Zogenix (NASDAQ:ZGNX) slumps 33% after hours in reaction to its announcement of “successful” results from a Phase 3 clinical trial
evaluating two doses of Fintepla (fenfluramine oral solution) (ZX008)
in patients with a severe form of childhood-onset epilepsy called
Lennox-Gastaut syndrome.
The company says the higher dose met the primary
endpoint of the change from baseline in seizure frequency at up to 20
weeks compared to placebo which is typically the average value. However,
it reported the median value without including the data range so the
results may not have been statistically valid. The results for the lower
dose were not statistically significant.
GW Pharmaceuticals (NASDAQ:GWPH), whose Epidiolex (cannabidiol) was approved for Lennox-Gastaut in June 2018, is up 9% after hours.
Advocates of government‐run health care have an ignoble tradition of cloaking their ideas in the rhetoric of choice:
In 2009 and thereafter, President Barack Obama repeatedly promised,
“If you like your health care plan, you’ll be able to keep your health
care plan, period. No one will take it away, no matter what.” He
promptly thew millions of Americans out of health plans they themselves
chose, liked, and wanted to keep.
Sen. Bernie Sanders says,
“If you are a human being, regardless of your immigration status, you
have a right to health care.” Sanders’ actual proposals, however, would
take health care rights away from everyone. His “Medicare for All”
proposal would take away Americans’ right to purchase the health care
they want by increasing taxes so much the average household’s after‐tax
income would drop by an estimated $35,000.
Just to be sure you cannot exercise your right to choose your health
plan, Sanders would outlaw private health insurance. Finally, he would
violate the right of immigrants to purchase the health care they want by
stopping them at the border.
South Bend Mayor Pete Buttigieg, who appears to have won the Iowa Democratic presidential caucuses, carries on that ignoble tradition.
Buttigieg proposes not a health care system of “Medicare for All,” but of “Medicare for All Who Want It.” Buttigieg purportedly proposes to turn Medicare into a “public option”
where all Americans the choice of participating in the program without
compulsion. “I trust the American people to make the right choice for
them,” Mayor Pete says. “Not my way or the highway.”
Buttigieg’s rhetoric obscures the fact that his plan would create
a single‐payer health program and reduce Americans’ health care choices
no less than Sanders’ plan would.
Before we examine how Buttigieg proposes to reduce Americans’ health
care choices, let’s examine what a program of “Medicare for All Who Want
It” would look like.
If Mayor Pete were really proposing Medicare for All Who Want It, he
would let taxpayers choose whether or not they participate in the
Medicare program. All who want Medicare could continue to pay taxes into
the current system. All who don’t want Medicare could instead
put those would‐be tax dollars into a personal account they themselves
own and control. Taxpayers who opt out of Medicare could invest those
funds, use them to make their own health care decisions in their later
years, and even pass them down to their children and grandchildren. All
who want to remain in the current Medicare system would get the finest
health care the government can deliver with whatever funds their
neighbors are willing to hand over to the government voluntarily.
If he were really proposing to turn Medicare into a “public option,”
Buttigieg would also make it an option for current enrollees. Instead of
pushing them into the traditional, fee‐for‐service Medicare program,
Medicare for All Who Want It would subsidize current enrollees with
a check–just like Social Security does–and let them choose whether to
spend that money on traditional Medicare or other health‐insurance
options. To ensure equity, older and sicker enrollees will get bigger
Medicare checks than younger, healthier enrollees. To ensure a level
playing field, traditional Medicare will get no subsidies from the
federal treasury aside from the funds that Americans who want Medicare
voluntarily contribute to the program.
Instead, Buttigieg proposes to continue to force taxpayers to
participate in Medicare whether they want it or not. Indeed, he would
ramp up the compulsion.
He would force Americans to pay (at least) an additional $1.7 trillion
in taxes — more than all the on‐budget tax increases in ObamaCare
combined — whether they want to pay those additional taxes or not.
Buttigieg’s plan thus reaffirms that a “public option,” as its intellectual father Jacob Hacker admitted, is not about expanding choice but leaving Americans with no choice:
Someone once said to me, “This is a Trojan Horse for
single‐payer,” and I said, “Well, it’s not a Trojan Horse—it’s right
there! I’m telling you: we’re going to get there, over time, slowly.”
Prof. Jacob Hacker
acknowledges the purpose of a “public option” is to eliminate private
insurance and create a government‐run single‐payer health system.
In the end, Buttigieg’s plan is not “Medicare for All Who
Want It.” It is instead a single‐payer, “Medicare for All” plan with
additional layers of deceptive rhetoric. Both Buttigieg’s and Sanders’
plans would deny Americans the right to make their own health care
decisions and hand those decisions to a government‐run single‐payer
system. Mayor Pete is just doing more to hide the fact. https://www.cato.org/blog/buttigiegs-medicare-all-who-want-it-fraud
Collegium Pharmaceutical (NASDAQ:COLL) +8.3% after-hours on news it agrees to acquire the U.S. rights to the Nucynta franchise from Assertio Therapeutics (NASDAQ:ASRT) for $375M; ASRT +56.7%.
Collegium calls the deal “financially
transformative… We expect the acquisition to improve annual EBITDA and
operating cash flows by more than $100M.”
The company says the Nucynta franchise, which
includes an extended-release and an immediate release formulation of
tapentadol, is supported by patents with expires in mid-June 2025, with
the potential for a six-month pediatric extension.
Q4 results for Merck (MRK-0.3%) and Bristol-Myers Squibb (BMY+2.3%)
present stark contrasts between their rival PD-1 inhibitors with the
former clearly demonstrating superior execution in sales and expanding
approved uses.
Merck’s Keytruda (pembrolizumab) is the company’s
top seller, averaging over 75% growth per quarter over the past two
years. Sales grew 45% yoy to $3,111M in Q4 2019.
BMY’s Opdivo (nivolumab), briefly its top drug,
now #2 again behind blood thinner Eliquis, has averaged almost 24%
growth per quarter over the same time frame, but the trend has been
steadily down since Q3 2018. Sales were $1,763M last quarter, down 2%
from a year ago.
The flu-like virus that exploded from China has researchers worldwide
once again scrambling to find a vaccine against a surprise health
threat, with no guarantee one will arrive in time.
Just days after Chinese scientists shared the genetic map of the
culprit coronavirus, researchers at the U.S. National Institutes of
Health had engineered a possible key ingredient for a vaccine they hope
to begin testing by April.
Scientists from Australia to France, along with a list of biotech and
vaccine companies, jumped in the race, pursuing different types of
inoculations.
And Texas researchers froze an experimental vaccine developed too
late to fight an earlier coronavirus — SARS, or severe acute respiratory
syndrome — but are pushing U.S. and Chinese authorities to give it a
try this time around. Because the new virus is a close cousin of SARS,
it just might protect, said Dr. Peter Hotez of Baylor College of
Medicine and Texas Children’s Hospital.
All that work is coming at lightning speed compared to past
outbreaks. Yet many experts agree it still may take a year — if every
step along the way goes well — for any vaccine to be ready for
widespread use. That’s if it’s even needed by then.
Globally, more than 28,000 people are infected and the death toll
climbed past 560. The overwhelming majority are in China, but more than
200 people with the illness have been reported in over two dozen other
countries.
For now, health officials are isolating the sick to fight spread of
the virus, which causes fever, cough and in severe cases pneumonia. With
no specific treatment, some doctors also are experimenting with
antiviral medicines developed for other conditions.
“Ours is already manufactured and could take off pretty quickly,”
said Hotez, who created the earlier SARS vaccine with Texas Children’s
colleague Maria Elena Bottazzi. But “there’s still no road map for what
you do to make a vaccine in the midst of a devastating public health
outbreak.”
NIH specialists say rather than chasing outbreaks, it’s time to
pursue prototype vaccine designs that could work for entire virus
families, ready to be pulled off the shelf at the first sign of a new
disease.
“We have the technology now. It’s feasible from an engineering and
biological standpoint,” said Dr. Barney Graham, deputy director of the
National Institute of Allergy and Infectious Diseases’Vaccine Research
Center. Without that step, “we’re going to be at risk for new
pandemics.”
A FASTER VACCINE RECIPE
Traditionally, making vaccines required first growing lots of virus
in a lab. The NIH team is pursuing a newer and far faster method: Simply
use a piece of the virus’ genetic code, called messenger RNA or mRNA,
that instructs cells to make a particular protein.
“We think of RNA as the software of life,” said Dr. Tal Zaks, chief
medical officer of Moderna Inc., which is developing mRNA vaccines for
other diseases and working with NIH on the new coronavirus.
Inject the right piece and “you’ve taught the body to make its own
medicine,” he explained. As cells produce just that protein, the immune
system learns to recognize it, primed to attack if the entire virus ever
comes along.
The target: A protein aptly named “spike” that lets the virus bind to
cells. It studs the surface of coronaviruses — the new one as well as
its cousins SARS, which erupted in China in 2002 and spread to 26
countries, and MERS, or Middle East respiratory syndrome, which emerged
in 2012.
Graham’s team zeroed in on the RNA responsible for the new virus’
production of spike and then — because prior research showed the protein
can change shape — engineered a more stable version of it.
Moderna is manufacturing samples of the synthetic mRNA vaccine for
NIH to use in animal studies and, hopefully within three months,
first-stage safety tests in people. If further testing proves it really
works, the hope is scientists could simply swap in a new spike code if
another coronavirus comes along.
That’s important because after three such outbreaks in less than 20
years, “this is not the last,” predicted Dr. Mark Denison, a virologist
at Vanderbilt University Medical Center. It’s key to find vaccine
“strategies that go after these unique things common to every
coronavirus.”
WHAT ELSE IS IN THE PIPELINE
Inovio Pharmaceuticals is pursuing a similar approach with synthetic
DNA, and recently reported promising results from first-stage testing of
a MERS vaccine. It’s collaborating with a Chinese company, Beijing
Advaccine, in hopes of being able to test a new vaccine candidate in
China later this year.
In France, researchers at the Pasteur Institute are piggybacking on
the tried-and-true vaccine against measles. They’ve had some early
success mixing genetic material from other viruses into that vaccine,
and now hope to put the immune system on alert against this new
coronavirus in the same way.
“The work we’re doing now involves making a vaccine against measles
but re-engineered in the sense that it has antigens from the new
coronavirus,” said virologist Frederic Tangy, head of Pasteur’s vaccine
innovation department.
What about Hotez’s old SARS vaccine? In that case a piece of the
spike protein was genetically engineered and grown in a lab, a classic
vaccine technology compared to the newer and less proven Moderna and
Inovio approaches. The Texas researchers showed the vaccine protected
animals but in 2016 ran out of money for further testing and froze what
was left. Every six months, Hotez thaws a small sample to make sure it’s
still usable.
CHASING OUTBREAKS
Past outbreaks are full of such missed opportunities: There’s no
commercial vaccine for MERS even though illnesses still occur. The birth
defect-causing Zika outbreak was ending by the time experimental shots
were ready to test.
The bright spot: Ebola vaccines. Some candidates began early testing
during the massive Ebola epidemic in West Africa in 2014-2016, although
the outbreak waned before scientists had proof they worked. But
authorities and vaccine companies kept up the research, and by 2018
shots were ready to help tamp down an outbreak still smouldering in
Congo.
The World Health Organization will meet next week to identify
promising drug and vaccine candidates for the new coronavirus and
fast-track their development, much like happened with Ebola.
“To put it bluntly, we’re shadow boxing,” said WHO Director-General
Tedros Adhanom Ghebreyesus. “We need to bring this shadow out into the
light so that we can attack it properly.” https://www.marketscreener.com/MODERNA-INC-47437573/news/Moderna-Experts-scramble-but-new-virus-vaccine-may-not-come-in-time-29953679/
