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Wednesday, August 8, 2018

Mallinckrodt Cut By Raymond James On Lack Of ‘Rational Valuation Framework’


Raymond James downgraded Mallinckrodt Public Limited Company MNK 0.42% on valuation after the drugmaker’s second-quarter report.

The Analyst

Raymond James analyst Elliot Wilbur downgraded Mallinckrodt from Outperform to Market Perform.

The Thesis

The Q2 print demonstrates Mallinckrodt’s resilience, as sales of HP Acthar were in line with projections, Wilbur said in a Wednesday note. (See his track record here.)
Sales of the drug increased 20 percent sequentially and an imminent decline seems unlikely, the analyst said.
“We are increasing our 2018 and 2019 adjusted EPS projections to $6.54 and $7.52, from $6.04 and $7.10, respectively, to account for [Q2] over performance, increased full-year 2018 guide and modest increases to 2019 top line expectations,” Wilbur said.
Raymond James is incorporating initial pipeline expectations in its post-2020 assumptions for the pharmaceutical company.
Wednesday’s downgrade is driven by the absence of a “rational valuation framework” to support significant upside to the stock, the analyst said.
“While pipeline optionality remains high with [the] valuation heavily discounting [the] potential to meaningfully buffer declining base product trends, even with [a] probability-adjusted contribution incorporated in post-2021 numbers, we expect EBITDA levels to drop meaningfully post-2020.”

Mizuho Upgrades Audentes On Promising Gene Therapy Candidate


Despite a second-quarter earnings loss, Audentes Therapeutics, Inc. BOLD 5.93%’s existing catalysts are reason enough for a bullish stance, according to Mizuho.

The Analyst

Mihuzo analyst Difei Yang upgraded Audentes Therapeutics from Neutral to Buy and raised the price target from $38 to $45.

The Thesis

Audentes Therapeutics is developing the AT-132 program, a gene therapy designed for the treatment of X-Linked myotubular myopathy.
Patients treated in the trial so far are continuing to show significant improvements, Yang said in the Wednesday upgrade note. (See the analyst’s track record here.)
“All patients treated with AT-132 so far in the ASPIRO trial have shown increases in neuromuscular and respiratory function. Notably, a second patient has achieved ventilator independence subsequent to the 24-week assessment,” the analyst said.
Muscle biopsy data from three trial participants showed robust myotubularin protein expression at week 24 compared to the baseline, according to Mizuho. “The histology of the cells improved drastically post-treatment on all patients,” Yang said.
Dose escalation is planned for the second group of patients receiving treatment in October, the analyst said, adding that the data will be “more than adequate” for approval if replicated in a Phase III study.
“We believe yesterday’s data reflects major progress and shows improvements across all patients dosed so far. We increased our pricing assumption for AT-132 to $1.6 million vs. $1 million previously, which we believe was too conservative when compared to other rare disease treatments in similar diseases settings such as spinal muscular atrophy.”

Terminally ill children, ages 9 and 11, euthanized in Belgium


Two kids with terminal illnesses were the youngest ever people to be euthanized after Belgium authorities allowed them to decide whether to live or die.
The children, ages 9 and 11, were given lethal injections in the European country which permits children with terminal illnesses who are in “unbearable suffering” to choose to die.
The cases, which happened in 2016 and 2017, were revealed in a report by the CFCEE – the commission that regulates euthanasia in Belgium – and their ages were confirmed by a Belgian official.
It said that doctors in Belgium had given lethal injections to three children over the two-year period, including a 17-year-old who was suffering from muscular dystrophy.
The 9-year-old suffered from a brain tumor, while the 11-year-old had cystic fibrosis.
A member of the CFCEE told The Washington Post they were the first children under the age of 12 to be euthanized anywhere.
Belgium changed its euthanasia law in 2014, giving doctors the legal right to terminate the life of a child, no matter how young the patient was.
But the child must be judged to have the mental capacity to make the decision and must also have parental consent.
The initial report, published on July 17, only indicated three minors were euthanized between Jan. 1, 2016 and Dec.r 31, 2017, but only said they were under 18.
However, an official confirmed their ages to the Washington Post.
Luc Proot, a member of the CFCEE, defended the decision to allow the euthanasia cases, saying: “I saw mental and physical suffering so overwhelming that I thought we did a good thing.”
Stefaan Van Gool, a professor and child cancer specialist in Belgium, said: “There is, in fact, no objective tool today available that really can help you say ‘this child has the full competence or capacity to give with full understanding informed consent.’”
Wim Distelmans, head of the Belgian euthanasia commission countered: “Thankfully, there are very few children who fit the criteria, but that doesn’t mean that we should refuse (them) the right to die with dignity.”

LabCorp Licensing MDNA Liquid Biopsy-Based Prostate Cancer Technology


MDNA Life Sciences announced today an exclusive licensing agreement with Laboratory Corporation of America for a liquid biopsy-based noninvasive test for patients who may have prostate cancer.
Under the terms of the deal, which covers the US, LabCorp will be able to use MDNA’s technology to develop and commercialize a test for patients with an elevated PSA to determine their risk of having clinically significant prostate cancer.
Financial and other terms of the agreement were not disclosed.
Based in West Palm Beach, Florida, MDNA is a molecular diagnostics company using liquid biopsy technology based on the mitochondrial genome. In late 2016 it launched its first noninvasive blood-based cancer test for prostate cancer test, signaling its move into the liquid biopsy space.
“We believe that the future commercialization of this unique biomarker will have a significant impact on how prostate biopsy decisions are made going forward, and we are very excited to be working with LabCorp to increase patient access to this technology in the U.S. market,” MDNA CEO Chris Mitton said in a statement.

FDA Breakthrough Device Tag for PapGene Blood-Based Cancer Test


Startup PapGene announced today that it has received Breakthrough Device designation from the US Food and Drug Administration for its blood-based cancer diagnostic assay.
The FDA granted the status based on the assay’s ability to detect both ovarian and pancreatic cancer. PapGene’s assay uses a combination of circulating tumor DNA and protein biomarkers to detect cancers in average-risk, asymptomatic individuals over the age of 65.
The FDA instituted the Breakthrough Devices Program in 2016 as part of its “Expedited Access Pathway” (EAP) program. The process helps patients have more timely access to devices and technology that provide more effective treatment or diagnosis for life-threatening diseases that do not otherwise exist. The Breakthrough Devices Program expands on the EAP program by making future 510(k) approvals eligible as well as Premarket Approval applications and de novo device submissions.
The firm’s assay is based on a similar test —called CancerSeek— developed by researchers at Johns Hopkins University. A study published in Science in January focused on the assay’s ability to detect localized cancers —including areas such as the ovaries, liver, stomach, pancreas, esophagus, colorectum, lungs, and breast— early, before metastasis has occurred and five-year survival rates drop.
“This is the first step toward our vision of making pan-cancer detection a reality for patients and dramatically improving cancer survival rates,” PapGene CEO Howard Kaufman said in a statement.
Formed in 2014 to commercialize cancer detection technology by its founders at JHU, PapGene is developing a clinical version of the assay that is durable, cost-effective, and reproducible for detecting cancer earlier than standard methods, the firm said.
“PapGene has developed substantial expertise in liquid biopsy and cancer detection through their work running thousands of cancer research samples in their CLIA lab,” Nickolas Papadopoulos, director of the Ludwig Center for Cancer Genetics and Therapeutics at JHU, said in a statement.

Italy Senate overturns mandatory vaccination law


Italy’s upper house of parliament has voted through legislation from the ruling anti-establishment government to remove the legal obligation to vaccinate schoolchildren.
A law compelling children to have 10 vaccinations in order to enrol at state schools came into effect in March, after a surge in the number of measles cases.
But the Five Star Movement and the League, which formed a ruling coalition two months ago, pledged to scrap the vaccination obligation during the run-up to elections in March, courting the so-called “anti-vax” vote.
The new legislation puts Italy out of step with other European countries such as France and Germany, which have been bolstering vaccine regulation. Critics say the government is eroding faith in science and nine Italian regional administrations that oppose the repeal have said they intend to appeal to the constitutional court or bring in their own laws to reinstate compulsory vaccines.
Last year Italy had 5,000 cases of measles, up from 870 in 2016. It had 29 per cent of all cases in the EU or European Economic Area in the year to June 2018.
Five Star has longstanding links to anti-vaccination campaigners. Giulia Grillo, the party’s health minister, says she supports vaccination but says current rules are too restrictive. Matteo Salvini, leader of the League, has said that having ten compulsory vaccines is “useless and sometimes dangerous”.
The amendment, passed by 148 to 110 votes, will not become law in time for the new school year as it still needs to pass the lower house after the parliamentary recess. If passed then it will postpone the obligation for parents to vaccinate children until the start of the next school year in 2019, but before then the coalition government intends to bring forward new legislation enshrining freedom of choice.
Vaccines are not a bureaucratic imposition but the best method of prevention Antonio Saitta Filippo Anelli, president of the federation of surgeons and orthodontists, said parliament “should respect science” while Antonio Saitta, health director for the Piedmont region and health co-ordinator for the federation of regions, said the vote risked taking “a step backwards” on a major public health issue.
“Vaccines are not a bureaucratic imposition but the best method of prevention. They allow us to reduce serious and lethal diseases, and even eliminate them,” he said.
While the legislation is pending, parents will no longer have to provide schools with a doctor’s note to show their children have been vaccinated.
The move has raised alarm among health experts who fear that compliance with vaccines will drop. Davide Faraone, of the Democractic party, said the measures left Italy as “a kind of Wild West in which the health of children will be left completely to the family”.

Some states seek limits on association health plans


Some state insurance regulators have expressed confusion and worry over the Trump administration’s new rule expanding association health plans, with some issuing emergency rules and guidances limiting the operation of such plans.
They also are upset that the U.S. Labor Department abruptly discontinued its weekly conference calls with them to discuss how to harmonize the federal AHP rule with state laws after 12 Democratic attorneys general sued the federal government on July 26 to block the rule.
At the National Association of Insurance Commissioners conference in Boston last weekend, a Labor Department representative declined to answer specific questions about states’ regulatory authority over AHPs, saying his legal counsel was not present, according to Washington state Insurance Commissioner Mike Kreidler.
On Aug. 2, Pennsylvania Insurance Commissioner Jessica Altman sent a letter to Labor Department Secretary Alex Acosta and HHS Secretary Alex Azar stating that, contrary to the federal rule finalized in June, associations cannot form for the primary purpose of selling health insurance. That favors well-established business associations and is considered an important protection against fraudulent or inexperienced plan sponsors.
The letter, citing existing Pennsylvania law, also stated that association plans must comply with state laws and Affordable Care Act provisions governing individual and small group plans. It also said self-employed individuals must receive all ACA benefits and protections if they join association plans. Both those provisions conflict with key parts of the federal rule, which is intended to make cheaper, leaner, non-ACA compliant coverage available to small employers and self-employed people, similar to coverage available to large employers.
Altman and other state regulators warn that expanding access to association health plans poses a greater threat to the stability of their markets than expanding the availability of short-term plans, another recent Trump administration move. That’s because they believe AHPs have the potential to draw far more people out of the Affordable Care Act-regulated market. They also point to the danger of fraud and insolvencies tied to lightly regulated association plans.
Some states have taken action or are considering action to limit or bar short-term plans.
To guard against the risks of association plans, state regulators say AHP sponsors and carriers will have to comply with state and federal requirements on essential benefits, protections for people with pre-existing conditions, out-of-pocket limits, medical loss ratios and other rules. Such requirements would make it difficult or impossible for AHPs to offer premiums lower than ACA plans. Many of the states taking this position are plaintiffs in the lawsuit seeking to block the AHP rule.
But business groups seeking to launch AHPs are threatening to legally challenge state moves to restrict AHPs.
On Aug. 1, Michael Pieciak, commissioner of the Vermont Department of Financial Regulation, issued an emergency rule stating that the federal rule does not pre-empt his state’s ability to regulate its insurance market and protect consumers against poorly run or fraudulent association plans. The rule said association plans must offer the ACA’s essential health benefits and other consumer protections and cannot discriminate against any applicants based on pre-existing medical conditions.
Insurance regulators in California, Massachusetts and New York have also issued bulletins announcing that AHPs will have to comply with existing state and ACA rules.
In the AHP final rule, which President Donald Trump last fall ordered agencies to draft, the Labor Department said that state authority to regulate AHPs is not modified or limited by the rule. It takes effect this year for new fully insured AHPs and in 2019 for new self-insured association plans.
But given the looming sales of AHPs, state regulators want to know as soon as possible what restrictions they can place on the plans. They fear the Trump administration may argue that state regulation is pre-empted by the federal Employee Retirement Income Security Act, which governs self-insured employer health plans.
“I wrote the letter because the new rule has created more questions than answers and there’s not currently a venue for regulators to get answers from the Labor Department,” Pennsylvania’s Altman said in an interview. “I said this is what we’re going to do, tell me if we’re off-base. Depending on what they say, we’ll decide whether to go forward.”
Vermont’s Pieciak said he issued the emergency rule because he wants to protect the stability of his state’s individual and small-group markets. Blue Cross and Blue Shield of Vermont asked for an additional 2.9% premium increase due to the likelihood that association plans will siphon healthier individuals and groups out of the ACA-regulated market.
“We’re saying AHPs have to compete on the same level playing field as ACA plans,” Pieciak said. “There’s the possibility for AHPs to disrupt our ACA market, and we want to mitigate that.”
California will not allow any new association plans to form, though the five existing multiple-employer welfare arrangements can sell plans to new employers in the same line of business, according to Janice Rocco, deputy commissioner of the California Department of Insurance.
The Massachusetts Division of Insurance likely will require any association plans to offer all essential benefits required under state law, which are similar to ACA essential benefits. Consumers buying plans without essential benefits would be subject to a tax penalty under the state’s requirement that everyone have insurance.
A Labor Department spokeswoman said her agency “has an open line of communication with stakeholders, including state officials, regarding implementation of the rule next month.” She said that includes several conference calls with state officials and that those calls would resume with one this week.
But Christopher Condeluci, a Republican healthcare lobbyist who is working with business groups to launch AHPs, said his clients will lobby state insurance departments and state lawmakers in Pennsylvania and elsewhere to allow association plans to move forward. Those business groups include the National Restaurant Association and the National Association of Realtors.
If state regulators stand by rules making it difficult or impossible for AHPs to operate, he warned that his clients will sue, alleging the such rules violate ERISA. Such lawsuits likely would come after resolution of the federal lawsuit filed in Washington by Democratic attorneys general.
“The position those states are taking is ripe for an ERISA pre-emption challenge by private parties,” Condeluci said.
The states that so far have issued new rules or policy statements limiting AHPs are Democratic-led states. But insurance regulators in both red and blue states are nervous about an expansion of AHPs given the long history of fraud and insolvencies involving these types of plans.
Mississippi Insurance Commissioner Mike Chaney, a Republican, said he’s seeking clarification from the Labor Department about the rules governing AHPs, and that he’ll require such plans to receive state licensing.
The Trump administration, however, wants associations to be able to readily sell health plans across state lines to small employers that are in the same general line of business. That prospect particularly alarms state regulators.
The U.S. Government Accountability Office identified 144 “unauthorized or bogus” plans from 2000 to 2002, covering at least 15,000 employers and more than 200,000 policyholders, leaving $252 million in unpaid medical claims. Some were run as pyramid schemes, while others charged too little for premiums and became insolvent.