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Monday, July 1, 2019

Regeneron Libtayo OKed for Cutaneous Squamous Cell Carcinoma in EU

Libtayo is the only treatment approved in the EU for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation
CSCC is one of the most common skin cancers worldwide and is especially difficult to treat in advanced stages
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has granted conditional marketing authorization for Libtayo® (cemiplimab) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved in advanced CSCC in the European Union (EU).
“With no other medical treatments approved for advanced CSCC in the EU, Libtayo represents an important new option for patients affected with this advanced skin cancer who cannot be cured by surgery or radiation,” said Axel Hauschild, M.D., Ph.D., an investigator in the pivotal CSCC clinical program and Professor and Head of the Interdisciplinary Skin Cancer Center at the University Hospital Schleswig-Holstein in Kiel, Germany. “Results from the Libtayo pivotal trial are very encouraging and demonstrated substantial and durable responses following Libtayo treatment, including in the elderly and regardless of PD-L1 expression levels.”
Updated data from the registrational EMPOWER-CSCC-1 trial were recently shared at the 2019 American Society of Clinical Oncology Annual Meeting.

Lonza fills portfolio hole by buying Novartis drug bottling plant

Lonza Group is buying a drug bottling plant from Novartis in northern Switzerland as the Swiss drug ingredients maker fills a gap in its offering for drugmakers seeking to outsource production.

Novartis is selling the so-called “fill and finish” facility because its production lines had been underutilised.
Lonza has been building up its drug products services business for three years and has been weighing whether to buy a factory from a rival where it can put the finishing touches on injectible medicines, o
r build such a facility itself like it is doing now in Visp, Switzerland. [https://reut.rs/32272tu]
In buying Novartis’s 10-year-old plant in Stein, Lonza will be able to speed up work for customers seeking to take their injectible medicines quickly into the clinic and onto the market, in particular for smaller lots of medicines aimed at niche populations, a Lonza spokeswoman said.
“Buying rather than building also means we will be operational immediately with an experienced team,” said Hanns-Christian Mahler, Lonza’s head of drug product services who the company poached in 2016 from Roche to build up the business.
Lonza shares were up 0.7 percent at 0830 GMT, bringing their rise this year to 29 percent.
Lonza plans to keep the facility’s employees and will continue to produce for Novartis.
SEAMLESS FIT
“The acquisition of the sterile bottling plant in Stein fits seamlessly into Lonza’s strategy to expand its drug development, production and formulation business,” Zuercher Kantonalbank analyst Philipp Gamper wrote in a note to investors. Gamper has a “market weight” rating on Lonza shares.
Lonza previously expanded into packaging operations for drugs when it bought Capsugel in 2016 for $5.5 billion.
Novartis is selling the drug bottling plant that it built in 2009 after reviewing alternatives for its under-used production lines.
“The planned sale of the two buildings is the best option to ensure the further employment and development of our employees and the continuation” of the site, a Novartis spokesman said. “Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers.”
This month, Lonza carved out its specialty ingredients operation which makes products such as anti-microbials for paint into a standalone business aiming to remedy problems there that have dragged on earnings.
Lonza has also sold a water care business as it seeks to expand its faster-growing biopharmaceuticals business.

Principia Biopharma started at Buy by Wainwright

Target $55

Boehringer Expands NASH R&D Pipeline With New Compound from Yuhan

  • Boehringer Ingelheim focuses on the development of next generation NASH treatments that target all three key drivers of the disease – steatosis, inflammation and fibrosis
  • Collaboration aims to develop first-in-class dual agonist (GLP1R/FGF21R agonist) for NASH
  • Yuhan Corporation to receive up to USD 870 million in upfront and success-based development and commercialization milestones, excluding royalties
 Boehringer Ingelheim Pharmaceuticals, Inc. and Yuhan Corporation today announced a collaboration and license agreement for the development of a first-in-class dual agonist for the treatment of NASH and related liver diseases that combines GLP-1 and FGF21 activity in one molecule. The collaboration brings together Yuhan Corporation’s expertise in FGF21 biology, obesity and NASH with Boehringer Ingelheim’s pharmaceutical expertise and commitment to bringing innovative medicines to patients with cardiometabolic diseases.

ZULRESSO for Treating Postpartum Depression Launched by Sage

Ligand Pharmaceuticals Inc. (NASDAQ: LGND) today announced that SAGE Therapeutics has launched ZULRESSO™ (brexanolone) injection, which was approved by the U.S. Food and Drug Administration (FDA) on March 19, 2019, and is the first and only treatment specifically approved for postpartum depression (PPD), one of the most common medical complications during and after pregnancy. ZULRESSO uses Ligand’s Captisol in its formulation. With this launch, ZULRESSO is the 11th FDA-approved drug to use Ligand’s patented Captisol technology.
ZULRESSO is administered via continuous intravenous (IV) infusion for 2.5 days under the supervision of healthcare providers in sites of care certified under the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS) program. For more information on ZULRESSO, including the final product label, visit ZULRESSO.COM or ZULRESSOREMS.COM.

Four massive problems with the Democrats’ Medicare-for-all plan

All the Democrats who are running for president are promising a version of free, universal health care, and it sounds terrific.
If the insurance is going to be better than what we have now — and cheaper — I’m all in.
You can see the appeal. Cut out a lot of middlemen. Cut out the health-insurance industry’s profits and costs. Free every family from a lot of risk.
Great, right?
Sure.
First, are we really sure we want to slash payments to doctors, nurses, other medical staff, hospitals and other organizations?
The Medicare-for-all crowd are saying that the new public organization will be paying “Medicare” rates for medical services.
Alas, according to a recent report in the journal Health Affairs, “the Medicare Payment Advisory Commission recently estimated that private insurers pay prices that are 50% higher than what Medicare pays.”
In other words, right now all of us with private insurance are basically subsidizing the people on Medicare and Medicaid. And under this new system, those subsidies vanish.
A move to Medicare rates means cutting payment rates by a third. How much of this is really “fat”? And how will reducing the incomes of doctors, say, increase the supply of doctors?
The problem of fraud
Second, what exactly are we going to do about, well, fraud?
I don’t mean to be gloomy, but Medicare-for-all is going to be Mardi Gras For All Fraudsters.
Critics of private health insurance point to its high administration costs as a sign of inefficiency. But those private-sector paper-shufflers may serve a purpose.
The federal government’s watchdog, the Government Accountability Office (GAO), reported recently that “improper payments” at Medicare are already running at more than $50 billion a year.
They might not all be fraud, the watchdog adds. Many of them have no paperwork, or the wrong paperwork, but maybe it’s no big deal.
Sure, why not?
The Centers for Medicare and Medicaid Services (CMS), which oversees the system, “has not conducted a fraud risk assessment for Medicare,” the GAO adds.
About 10% of Medicare’s fee-for-service payments are “improper payments,” the CMS itself acknowledges.
And that’s in a system that caters almost entirely to those over 65. I don’t want to be rude to America’s senior citizens, but I suspect most of them have passed the peak age for running a con.
Now we’re going to open the system to the young and middle-aged as well. And we’re going to quadruple the number of customers, from 60 million to 230 million. What could go wrong?
Even at the current rate, we’re looking at $200 billion in “improper payments,” right?
Third, if we’re opening the system to anyone who comes here, legally or illegally, aren’t we just giving an enormous incentive to everyone from, say, Tijuana to Tierra del Fuego to make a sometimes long and dangerous trek to America?
If some people will risk everything for the chance to pick lettuce or bus tables, think how many will do so for the chance to get prime health care for themselves and their families.
Maybe we could save them the trip and start opening clinics south of the border.
What about stockholders?
Fourth, and finally, can you tell me why we are apparently preparing to take about $600 billion from the stockholders in insurance companies without any compensation?
The current plans include no payments to investors, even if their business is essentially made illegal.
I know the current fashion in the Democratic Party is to consider all investors and all profits to be the work of the (secular!) devil. But the biggest investors in health-insurance giants such as UnitedHealth Group UNH, -0.34% AnthemANTM, -0.47%  and Cigna CI, +0.79% are retail mutual funds, such as Vanguard funds, State Street’s SDPR exchange traded funds and BlackRock’s iShares. They should just be expropriated?
The major publicly traded health insurers are valued in total at about $600 billion, and account for about 2.5% of the value of the broad S&P 1500 Index.
Doesn’t this seem like the behavior of a dubious market with a questionable rule of law? And what sort of precedent does it set? Investors will certainly think twice about risking their capital if the stocks that win are likely to get seized.
Even the Fifth Amendment of the Constitution talks about paying “just compensation” when private citizens are deprived of their property in the public good. And this is usually the practice when state governments seize property by eminent domain.
It would be quite easy to buy them out, too. At current levels, $600 billion in Treasury bonds would cost the taxpayer about $16 billion a year in interest. Chicken feed. And that’s before taxes.

Puma Bio files U.S. marketing application for expanded use of Nerlynx

Puma Biotechnology (NASDAQ:PBYI) has submitted a supplemental marketing application to the FDA seeking approval to use Nerlynx (neratinib), combined with chemo agent capecitabine, to treat patients with HER2-positive metastatic breast cancer who have failed at least two prior lines of therapy.
The FDA approved the kinase inhibitor two years ago for the extended adjuvant treatment of early-stage HER2-positive breast cancer.