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Wednesday, October 16, 2019

Abbott down 2% premarket after trimming EPS range

Abbott Laboratories (ABT) Q3 results: Revenues: $8,076M (+5.5%); Nutrition: $1,874M (+2.0%); Diagnostics: $1,909M (+4.7%); Established Pharmaceuticals: $1,212M (+4.4%); Medical Devices: $3,065M (+8.9%).
Net Income: $960M (+73.9%); EPS: $0.53 (+71.0%); Non-GAAP Net Income: $1,514M (+12.8%); Non-GAAP EPS: $0.84 (+12.0%).
2019 Guidance: GAAP EPS: $2.06 – 2.08 from $2.06 – 2.12; Non-GAAP EPS: $3.23 – 3.25 from $3.21 – 3.27.
Q4 Guidance: GAAP EPS: $0.59 – 0.61; Non-GAAP EPS: $0.94 – 0.96.
Shares are down 2% premarket.
https://seekingalpha.com/news/3506062-abbott-2-percent-premarket-trimming-eps-range

Lilly’s pegilodecakin flunks late-stage study

Eli Lilly (NYSE:LLY) slips 2% premarket on light volume in reaction to unsuccessful results from a Phase 3 clinical trial, SEQUOIA, evaluating pepilodecakin plus the chemo regimen FOLFOX compared to FOLFOX alone in metastatic pancreatic cancer patients who progressed during or following first-line treatment with a gemcitabine-containing regimen.
The study failed to achieve the primary endpoint of overall survival.
On the safety front, the most common serious/life-threatening treatment-emergent adverse events were neutropenia, thrombocytopenia, fatigue and anemia.
Detailed results will be submitted for presentation at a future medical conference.
Lilly acquired the rights to pegilodecakin, a long-acting (PEGylated) form of IL-10, via its acquisition of ARMO BioSciences in June 2018.
https://seekingalpha.com/news/3506048-lillys-pegilodecakin-flunks-late-stage-study-shares-2-percent-premarket

Achillion up 81% on $930M bid from Alexion

Alexion Pharmaceuticals (NASDAQ:ALXN) has agreed to acquire Achillion Pharmaceuticals (NASDAQ:ACHN) for $6.30 per share in cash for a total of ~$930M, including Achillion’s cash on hand of ~$230M.
The deal includes non-tradeable contingent value rights (CVRs) that will pay Achillion shareholders $1.00 per share if danicopan is approved in the U.S. and $1.00 per share upon the start of Phase 3 development of complement factor D inhibitor ACH-5228.
The transaction should close in H1 2020.
ACHN, which closed at $3.65 yesterday, is up 81% premarket on modest volume.
https://seekingalpha.com/news/3506037-achillion-81-percent-930m-bid-alexion

Abbott Laboratories EPS and revenue in-line

Abbott Laboratories (NYSE:ABT): Q3 Non-GAAP EPS of $0.84 in-line; GAAP EPS of $0.53 misses by $0.03.
Revenue of $8.1B (+5.7% Y/Y) in-line.
Shares +0.37% PM.
https://seekingalpha.com/news/3506054-abbott-laboratories-eps-revenue-line

Opioid associated players up on improved settlement prospects

The spike in buying in drug distributors yesterday after the close in reaction to the news that they are closing in on a broad settlement with states and local governments over their role in the opioid epidemic has other companies with potential legal exposure in the green premarket.
Teva Pharmaceutical Industries (NYSE:TEVA) (+5%), Endo International (NASDAQ:ENDP) (+3%), Mallinckrodt (NYSE:MNK) (+8%), Johnson & Johnson (NYSE:JNJ) (+1%)
https://seekingalpha.com/news/3506044-opioid-associated-players-improved-settlement-prospects

Tuesday, October 15, 2019

Spoiler Alert: Medicare for All Isn’t Going to Happen

I am going to make a prediction here. No matter whom we elect in 2020, Bernie or Trump or anything in between, Medicare for All is not going to happen in America. One can run an electrifying campaign on the promise of Medicare for All, or be indignantly against it, but this is pure theater on both sides. I don’t know if God can make a rock so big and heavy that even He can’t lift it, but I do know that the government can make corporations so big and powerful that even the government itself can’t break them.
For decades, our government encouraged the healthcare industry to consolidate vertically, horizontally, and obliquely so it can achieve “economies of scale” and, therefore, lower consumer prices. In the last couple of decades, the government also compelled the industry to computerize its operations, because technology makes everything better and cheaper. Once the resulting monopolistic behemoths were summoned into existence, it was time to nationalize the whole lot, into one super monopoly, with super technology and super economies of scale. The only other example of such government monopoly in America is the military.
Obviously, our standing armies must be, by definition, a national monopoly, but note that the Navy is not building its own ships, and the Air Force is not building its own planes, and the Army is not manufacturing tanks. The government is contracting with private suppliers for pretty much everything, from butter to bullets. The military-industrial complex is a network of very large and utterly corrupt contractors for the government, yielding more power over foreign and fiscal policy than Congress, the president, and all citizens put together, while delivering practically nothing either on budget or on time. A powerful military is essential to America’s safety and global success, so we grind our teeth and keep paying. And medical care for hundreds of millions of people is at least as important.
I am not entirely sure how people think Medicare for All is going to work. Are you folks envisioning an angry President Bernie dragging Samuel Hazen into the Oval, wagging his finger at him, and making an offer Mr. Hazen cannot refuse? Something like, “I will pay $50 per head and not a penny more, because healthcare is a human right, and if you want to be a disgusting millionaire or billionaire, go write a bestselling book, like I did …”, at which point Mr. Hazen will be hanging his head down in shame and gratefully take the $50 deal. Upon his return to Nashville, Mr. Hazen will immediately schedule book writing workshops for all HCA department chiefs to compensate for cutting all salaries in half. Yeah … no, that’s not how this works.
Go ask Northrop Grumman or Lockheed Martin or General Dynamics or even Boeing or Booz Allen or any other “beltway bandit” how getting money from the Feds really works. There are well-greased revolving doors between the Pentagon and its contractors. There are stock options and executive positions for high-ranking federal employees. There are 535 people in Congress responsible for allocating budgets, and all 535 are for sale.
Most of this infrastructure is already in place for healthcare too, and building the HHS Heptagon shouldn’t take very long. The American president has little to no power over federal spending, and even less so when it comes to large procurement contracts, as the current occupant of the White House discovered the hard way, during the Lockheed F-35 kerfuffle.
Clearly, large health systems will survive and thrive under a Medicare for All law, but how about private health insurance? Future President Bernie says they will all be banned. Is that so? Currently, a full third of Medicare beneficiaries are insured and “managed” by a handful of large private health insurers. Medicare is paying those private contractors fixed amounts of money per head for their services. Medicaid is doing the same for most of its beneficiaries, and all military health insurance (TRICARE) is contracted out to the usual suspects.
Basically, the vast majority of people covered by public insurance are really insured by gigantic insurance corporations. Fact: Under the hood, taxpayer-funded healthcare is the bread and butter of private health insurance companies.
When future President Bernie and the hordes of uninformed supporting characters in the 2020 elections festival say that private health insurance will be banned, they are lying to you. What will be banned under a Medicare for All law is your ability or your employer’s ability to purchase health insurance directly from a private company. Instead, the government will procure contracts in bulk as it sees fit, assign people to them as it sees fit, and pay for these contracts with tax revenue as it sees fit. Just like they pay for battleships, fighter planes, bombs, tanks, and such. The U.S. military is known for lots of great things. Value-based purchasing, and cost-effectiveness in general, are not among those things.
Depending on whom you ask and what is included in the definition of healthcare, Medicare for All is projected to cost between three trillion and four trillion dollars per year, which is five times the amount we spend on the military. This number is calculated based on costs under current law, minus the waste generated by the cacophony of hundreds and thousands of different insurance plans, different healthcare facilities, and their too-many-to-count service and product vendors.
The projections do not include the effects of the inevitable massive consolidation of everything healthcare into a dozen or so federal contractors, able and willing to demand multi-billion dollar contracts for services worth a few million dollars at most on the open market. Remember the Obamacare marketplace website? Multiply that by orders of magnitude, and you have Medicare for All.
Medicare for All is as egregious a misnomer for this plan as the Affordable Care Act was. When they say Medicare for All, they mean federal government procured health insurance for all. When they say everything soup to nuts will be covered, they mean everything the heavily indebted federal government thinks should be covered, and can afford to cover, will be covered. When they say healthcare will be better, more plentiful, and much more affordable, they mean please vote for me in 2020.
Medicare for All will be built on the largely immovable foundation our government chartered and nurtured for half a century. If you want a glimpse into a Medicare for All future, go look at any Medicaid Managed Care plan in any impoverished southern state, and look at the balance sheets of the associated contractors and sub-contractors.
It doesn’t have to be this way. We don’t need to bulldoze over everything we have, and we certainly don’t need to pretend that we can, or that we must. And we need to remember that the proper role of government in a free country is not to manage the health or the care of all its citizens. Free people are not the wards of a State responsible for keeping them healthy, productive, and happy. The role of a democratic government is to keep predators, foreign and domestic, including corporate ones, at bay, while providing a sturdy safety net for the few who cannot care for themselves.
Let’s do that instead. It will be better, faster, and cheaper than the fictional construct called Medicare for All.
Margalit Gur-Arie, MSc, is founder of BizMed. She blogs at On Health Care Tech & Policy. This post originally appeared on KevinMD.
https://www.medpagetoday.com/blogs/kevinmd/82756

Shionogi New Antibiotic for Urinary Infections Set for FDA Advisory Review

Cefiderocol, a new antibiotic, appeared effective and generally safe for treatment of complicated urinary tract infections (cUTI) including pyelonephritis in patients with limited treatment options, FDA staff indicated in briefing documents ahead of an advisory committee meeting scheduled for Wednesday.
However, questions remained about its use in critically ill patients with carbapenem-resistant infections, which the FDA’s Antimicrobial Drugs Advisory Committee will be addressing. In addition to the usual safety and efficacy questions, FDA staff has asked the committee to assess “the finding of increased mortality” in one of the studies “in the overall risk benefit considerations for cefiderocol.”
Cefiderocol is a siderophore cephalosporin, described as having activity against several Gram-negative bacteria, with a proposed dose of 2 g intravenously every 8 hours, with dose adjustments for altered renal function. In 2015, the drug was granted both fast track and Qualified Infectious Disease Product designation for cUTI, hospital-acquired bacterial pneumonia (HAP), ventilator-associated bacterial pneumonia (VAP), and bacteremia, or bloodstream infections, agency staff said.
Drug maker Shionogi submitted data from three trials — the non-inferiority trial comparing cefiderocol with imipenem-cilastatin (IMP) for treatment of cUTI, with a non-inferiority margin no larger than 15%. APEKS-NP, a phase III trial comparing cefiderocol to meropenem in patients with HAP or VAP. Data from this trial was presented at the 2019 IDWeek meeting, which found mortality rates with cefiderocol to be non-inferior to meropenem in patients with nosocomial pneumonia. FDA staff noted that this trial was completed while the product was under review, and only top-line results were included.
The manufacturer also presented data from the CREDIBLE-CR trial, comparing cefiderocol to the best available therapy for infections caused by carbapenem resistant organisms “at various anatomical sites.” Results from trial datasets were submitted, agency staff said, but not the final clinical study report.
FDA staff seemed mostly satisfied with results of the non-inferiority trial, which met its non-inferiority endpoint of 15% for clinical and microbiologic success rates at test of cure visit (72.6% for cefiderocol vs 54.6% for IMP). However, they noted that “clinical response rates were similar between the treatment groups and the difference in overall response was driven primarily by the microbiologic success component of the composite endpoint.”
The most common adverse events (AEs) included diarrhea, hypertension, constipation, rash, and infusion site reactions. Agency staff also noted cephalosporin-class AEs, including hypersensitivity reactions, Clostridioides difficile colitis, seizure, and hepatobiliary adverse events. They also said there was one death in the cefiderocol arm unrelated to the study drug.
But FDA staff seemed concerned with the increased mortality in the CREDIBLE-CR study, where patients with either HAP or VAP, cUTI, and body substance isolation/sepsis due to carbapenem-resistant organisms were randomized to cefiderocol or the best available therapy (about two-thirds of which were colistin-based regimens). Not only was all-cause mortality higher in the cefiderocol group at day 14 (18.8% vs 12.2%, respectively), but also at day 28 (24.8% vs 18.4%), with the greatest mortality difference disfavoring cefiderocol in the HAP or VAP groups.
“An independent adjudication committee determined that a greater percentage of patients in the cefiderocol group than in the [best available therapy] group had infection-related death with treatment failure (15.8% vs. 8.2%), but also noted an imbalance in death due to underlying co-morbidities (9.9% vs. 4.1%),” agency staff wrote.
In addition, treatment-emergent AEs leading to death in the cefiderocol group were generally infection-related, FDA staff noted, such as septic shock, pneumonia, sepsis, and bacteremia.
They speculated on the reasons for the difference in mortality rates, noting that deaths were more common in patients with infections by organisms such as Acinetobacter baumannii, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa.
Whether this difference in mortality is a chance finding or truly reflects a deficit in the activity of cefiderocol in critically ill patients is unclear,” FDA staff wrote.
https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/82754