.7 billion BeiGene tie-up, a large part of which also ends seven years after commercialization. Together, they represent Amgen’s growing interest in the Asia market, from which it’s expecting 25% of growth in the next decade.
Currently, the Japanese JV is responsible for selling PCSK9 heart drug Repatha, leukemia therapy Blincyto and osteoporosis med Evenity. Moving forward, Amgen and Astellas will continue to co-promote these drugs, with Astellas responsible for distribution and sales. As for Amgen K.K., it will focus on bringing the company’s remaining innovative medicines to Japan.
Financial terms were not disclosed. Amgen didn’t immediately respond to a FiercePharma request by publication time.
The move isn’t unexpected; eventually becoming the business’ sole owner was Amgen’s plan when it unveiled the partnership in 2013. Over the years, the business “has grown into an organization with over 600 employees and comprehensive functions to be fully operational as a marketing authorization holder in Japan,” the companies said.
It follows closely a cancer-focused team-up Amgen established with BeiGene in China. The two deals bear some resemblance. In the BeiGene deal, the Chinese biotech will commercialize Xgeva, Kyprolis and Blincyto in its home country. It will have the right to retain one product but will return rights to the other two after five years and seven years respectively.

The pair will also collaborate on developing 20 oncology pipeline assets, to which BeiGene will oversee selling in China for—you guessed it—seven years. Beyond that point, BeiGene can keep up to six of those products. In exchange, Amgen is paying $2.7 billion to acquire a 20.5% stake in BeiGene.
Just as Amgen was leveraging Astellas’ commercial and regulatory knowledge in Japan before learning the ropes to run the show on its own seven years later, the BeiGene pact is meant to tap the company’s oncology knowhow and fast-growing local sales force to gain access to China.
The Astellas JV buyout also follows shortly the unit folding in the local Otezla business from Celgene by establishing a new inflammation and immunology business unit.
Astellas isn’t the only company Amgen has teamed up with in Japan. In early 2018, Amgen paid Kirin Holdings $780 million to gain full control of Kirin-Amgen, a formerly 50-50 JV founded in 1984, just four years after Amgen’s establishment in Thousand Oaks, California. That JV was actually the intellectual property holder for many popular Amgen drugs, including anemia med Epogen, as well as Neupogen and Neulasta, among others.

So far, Amgen is deeply reliant on the U.S. market, which made up 77% of its total sales in 2018. But it’s among a growing number of multinationals counting on Asia for growth. The company’s expecting 25% of its growth to come from Asia in the next decade, CEO Robert Bradway told Reuters on the sidelines of the annual J.P. Morgan Healthcare conference.
“China and Japan are the second and third largest markets in our industry,” Bradway said. “In the case of China, it is a rapidly growing market. … Japan has an aging population and we expect that will be a growth market for us.”
He said the Astellas JV is indeed what inspired the BeiGene partnership—to “work on a basket of drugs together, then after a period of time, the rights would return to us.”
https://www.fiercepharma.com/pharma-asia/amgen-wades-deeper-into-asia-by-assuming-full-control-astellas-japanese-jv