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Monday, May 21, 2018

Healthscope rejects Brookfield, BGH Capital takeover offers

Australian hospital group Healthscope on Tuesday rejected takeover offers worth more than $3 billion from rival suitors Brookfield Asset Management and BGH Capital, saying both offers undervalue the company.

Healthscope also trimmed its earnings guidance and said it has put its Asian pathology business up for sale after receiving approaches from a number of parties.
Canadian investment firm Brookfield Asset Management offered about $3.3 billion for the hospital operator earlier this month, topping a $3.1 billion offer in April from new Australian private equity player BGH Capital.
“The Directors have carefully considered each proposal and concluded that neither proposal adequately reflects the long term value of Healthscope, nor its underlying assets nor future potential,” Healthscope Chairman Paula Dwyer said.
The company said it plans a strategic review of its hospital property portfolio, and would look at the merits of a sale and leaseback transaction to unlock value for shareholders.
Healthscope also downgraded its guidance for core earnings from hospital operations to A$340 million to A$345 million ($258 million-$262 million) for fiscal 2018, compared to core earnings of A$359.4 million in 2017. It had previously indicated core earnings would be broadly similar.
The company said it was targeting core earnings growth of at least 10 percent from its hospital operations in 2019.

Americans Less Confident in Vaccine System

Americans have less confidence in the U.S. vaccine system than they did a decade ago, a survey found.
Overall, 77% of respondents were confident in the current system in the U.S. for evaluating the safety of vaccines and recommendations for when they should be given, down 8 percentage points from 2008, according to a survey of about 1,000 adults commissioned by Research!America and the American Society of Microbiology.
“This is startling — how could anyone think they weren’t benefiting [from vaccine development]?” Research!America president and CEO Mary Woolley said Monday at a briefing sponsored by the two organizations. “Perhaps we’re not getting the word out effectively; perhaps not enough people are taking the time to engage with the community. It’s very important to take this seriously.”
When asked how important they believe it is for parents to have their children vaccinated, 90% of respondents said “very important” or “somewhat important,” compared with 96% in 2008, according to the survey, which was conducted by Zogby Analytics. “We can see that it’s slipping … [The result is] on the edge of being [statistically] significant, but it’s something to watch out for,” said Woolley.
Turning to other vaccines, 53% of respondents reported that they did not get the flu vaccine during the last flu season. “Among those who said no, 48% said they do not trust the flu vaccine, 40% said they do not feel they need it to prevent the flu, and 26% said the flu vaccine is not effective and therefore not worth getting,” Research!America said in a press release.
There was some good news, Woolley noted: 61% of respondents agreed with the statement that parents who don’t vaccinate their children put both their children and their communities at risk, up 10 percentage points from 2008. “That recognition is strong and important and we trust it will continue to move in that direction,” she said.
People should keep in mind that opponents of vaccination are not a homogeneous group, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in Bethesda, Maryland. He offered tips on how to win over skeptics.
“Don’t create an adversarial role; one thing that never wins is saying ‘You’re wrong.’ Don’t have it be that you’re thinking they’re bad people for [not vaccinating]. There is a hard-core group you’ll never convince, but there is also a pretty good group of people that if you just give them information and debunk false information in a collegial way, you’ll win over a substantial portion of them.”
In addition, “there are some people who don’t get vaccinated for a variety of reasons; that’s when you open up a dialogue and discuss with them why it is,” Fauci added. “Very often you can convince them to change their minds.”
And physicians can play in important role in that conversation, according to the survey, which found that 45% of respondents do not think the public receives enough information from their doctors about vaccinations. “The most important thing is saying ‘We work for you,'” said Woolley. “We’re aligned in trying to put an end to deadly diseases … Because we work for you, we want to hear your questions.”
“The real questions can help sort the way forward … Is this about refuting misinformation or really helping people get more comfortable with sources they look to for information?” she said. “[You want] to avoid lecturing or speaking with prepared scripts, and to acknowledge we don’t know everything — that it’s three steps forward, two steps back.”
A lot of the work around vaccine acceptance “is local — it’s really about local conversations,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. For example, the drivers of undervaccination among Somalis in Minnesota — a community that had a measles outbreak — were very different, she said, from the drivers of undervaccination among families going to Disneyland in California, where dozens of people contracted measles in late 2014.
“During the Disney measles outbreak, I was surprised that some parents didn’t realize their kids were going to schools where maybe half the kids were undervaccinated. That kind of information can really energize communities. And data are consistent that people still trust their healthcare provider. A lot of it comes down to the one-on-one [relationship] the parent has with their provider; that’s what driving their decision to get vaccinated.”
The survey also asked about the idea of a universal flu vaccine; only 21% of respondents had heard about the idea. “I think that when the promise and opportunity in science is put to work to achieve this critically important goal … there will be a surge in public support and confidence in scientific enterprise and public health work, and it will be well deserved,” said Woolley.
The survey has a margin of error of ±3.1 percentage points.

Prothena cut, Achillion upped by Barclays

Barclays revised its view of several smaller mid-cap biotech stocks after the first-quarter earnings season, issuing re-ratings Monday for Prothena Corporation PLC PRTA 4.12% and Achillion Pharmaceuticals, Inc. ACHN 1.08%.

The Analyst

Barclays analyst Geoff Meacham downgraded Prothena from Equal Weight to Underweight and cut the price target from $14 to $12.
The analyst upgraded Achillion from Underweight to Equal Weight and maintained a $5 price target

The Thesis

Meacham sees limited near-term value-creating opportunities for Prothena. His reassessment of the company follows the discontinuation of its core development program in AL amyloidosis.
Other programs — namely partnerships with Roche in Parkinson’s disease and Celgene Corporation CELG 4.7% in ATTR Amyloidosis — do present some upside in the longer term, the analyst said. Both are too early in their development for the analyst to ascribe significant value, he said.
Achillion has become better positioned to succeed, according to Meacham; he cited the company’s progress on shifting its focus from Hepatitis C to orphan diseases.
Given the company’s current price, the Factor-D program has not been fully priced in, warranting a higher valuation, Meacham said. Investors will likely wait to see more derisking data that’s expected to be presented later this year, he said.
“We do not have enough conviction to move to Overweight, but see minimal downside risk at current levels.”
Elsewhere in the sector, Barclays reviewed its investment theses on Acceleron Pharma Inc XLRN 1.87% and BioXcel Therapeutics Inc BTAI 4.25%Meacham reiterated Overweight ratings on both and maintained $54 and $15 price targets, respectively.

Could a virus with a sweet tooth become a weapon against cancer?

Historically, bacteria, parasites, and viruses have been considered dangerous because they spread infectious diseases. But scientists have started to try to harness pathogens for beneficial purposes. Researchers have discovered ways bacteria in our gut help us digest food, and are even trying to develop certain bacteria and parasitesas medicines for a range of disorders.
But unlike bacteria and parasites, viruses aren’t actually living cells. They must infect and exploit a living cell to stay alive and reproduce, so it’s hard to imagine how to turn them from foe to friend. But recently, researchers from Umeå University in Sweden identified a virus that is very choosy about what types of cells it invades. As it turns out, it prefers cancer cells.
It’s an adenovirus, which are a common group of viruses composed of a clump of DNA encased in a protein coat. Decorating the coat are fiber proteins that the virus uses to attach to specific molecules on its cellular target. Once attached, the host cell ingests the virus and ruptures its protein coat, expelling the viral DNA inside the cell. The viral DNA then supplants the cell’s previous genetic program, instructing it to manufacture more viruses. Eventually, these cause the bulging infected cell to burst, unleashing freshly-minted adenoviruses that seek out other cells and spread the infection.

Adenoviruses at large

What makes this particular adenovirus, called HAdV-52, special is its two distinct fiber proteins. Most adenoviruses have one type of fiber that recognizes protein receptors found on many cells throughout the body. As a result, they can infect cells relatively indiscriminately. But HAdV-52 also has a second, shorter fiber that doesn’t bind a protein at all. In 2015, the Swedish researchers reported that this second fiber binds to sialic acid, a type of carbohydrate that adorns many cell surface proteins.
Many forms of sialic acid are found throughout our cells, but certain forms are particularly rare. Like other carbohydrates, sialic acid exists in polymer chains of varying length and shape. The shape of these chains is important: Consider starch and cellulose, two common polysaccharides of glucose. Our bodies can easily break down starch into useful glucose units our muscles can use, but cellulose passes through our digestive tracts unaltered. The critical difference between them lies in which linkages are recognized by our proteins.
The researchers wondered if HAdV-52′s short fiber could likewise discriminate between different forms of sialic acid on cell membranes – in their 2018 study, they took the short fiber protein and exposed it to a synthetic array of different forms of sialic acid in order to identify which form it prefers. They found the strongest interaction with a single unique linkage of five or more sugar units called polysialic acid (polySia).
During human brain development, polySia is abundant in neural cells, and after maturation, it’s only found in regions undergoing the formation of new synapses. But it turns out that some lung and brain tumors also express polySia – and its detection is associated with a poor prognosis. To confirm the finding from the array in a cellular context, the researchers exposed the short fiber protein to two different cell lines from a single cancer patient. Both cell lines had sialic acid on their membranes, but only one had polySia. The cells which had polySia bound to the short fiber more than five times more strongly than the cells lacking polySia.

An electrostatic whip

PolySia is like an electrostatic whip that can disrupt nearby membrane proteins, such as those involved with anchoring the cell in place. Cells throw negatively charged polySia on their membranes for a specific reason: to detach from a rigid matrix of cells and migrate somewhere else. This explains polySia’s function in regions of the brain that are rearranging to form new neural architecture, as well as in metastatic cancer cells that are detaching from their primary tissue. Ironically, HAdV-52’s short fiber forms a tight interaction with polySia, a molecule that repulses pretty much everything else.
When the researchers examined how the virus’ short fiber and polySia interacted using a technique called nuclear magnetic resonance, they found the explanation for why HAdV-52 prefers this form of the sugar. Only the last sialic acid unit fits into a binding pocket on the short fiber, while the other units in the chain stick out along a positively-charged surface of the viral protein. Molecular modeling simulations suggest the other sialic acid units form electrostatic interactions with this surface, stabilizing the link.
Virologists appreciate the new atomic-level understanding of HAdV-52’s affinity for polySia, but almost everyone else cares more about its applications: can it be repurposed as a cancer-fighting tool known as an oncolytic virus? A tumor-targeting virus has already been FDA-approved for the treatment of melanoma, but it required genetic manipulation of the virus’s fiber protein to direct it at tumor cells. In contrast, HAdV-52 could potentially be used as is, although further research is needed to prove its safety and efficacy in lab animals before being tested as a human cancer treatment.
Other recent advances in cancer treatment have similarly used technologies that exploit particular features of cancer tissue. For instance, the recently-approved immunotherapy CAR-T is proving to be transformative for patients with aggressive blood cancers. But solid tumors pose larger obstacles for CAR-T, in part because they cloak themselves in sugar molecules that shield them from drugs and immune cells. Therapies based on HAdV-52 could turn those sugars against the cancer – a potential game changer for treating the kinds of cancer with the worst outlooks.
As cancer treatment paradigms evolve from small molecule drugs to more exotic processes, keep an eye out for this kind of cancer-fighting virus.

Cigna CEO David Cordani on Express Scripts transaction, ACA exchanges

Cigna CEO David Cordani doesn’t view his company as merely a health insurer. The Bloomfield, Conn.-based company, he said, is in the business of delivering “health services.” A prime example: collaborating with physicians around some 500 accountable care organizations and patient-centered medical homes. Cigna’s proposed $54 billion acquisition of pharmacy benefit manager Express Scripts falls right in line with that philosophy, he said, arguing that the combined entity will be able to deliver on the promise of better care coordination and lower costs. Federal regulators are reviewing the deal. Cordani spoke with the Modern Healthcare editorial team. The following is an edited transcript.
Modern Healthcare: You point to the Express Scripts acquisition as a way todrive down prices, but we haven’t seen that play out in other large mergers.What makes you think that this deal will have an impact?
David Cordani: First, we have to look at it structurally. Today, 85% of all of our clients or employer relationships in the U.S. are transparent, self-funded relationships. We’re unique in that. The other 15% is broken up into shared returns and traditional guaranteed costs.
Typically, an insurer has a large guaranteed-cost block of business, where if costs go down, the insurer benefits. Our book of business is the exact opposite. So if we just round it and put the shared returns in with the self-funded, 90% of all our clients have full transparency and pass-through. We’re incentivized to deliver the value for them. We’re aligned with them, and we actually operate that way.
Also, in the post-Affordable Care Act environment, with the medical-loss ratio threshold put in place, only 10% of our portfolio is actually guaranteed cost. If the medical costs are below a certain level, they have to structurally be credited back.
Lastly, when we announced the transaction, we made it clear to our investors that the preponderance of all the medical and pharmacy costs savings float to our clients and customers. We didn’t promise it back to our shareholders because we’re guided to be able to provide it back to our customers and clients.
MH: Why even go down this path when it’s expected that change is comingto the pharmacy benefit management world?
Cordani: We think change is present in all aspects of the business, whether it’s PBMs, the medical side, the behavioral side, rebates or value-based contracts. We embrace change.
We’re guided by transparency and alignment, so we don’t seek to preserve the past. When we start with those basic tenets—change and transparency—alignment needs to transpire.
Today, with Express Scripts, about half of their clients have full pass- through rebate models. The other half don’t. The client chooses that. So there are different ways a client can finance their purchase. There’s choice.
We own and operate our own captive PBM as well. We only sell it on integrative basis. We give choice back to clients. In most cases, the employer chooses to have a large portion of the rebates fall back to them, and they use that large portion of the rebates to lower the overall premium and/or deductibles and/or co-pay levels. That’s how the mechanism works today.
There’s plenty that are full pass-through rebates. There are other ways that employers pay for their services. Express Scripts has the same part of the equation. We believe that this too will change. We’re excited to be a force for change around that.
We’re excited to drive even further alignment, both with the client, but, importantly, back with the pharmaceutical manufacturer because we’ve been very public that we see this as an opportunity to dramatically accelerate the number of and breadth of value-based contracts with the pharmaceutical manufacturers that offer rewards based on clinical outcomes, not just consumption of the medication.
MH: After your earnings calls, there’s been some question about debtrestructuring and whether that means Cigna is positioning itself for moreM&A activity. Is that a focus?
Cordani: The Express Scripts deal is a bit unique in that it is such a large transaction. Oftentimes, when one of this size happens, a company has to largely focus on nothing but the financing of it for a pretty prolonged period of time after closure.
The lowered capital intensity of our business allows us to pay down the debt levels back to within our strategic leverage ratio within 18 to 24 months. That’s really quick.
During that time frame, we still leave capital available to fund our innovation portfolio because change needs to continue to be driven.
We weren’t signaling that we were going to transact again. We were actually signaling what we think is a really important strategic advantage: Significant financial and strategic flexibility in what is indisputably a rapidly changing environment, as opposed to being involved in a transaction where you’re, I’ll call it, a little more cash-strapped, strategically strapped and structurally strapped in a changing environment.
MH: You’ve said that Cigna is moving beyond the traditional realm of aninsurer into a more holistic company. If you’re already starting down thispath, why would you need to consolidate further?
Cordani: The good news is we didn’t have to. We had choices. And we think that in a well-run company, you position yourself to have options.
We came forth with a pretty bold statement. We target to deliver a medical cost trend at a Consumer Price Index-level by 2021. We don’t think the status quo is acceptable.
Pharmaceutical costs have rapidly grown to between 20% and 25% of the overall cost equation. Not that long ago it was 10%. Two-thirds of that is specialty pharma. Half of the specialty pharma is not managed in the PBM relationship. It’s embedded in the medical part of the equation.
Having the relationships that we have through 500 (accountable care) collaboratives—and the specialty pharmacy that Express Scripts has—will lead to better integration and coordination for the patient, whether it’s at home, at the physician’s office, in an infusion suite, or in a facility.

Supreme Court rules in favor of Epic in arbitration case

The Supreme Court ruled Monday that companies can prohibit workers from using class-action litigation to resolve workplace disputes, handing Epic Systems Corp. and other employers a win.
In a 5-4 decision on three consolidated cases, the justices said companies can include clauses in employment contracts that require employees to use individual arbitration to resolve disputes. That decision could affect about 25 million employees.
In one of the consolidated cases, Jacob Lewis wanted to sue Epic, his former employer, on behalf of a group of employees who said the electronic health record vendor denied them overtime pay. Epic contended that its contracts prohibited employees from such group litigation and required them to individually undergo arbitration.
This kind of requirement tends to decrease the number of claims brought against companies, according to Alexander Colvin, a Cornell University professor writing for the Economic Policy Institute.
The Supreme Court ultimately agreed with Epic, saying that companies can require employees to resolve disputes individually outside of court, even if the situation affects many people.
“The virtues Congress originally saw in arbitration, its speed and simplicity and inexpensiveness, would be shorn away and arbitration would wind up looking like the litigation it was meant to displace” if workers gathered their complaints under class action lawsuits, Justice Neil Gorsuch wrote for the court.
But bringing individual claims could be cost-prohibitive for employees.
“This is a major victory for employers,” said Richard Glovsky, co-chair of Locke Lord’s labor and employment practice group. “The court’s ruling clears the path, and a judicial logjam, to employers restricting the rights of employees to participate in class actions and who insist that they have their day in court.”
Some employee advocates worried that the decision could stymie workers’ challenges against sexual harassment in the workplace—a concern that’s been in the foreground as a result of the #MeToo movement.
“Forced arbitration means women have to pursue their claims alone,” said Christine Owens, executive director of the National Employment Law Project, in a statement.
Justice Ruth Bader Ginsburg called the majority opinion “egregiously wrong” and said the decision would lead to “huge under-enforcement of federal and state statutes designed to advance the well-being of vulnerable workers.”
Epic founder and CEO Judy Faulkner was satisfied with the outcome. “When it comes to grievances regarding wages and hours, we believe individual arbitration agreements strike that reasonable balance and are pleased with the court’s decision in support of this,” she said in a statement.
Although one of the Supreme Court cases involved Epic, the decision doesn’t single out healthcare companies and won’t have a unique impact on the industry.

Celgene adds $65M discovery alliance with Evotec to spur new cancer drugs

Celgene has added a $65 million upfront portion of oncology discovery work with Evotec, 18 months after the two companies allied on neurodegeneration work.
As is typically the case with Celgene $CELG and Evotec, there aren’t an awful lot of details to work with. There’s no mention about milestones in the two-paragraph release, other than a reference to “significant” biobucks. Given the size of the upfront, though, those back-ended milestones are likely to run into the hundreds of millions of dollars.

Cancer R&D is the biggest leg of the R&D table at Celgene, which has been looking to expand beyond Revlimid with new therapies in the oncology field. Beyond its marketed cancer drugs, which includes Pomalyst and Thalomid, Celgene has the BCMA CAR-T bb2121 in the pivotal part of the pipeline, racing with the competition to stay in the lead on that score.
There’s also a major emphasis on inflammation and immunology as researchers scramble to get ozanimod back in front of regulators.
Celgene has been spending big bucks on its pipeline for years. But new CEO Mark Alles is expected to get some new revenue rolling in, so it won’t be dependent on big annual price hikes on Revlimid, which has attracted some unfavorable attention from the Trump administration.
Evotec, of course, won’t be offering any immediate help on that score. But it has another big notch to add to a belt crowded with discovery alliances like these.