InterMune Inc. (ITMN)

[WID]

Here is what I posted on the other message board:

Boehringer Kept Pradaxa Analysis From FDA, Records Show

Bad practice!

Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.

Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show.

The Food and Drug Administration was reviewing the bleeding as part of a safety check spurred by results seen in adverse incident reports sent to the agency. Andreas Clemens, an executive who oversees Pradaxa, acknowledged the Ingelheim, Germany-based company shared only one of the analyses and said he couldn’t say why, according to the unsealed court filings.

“Having run an analysis in several ways, there is no good reason not to disclose all the results,” said Harlan Krumholz, a Yale University cardiologist in New Haven, Connecticut, who is leading an effort to get companies and researchers to share their findings fully.

Boehringer gave the FDA the underlying data and provided an analysis using what the drugmaker considered to be the most appropriate comparison, said Marjorie Moeling, a company spokeswoman, in an e-mailed response to questions. “The company is completely confident that all of the facts will show that Boehringer Ingelheim acted appropriately and responsibly.”

2,000 Lawsuits

A company filing this month said Boehringer faces more than 2,000 suits involving Pradaxa, a treatment used to prevent strokes in patients who suffer from atrial fibrillation, a heart-rhythm disorder. Regulators cleared the drug, which generated $1.4 billion in 2012 sales, as the first alternative to warfarin, a product sold by Bristol-Myers Squibb Co. under the brand name Coumadin that’s been used for 50 years to avert strokes caused by blood clots.

http://www.bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html

[someconcerns]

I believe the company PR said they would apply to the FDA sometime in 3Q2014.

[breezy1]

Nice to be on the right side congrats

[rayray33]

When is the FDA approval vote??

[rayray33]

Congrats to Everyone!! .. When are we up for possible FDA approval ?

[MONEYMADE]

,,,,,,,Nice rocket $35

[someconcerns]

Clearly it's going against my directional call, which was based on my gut anyway. It clearly will be a benefit to society, or at least the narrow segment of people with mid to moderate IPF. Keep holding!

[Fergo]

What’s up ManicTrader? Not bad; less than three months. Sell the news - when it stops! From the chart analysis side though, a classic cup and handle emerged after an intermittent retracement. If one were to highly regard chart analysis we may be reaching 5-yr high supports before news dwindles. Dig-it, dig-it, wow, wow. GLTA and trade well

[ghmm]

Congratulations nothing wrong with taking some money off the table. I had sold some earlier so I wasn't as confident (more I didn't like the much slower EU rollout). These results were better than I expected. I didn't expect them to hit a stat significant even pooled on survival and I thought showing 6MW significance would be hard to do as well. I tend to think the price will steadily rise but I am not one to predict short-term.

[stockprofitter]

$ITMN Wish on I had a larger position - OH WELL.
Super fun stock.

[someconcerns]

GHMM,

I agree that it SHOULD be a slam dunk FDA approval and feel the US market will likely see slightly higher net product prices per patient-year. The 7 and 10 year exclusivity should be a sufficient time horizon.

However, I succumbed to temptation and sold my shares this morning, remembering how I didn't sell when the Europeans approved Esbriet shortly after the FDA denied approval. Kicked myself frequently as the shares dropped subsequently.

I do expect the price to drop to at least 30 and possibly to 25, when people start focusing on the timeline before FDA approval (application in the 3Q2014). I plan on buying back in, a luxury afforded by trading in a Roth account, although I too am typically a holder long-term.

I hope your forecast is accurate long-term and that mine is accurate short-term.

Steve

[ghmm]

Hi Steve,

I had sold some prior to this data but my current thinking is not to sell at least till approval and likely longer. I am generally a long term holder. I think the data easily support US approval and I would expect much better uptake in the US and as the data gets out x-US uptake could see a meaningful pickup too and likely better compliance too. Still some concerns for me around the IP position and generic/followon analogs though ITMN would have at least Orphan exclusivity (7 years in US, 10 in EU)

[someconcerns]

GHMM,

Yes, read the news and am happy I'm still long as well. Are you going to sell on the pop? Holding thru FDA approval? Or holding long term? GLTU!

Steve

[ghmm]

The ASCEND results are quite good. Here is what I wrote on another board.

At first glance this would be a triple and would seem superior to what we know about the BI drug to date. Meeting the survival end point (pooled with CAPACITY) which was predefined was a key. Also the 6 minute walk test showing significance is important as its used in other lung diseases for approval. A home run would have been meeting survival in ASCEND alone, it should be noted the company had PREVIOUSLY stated the trial was not powered to do so, nor was it a stated requirement for approval but pooled at least a trend would have been necessary.

For disclosure I am still long ITMN but had sold a descent portion of my holdings prior and I am long ITMN in my SI portfolio.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=97801516

[someconcerns]

GLTAL

[Fergo]

someconcerns; good metaphor to knight’s tale. Hope the new achieved SP after recent issuance of stock is segue to positive drug news. In any event, looks like the birth of an uptrend. Fingers crossed. GLTA and trade well.

[someconcerns]

I guess resistance was tested - and found wanting (as in the old Heath Ledger movie).

[Fergo]

Will do ManicT. She’s testing 2-yr 17.09 resistance (momentum from yesterday I'll bet). Again, appreciate immensely your 2 cents on this. GLTA and trade well

[ManicTrader]

Hey buddy good to hear from u and alls well. 1st level we have to break is the 16.00 and then the 200ma resistance on the weekly chart. That 5 yr resistance was from good PDFU results and i got killed trying to short it, was not fun, let me tell u but hey after passing that 200ma, all it takes is some good drug news to send it higher. I have some friends that work in the bio sector and let me ask whats going on with ITMN and get back to u or hit me up in a week or so ok? 8)

[Fergo]

MinicT – you're spot on with testing support. In addition, SEC authorized 6.5m additional shares - She sold out and I thought she’d tank for sure; but, she held steady, recovered, and excelled. She’s at her 2 yr high. IYHO, do you think she’ll drive on to test 5 year resistances (in such case I will retire)? Or, do you think she'll exhaust? I seek your expert opinion. Thanks immensely. V | R, Fergo. GLTA and trade well.

[surf1944]

7:32AM InterMune sees Q4 revs above estimates; sees FY14 revs in-line with consensus (ITMN) 15.13 : Co issues upside guidance for Q4 (Dec), sees Q4 (Dec) revs of $25.6 mln vs. $22.74 mln Capital IQ Consensus Estimate. Co issues in-line guidance for FY14 (Dec), sees FY14 (Dec) revs of $115-135 mln vs. $132.36 mln Capital IQ Consensus Estimate.

2013 Highlights:
Unaudited Esbriet revenue in the fourth quarter of 2013 totaled ~$25.6 mln, compared with $8.2 mln in the fourth quarter of 2012, an increase of 212 percent. Unaudited Esbriet revenue totaled ~$70.2 mln for the full-year 2013, compared with $26.2 mln in 2012, an increase of 168 percent.

Guidance for 2013 Operating Expenses
The company refined its financial guidance for 2013 operating expenses:

R&D expense: currently anticipated to be in the range of $110-115 mln versus the previous guidance range of $100-120 mln.
SG&A expense: currently anticipated to be in the range of $145-150 mln versus the previous guidance range of $145-165 mln.
Total Operating Expenses (R&D and SG&A): currently anticipated to be in the range of $255-265 mln compared to the previous guidance range of $245-285 mln.

2014 Outlook and Milestones
Esbriet in Europe
The company expects to continue its growth of Esbriet revenue in the 13 of 15 targeted countries in which Esbriet has now been launched.
InterMune expects to have further information on the status of pricing and reimbursement of Esbriet in Spain and the Netherlands in the first half of 2014.
In late 2014, the company expects to begin commercializing Esbriet in other countries beyond its initial EU priority 15 countries.
ASCEND and U.S. Pre-Launch Preparations
InterMune currently expects to report top-line results from ASCEND early in the second quarter of 2014 and to present study results at the May 2014 International Conference of the American Thoracic Society (ATS) in San Diego.
The company plans to provide a timeline for the Esbriet NDA resubmission when it announces the top-line results of ASCEND in the second quarter of 2014.

Guidance for 2014 Revenue and Operating Expenses
Esbriet revenue: currently projected to be in a range of $115-135 mln, compared-70.2 mln in 2013. The guidance range includes the recent decrease in the mandatory industry rebate in Germany from 16% to a maximum of 7% of gross revenues effective January 1, 2014.
The revenue guidance range includes potential Esbriet revenues from Spain and the Netherlands and potential revenues in late 2014 from other countries beyond the first-priority 15 EU countries.
InterMune expects to have additional clarity on the status of Esbriet reimbursement in Spain and the Netherlands during the first half of 2014.
The revenue guidance also accounts for the projected time needed to address public reimbursement procedures in Canada before meaningful Esbriet revenues can be achieved in all provinces and territories in that country.
Total Operating Expenses (R&D and SG&A): currently anticipated to be in a range of $320-345 mln.

[ghmm]

The disease definitely needs some hope for patients and while neither drug will stop the disease they would at least be a step forward. With some success more interest and research could come like happened in PAH.

Hope you have a Happy new year as well!

[someconcerns]

I hope the study is a smashing success, regardless of how others' drugs do.

Have a happy and healthy New Year!

[ghmm]

Summer Street thinks ASCEND will be successful and BI's nintedanib will fail. I believe they've been bullish on ITMN for a long time so they may be a bit biased.

http://www.streetinsider.com/Analyst+Comments/InterMune+%28ITMN%29+Stock+Can+Continue+to+Run+in+the+First+Quarter+of+2014+-+Summer+Street/9012043.html

[ManicTrader]

$ITMN 13.70 Golden Cross Setting up, shes retesting previous support now, 12.58 area 100ma support

[Fergo]

ManicT - Excellent ABC, Flag/Pennant, and cup-and-handle patterns; all these at once. Solid rumors. Get ready!! GLTA and trade well

[ManicTrader]

116% and Counting! Manic Stock Alerts On $ITMN Since 9/04/12

$ITMN Will Be Huge imo, Keep $ITMN on Heavy Radar, 7.41 alert 9/04/12

ManicTrader Member Level

Tuesday, September 04, 2012 1:45:09 PM
Re: cha-ching post# 9039
Post # of 11529
$ITMN 7.41, Held 7.21 support and moving on up, i fully endorse as long as she holds

[Fergo]

Excellent Steve. I have been holding long on itman as well. I'll continue trailing for the time being

[someconcerns]

Fergo, I think it is a long term winner. I generally buy and hold, so long term is my game. Steve

[Fergo]

Someconcerns,
Thanks for the report. IMO, it isn't positive or negative and that's a good thing all the way around. More time is obviously needed to effectively ferret out observations. IMO, the recent Italian sale coupled with possible near term FDA approval will cause pps to continue climbing. This month (what a month) is just the beginning. We'll see. Go itman! GLTA and trade well

[someconcerns]

So, treat IPF with viagra? Go out with a bang!

[ghmm]

Interesting analysis of acute exacerbation in the Sildenafil trial

http://respiratory-research.com/content/pdf/1465-9921-14-73.pdf

[ECole]

JMP securities updates


Interesting comments made by Intermune.. worth reading
Read here

[Fergo]

$ITMN$$ has much potentiality for a major move up - go itman!

[Fergo]

$ITMN$ has been uptrending for 6 months and hasn't seen $11 for a year. She's waking up

[someconcerns]

Let's hope!

[Fergo]

Thanks someconcerns - anyway looks like some good news out of Italy. Maybe we'll see a turnaround despite recent negative news

[someconcerns]

Fergo,

If you go here:

http://www.secform4.com/insider-trading/1087432.htm

You'll see most transactions are described as "tax withholding".

Steve

[Renee]

ITMN: SEC Charges Former Officer of Intermune, Inc. with Insider Trading

http://www.sec.gov/litigation/litreleases/2013/lr22717.htm

[Fergo]

Any idea on why so many buys, now? Usually it's onezies and twozies every couple months and mostly sells. Curoius. Thanks

[ghmm]

Only thing I saw were just employee/director options

[Fergo]

Something's amiss - lots of insider buying scheduled

[ghmm]

I'm not sure which specific person you are referring too. Its pretty common though that the people involved in the study are often involved in studies of other drugs in the same or similar indication. Since they are usually experts in the field who are heavily involved in research. So I don't make too much of that.

Yeah we knew a while back the study had failed but it not only did that but had statistical significance for being worse than placebo! That doesn't happen often. I think this may be a strong hint as why Actelion never pushed their drug (if not familiar bosentan is in the same class though slightly different) even after claiming a trend. I have not seen them publish their results either.

[someconcerns]

GHMM,
It was interesting to see how bad the results were. Also interesting was the list of drug firms which paid some of the doctor's expenses. Have you seen any information as to why ITMN paid his travel expenses as it was a Gilead drug?
Steve

[ghmm]

Here is a link to the journal article

http://annals.org/article.aspx?articleid=1684850

[ghmm]

Talk about bad results Ambrisentan (Letairis) not only failed but had a statistically significant increase in disease progression (p=.01) and the Hazard Ratio was 1.74!

http://www.medpagetoday.com/Pulmonology/GeneralPulmonary/38925

[biocqr]

ITMN - InterMune Flush With Cash And ASCEND Positioned To Succeed..

http://www.biotechinvestorsnetwork.com/#!featured-article/c17ob

[someconcerns]

GHMM, Thanks for the posts. Just trying to catch up.

[ManicTrader]

Manic Stock Alerts On $ITMN Since 9/04/12

$ITMN Will Be Huge imo, Keep $ITMN on Heavy Radar, 7.41 alert 9/04/12

ManicTrader Member Level

Tuesday, September 04, 2012 1:45:09 PM
Re: cha-ching post# 9039
Post # of 11529
$ITMN 7.41, Held 7.21 support and moving on up, i fully endorse as long as she holds

http://seekingalpha.com/article/1036791-intermune-gearing-up-for-another-round-with-the-fda?source=yahoo

[ghmm]

Its not a surprise that NICE didn't support funding for Esbriet and I think if they do partially fund it that would be upside at this point. For those interested here are some links to the bureaucratic documents.

http://www.nelm.nhs.uk/en/NeLM-Area/News/2012---November/29/NICE-issues-Appraisal-Consultation-Document-on-pirfenidone-for-idiopathic-pulmonary-fibrosis/
http://www.nice.org.uk/newsroom/pressreleases/NICEConsultsDrugIdiopathicPulmonaryFibrosis.jsp
http://guidance.nice.org.uk/TA/Wave23/25