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NCE? R-I interim? Additional overseas rights?
Halted for news.
AK, if layman like you and me know that, how come FDA and PCPs not advocated such important life saving theory.
BC, since you are the technical type, you might appreciate that,
http://www.eejournal.com/archives/articles/20150501-intl-altr/
I am massively long in ALTR.
Totally agree and Amarin's survival is pretty much assured having a rich "uncle" like BB to lean on. It won't shock me that BB is giving JT and management some strategic advice as well.
BB's top 10 holdings as of 12/31/14
No. Security Ticker Shares Value (x$1000) Activity % Port
1.
Pharmacyclics Inc
PCYC 9,129,231 $1,116,140 -6% 11.39%
2.
Incyte Corp
INCY 14,845,559 $1,085,359 11.07%
3.
Synageva Biopharma Corp
GEVA 10,660,432 $989,182 10.09%
4.
Seattle Genetics Inc
SGEN 27,861,720 $895,197 +24% 9.13%
5.
Avanir Pharmaceuticlas Inc
AVNR 38,513,713 $652,807 +84% 6.66%
6.
Acadia Pharmaceuticals
ACAD 20,481,442 $650,286 6.63%
7.
Salix Pharmaceuticals LtdBOND
SLXP 219,440,000 $542,741 5.53%
8.
Genomic Health Inc
GHDX 13,656,318 $436,592 +1% 4.45%
9.
Incyte CorpBOND
INCY 274,500,000 $421,613 4.3%
10.
Incyte CorpBOND
INCY 259,000,000 $388,039 3.96%
PCYC, GEVA, AVNR and SLXP have all been taken over recently. Folks, we are with good company in our Amarin investment.
The content of the research report is much more important than the price target. The highest Wall Street price target for GEVA is $125 and now it's taking over for over $200.
The Baker Brothers hook another one.
Alexion agrees to acquire Synageva in transaction valued at $8.4B net of cash
Alexion (ALXN) and Synageva (GEVA) announced that they have entered into a definitive agreement pursuant to which Alexion will acquire Synageva for consideration of $115 in cash and 0.6581 Alexion shares, for each share of Synageva, implying a total per share value of $230 based on the nine day volume-weighted average closing price of Alexion stock through May 5, 2015. The transaction has been unanimously approved by both companies’ boards, and is valued at approximately $8.4B net of Synageva’s cash. The transaction is expected to accelerate and diversify Alexion’s growing revenues, and Alexion expects to achieve annual cost synergies starting this year and growing to at least $150M in 2017. In addition, the transaction is expected to be accretive to non-GAAP earnings per share in 2018. The completion of the exchange offer and the merger are subject to customary closing conditions, the tender of a majority of the outstanding shares of Synageva common stock and receipt of required regulatory approval. The transaction is expected to close mid-2015. The merger agreement provides that Alexion may, in certain circumstances, determine to alternatively effect the transaction through a one-step merger, in which case a meeting of Synageva stockholders would be held to vote on the transaction. In connection with the Transaction, Synageva shareholders, including affiliates of Baker Brothers Investments, have entered into voting and support agreements with Alexion covering approximately 33.5% of Synageva’s outstanding shares. Alexion has received committed financing of $3.5Bfrom Bank of America Merrill Lynch and J.P. Morgan in connection with the transaction. :theflyonthewall.com
To close out a day of lively debate, I would like to quote the great Bruce Lee,
"Absorb what is useful, Discard what is not, Add what is uniquely your own"
Have a good night everybody.
Profitable opportunities exist when you make the correct assumptions not after the fact, based on my over 20 years of investment experience.
HD, thanks for coming to the rescue. I couldn't say it any better. Have a great day.
BC, I know. I just try to give AK a hypothetical example. All we know is :
1) the trial is tracking to the expected event rate, according to management.
2) 967th event will occur in 2016.
3) 1612th event will occur in late 2017.
4) management is very confident about the trial success by mentioning interim analysis repeatedly.
5) the Bakers Brothers know more about the progress of R-I trial than anybody on this board.
6) the two smartest posters I know, JL and HD, are confident about the success of R-I.
Have a great day.
Thanks JL. Always learn something from reading your post. Have a great day.
AK asked,
"Would placing these patients , with prior history , on Crestor or Lipitor to get their LDL under 100 ,made any difference ?"
It'll make a difference. The event rate for the control arm probably drops from 5.9% to 5.2% (because management said events is tracking to the expected rate). The Vascepa arm event rate probably drops from 2.2% to 2.0%, IMO, just try to agree with your LDL theory.
"The JUPITER investigators randomly allocated 11 001 men and 6801 women who had hsCRP levels >2 mg/L (median, 4.2 mg/L) and LDL cholesterol levels <130 mg/dL (median, 108 mg/dL) to either rosuvastatin 20 mg or to placebo."
It's funny that a statin trial enroll patients with normal LDL level. Jupiter should be called hsCRP trial.
I can't see a 50% reduction in LDL as AK suggested since the medium LDL is already at a low level of 108.
I'll be much more impressed with the trial results if the patients have normal hsCRP but abnormmally high LDL. I am sure AK can point me to such outcome trial.
"reduced LDL 50% and we got about 50% reduction in events",
What's the name of such outcome trial? TIA.
AK, your point is not valid because R-I is tracking to the expected event rate so far, right? Furthermore, the Vascepa arm's event rate should be less than 2.2% since their LDL level is less than 100 (much lower than its Japanese counterpart)based on your theory.
JL, you are right.
SK made the following comments in recent CC,
"We know that in JELIS, the level of EPA achieved in plasma with a 1.8-gram per day dose was relatively high. This is likely due in large part to the Japanese diet, which generally consists of greater fish consumption, resulting in higher baseline levels of EPA. In REDUCE-IT, 4 grams of EPA per day is intended to raise EPA concentrations in plasma to high levels that are similar to or slightly higher than those observed in JELIS, and to sustain these high-plasma EPA concentrations throughout the study. With statin-treated baseline triglyceride levels of 200 to 499 milligrams per deciliter, the lipid profiles of ANCHOR patients most closely resembled REDUCE-IT patients. Patients in ANCHOR had baseline plasma EPA levels that were less than 1/3 of baseline levels in JELIS. But Vascepa 4 grams per day raised plasma EPA levels in ANCHOR to comparable levels as observed in JELIS. Vascepa 4 grams per day in MARINE raised plasma EPA levels even higher in patients with baseline triglycerides of 500 to 2,000 milligrams per deciliter. While there can be no assurance that REDUCE-IT will be successful, 4 grams per day dosing in REDUCE-IT is an intentional step towards positioning REDUCE-IT for success."
HD, can we read that actual event rate is closer to 5.9% as Amarin has slowed down the R-I enrollment process in the last few months?
After Feb 2016 is not the same as late 2016. You can't, like the FDA, has it both ways.
AK, the 20% efficacy doesn't correlate with late 2016 interim readout because lower efficacy leads to earlier interim. HD had a brilliant explanation and R-I interim calculation few months back. I hope he can repeat that exercise again here.
We know the following about R-I,
1) the 1612th event will occur end of 2017
2) the 967th event will occur sometimes in 2016
3) the lower the efficacy, the earlier the R-I interim
JL put out the most "ILLUMINATING" theory months ago.
Amarin knows the number of events occurred so far in R-I. They calculated the placebo rate around Q2 of 2013 (before the Vascepa effect fully kicked in) based on the number of events up to that point, say 5%. Amarin then increased the TG requirement for R-I to enrich the trial in order to get sicker patients hence making the calculated placebo rate even more reliable. In Q3 of 2014, Amarin calculated the updated event rate again (pick a number), say 4%. That translate to 40% Vascepa efficacy. It's at that time that Amarin decided to re-affirm the continuation of R-I, drop the appeal of ANCHOR sNDA (since the court case outcome would surely come after the R-I interim) and JT talked up R-I interim every chance he got.
I am sure Stonepine and BB had followed the Amarin saga and tried to get more info. from JT and management about the progress of R-I around end of 2014. They then made their investment after extensive DD and meeting with management.
My theory above hinges on one important thing ...
Is JT a slimeball? He could talk up R-I interim just to support the stock price despite getting disappointing updated R-I event rate. He seems to be a stand up guy, constantly saying ANCHOR sNDA is an uphill battle and promised to sell non-US Vascepa rights, both turn out to be true.
You bet. Funds like BB got into a stock position because of certain long range catalysts and events. Unlike you and me, they are not swayed by the day to day stock fluctuation. Look at how they do with stocks like PCYC, SLXP, ANAC, etc.
FDA could approve drugs for new uses on less data: draft law,
(Reuters) - Draft U.S. legislation released on Wednesday could make it easier for drug companies to win Food and Drug Administration approval of products for new uses.
Currently a company with a drug approved for lung cancer must conduct additional studies if it wants to market it for breast cancer.
A bill drafted by the House Energy & Commerce Committee's health panel would eliminate the need for randomized, controlled clinical trials, the gold standard for assessing whether a product is safe and effective.
Instead companies could submit data from observational studies, in which researchers have no control over the experiment, ongoing surveillance studies and other clinical experience.
"Calling for the FDA to use this data is pretty revolutionary," said Peter Pitts, a former FDA associate commissioner for external relations and co-founder of the industry-funded Center for Medicine in the Public Interest. "In the past this kind of data was not considered gold standard."
If included in the final version of the bill, known as 21st Century Cures, "it really would allow the FDA to have a broader view of how the drugs work in the real world," he added.
In addition, the FDA would be allowed to approve new indications based on a review of clinical data summaries, rather than full packages, potentially speeding up the approval time.
The bill would also require the agency to consider using real world experience as opposed to randomized trials to support or satisfy requirements for post-market studies.
The FDA frequently approves drugs based on "surrogate" endpoints that are expected to reflect clinical benefits. If a drug causes a tumor to shrink there is an expectation it could also delay progression of the disease or prolong life.
But companies are required to conduct additional trials to confirm that the expected benefit actually materializes. The bill would reduce the need for such trials.
It would also make it easier for companies to provide economic analyses to insurance companies and others involved in reimbursement. A company with a high-priced drug might want to show why it is more economical than others in the long run.
An prior version of the bill was circulated for discussion earlier this year. A parallel bill is being developed in the Senate.
(Reporting by Toni Clarke in Washington; Editing by Ted Botha)
***
Shall I say the blinds leading the corrupts.
http://in.mobile.reuters.com/article/idINKBN0NK2FA20150429?irpc=932
HD, based on your Q12016 interim estimate, what's the efficacy expectation?
New updated Amarin investor presentation,
http://files.shareholder.com/downloads/AMRN/3172500589x0x799267/B882FB49-4910-4F4D-9534-301ED99C78ED/Amarin_Investor_Presentation_april_2015.pdf
More color on China deal and increase sales rep. to 150?
Regarding the Vascepa Savings Card,
"The patient is responsible for the first $9 of their copay and the card pays up to the next $70 of their remaining copay prior to 12/31/2015."
From the following article,
http://seekingalpha.com/article/1639082-glaxosmithkline-clearing-the-clouds-over-nce-prospects-of-amarins-vascepa
We learned FDA's view about Lovaza,
1) The entire fish-oil based mixture in Lovaza, not just the ethyl esters of omega-3 fatty acids, constitutes the active ingredient.
2) The active ingredient of Lovaza is not simply the seven omega-3-acid ethyl esters, but the entire mixture.
3) In concluding that Lovaza was entitled to five-year exclusivity as a new chemical entity, FDA determined that Lovaza is a single active ingredient product, comprised of a single, complex mixture. Lovaza's safety and effectiveness were based on the entire mixture.
4) In a November 1, 2004 facsimile to Lovaza's sponser, FDA noted that the sponsor had requested that the established name for Lovaza be changed from "omega-3-acid ethyl esters" to a combination of ... two main components of Lovaza, EPA ethyl ester and DHA ethyl ester. FDA rejected this approach, noting that the sponsor's proposed name did not correspond to the drug substance of Lovaza, as it "implies that there are no other components to the drug substance, when, in fact, there are."
If Judge Moss says “No” to Vascepa being an NCE, any individual component of an already approved uncharacterized mixture will never be eligible for NCE in the future of drug development to save life. If a component of an already approved uncharacterized mixture could cure cancer, we’ll never know because no drug company is going to invest R&D dollar for such investigation. I believe the future of American healthcare and citizens’ well beings are in the hands of Judge Moss.
BB, do you think Judge Moss is aware of FDA's rejection of Fusion CP? hence agreeing with GSK that Lovaza is an un-characterized O3 mixture. If yes, Judge Moss can easily recognize that FDA talks from both sides of their mouth and make Vascepa's NCE designation a easy call.
Quote from the article Zum posted,
"According to Amy Jamieson, MS, PES, AASDN, a nutrition lecturer and faculty of the Department of Exercise and Sport Studies at UCSB, DHA has many other benefits for our bodies also.
“Health benefits include an increase in HDL — the good cholesterol — and a decrease in LDL — the bad cholesterol — which results in improved blood cholesterol levels and reduced risk of heart disease,” Jamieson said."
I don't want Ms. Jamieson to advise me on nutrition ever.
Should The FDA Require CV Outcome Studies For Diabetes Drugs Before Approval?
http://www.forbes.com/sites/johnlamattina/2015/04/13/should-the-fda-require-cv-outcome-studies-for-diabetes-drugs-before-approval/
AT, count me as a 5th grader then.
The slip of the tongue from the late Eric Colman,
pay attention @ the 45 sec mark of the following video,
BB, the Fusion CP and NCE decision are clearly linked since they came out at the same time. FDA could have said "Yes" to Fusion CP which would strengthen its "No" NCE argument. Why FDA said "No" to Fusion CP? TIA.
Great news on scripts,
Vascepa
TR x: 11,158 (up 2.6% from 10,872 prior week; all time high)
NR x: 4,928 (down 0.2% from 4,940; all time high was 5,020 for WE 03/06/2015)
For comparison...
................Lovaza............................................................Generic Lovaza
TR x:......7,715 (down 2.2% from 7,892)............... 66,154 (up 2.1% from 64,774)
NR x: ....2,331 (down 7.4% from 2,518)................25,837 (down 3.2% from 26,687)
Thanks for keystone in YMB. Was last week a short week too?
Randy Moss, a great player and a great Judge!
The Senate on Thursday confirmed Randolph Moss to the U.S. District Court for the District of Columbia by a 54-45 vote.
The Senators largely split along party lines. Sen. Susan Collins, R-Maine, crossed the aisle to confirm Moss, while Sen. Joe Manchin, D-W.Va., voted against him alongside the Republicans.
Moss, a partner in Wilmer Cutler Pickering Hale and Dorr’s Washington office and former clerk to U.S. Supreme Court Justice John Paul Stevens, will take the seat vacated by Judge Robert Wilkins, who was confirmed to the D.C. Circuit in January.
Though his confirmation was never in danger while the Democrats held the Senate, Moss did face resistance from Republicans, who took issue with statements he made in private practice supporting campaign finance reform and gun control.
During Moss’ confirmation hearings in June, Sen. Chuck Grassley, R-Iowa, the ranking member of the Senate Judiciary Committee, said, “I’ve observed a tendency in his approach to constitutional interpretation that incorrectly and inappropriately curtails the scope and nature of the rights individual Americans enjoy.”
Moss, who punctuated his years at Wilmer with a stint at U.S. Department of Justice's Office of Legal Counsel from 1996 to 2001, passed through the Judiciary Committee by an 11-7 vote. Sen. Orrin Hatch, R-Utah, voted with the Democrats to send Moss from the committee to the full Senate, but he sided against Moss’ confirmation on Wednesday.
Immediately after Moss’ confirmation, the Senate approved Leigh Martin May to be a U.S. district judge in the Northern District of Georgia by a 99-0 vote.
Read more: http://www.nationallawjournal.com/legaltimes/id=1202676337921/Wilmers-Randy-Moss-Confirmed-to-DC-Federal-Trial-Bench#ixzz3WAFrAhbi
http://www.nationallawjournal.com/legaltimes/id=1202676337921/Wilmers-Randy-Moss-Confirmed-to-DC-Federal-Trial-Bench
Association Between Apple Consumption and Physician Visits,
Importance Fruit consumption is believed to have beneficial health effects, and some claim, “An apple a day keeps the doctor away.”
Objective To examine the relationship between eating an apple a day and keeping the doctor away.
Design, Setting, and Participants A cross-sectional study of a nationally representative sample of the noninstitutionalized US adult population. A total of 8728 adults 18 years and older from the 2007-2008 and 2009-2010 National Health and Nutrition Examination Survey completed a 24-hour dietary recall questionnaire and reported that the quantity of food they ate was reflective of their usual daily diet.
Exposures Daily apple eaters (consuming the equivalent of at least 1 small apple daily, or 149 g of raw apple) vs non–apple eaters, based on the reported quantity of whole apple consumed during the 24-hour dietary recall period.
Main Outcomes and Measures The primary outcome measure was success at “keeping the doctor away,” measured as no more than 1 visit (self-reported) to a physician during the past year; secondary outcomes included successful avoidance of other health care services (ie, no overnight hospital stays, visits to a mental health professional, or prescription medications).
Results Of 8399 eligible study participants who completed the dietary recall questionnaire, we identified 753 adult apple eaters (9.0%)—those who typically consume at least 1 small apple per day. Compared with the 7646 non–apple eaters (91.0%), apple eaters had higher educational attainment, were more likely to be from a racial or ethnic minority, and were less likely to smoke (P?<?.001 for each comparison). Apple eaters were more likely, in the crude analysis, to keep the doctor (and prescription medications) away: 39.0% of apple eaters avoided physician visits vs 33.9% of non–apple eaters (P?=?.03). After adjusting for sociodemographic and health-related characteristics, however, the association was no longer statistically significant (OR, 1.19; 95% CI, 0.93-1.53; P?=?.15). In the adjusted analysis, apple eaters also remained marginally more successful at avoiding prescription medications (odds ratio, 1.27; 95% CI, 1.00-1.63). There were no differences seen in overnight hospital stay or mental health visits.
Conclusions and Relevance Evidence does not support that an apple a day keeps the doctor away; however, the small fraction of US adults who eat an apple a day do appear to use fewer prescription medications.
http://archinte.jamanetwork.com/article.aspx?articleid=2210883
Mr. 1bill, I like your style, all action and not just pure talk. Hope Mr. Seiffert shows some interest in our little amarin corp.
FDA panelist confirms conflict of interest following Sarepta drug discussions,
http://www.bizjournals.com/boston/blog/bioflash/2015/03/fda-panelist-confirms-conflict-of-interest.html?ana=twt
I wish the Boston Business Journal would investigate Amarin ADCOM panel's conflict of interest.
BB, can you expand on the reasoning when you have time?
"Only reason FDA ruled against Fuson petition? They where caught red handed trying to rob Amarin stakeholders blind."
TIA.