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Saturday, May 12, 2018

Lannett Acquires 23 Approved Drug Product Applications from Endo

On May 7, 2018, the Company announced that it has acquired 23 approved and one pending drug product applications from a subsidiary of Endo International PLC (NASDAQ: ENDP) (“Endo”) for an upfront payment plus future milestone payments. The portfolio primarily consists of oral solutions with a few semi-solid products. Other financial terms were not disclosed.

More recent graduates are living at home than ever before

More graduates are walking across the stage to pick up their diplomas—and then walking right back home to mom and dad’s house.
The share of recent graduates moving back into their parents’ homes jumped to 28% in 2016 from 19% in 2005, and the trend is more pronounced in areas particularly affected by the housing bubble of the late 2000s. Those areas include Las Vegas and Riverside, Calif., according to real estate site Zillow’s Z, -0.76%   recent analysis of U.S. Census data, as well as perennially expensive cities like New York City and Los Angeles.
In Las Vegas, which had one of the biggest housing busts in the country, the percentage of graduates living with their parents rose from 13% in 2005 to 39% in 2016. Near the end of 2004, homes in Las Vegas were rising in value by nearly 50% each year. When the market collapsed, home values plunged by 62%, more than any other major U.S. market. In Riverside, Calif., the share of grads living at home jumped from 27% to 51% over the same period.
Elsewhere, Miami and New York City had the highest share of college graduates living with mom and dad in 2016—with 45% and 42% living with their parents, respectively— followed by Los Angeles and Philadelphia (38%), Chicago (34%). The lowest percentages were in Austin, Texas (13%), Columbus, Ohio and Denver (15%), Seattle (16%) and Kansas City (19%).
Over the same time period, the percentage of young college graduates likely to live with a romantic partner fell to 34% from 44%.
Why are more graduates returning home to mom and dad?
Because getting a home loan for a young buyer has become increasingly difficult. In the early 2000s, lenders had looser standards and home builders were working hard to meet housing demands.
“Underemployment or more precarious jobs make it much harder to save up enough to move out,” Zillow senior economist Aaron Terrazas said. “When rents keep climbing and competition is fierce for the most affordable homes, living with mom and dad can be a good option to build up some savings.”
It’s increasingly difficult to save up a deposit, however. Rents are also on the rise, studies show.
This spring season is perhaps the most competitive home buying season since the Great Recession, because home prices are rising along with interest rates and a record low number of homes are up for sale.

Millennials—the generation just older than recent college graduates—have found home buying to be particularly hard. Between staggering student loan debt and other financial obligations, they are having trouble saving for a down payment, according to the National Association of Realtors and education financing nonprofit American Student Assistance. As a result, they’re delaying purchasing their first homes for a median of seven years.
Young adults often get a lot of flak for moving back home after college, and are called lazy and entitled for this decision. But that’s not always the case. Some millennials use the opportunity, thanks to their parents’ generosity, to find a job, get situated and save money for their futures. As a result, when they do buy homes, they’re skipping the starter home and going for a larger house in the suburbs.
Generation Z—the generation born between the early 1990s and early 2000s—can’t wait to buy homes, even if at the moment they can’t afford them, according to a separate Zillow study, and that means they’re optimistic about home ownership and will save accordingly. Case in point: Nearly 100,000 members of Gen Z, or those 23 and younger, already own a home, with an average mortgage balance of $140,000.

Bayer CFO sees lower Monsanto synergies after divestments

Bayer’s potential synergies from buying U.S. rival Monsanto will be lower than $1.5 billion because of anti-trust divestments, the German company’s Chief Financial Officer told Germany’s Boersen-Zeitung.
The $1.5 billion savings targeted within three years are a “pro forma” synergy goal, which excluded the impact of divestments, Johannes Dietsch told the newspaper.
“The basis for revenue synergies is now lower. We will give an update on the topic of synergies,” Dietsch told the paper.
Last month Bayer said it had agreed to sell crop science businesses to German rival BASF to help win regulatory approval for the takeover of Monsanto.
Dietsch also said Bayer still plans to go ahead with a capital increase, declining to speculate about the size. The capital hike will happen around the time of the closing of the Monsanto deal, and will not come before May 25, he told Boersen-Zeitung.
Bayer will be preoccupied with reducing its debt levels in the immediate aftermath of a successful Monsanto acquisition, Dietsch told the paper.
When asked whether Bayer faces a “patent cliff” in its pharmaceuticals business once licenses for blockbuster drugs Xarelto and Eylea expire, Dietsch said, “The question is how do you strengthen the pharma pipeline. Do you need a large acquisition or are there other opportunities like cooperations, partnerships licensing deals and perhaps smaller acquisitions?”
“Nobody should expect that when two of our successful products become generic, that we can just replace them in the year after. In the medium term Pharma will be a growing business,” the paper quoted him as saying.

Medtronic ‘encouraged’ by transcatheter pacing study results

Medtronic announced new clinical study results demonstrating that an investigational algorithm, utilizing the accelerometer signal in the Micra Transcatheter Pacing System may restore AV synchrony, improving cardiac function in patients with sinus rhythm and atrioventricular block. The results from the MARVEL feasibility study were presented today during a late-breaking session at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions, and simultaneously published in Heart Rhythm. “The results of MARVEL indicate that this novel mechanical sensor may allow more patients to benefit from a miniaturized leadless pacemaker,” said Larry Chinitz, M.D., MARVEL study principal investigator and cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center in New York City. “Although single-chamber pacing in the ventricle is quite safe for these patients, the preferred option is to treat them with a wired pacemaker in two chambers to maintain synchrony and cardiac function. However, patients with these traditional pacemakers are at risk of experiencing complications related to the pocket and the leads, and leadless pacemakers remove these risks.” “We are encouraged by the results of MARVEL, which support our commitment to extending the benefits of Micra TPS to broader patient groups,” said Rob Kowal, M.D., Ph.D., vice president and chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. “We are investing in additional clinical studies to confirm this accelerometer-based leadless pacing approach will benefit patients with AV block who make up approximately 40 percent of the pacemaker population worldwide.”

Boston Scientific comments on Smart Pass success

Boston Scientific announced results from an analysis of the LATITUDE database which evaluated the successful reduction of inappropriate shocks using the SMART Pass sensing filter in patients implanted with the EMBLEM Subcutaneous Implantable Defibrillator System. The real-world data were presented during a late-breaking clinical trial at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions in Boston, and demonstrated that when the sensing filter was in use, the rate of inappropriate shocks was reduced to 4.3% at one year. The analysis was also published online today in the Heart Rhythm Journal. The SMART Pass sensing filter is an advanced algorithm within the EMBLEM S-ICD System that filters out certain signals that are the primary reason for inappropriate shocks, while maintaining the ability to accurately detect ventricular tachycardia or ventricular fibrillation and deliver lifesaving therapy. Study authors evaluated the effect of SMART Pass on shocks in ambulatory patients and found that the filter reduced the risk for the first inappropriate shock by 50% and the risk for all inappropriate shocks by 68%, without a negative impact on delivery of appropriate shocks.

UnitedHealth ‘welcomes’ Administration focus on reducing drug costs

UnitedHealth Group released the following statement on the Trump Administration’s drug policy proposal: “The fundamental issues with prescription drug affordability are the high prices set by and marketing practices of pharmaceutical manufacturers, so we welcome the Administration’s focus on reducing drug costs. UnitedHealth Group remains committed to offering concrete solutions to further protect consumers from rising drug prices and building programs to help make prescription drug costs more affordable, predictable and stable – programs like our industry-first initiative to provide point of sale pharmacy discounts for our commercial customers, and our application of advanced technology to provide drug cost transparency right in the doctor’s office.”

‘Desperate’ rural hospitals team with lab companies

Lab billing company arrangements with hospitals, in which the lab tries to boost its reimbursement by using a hospital’s insurance contracts, can take on several forms, according to Brian Bauer, an attorney with Hall Render in Detroit who has studied lab billing arrangements and advised hospitals considering them. He estimates he’s seen 25 to 30 cases.
At one extreme, a company buys the struggling rural hospital and uses its favorable reimbursement contracts with commercial insurers to get better reimbursement for labs, even labs from patients who didn’t visit that hospital. Other arrangements may involve companies partnering with hospitals to increase their lab revenue.
Rural hospitals receive more for tests than lab companies because of their higher fixed costs and lower volume, Bauer said. In a lawsuit filed in September, Aetna alleged a group of lab companies bilked the insurer and others out of more than $21 million by billing for labs from a rural Oklahoma hospital, even though they were performed at labs across the country, thereby taking advantage of the hospital’s higher reimbursement rate. In one example, Aetna said it paid the hospital $2,250 for a test it would have paid a “large legitimate” lab company $120 to perform.
The arrangements are typically structured so that they’re legally compliant, although they don’t always square with insurers’ provider agreements, Bauer said.
Bauer wasn’t familiar with Rennova Health, a lab company that is getting into the hospital business, but said the potential for creating such a lab arrangement could be a potential motivator for buying the hospital, given the hospital’s financial situation.
Rennova CEO Seamus Lagan , who also currently serves as Rennova’s interim CFO after a former interim CFO resigned in October, remains unfazed. He said he can’t “can’t change the perception of some people,” but that months down the road they’ll be proven wrong. “We’re quite proud of our record of compliance.” He said Rennova does not plan to perform toxicology testing in the hospital, nor does the company plan to use the hospital to bill for toxicology or other types of lab tests for anything outside of care provided to patients in the hospital or by local doctors.
Brock Slabach, senior vice president of the National Rural Health Association, said partnerships between lab companies and hospitals can work out for hospitals, so long as they agree to prudent purchasing fees with the labs and controls over who does the billing. Slabach said he’s also aware of cases where such arrangements ended with insurers canceling their contracts with hospitals. Even then, he doesn’t blame hospital decision-makers.
“When you’re desperate, you’re looking at bankruptcy or you’re looking some kind of dire situation you’re facing financially, and one of these companies comes along and offers something that’s too good to be true, it’s tempting to listen to this presentation and say, ‘Well, one answer is, what do we have to lose? We’re going to close anyway,'” he said.
Slabach said he’s also aware of cases where such arrangements ended with insurers canceling their contracts with hospitals. Even then, he doesn’t blame hospital decision-makers.
“When you’re desperate, you’re looking at bankruptcy or you’re looking some kind of dire situation you’re facing financially, and one of these companies comes along and offers something that’s too good to be true, it’s tempting to listen to this presentation and say, ‘Well, one answer is, what do we have to lose? We’re going to close anyway,'” he said.
Michael Lane, managing director with the healthcare strategic advisory firm Hammond Hanlon Camp in Chicago, said he’s never seen a lab testing company buy a hospital for the purpose of running a hospital.
That said, Lane said big commercial insurers are well aware of the arrangements and are cracking down on them nationwide. Most of the disputes are being settled outside of the courts, through arbitration and mediation, he said.
“You’re seeing less and less of that happening,” Lane said. “I think it’s all unraveling right now, frankly.”