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HD: With all due respect, you are flat out wrong.
zip: I'm just giving you my interpretation of the
events as I chronicled them from 2010 to present.
Just remember, nothing happens for nothing.
This management team put us behind the eight ball in
the first place. JT is not the leader that AMRN
needs. From day one, We had JZ , who though fired for
getting us in trouble with FDA in the first place, is
still a Director of the Co. The 1st Amendment tactic was brilliant,though I suspect their Legal Team initiated the
strategy, and played their hand well. To put it all in
the right context, we started with JZ's "Pump and Dump,
setting an antagonistic tone with the FDA that resulted in his
not being permitted to attend the Anchor Panel. Rapidly enrolling the first 2000 R-IT patients with out paying attention to the low
Trig levels @150 mg/dl so he could file for Anchor as quickly
as possible. MGMT's only goal was to sell the Co as rapidly
as possible, and that didn't serve the shareholders best interest, as a matter of fact causing $M's of losses. Have you forgotten GIA, and the harm to shareholders that ensued. Oh, I almost forgot MGMT setting a precedent by dumping millions of shares into the Marine approval, a first in Biotech history. As for the current team, they have been pathetic. This is widely accepted by the Investment Community. A non Scientifically trained CFO,(CPA) who out of necessity stepped in as
CEO , with no knowledge of how the FDA worked, of not being fluent in FDA Speak, or Agency matters. Did you forget the disaster of MLK weekend ? Your selective memory serves no one well. An experienced MGMT, a CEO with industry experience ,
having actually successfully launched a new product. A team with
solid Industry relationships, that's what is needed to get the Co. to the next level and help shareholders get whole again.
next levels
jesse: I posted it late Friday as it was hot off the press. BioCentury published a comprehensive article which they do best. If it bored you, so be it. The press release Friday morning was boiler plate, BioCentury , which I'm sure you don't subscribe to, gives our Industry's take which IMO will set the stage for near term PPS. Just responding to your inane comment
is most likely an exercise in futility.
The U.S. District Court for the Southern District of New York granted preliminary relief to Amarin Corp. plc (NASDAQ:AMRN) allowing the company to engage in "truthful and non-misleading speech" under the First Amendment to promote off-label use of Vascepa icosapent ethyl. The court's opinion said such speech "may not form the basis of a prosecution for misbranding."
According to Amarin's suit, FDA's interpretation of off-label promotion by a drug manufacturer as misbranding put Amarin at risk for criminal prosecution. The suit seeks a declaration that FDA's regulations are an unconstitutional infringement on its right to free speech and due process, and preliminary and permanent injunctions preventing FDA from taking action against Amarin on the basis of truthful, non-misleading speech used in off-label promotion of Vascepa. During oral arguments held in July, Amarin said that as an alternative to an injunction, effective relief could constitute a declaration that its intended communications are protected against a misbranding action.
Amarin filed the suit weeks after FDA issued a complete response letter denying Amarin's request to include language on Vascepa's label, with certain disclaimers, describing efficacy results from the Phase III ANCHOR trial. In the trial, Vascepa plus statins led to lower triglycerides in patients with baseline triglycerides =200 mg/dL and <500 mg/dL. The >96% pure ethyl ester of eicosapentaenoic acid (ethyl-EPA) is approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridema (levels >500 mg/dL) (see BioCentury Extra, May 8).
Friday's ruling allows Amarin to make specific combinations of statements and disclosures to health professionals about results from the ANCHOR trial. The company may also distribute relevant peer-reviewed articles and additional efficacy data from the trial.
The opinion was based on a 2012 ruling by the U.S. Court of Appeals for the Second Circuit that the "government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of an FDA-approved drug" (see BioCentury Extra, Dec. 3, 2012).
The court's opinion noted that Amarin's statements regarding off-label use of Vascepa may become "incomplete or otherwise misleading" as new data are released, and said the company bears responsibility for assuring its future communications remain truthful and non-misleading.
Amarin plans to begin off-label promotional activities "as soon as possible." Meanwhile, the district court is expected to issue an order outlining next steps in the litigation process; no timeline was disclosed.
An appeal can be filed within 60 days. FDA spokesperson Andrea Fischer declined to comment on the ruling.
zip: I unfortunately, like others, not being an
attorney, believed the post.
Robin: It's not good news for us.
epinephrine: I have doubts that he would be able to
answer your question. He's Cerebrally challenged.
ggwpq: I never did respond to your prescient comment
on my using capital letters. If the truth be known,
it was my not recognizing that the Cap lock light
was still on. I do get sloppy with stuff like that
and when I recognize it, I'm just too lazy to change
it.
ggwpq: I never did respond to your prescient comment
on my using capital letters. If the truth be known,
it was my not recognizing that the Cap lock light
was still on. I do get sloppy with stuff like that
and when I recognize it, I'm just too lazy to change
it.
BB: I have always felt that way because they
have patent life on Crestor, and could command
significant pricing power for a Combo. Don't
forget GSK, as they are still trying to replace
the $1.3B in revenues they lost when Lovaza went
generic.
HD: Please check it out. I'm not stating that
all patients enrolled had Trigs exactly at 150.
I'm saying that it was reported that the average
Trigs of the first 2000 patents was 150. You are
correct that after the change, the 3000 some odd
patients you allude to were between 150-200. It's
verifiable, BTW, FDA was the one who set the enrollment
criteria for Trigs at 150mg/dl. If I was paranoid I
would conclude that FDA was trying to undermine AMRN's
chance of success. That said, they did go along with the
switch to over 200mg/dl
HD: It was reported at the time of the switch
to enrolling patients with Trigs over 200mg/dl
AMRN's CMO correctly picked that up and switched
enrollment criteria in 2013.
kIWI: Unfortunately, if you check, almost all of the
first 2000 patients enrolled in R-IT averaged +- 150mg/dl
sts66: Just remember one big fact. The amount of
money spent on Health Care is approximately 18.7%
of GDP. Regardless of the price of Oil, Interest
Rates, the Economy, the price of Gold etc, there
is only ONE given in life. People will still get sick
and Dr's will still write prescriptions. BioPharm
has taken AIDS, a fatal disease, and turned it into
a Chronic Managed Condition. The survival rates in
Lung Ca, Colorectal Ca, Renal Ca etc have gone up
exponentially. Yes drugs are outrageously priced,
but like everything else in life people pay for
innovation and the ability to survive, The cost of
taking a Drug from the Bench to the Bedside is about
$1B. Who will supply the risk capital for innovation,
without a handsome return ? The choice is to stop
innovating new cures and therapeutics, or pay for the
ability to live.
ggwpq: They are the facts, and I suggest you recheck
your information. Ask Zum or any of the more reliable
posters.
drrc1949: I agree with you about Statins. If you recall,
20 years ago Lipitor showed a significant reduction in
MACE, by lowering LDL, and became the largest grossing
drug in history, $17.3B/ yr. I believe the PCSK9 Class
could do as well, and replace Statins.
Kiwi: I understand where you are coming from. I was only
trying to be of help, as I have a very strong conviction
about the future of PCSK9. I also understand Kaiser's
decision to await the Outcome studies. That said, it's
both prudent and financially sound from a business point
of view. I just believe as a Physician that the class was
the answer to your specific family history. I believe that
AMGN and REGN may very well have Outcome results within a year.
I wouldn't be surprised if it came earlier than R-IT. They
have been fully enrolled and with large numbers of patients,
are powered to the Max. AMRN is still not completely enrolled,
(cost constraints) , and if you recall, the first 2000 patients
enrolled, had Trigs on average of 150mg/dl. IMO you are absolutely
correct about Vascepa being the perfect add on for PCSK9. Don't R/O one of the Co's involved BO AMRN. It's a marriage made in heaven. With the exception of AZN's cherry picked, non FDA sanctioned Crestor trial, no other Statin Co has shown a benefit
in CVD outcomes since prior to 2000. The Crestor study was not
acceptable to FDA, and IMO, was designed and run in a stealth like
fashion just to pump up Crestor sales.
Kiwi:
1bill: You are absolutely correct. Inflammation is key,
no question about that. Cholesterol lowering is also
key. The combination could be astonishing
invest2992: Respectively, An old friend is PI at the largest private hospital in LA, and also West of Chicago. He is very excited by what he see's daily. Over time he has become more
excited about the Class. He's savvy, and feels the eventual
market, like Lipitor 20 years ago, will be at a number that is
equal to all the patients on Statins cumulatively. It's more than anecdotal from my POV. And I state this without being privy to any information that is not already public. I really like the Class. I believe they will replace Statins, and prove to be
the preventative of choice to the Millennials. (ESPR),
also is a very interesting company you might want
to take a look at. the stock sold off like REGN .
on Friday. I'd like to see it lose another 10 pts.
That would make it even more interesting.
Good luck !
As the old erratic poster, I have some comments to make.
I hear an excitement among Academic Cardiologists
re PCSK9 that I haven't heard since Statins entered
the therapeutic arena for reducing MI's and Strokes.
The reported connection to loss of short term memory
issues are not very different from some of the old articles incriminating Statins for the very same problem. And yet there are 40M patients taking Statins. The issue of HMO's prescribing
PCSK9 drugs to the very patients who need them most, is in
reality a financial issue and not necessarily an issue with
an unproven drug. HMO's like Kaiser are well known for throwing Quarters around as if they were Manhole Covers. As for sour grapes, that lowering Trigs are not considered a non statin
lipid lowering agent is a fact according to the AHA/ACC's new
guidelines. Since lowering LDL is the only lipid metric
accepted for approval by FDA, prior to Outcomes Trials
results, bears weight. Unfortunately if Trigs were an
accepted metric, we all would be thrilled and wealthy,
as Anchor would have been approved and AMRN stock would
be exponentially higher. The "King" and self proclaimed
Maven on Lipidology is as usual his sarcastic, insulting
boorish self. As for his lapdog cheering him on, I have one
comment. You are probably a nice guy, and IMO I would hope
that the PCSK9's are prescribed for you. You are the classic patient they are best suited for.
ggwpq: I agree that anyone with an LDL over
150 is a candidate for treatment.
raf: Agreed
ggwpq: I PERSONALLY WOULD BE VERY HAPPY
WITH AN LDL OF 90, WHICH IS WHAT MINE
IS ON LIVALO 2MG/ DAY
sts: Surprisingly the EMA is more forward thinking
on the class than we are. If there was no ACA, I'm
sure the US would have been as well. There are new
pricing models that are being negotiated as we speak
to tie pricing to Outcomes. For example NVS just had
an exciting drug approval for Heart Failure Drug, and
has suggested to third party payer's that reimbursement
be calculated on the decrease in Hospital Days, plus
a reduced base price, with their drug. They will get
close to retail price as an add on to base price
on reduced Hospital Days. That will be a paradigm shift
in Drug Development.
sts: Excellent question . There are 4 Co's that have
run large clinical trials on their respective PCSK9
drugs. Two of them have fully enrolled Outcomes Trials,
(Cant believe AMRN has not fully enrolled yet) I believe
the reason is to preserve cash. That said, PCSK9's have
been tested on thousands of patients and Muscular Skeletal
problems are not an issue. The real issue will be
reimbursement. Again from the data I've seen from REGN,
and AMGN I believe they will eventually replace Statins.
BTW,PFE's efficacy is the best thus far, lowering LDL
by 71% in their first PH III trial.
louiebloui: Thank you !I stand corrected! I misheard the
price. Appreciate the correction .
Kiwi; The actual retail price is $12k and I suspect
there will be a slight reduction, maybe $1500/year.
I have heard on good authority that the Large Biotech
and Pharma Co's will not do business with the PBM's
as Abbie did in Hep C as they are reasonably equal in
efficacy, as opposed to ABBV whose drug was grossly
inferior to Gilead's Hep C drug. They're prepared to
play hardball. Yes I was referring to a CV drug. Fuck
the Insurance Co's ! They are raking in cash hand over
fist. They are the ones that should be regulated, not
Life Saving BioPharm Co's. Let their mothers worry about
it. CVD is still the number one killer in the US.
ggwpg: You should be better informed as to why LDL
is the only Lipid metric that AHA/ACC and FDA accept
prior to outcome trial results. Unfortunately they
don't even list Trig reduction as an acceptable
Lipid lowering metric in the new guidelines. You do
your own diligence and go through the new AHA/ACC
guidelines as I did and just maybe you'll answer your
own question. I'm just posting information that is
accepted by all. I believe the PCSK9's will eventually
replace Statins, but that remains to be seen.
BB: The PCSK9's are IMO the best drug to come along in
20 years. Their outcomes trial has been fully enrolled,
REGN. AMGN, PFE, are all doing CVE outcomes trials. I
personally believe PFE's entry in the class is the most
efficacious of all. I'd love to see you noodle something
whereby one of these Large Cap guys steps up and buys
AMRN. The Combo would be a Humongous Blockbuster, and
individuate the BO partner from all other PCSK9's. It
would treat LDL, as well as Trigs and Inflammation.
AMRN would have the potential to be worth a fortune.
James: When Fierce Biotech published their
piece, the Label hadn't as yet been released.
In my prior post, I cut and pasted the label.
sts: I posted the Label on the prior post.
In spite of the Independent Advisors balking
at the expanded demographic. Could the FDA
change their mind ? Absolutely ! Suffice it
to say PCSK9's are vastly superior to Statins.
That said, the outcomes trials should be coming
out in 2016-17.
PCSK9
Label. Includes HeFH and secondary prevention patients, including those who are statin intolerant that fit into one/both of those two categories.
~8-10 M patients in the US eligible for Praluent. Vast majority are secondary prevention, minority are HeFH, and ~10% of patients are statin intolerant.
Launch. REGN/SNY expect gradual uptake at launch. Production of Praluent will begin on Monday July 27 and the product will be available July 29.
Payer mix. REGN estimates that 60% of patients coming from commercial side, 35% from the Medicare side, and the rest from Medicaid
sts: It's a lot less than Lipitor's and Zocor's
initial pricing. Considerably less side effects.
PCSK9: This will be a Blockbuster as FDA gave it a Broad
label to include FH patients Statin Intolerant Patients,
as well as preventative use with Statins. The injection
is in ones "love handles" just like Diabetics. I'd love
to see it used with Vascepa, as it would represent the
best of all possible worlds for AMRN. It would knock out
AZN and Crestor. JMO
Interesting Note by an Economist
Replace the FDA
But the worst flaw is in our drug regulatory process. Only a few months ago the FDA (Food and Drug Administration) was doing everything it could to slow down the development of new drugs for Ebola. Now that there are a few cases of Ebola in the US and we have a general news panic, it seems they can’t encourage drug development fast enough. Nothing changed except the politics.
A few people in the US contract Ebola and suddenly the FDA allows companies to pull out all the stops. My side bet is that we will have a cure for Ebola in the not-too-distant future.
The serious tragedy here is that millions of people die every year from all sorts of diseases that are on the verge of being cured. There are very hopeful new technologies in the labs, but the FDA is preventing them from getting to you. When I say millions of people that is NOT an exaggeration. But those diseases haven’t caused a political firestorm. We need to change that. We need to create a firestorm to force change on the most deadly bureaucracy in America.
There are hundreds of life-saving drugs and other therapies that are being kept from you and me because bureaucrats are using 19th-century science to try to deal with technologies developed in the 21st century. They are more interested in protecting their personal fiefdoms and reputations than in saving lives. Gods forbid we have a drug that might cause a problem, so they sacrifice progress and our collective health – indeed our very lives – on the altar of self-interested bureaucratic expediency. Oh, they couch it in all sorts of high-sounding words, but the results are the same. You and I are prevented from making good choices about our own healthcare and saving the lives of our loved ones.
The FDA does not need to be reformed; it needs to be replaced. We need as a country to create a commission to design a 21st-century Drug Regulatory Authority and then turn over the regulatory process to this new authority. If any of the current structure fits in the new system, then fine. Otherwise, close it down.
As an economist, I would point out that we are leading the world in biotechnology research, but we’re going to see that research create jobs elsewhere if we don’t figure out how to develop the cures and procedures in this country. We need to slash the cost of drug development by 90%. If we do that, we will see the number of new drugs and procedures increase by orders of magnitude.
Robin: FYI, Coconut oil is loaded with saturated fats,
and elevates both LDL and total Cholesterol. I love
Chi Chis, but have switched to Vodka Martinis, in
the name of good health.
Unfortunately this is how pissed off Congress was with the FDA
or. how some of us didn't have the story accurately !
FDA funding added to 21st Century Cures Act
The U.S. House Energy & Commerce Committee passed the 21st Century Cures Act (H.R. 6) on Thursday by a 51-0 vote following the last minute addition of FDA funding provisions. The bill includes a “Cures Innovation Fund” that provides FDA $110 million per year for five years. The $550 million total falls short of the $960 million FDA estimates it will cost to implement the bill, but is nonetheless a major achievement for FDA because prior versions did not appropriate additional money for the
agency.
The bill also includes requests to the House Appropriations Committee to appropriate additional funding to FDA, and a provision exempting user fees from sequestration.
The E&C Committee agreed to measures intended to offset the bill's costs, which include a $10 billion five-year NIH “Innovation Fund.” The offset measures include a change to the timing of Medicare’s monthly reinsurance pre-payments to Medicare Advantage Part D prescription drug sponsors so that the federal government, rather than insurance companies, keeps interest revenue. This change is expected to generate $5-$7 billion. Other offsets include sales of oil from the Strategic Petroleum Reserve pegged at $5.2 billion, and $2.8 billion in savings from limiting Medicaid spending to Medicare payment levels on certain durable medical equipment.
In remarks to rare disease advocates a few hours after the committee vote, E&C Chairman Rep. Fred Upton (R-Mich.) predicted that the full House will pass H.R. 6 this summer with 300-350 votes. Upton said he expects the Senate to pass a much more modest medical innovation bill. Upton said he hopes the two bills would be reconciled into a single bill that can be sent with bipartisan support to President Obama. Back to top