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Tuesday, July 30, 2019

UnitedHealth’s Optum: We’ll Lure More Providers To New Partnership Model

Executives at UnitedHealth Group’s Optum health services unit believe more medical care providers will be drawn to the company’s new strategy to take on non-clinical operations for local health systems.
Optum this week announced plans to take over the ‘non-clinical functions’ of John Muir Health in California’s San Francisco Bay area for an undisclosed sum. Optum said it will take on information technology, revenue cycle management, analytics, purchasing and claims management. About 540 John Muir Health employees, or nearly 10% of the health system’s workforce, will become part of Optum, the companies said.
The arrangement is a different kind for Optum, which has been buying up doctor practices, outpatient clinics, surgery centers and urgent care facilities across the country. But Optum expects expects this new model to be a success that will interest more health systems like John Muir, a healthcare system that boasts a network of more than 1,000 physicians and two large hospitals east of San Francisco.
“Our market knowledge suggests that several hundred regional health systems have similar size and market opportunity as John Muir,” Eric Murphy, CEO at OptumInsight told analysts on the company’s second quarter earnings call. “We’re already in discussions with several high performing independent community based systems and look forward to establishing continued partnerships, similar to John Muir Health, with health systems across the industry.”
UnitedHealth and Optum executives described the partnership with John Muir as a “multi-year relationship.”
“Our partnership with John Muir Health really represents one of the most comprehensive in the healthcare industry, between a delivery system and a health care services company,” Murphy said. “The integrated scope of services includes acute and ambulatory revenue cycle management end-to-end information technology services, ambulatory care coordination, enterprise analytics, purchasing and consulting services.”

FDA fast-tracks NeuroVive’s traumatic brain injury drug

The FDA has fast-tracked a drug to treat severe traumatic brain injury from Swedish pharma NeuroVive, hastening its development and review.
Based in Lund, NeuroVive is developing NeuroSTAT for moderate to severe traumatic brain injury (TBI).
With the Fast Track designation from the FDA, NeuroVive is eligible for more frequent meetings and communication with the FDA during the development process, and feedback on each section of its filing.
Fast Track status is reserved for drugs for serious conditions where there are few or no other options, in order to get the product approved and to patients faster.
NeuroSTAT works by protecting and stabilising mitochondria, which generate energy in most living cells.
The drug aims to prevent the emergence of neurological and functional secondary brain damage after a traumatic brain injury (TBI).
It’s hoped this will lead to increased survival, improved quality of life, and preserved neurological function.
The drug has already shown “favourable properties” in a phase 2 trial that investigated safety, tolerability, and whether the drug passes into the brain, the company said.
Analyses of brain cell damage biomarkers in samples from patients have given a first signal of clinical effect.
In advanced brain cell damage in experimental models at the University of Pennsylvania, there was a 35% decrease in volume of brain injury after NeuroSTAT treatment.
There were also positive changes in brain energy metabolite levels and mitochondrial respiratory function, and decreased generation of reactive oxygen species.
NeuroSTAT also has orphan drug designation in both Europe and the US, which could give it market exclusivity benefits if approved.
There are few options available for TBI, although NeuroSTAT research from Rutgers University in New Jersey offers some hope.
While nearly all other treatments focus on preventing nerve cells from degenerating the scientists at Rutgers suggested that restoring a patient’s memory would also be helpful.
They hope that a protein called cypin could help in this regard by speeding the breakdown of guanine products, protecting neurons from injury and retaining brain function.

Alnylam, GENESIS to Commercialize ONPATTRO in South East Europe

Alnylam and GENESIS Pharma, a leading regional biopharma company operating in the broader region of South East Europe, announced today an exclusive agreement to commercialize ONPATTRO®, a first-in-class RNAi therapeutic, in 12 countries: Greece, Cyprus, Bulgaria, Romania, Slovenia, Croatia, Serbia, Bosnia and Herzegovina, Albania, Republic of North Macedonia, Montenegro as well as Malta.
“Our partnership with GENESIS Pharma enables us to extend access to ONPATTRO to patients suffering from hereditary ATTR (hATTR) amyloidosis in areas of Europe where we currently don’t have a presence,” said Theresa Heggie, SVP and Head of Europe, Middle East and Africa, and Canada, Alnylam Pharmaceuticals. “We know that patients in these countries have an urgent need for new treatment options, and as the only company with an RNAi therapeutic approved in the European Union, we are delighted to partner with GENESIS Pharma to bring ONPATTRO and potential future therapies to patients in South East Europe.”

Fresenius ups 2019 outlook, highlights emerging markets

German healthcare group Freseniusraised its full-year revenue target on Tuesday as strong generic drug sales in emerging markets helped offset a softer performance in the U.S. generics business and at its key dialysis unit.

Fresenius highlighted continued strong growth of its generic infusions unit Kabi in markets including China, Asia-Pacific and Latin America, while noting increased competition and easing shortages in the U.S. market.
The parent said it now expected full-year revenue growth of between 4% and 7% at constant currency rates, compared with a previous range of 3% to 6%. The outlook includes the sales and earnings effects of its February acquisition of U.S. home dialysis firm NxStage, Fresenius said.
“We are reporting a good second quarter 2019, with healthy organic growth in all four business segments,” Fresenius Chief Executive Stephan Sturm said in a statement. “We are very confident about the second half and the coming years.”
The positive update contrasted with last October when the group cut its earnings target for the year, citing slower growth in dialysis services in North America, its largest market, sparking one of its biggest-ever daily share declines.
The separately listed dialysis unit Fresenius Medical Care (FMC) maintained its 2019 revenue and income outlook after reporting adjusted second-quarter revenue of 4.28 billion euros (£3.93 billion), below the 4.35 billion expected on average by analysts in a Refinitiv poll.
The group also said its hospitals division Helios, which had long acted as a drag on its results due to decreasing admissions and staff shortages in Germany, recorded strong organic sales growth in its home market.
“Helios is no longer a reason for major concerns,” Bankhaus Lampe said in a note. “The key message, in our view, is that the results of Fresenius Helios appear to be stabilising earlier than anticipated.”
Fresenius said its comparable group second-quarter core operating profit (EBIT) fell by 7% in currency-adjusted terms to 1.08 billion euros, while currency-adjusted revenue rose 6% to 8.8 billion euros, broadly in line with analysts’ expectations.
Dialysis specialist Fresenius Medical repeated it welcomed U.S. President Donald Trump’s administration goals to move more kidney disease treatment into patients’ homes, saying it supported the company’s investment in home dialysis.
Fresenius Medical will continue to increase the number of treatments it carries out in the home setting in North America, it said.

Bayer says 2019 profit goal becoming a stretch

Germany’s Bayer has warned that its 2019 earnings target had become harder to reach, becoming the latest agricultural supplies company to be affected by flooded U.S. farms and trade disputes.
The company said it was still aiming for an increase in 2019 adjusted core earnings or EBITDA to about 12.2 billion euros ($13.6 billion), excluding the effect of currency swings and the planned sale of assets such as its animal health unit.
“This outlook is becoming increasingly ambitious in view of the challenging environment for the Crop Science business,” the company, which last year acquired Monsanto for $63 billion, added in a statement on Tuesday.
Sales at the Crop Science unit jumped by almost 60% to 4.8 billion euros in the quarter, thanks to the addition of Monsanto in June 2018, but a like-for-like comparison of the combined agriculture business showed a 9.9% sales decline, also adjusted for currency swings.

“Flooding and heavy rains in the midwestern United States and drought in large parts of Europe and in Canada had a negative effect. Ongoing trade disputes also weighed on business,” it said.
Adjusted EBITDA rose by about a quarter to 2.9 billion euros, bolstered by new prescriptions of stroke prevention drug Xarelto and eye treatment Eylea, broadly in line with market expectations.
But the number of lawsuits over Bayer’s glyphosate-based weedkillers, which it acquired as part of the Monsanto takeover, continued to swell.
It said 18,400 plaintiffs were seeking damages over an alleged cancer-causing effect of weedkillers Roundup or RangerPro, up from 13,400 in April.

Bayer has seen its market value slashed by more than 30 billion euros since August last year, when a California jury in the first such lawsuit found that Monsanto should have warned of the alleged cancer risks.
Bayer, which says regulators and extensive research have found glyphosate to be safe, is banking on U.S. appeals courts to reverse or lessen the initial court rulings that have so far awarded tens of millions of dollars to each plaintiff.

Teva hit with pay-for-delay settlement

Four pharmaceutical companies collectively are agreeing to pay California nearly $70M to settle allegations that they delayed generic narcolepsy drug, Provigil, from entering the market for nearly six years to keep prices high.
The bulk of the money will come from Teva Pharmaceutical (NYSE:TEVA) and its affiliates, which are paying $69M, the largest pay-for-delay settlement received by any state.
Teva said the money will come from a pre-existing fund that was created in 2015 as part of the company’s settlement with the FTC over similar claims, and it will not make any additional payments.

Hospitals might be required to publish negotiated prices

Looking to lower healthcare costs, the Trump administration is proposing a rule that would require hospitals that accept Medicare to publish prices that are negotiated with insurers or risk being fined up to $300 a day.
Hospitals and insurers are certain to fight the proposed rule. These companies have already criticized Trump’s executive order requiring hospitals and insurers to disclose negotiated rates for services, saying transparency could actually increase prices.
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