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HD: In many cases of an interim look with sufficient
efficacy, the only reason they may not stop the trial
would be to have more patients from a safety point of
view. I honestly can't think of any safety issues, but
with the historical animosity between FDA and AMRN,
it's not an easy call. FDA never forgets a grudge. Let's
hope AMRN has wisely done some fence mending.
Kiwi: Kudos to management for the bang up job they
did on the CC. It was upbeat, significant and pointed
toward an ability to get to R-IT results, and expand
the label. My only concern is that the clock may run
into 2018. I say that because of the initial enrollment
of low Trigs in the first 2000 patients. The event rate,
Power, and Hazard Ratio speak to the need for the required
8000 patients in the original design of the trial. Question,
when I occasionally visit this site, I see interim efficacy
numbers significantly higher than required for approval. How
are folks coming up with such great numbers ? I obviously
don't know the answer, but the numbers, if correct, will
rocket the stock. Congrats to you and all the longs who
hung in and endured a very bumpy ride. I believe Zum should
get credit for assiduously pumping out supportive information
that IMO prevented a mass exodus. I believe JL also had an
enormous positive influence. Kudos again.
zip: Don't confuse Chinese patent law with that in the
West. They're at the bottom, just ahead of India, A
Chinese competitor comes in with Valid patents, issued
in China, guess who wins ? AMRN doesn't have an NCE or
Composition of Matter patent. Gilead Sciences Hep C drug
Sovaldi, which FDA thought of as a breakthrough. It only
did a tad over $12.5B last year, it's first year of launch.
India invalidated GILD's Composition Matter patent. Just
think it through Zip, you're a very bright guy.
couldbebetter: On the surface it appears to be a significant
deal, particularly, the nonrefundable milestones, that IMO
is an inflection point for the Co. The only Caveat would be
how safe is any deal with the Chinese. In business they get
down and dirty, and have a Government that will always back
them up.
zum: Never the less, if you were to send JZ to the
NIH Pathology Department, the Path Report would
read "Malignant Asshole" Zum if anyone on this Site
is aware of the near catastrophic damage he caused
Shareholders and the Company, my friend, it's You.
drrc1949: Because he's a Narcissistic Asshole !!!
drc1949: You've got that partially right. The game playing
on the part of HF's has more to do with "naked shorting"
and it involves many small cap NASDAQ stocks. But the pattern
of intra day trading is quite obvious. And it's not kosher,
as naked shorting is illegal. It means you sell the stock
on a down tick, without legally "borrowing" the shares.
sts66: Au Contraire. By the time the PBM's extract their significant discounts, ( GILD discounted its Hep C cure
over 43%, because ABBV got an exclusive from Express Scripts
which took GILD's far superior drug off formulary) We are
in a new price war paradigm, and at the end of the day the
far newer PCSK9 drugs will be just a bit more than statins.
They are so far superior to statins that Cardiologists will
insist on prescribing them and patients may have a slightly
higher co pay, but they'll all be covered. When Express Scripts
did the ABBVE exclusive deal, they discounted the Viepak 50%.
Still GILD's Harvoni is dominating the Hep C space with 85%
market share. Great new drugs will take a big price haircut,
but still be dominant in market share. PCSK9 drugs will
dominate the Lipid market once they are all up and running.
REGN, and SNY paid $67M for the voucher to get first mover
advantage over AMGN, and only by 4-5 weeks.
Kiwi, I take your point, but to the best of my knowledge
Dr's write prescriptions, not Insurance Co's. I believe
based on what I'm hearing from Cardiologists at both Cedars
Sinai and USC, that the excitement over the PCKS9 drugs has
produced a buzz similar to the early days of Statins. It's
tough to reign that in. One important point is that their
are no muscular skeletal side effects which lead to non compliance. The pricing will be determined by PBM's and
Insurance Co's will have to pay. That said, the discounts
will be steep, and nowhere near the suggested price the
Innovators plan on asking. It should only happen to AMRN.
Kiwi,
I'm not certain you are fully aware of the FDA approval
strategies that BioPharm utilize. The Co's mentioned
previously went after the low hanging fruit, ie Familial
Hypercholesterolemia. They are all pursuing the same
indications that Statin's are approved for and these are
all involved with Outcome Trials, not dissimilar to R-IT.
When all the approvals are in, then and only then we they
replace Statin's as they are significantly more efficacious.
Btw, may I inquire as to your thinking process that made you
decline the REGN trial ? They just might be best in class.
Kiwi: Excellent point but a bit overstated. The PCSK9
drugs will be facing large discounts from the PBM's,
just as we are witnessing in Hepatitis C between GILD
and ABBV. They are so far superior to Statins, that
when I say 'all" I'm really referring to a continuous
erosion in sales from the Private Sector. Managed Care
and the ACA will only reimburse and dispense the cheap
generic Statins, until the ACC/AHA take a decisive stand.
Their efficacy data and safety profile are most compelling.
The average lowering of LDL C is about 70%. There are
numerous players, AMGN, REGN,SNY, PFE etc. this IMO will
set off the mother of all price wars. Stay tuned.
Kiwi: The data I've seen with multiple PCKS9 drugs
convinces me that they will expand the label to all
indications and will eventually replace Statins. If
you recall I sent you a private email, I want to say
at least 10-12 months ago for PCSK9 drugs. The very
first approval will be for your Dx. Most Cardiologists
in Acadeem feel that the future could be PCSK9 + Esperion's
drug. I'd bet dollars to doughnuts that if the ACC wises
up, they will add Vascepa as a three drug cocktail for
probably all Lipid disorders. I am very happy for you that
approval should be late 2015, as it will prevent IMO the
very risk factors that have made you cringe.
Zum: It's been quite a while. I have been reading your posts
and you've certainly put a lot of information out there. As
far as Statins are concerned, IMO they will be replaced over
time by the new PCKS9 drugs. These are as close to amazing as
amazing gets. Minimal and very tolerable side effects as compared to statins. They produce a far greater lowering of LDL C, and
I believe they will have excellent outcome data. With the exception of AZN's Crestor in a questionable non FDA sponsored trial, no Statin has shown positive outcomes trials in a very
long time. AZN's suspect trial was in 2006. If I had to pick
one, I'd probably go for (REGN)(SNY)compound. What would be great is to see a combo of PCKS9 and Vascepa. Congrats on the lift in
PPS, and the script numbers. Keep up your excellent work. It
matters !
Hot off the press. The next new drug in the fight against Heart
Disease. Read carefully.
SAN FRANCISCO--Keeping up the rear in a three-way race to commercialize the first of a new class of anticholesterol antibodies, Pfizer ($PFE) is at work on a pill that attacks the same target, planning to build a franchise in what is expected to be a blockbuster new therapeutic area.
Pfizer R&D chief Mikael Dolsten
At the JP Morgan Healthcare Conference in San Francisco, Pfizer R&D chief Mikael Dolsten told Reuters that the company is developing a small-molecule inhibitor of the protein PCSK9, which stands in the way of the body's ability to clear LDL, or "bad," cholesterol from the blood. As it stands, Amgen ($AMGN) and a team of Sanofi ($SNY) and Regeneron ($REGN) lead the race to commercialize injectable therapies that block PCSK9, with Pfizer bringing up the rear with a Phase III program of its own.
The company expects to begin a human trial of its anti-PCSK9 pill later this year, Dolsten told the news service, touting "a substantial reduction" in cholesterol in preclinical animal studies.
Pfizer's antibody, bococizumab, is likely to hit the market after its two main rivals, but Dolsten is taking the long view on PCSK9. Looking beyond first-generation therapies, Pfizer's approach to cholesterol includes the aforementioned pill and an early-stage vaccine candidate--which would block the protein's expression through an annual injection--that could enter Phase I next year.
A pill that inhibits PCSK9 is "a Holy Grail" in the world of lowering LDL cholesterol, according to Esperion ($ESPR) CEO Tim Mayleben, whose company is at work on a small-molecule cardio treatment that taps a different pathway. And if Pfizer can pull off such a feat, its third-place finish in the blockbuster race in PCSK9 antibodies could eventually be lost to history.
Meanwhile, Amgen, long the leader in PCSK9 inhibitors, is expecting to win FDA approval for its treatment no later than Aug. 27. That would have given it months of market exclusivity, but, over the summer, Sanofi and Regeneron paid $67.5 million for an FDA voucher that will cut the review time for their alirocumab down from 10 months to 6 months. Assuming the pair files its drug by year's end as planned, alirocumab will likely be up for approval at the same time if not before Amgen's contender. Further complicating matters, Amgen is suing its rivals over alleged patent infringement.
zip: I visit infrequently, but read your inaccurate post
on what you perceived as why JL was a bit miffed, and
left this Board. For the record my post was very different
than your recollection. I quoted former Israeli Prime Minister
Shimon Peres, a brilliant Nobel Laureat, and well respected Moderate Liberal great Israeli Politician.
" If a problem has no solution, it may not be a problem,
but a fact, not to be solved, but to be coped with"
I know JL is a friend and former colleague, that said,
his response to the Quote was "He's an expletive Moron"
Not exactly the response I expected from anyone on this
site, let alone JL. He and I have had our run ins, but I
had a lot of company in that regard.. My response to JL.
"I hope there wasn't a hint of Anti Semitism wafting
through your post"
I hope this refreshes your recollection. You referred to
the current Prime Minister Netanyahu, and miss read my
post, and probably missed the quote. My quote was an
obvious reference to the current challenges facing AMRN.
Dew: Thanks for posting the slides. If it weren't for
the Best Mgmt Team in BioPharm, I'd probably have been
a bit nervous today.
New drug approvals in U.S. highest in 18 years
Biotech and pharmaceutical firms bounced back from patent losses and regained the ability to get new drugs into the market in 2014, as evidenced by the record number of approved drugs in the U.S. and higher number of approval recommendations in Europe. The FDA cleared 41 drugs in 2014, which is the highest number in 18 years and up 14 from 2013. In Europe, a total of 82 new drugs, including generics, were endorsed for approval
If it's the FDA as culprit, how does one explain the above. It
is obvious that FDA has always held grudges, and unfortunately
AMRN has been in their crosshairs. WHY ???
Jesse: He was a great man and Nobel Laureat. History will record him that way. There are many problems and only one Einstein. You
are entitled to your own opinion, and I trust there wasn't a hint
of Anti Semitism wafting through your response.
Jeese: "If a problem has no obvious solution, it may
not be a problem, but a fact, not to be solved but
to be coped with"
Israeli Prime Minister
Shimon Peres
Kiwi: Fortunately I had a very good year and closed my
book 10 days ago. I just arrived in Aspen and hope to
avoid looking at a screen except for emails. Btw, the
snow is the best I've seen in many years. Nice dry
Colorado powder. The Best ! Happy Holidays to you and
all the longs on the board.
kIWI: It's already caused a huge sell off and I would bet
the selloff will continue. In the 45 year history of Biotech
there's never been a price war. The prohibitive cost of taking
a drug from the bench to the bedside, requires pricing power.
That has always been the attraction to investors. Why did the
Industry Organizations give Obama Care $80B ? Obviously to avoid
a Price War. I don't believe you comprehend the significance
of what happened. GILD, Celgene, Amgen, Biogen, Regeneron,
and all large and Mid Size Biotech have already down 15-30
points.
Jesse: Biotech has entered a New Order of the Universe, and
may take a year or more to recover, albeit at lower valuations.
I am expecting a correction of at least 15% or more. The reason is interesting, in that BIO and PHRMA, the two Industry Organizations negotiated with the Govt in 2009, agreeing to give $80B over the next decade to help fund Obama Care. In return, the Govt agreed to write into the ACA a provision whereby they relinquish the right to negotiate Drug Prices, a major Industry win. Yesterday, as you probably know, Express Scripts cut a deal with Abbvie for their Hep C drug, which is IMO significantly inferior to Gilead's Hep C drug Harvoni. Abbvie gave ESRX a reported 23% discount to the sticker price. In return ESRX gave Abbvie exclusivity , taking Gilead's Harvoni off their formulary. This will cause price slashing of Newly Innovated , as well as currently marketed drugs. Bottom line a Price War ! The loss of pricing power will take all the multiples down and IMO continue the Biotech sell off. I believe it will significantly decrease the flow of risk capital into the sector, and decrease innovation. I would appreciate your thoughts on the matter. Thanks !
JL: Agree with one addition, I believe it's color is green.
JL: Roger that.
BioChica: I simply switched email addresses. IMO
you are a loyal long. That said, you don't have
the skills, knowledge or ability to comment on
what I post. I only wish you well, as I do all
the loyal longs. I'm surprised that someone who
has been on this site daily for so long can't
recall back 3 years. I have been on this site
since early 2010.
BB: I posted three years ago that GSK has the most
to lose and the most to gain re Vascepa. I still
believe that to be true.
LOUIEBLOUIE: Great Post ! We brought out the monster
in Bio Bill. Go Get Em !!!
An FYI
Veloxis Pharmaceuticals A/S (CSE:VELO) filed suit in the U.S. District Court for the District of Columbia seeking an order requiring FDA to grant final approval to immunosuppressant Envarsus XR tacrolimus and allow Envarsus XR to be immediately approved for sale in the U.S.
In October, FDA sent Veloxis a tentative approval letter for once-daily Envarsus XR, which delayed final marketing approval until exclusivity expires for once-daily Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503) on July 19, 2016 (see BioCentury Extra, Oct. 31).
According to the suit, Veloxis believes Astagraf XL is not entitled to exclusivity and that FDA's failure to immediately approve Envasus XR exceeds its statutory authority. Specifically, Veloxis argues Astagraf XL did not meet the statutory test for exclusivity for antibiotic-containing compounds based on the date Astellas submitted in its NDA.
Veloxis is seeking an injunction ordering FDA to rescind the marketing exclusivity awarded to Astagraf XL.
Envarsus XR is approved in Europe, where partner Chiesi Farmaceutici S.p.A. (Parma, Italy) has commercialization rights. The product delivers tacrolimus using Veloxis' MeltDose technology.
Veloxis fell DKK0.04 to DKK1.12 on Tuesday. B
BB: I believe Zip is correct. FDA is neither stupid
or corrupt. I believe ZIP is correct. At least it's
been my experience over the last 22 years. I've sat
on two Oncology panels and saw them up and personal.
I hate what happened with AMRN, but I believe that
other factors were involved. Political yes, but not
stupid or corrupt. You ought to stop passing gas for
a living and give fiction a shot. Particularly Mystery
Thrillers. Your conspiracy theories would be great.
You might make a lot of bucks doing that. I do love
you Will, but some of your theories would make great
fiction. Why don't you start with "Amarin, a Biotechnology
Love Story".
sts: It has nothing to do with FDA bribes
or anything like that. The Co. that has the
Priority Review can and has on multiple
occasions sold it. Curiously the price
keeps going up. SNY, REGN, AMGN, and PFE
will be approved at basically the same time.
PDUFA,s trump all else. I personally am
very impressed with the PCSK9 drugs and
would hope after RE-IT, they do a deal
with PFE. I believe PFE's data is the best.
They could possibly replace Statins, assuming
the outcomes trials are positive. It could
be close in timing to RE-IT outcome data.
IMO, PCSK9 could potentially add great value
to AMRN . Stay tuned !
JL: I agree about PPS, but feel AMRN will be under
pressure due to year end tax loss selling.
concapk: Thank you for your erudite post. Obviously I wasn't
there, and like everyone in the business, we depend on "our
sources" Basically I believe the information I communicated
to be accurate. In case you weren't on board earlier, my fund
charter doesn't permit me to be involved in "Binary Events"
I was out of the stock during the run up to the panel meeting.
I have no skin in the game. My only interest has been that I
believe Vascepa is an excellent drug that should be on the market.
Thanks to JL and others, a most compelling case for EPA was made
on this site. I too did my own diligence. As a Physician, I do
understand the science, which I have always maintained was pristine, and as an investor I understand the quirky nature of
of the Investment Community. I have always believed that AF must
have had information no one else had. Sadly in point of fact he
was correct. My only interest in visiting this site from time to time is to follow the chatter, and hopefully live to see Vascepa become a mainstay of Cardio Vascular preventative Medicine.
BB: excellent questions . I won't attempt to answer
all of them as I don't have high conviction levels
on all. That said, AMRN shareholders have every right
to be pissed. JMO, but just being pissed at FDA is
wrongheaded. MGMT's actions/inactions, management
style, poisoning the FDA well, make them complicit
as well.
RobinF: When you're right you're right !
HD: Thanks about the Cap Lock heads up. As far
as your example goes, I'm not sure it really
applies to this situation. Apparently, from what
I could cull JT wanted a full Anchor approval
and was unwilling to compromise. Now you have
all the info I have. Lesson learned, never play
hard ball with the FDA. It's a lose/lose proposition.
HD: I RESPECTFULLY DISAGREE WITH YOU. AMRN
COULD HAVE STARTED A BETTER RELATIONSHIP WITH
AGENCY, WHICH IMO WOULD HAVE BEEN A GIANT STEP
FORWARD.
HD: What I am led to believe is that a few weeks prior
to AD COM FDA was privy to the new AHA/ACA guidelines
where the only Non Statin drugs that were written into
the new guidelines were to lower LDL C. TG's were not
included. I believe but don't know for sure that FDA
considered that as new science. I believe FDA wanted
to revise the SPA to include RE-IT results. I have not
one clue as to why JT didn't agree to the revision. That's
all I know.
RobinF: I completely agree with you. That said,
in spite of Legal Council, AMRN wasn't familiar
with FDA procedure and didn't realize that FDA
only negotiates an issue for about 3 days. I
referred to it as fluent in FDA speak. I understand
your confusion.
HD: It was the Anchor SPA
HD: Thanks for your note. I was part of EPADI, and following
ADCOM, I volunteered to contact Waxman. I had been his Constituent
for over 25 years (living in Beverly Hills). I had personally
contributed to his campaigns, and actually had several conversations with him over the years. I was impressed by his signature 1997 Hatch/Waxman legislation, which ostensibly had
the purpose of leveling the playing field for Small Biotech vs
Large Pharma. It accelerated the approval process, put in place
PDUFA fees, and created the SPA. Since he knew I was a constituent, getting to him was easy. I initially crafted a letter
exposing the ADCOM Sham, and IMO breeching his legislation by
negating the Anchor SPA. He was receptive and we had several
interactions. After he became involved, the SPA was eventually
put back on the table. Epadi, Zum, Go Seek and others told me that
John Thero had acknowledged that his involvement along with Senator Chuck Grassley (who I also luckily got in touch with) was
very helpful in getting the SPA put back on the table. That's
exactly how it came down. What happened MLK weekend, was that after 3 days of negotiating ( FDA and Thero and AMRN'S CMO) the
FDA pulled the plug. There were quite a few HF's involved and the
story that I heard was that FDA wanted to revise the SPA, and AMRN
didn't agree. As to the compromise, that was just Wall Street chatter. It was published in an Industry Publication, and the word
spread. Unfortunately retail investors don't have the same access
to information that the Investment Community does. Someone always knows something we don't know.