InterMune Inc. (ITMN)

[ghmm]

Very Interesting study of Pirfenidone. I recall a very early pilot study that tested a much higher dose (I believe 3600mg also) that was actually in more severe patient that had some signs of efficacy (it was a very small uncontrolled study so hard to draw firm conclusion). I don't recall a study dosed on weight before.

http://clinicaltrials.gov/ct2/show/NCT00080223

EDIT: OK this is the original early access program so not news!

[jasonchanning]

$ITMN low floater, looks like a strong buy. Needs to break 9.40 it will hit 10s easily. Sky high!

[someconcerns]

Reimbursement rate in France for Esbriet.

From: http://biz.yahoo.com/e/121017/itmn8-k.html

"Form 8-K for INTERMUNE INC
17-Oct-2012
Other Events

Item 8.01 Other Events.

On October 16, 2012, the Journal Officiel de la R?publique Fran?aise (the official gazette of the French Republic, which serves as the primary source by which the national government of France disseminates legal information about its activities) published the price of Esbriet? (pirfenidone). The publication of price in the Journal Officiel is the final step in the reimbursement process for a new medicine in France. As announced by InterMune, Inc. ("InterMune") on September 11, 2012, the Comit? Economique des Produits de Sant? (France's Economic Committee on Health Care Products) authorized an ex-factory reimbursed price of 1.923,08? for a four-week treatment pack of Esbriet, corresponding to 25,000? per patient, per year (approximately $32,000 USD at the then current exchange rates). InterMune expects to commence the commercial launch of Esbriet in France for the treatment of idiopathic pulmonary fibrosis (IPF) in the second half of November 2012. "

[someconcerns]

But it does raise the profile of treatments in this sector and, to the extent the ITMN product has fewer side effects and is as or more effective, will attract attention to pirfenidone. Meanwhile, the news from France and Canada is all good.

[ghmm]

Recruitment complete for two pivotal Phase III studies of nintedanib* in patients with idiopathic pulmonary fibrosis
http://www.moneylife.in/business-wire-news/recruitment-complete-for-two-pivotal-phase-iii-studies-of-nintedanib-in-patients-with-idiopathic-pulmonary-fibrosis/32754.html

This is BI's drug that seems to have gotten a lot of hopefully press. They had a large number of drop outs (like most IPF trials) the little I recall the data was OK but I don't recall a great P value. Its unlikely IMO that this and Pirfenidone would be used in combo therapy as I believe I posted here (or some place) it has more GI sideeffects than Pirfenidone.

[surf1944]

7:05AM InterMune reports France's Economic Committee authorized reimbursement of Esbriet (pirfenidone) (ITMN) 8.38 : Co reported that the Comite Economique des Produits de Sante (CEPS) has granted reimbursement for Esbriet (pirfenidone), making it the first medicine for the treatment of idiopathic pulmonary fibrosis to be reimbursed in France. The price of Esbriet is expected to be published in France's Journal Officiel in the fourth quarter of 2012; the final step in the reimbursement process for a new medicine in France. Esbriet will be reimbursed as a "Medicament d'Exception," which means that it will be reimbursed only for the labeled indication, defined previously by the Commission de Transparence of the French High Health Authority (CT) as IPF patients with forced vital capacity (FVC) > 50% and carbon monoxide diffusing capacity (DLco) > 35%.

[surf1944]

1:04AM InterMune reports new analyses from the RECAP study of Esbriet (ITMN) 7.37 : Co announces that new analyses of data from the RECAP extension study of Esbriet. These analyses show that patients with mild-to-moderate IPF newly-treated with Esbriet in RECAP for 60 weeks had similar FVC and survival outcomes when compared to those treated with Esbriet for the same duration in CAPACITY. Analysis of pooled data demonstrated that treatment with Esbriet resulted in a 32% reduction in the percentage of patients who experienced an FVC decrement of at least 10% at week 60. A comparison of outcomes in patients newly treated with Esbriet in RECAP showed similar results: the proportion of patients who experienced a 10% or greater decline in FVC at week 60 was 16.3% among patients newly treated with Esbriet in RECAP, compared with 16.8% in the Esbriet group in CAPACITY. The proportion of placebo-treated patients meeting this criterion in CAPACITY was 24.8%. The second analysis was based on the mean change from baseline in percent predicted FVC in the entire population of patients. The analysis of data at week 60 showed that the mean change in percent predicted FVC in patients newly treated with Esbriet in RECAP was -5.8%; the mean change over the corresponding interval during CAPACITY was -7.0% in patients treated with Esbriet and -9.4% in patients treated with placebo. Analysis of data at earlier time points also showed very similar results between patients newly treated with Esbriet in RECAP and those originally treated with Esbriet in CAPACITY. The last analysis examined overall survival from baseline to week 60 in patients newly treated with Esbriet during RECAP. While neither RECAP nor CAPACITY was powered to evaluate the effect of treatment on survival, analyses showed that overall survival at 60 weeks post initiation of therapy was similar in patients newly treated with Esbriet in RECAP and CAPACITY, and greater than that of patients who were treated with placebo in CAPACITY. Additionally, fewer treatment emergent deaths, defined as deaths occurring within 28 days of the last dose of study drug, were observed among Esbriet-treated patients in both RECAP and CAPACITY compared with patients who were treated with placebo during CAPACITY. Treatment-emergent death occurred in 3.4% and 2.9% of Esbriet-treated patients in RECAP and CAPACITY, respectively, compared with 5.8% of patients treated with placebo in CAPACITY.

[Master Bread Maker]

I hate to say it but by reading the financials last night this stock is heading down to the abyss. Very disappointing to say the least! I thought this one would do well at one time

[ghmm]

Its (mildly) interesting ITMN has the Q4 conference call for 8:30am Eastern considering that is 5:30am local.

They generally have there Earnings calls at 4:30pm (Eastern). Going back through the 8:30am calls were:
1/5/12 Business update (They talked about how well the launch in Germany was going)
9/12/11 - Germany Launch Announcement (Theoretically a big milestone for the company)
5/26/11 - Analyst Meeting (this probably doesn't count since was in NY)
4/28/11 - Q4 2010 (this was shortly after the EU Approval decision)
12/17/10 - This is the Big one the CHMP Positive Opinion.

and prior to that last I noticed was
2/3/09 - Phase 3 CAPACITY Results (mixed but eventually led to EU approval)
1/12/09 - ITMN 191 Triple combo results (which was a big deal at the time).


Now this could all be nothing maybe Dan Welch just wants to get started on his vacation early or has a dentist appointment that morning

[ghmm]

Letaris is bad for IPF patients!

http://www.reuters.com/article/2012/07/12/us-glaxosmithkline-volibris-idUSBRE86B0XZ20120712

The warning letter followed a clinical trial which found higher rates of disease progression or deaths in IPF patients on Volibris when compared to placebo.

Actelion said Bosentan had a trend but yet they stopped further development. Its the same class as Letaris so my guess is they saw something that scared them from proceeding.

[Pyckstocks]

ITMN InterMune Completes Divestiture of Actimmune? (interferon gamma-1b)

Company also provides updated expense guidance for 2012 --

BRISBANE, Calif., June 20, 2012 /PRNewswire via COMTEX/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that on June 19, 2012, the company completed the previously announced sale of its rights to Actimmune? (interferon gamma-1b) to Vidara Therapeutics International Limited (Vidara). Vidara is part of an international specialty pharmaceutical group of companies with operations in Ireland and the United States.
Gross proceeds from the sale totaled $55.0 million. In addition, InterMune is eligible to receive a two-year royalty stream based on net sales of Actimmune, which is expected to contribute an aggregate amount of approximately $2-$4 million over the two-year period.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "We are pleased to complete the divestiture of Actimmune. The cash infusion from this transaction combined with $377.2 million of existing cash and cash equivalents at the end of Q1 2012, and our new estimates for lower operating expenses in 2012, will provide additional financial flexibility as we launch Esbriet? (pirfenidone) in Europe and work to make the medicine available to idiopathic pulmonary fibrosis patients in the United States and in other countries."

Guidance for 2012 Expenses

The company today updated its forward-looking financial guidance for operating expenses in 2012, initially provided on January 5, 2012:

R&D expense: currently anticipated to be in a range of $90 to $105 million (previously $95 to $115 million). The updated R&D expense range reflects anticipated timing of completion of enrollment in the ASCEND Phase 3 study, which is currently expected around the end of 2012, as well as a delay of investments in certain non-Esbriet R&D activities.

SG&A expense: currently anticipated to be in a range of $110 to $130 million (previously $120 to $145 million). The updated SG&A expense range reflects the company's current expectations for the timing of the completion of pricing and reimbursement discussions for Esbriet in Europe.

Total Operating Expenses (R&D and SG&A): currently anticipated to be in a range of $200 to $235 million (previously $215 to $260 million).

About Actimmune?

Actimmune is a synthesized version of interferon gamma, a naturally occurring protein believed to stimulate the immune system. Actimmune is FDA approved for the treatment of two life-threatening, ultra-orphan, congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most common side effects are flu-like symptoms, including headache, fatigue, fever, chills and rash. Physicians and patients can obtain additional prescribing information regarding Actimmune, including the product's safety profile, by visiting www.actimmune.com.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in the EU as Esbriet? and is currently in a Phase 3 clinical trial to support regulatory registration in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including, without limitation, the statements related to our expectations regarding the amount of royalties we may receive during the two-year period for sales of Actimmune, the uses of the capital from the divestiture of Actimmune for investing in the development and commercialization of Esbriet, our projections for anticipated operating expenses for 2012, and our expectation regarding the timing of full enrollment in the ASCEND study.

Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from any results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 29, 2012 (the "Form 10-K") and quarterly report on Form 10-Q for the three months ended March 31, 2012 filed with the SEC on May 10, 2012 (the "Form 10-Q"), and other periodic reports filed with the SEC, including but not limited to the following: (i) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (ii) risks related to unexpected regulatory actions or delays or government regulation generally; (iii) risks related to our ability to successfully launch and commercialize Esbriet in the EU, including successfully establishing a commercial operation in the EU and receiving favorable governmental pricing and reimbursement approvals in each EU country; and (iv) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and Form 10-Q and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.

Actimmune? and Esbriet? are registered trademarks of InterMune, Inc.

SOURCE InterMune, Inc.

www.prnewswire.com
Copyright (C) 2012 PR Newswire. All rights reserved

[someconcerns]

Interesting article.

[ghmm]

Interesting article on Pirfenidone. Granted its a meta-analysis but should help support the case for use of Pirfenidone. I am pretty sure InterMune knew about this for some time as Dan Welch was asked once to quantify the benefit of Pirfenidone and I vaguely recall the 30% figure.

http://err.ersjournals.com/content/21/124/147.full.pdf+html

[someconcerns]

InterMune to Divest Actimmune® (Interferon Gamma-1b)
-- To divest Actimmune for $55 million in cash plus a two-year royalty stream --
-- Transaction provides additional financial flexibility --
PR NewswirePress Release: InterMune, Inc. – 4 minutes 35 seconds ago

http://finance.yahoo.com/news/intermune-divest-actimmune-interferon-gamma-205000111.html

BRISBANE, Calif., May 21, 2012 /PRNewswire/ -- InterMune, Inc. (ITMN) today announced that it has reached a definitive agreement with Vidara Therapeutics International Limited (Vidara) to sell its rights to Actimmune® (interferon gamma-1b) in a cash transaction valued at $55 million plus a two-year royalty stream. Vidara is part of an international specialty pharmaceutical group of companies with operations in Ireland and the United States.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "Several years ago, we stopped investigating new uses for Actimmune and it became a tactical financial asset for InterMune. The divesture of Actimmune will provide additional capital for InterMune to continue to focus on and invest in the registration and commercialization of Esbriet® (pirfenidone) in Europe and elsewhere and to continue to advance our R&D programs. The cash infusion from this transaction combined with $377.2 million of existing cash and cash equivalents at the end of Q1 2012 will provide additional financial resources to execute our Vision 2015 strategic plan."

The transaction with Vidara is expected to close during the second quarter of 2012, subject to satisfaction of certain closing conditions. Locust Walk Partners LLC is acting as exclusive financial advisor to InterMune in connection with the transaction.

[someconcerns]

Would not be surprised if that study team next tried a low-dose regimen of strychnine.

[ghmm]

If you have IPF Warfarin is likely a very bad idea

http://ajrccm.atsjournals.org/content/early/2012/05/02/rccm.201202-0314OC.abstract

[ghmm]

On the Morphosys call they said the program has been stopped in the oncology indication but continues in IPF. I just went to the link and it is listed as completed (don't know if I went to wrong program link or the record was changed).

[ghmm]

Fibrogen's IPF program seems to be promising

http://www.fibrogen.com/press/release/pr_1336023017

[ghmm]

Another IPF drug fails

http://clinicaltrials.gov/ct2/show/NCT00581997

( Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date. )

[Penny Roger$]

~ Thursday! $ITMN ~ Q1 Earnings posted, pending or coming soon! In Charts and Links Below!

~ $ITMN ~ Earnings expected on Thursday *
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[ghmm]

Industry Voices: The Fibrosis Stampede

http://www.fiercebiotech.com/story/industry-voices-fibrosis-stampede/2012-04-04

This is a nice article on IPF and clinical development. I believe there was an FDA event recently but unfortunately I don't have any info about it (if someone does please post). The author sounds much more more confident on the mechanism and how to measure clinical progression than I would have expected. It should be noted he is an interested party (founding Stromedix).

[Willsmith3]

This thing is dropping like a penny stock

[mlkrborn]

UPDATE 1-German reimbursement body rules in favor of InterMune's drug



March 15 | Thu Mar 15, 2012 9:07am EDT

(Reuters) - InterMune Inc said the German reimbursement body ruled that its drug Esbriet provided additional benefit to patients suffering from lung scarring, sending its shares up 16 percent in premarket trade.

The decision by the Germany's Federal Joint Committee (G-BA) comes after a negative recommendation from the Institute for Quality and Efficiency in Health Care (IQWiG) on Esbriet in December last year.

"Today's decision applies to all adult patients with mild-to-moderate IPF (idiopathic pulmonary fibrosis) and ensures continued reimbursement in Germany," InterMune's chief executive Dan Welch said in a statement.

G-BA classified the benefit as stage 4, a non-quantifiable benefit, while IQWiG had said Esbriet, also known as pirfenidone, showed no "additional benefit" or effect on the mortality rate or quality of life.

G-BA is the highest decision-making body of the self-governing healthcare system in Germany, the company said.

Esbriet, which has a "orphan drug" status in Europe, was approved by the European regulatory authorities in March 2011 as a treatment for idiopathic pulmonary fibrosis -- the scarring or thickening of the lungs without a known cause.

Shares of InterMune jumped as much as 16 percent in premarket trade to $17.24 on Thursday. They closed at $14.80 on Wednesday on the Nasdaq.

[crazystockace]

3-2-1 liftoff!!! In at 16.28, this is going to skyrocket. I very quiet German approval of epic proportion.

[someconcerns]

Thanks for the links and thoughts. Been away.

[ghmm]

Another IPF drug fails (seems tox was an issue)

http://clinicaltrials.gov/ct2/show/NCT00786201

[ghmm]

Inhaled Interferon Gamma Pilot study
abstract: http://online.liebertpub.com/doi/abs/10.1089/jamp.2011.0919
pdf: http://online.liebertpub.com/doi/pdf/10.1089/jamp.2011.0919

[ghmm]

Most IPF treatment trials I have seen have similar FVC and DLCO entry criteria. I can't imagine anyone targeting more severe patients at this point in understanding for the disease but given the limited understanding I wouldn't be shocked to see someone with a theory why more severe patients could show a benefit easier then mild-to-moderate. Actually early on Pirfenidone was used in more severe IPF patients (I believe they may have also been using a higher dose but going by memory not 100% sure)

There are quite a number of companies pursuing IPF. I've posted some on this board (probably have to go through my posts here for a few years to get some). I have some bookmarked and some just see on clinicaltrials.gov.

The current most advanced is probably the BI compound.
http://clinicaltrials.gov/ct2/show/NCT01335464

[someconcerns]

Interesting article, tho I did not see whether the drug was aimed at mild-to-moderate IPF like Esbriet or if it was for more severe cases. Are these the full range of competition for marketing an IPF drug?

[ghmm]

Here is a link to a story on the drug BIIB (re)acquired for IPF

http://www.checkorphan.org/grid/news/treatment/biogen-gains-fibrosis-drug-in-562m-stromedix-deal

[Penny Roger$]

~ Wednesday! $ITMN ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $ITMN ~ Earnings expected on Wednesday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
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[someconcerns]

They really should pursue legal action, as a small company introducing a new drug can't afford much bad publicity. There have to be many people here in the US who are desperate enough to try buying from a "Canadian" pharmacy.

[ghmm]

I have seen spam saying about buying it in Canada already. InterMune isn't marketing it there so I think those are illegal Pharmacies dispensing it. I don't if InterMune has started going after them yet or if they even amount to anything sales wise to warrant attention at this point.

[someconcerns]

Really had to turn up the sound on that one. I did not realize it is available in Canada now, per this doctor.

[someconcerns]

4:06 PM InterMune (ITMN): Q4 EPS of -$0.69 beats by $0.02. Revenue of $7.81M (-96.8% Y/Y) in-line. Shares +2.3% AH. (PR) [Earnings, Healthcare, On the Move] Comment!

[someconcerns]

ITMN 4th quarter results in: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1659178&highlight=&source=email_rt_mc&ifp=0


InterMune Reports Fourth Quarter and Full Year 2011 Financial Results and Business Highlights

BRISBANE, Calif., Feb. 9, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced results from operations for the fourth quarter and full year ended December 31, 2011.

InterMune reported product revenue in the fourth quarter of 2011 of $7.8 million, consisting of $2.7 million from sales of Esbriet in Europe, and Actimmune® (gamma interferon-1b) revenue of approximately $5.2 million. Product sales in the fourth quarter 2010 consisted solely of $4.9 million of Actimmune revenue, as the initial commercial launch of Esbriet was in Germany in September 2011.

InterMune reported a net loss for the fourth quarter of 2011 of $44.5 million, or $0.69 per share, compared with net income of $206.1 million, or $3.34 per diluted share, in the fourth quarter of 2010. Net income in the fourth quarter of 2010 was driven by the sale of InterMune's danoprevir asset to Roche and the accelerated recognition of deferred revenue in connection with the termination of InterMune's 2006 collaboration agreement with Roche.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "The fourth quarter was the first full quarter of the commercial launch of Esbriet in Germany, marking the first commercial launch in Europe of an approved therapy for idiopathic pulmonary fibrosis (IPF). We are very pleased that the Esbriet launch is off to a very strong start and is among the most successful launches of a specialty product in Germany in terms of revenue and new patient prescriptions. We are also very encouraged by the new Forced Vital Capacity (FVC) and survival data from our RECAP study which illustrates favorable outcomes observed in IPF patients treated with pirfenidone for a year or more."

Recent Business and Clinical Development Highlights ...

[ghmm]

A doctor doing a presentation on IPF. I skimmed through it as it didn't seem extremely substantive (nice overview though for those unfamiliar). In this clip (#3) he does give anecdotal support for Pirfenidone in one of his patients.

http://breathmatters.org/video-idiopathic-pulmonary-fibrosis-3.php

[someconcerns]

OK, Thanks.

[ghmm]

I believe the article was a reference to an article in BioCentury (which I am not a subscriber too):

Here is another link with similar content. Its basically people speaking in support of Pirfenidone and against IQWiG saying their decision goes against the law.

http://www.bioportfolio.com/news/article/925099/German-Pharma-Association-Speaks-Out-On-Esbriet-Assessment.html

No, I am not in the DC area.

[someconcerns]

GHMM, The link is no longer functioning. Would you mind reposting?


BTW, are you located here in the DC area?

[ghmm]

This must be one of the compounds Gilead acquired a little while ago.

http://clinicaltrials.gov/ct2/show/NCT01362231

Its funny IQWiG complained about meaningfulness of FVC but almost everyone doing studies now is using that as a primary end point.

[ghmm]

Interesting study using Rituxan+Steriods for acute exacerbations.

http://clinicaltrials.gov/ct2/show/NCT01524068

The theory in the clinical trials record makes some sense

The investigators central hypothesis is that antibody-mediated autoimmunity can play an important role in IPF exacerbations. The investigators propose to test our central hypothesis by establishing the efficacy of autoantibody removal by plasma exchange (PEX), in conjunction with B-cell depletion by rituximab to deplete immunoglobulins and minimize their further production, among patients with acute IPF exacerbations.

Acute exacerbations lead to a very high mortality rate in the couple months after occurring (I don't recall the figures off hand but believe its over 50%).

[ghmm]

Here is a paper on the increase in incidence of IPF in the UK. Also its generally believed once an approved therapy is available a disease tends to get more diagnosed. IPF is a little tricky because some other ILD's are often called IPF.

http://www.sarcoidosis-sarcoid.com/2012/01/incidence-and-mortality-of-idiopathic.html

[ghmm]

The PANTHER study updated for just having the one treatment arm now (NAC)

clinicaltrials.gov/ct2/show/NCT00650091

[ghmm]

Interesting medcape article on survival of IPF patients with GERD with/without treatment. I've seen in the literature before about recommending treatment but these results are pretty strong evidence! From an investor point of one one should be careful to look to see if there is an imbalance of both GERD patients and those receiving treatment for GERD.

http://www.medscape.com/viewarticle/757002

[ghmm]

German pharma association speaks out on Esbriet assessment

http://www.wusa9.com/news/local/story.aspx?storyid=186001

It would seem InterMune is doing a good job of getting other parties to support them in the Germany pricing of Esbriet. In the conference calls they mentioned about dossiers from doctors contradicting the IQWiG statements.

[someconcerns]

GHMM, Yes. Thanks. Steve

[ghmm]

I wouldn't do (another) costly Phase 3 without a partnership. The other trials I talk about are much cheaper and over the next couple years. My preference is not to do Investigator ones since they take for ever to enroll but I would do that as a last resort (for a promising proof of concept).

On the 12/15 JP Morgan sponsored call they did not give a sense of changing their plans as far as rollouts. I think France, Spain and Italy are pretty far along in the negations. If we get to Q2 and no more big territories have pricing agreements then I would start worrying the IQWiG recommendations are having an impact on negotiations.

At this point I am not too concerned about the impact outside of Germany. And even in Germany I think the impact will be a mid to modest price reduction (but they announced a higher price then I expected to begin with). People can't just ignore the label and frankly its far superior then I would have expected (particularly morality mention and allowing things from the failed study).

The German negations process will be a long one. The next step is a formal response by the company (I think by January 5/6 or something like that). I would expect Dan Welch to update investors at the JP Morgan call later this month.

Hope that info helps.

[someconcerns]

Hi GHMM,

Do you think that they have the cash to do all those studies, above and beyond their costs to pursue their rollout in country after country in Europe?

Has anyone heard a possiblity of slowing or altering the order of rollouts given the (now-old) news from Germany?

Has anyone heard about specific actions they are taking to fight that negative recommendation in Germany?

Steve
Disc: I am long ITMN

[ghmm]

Since it’s a new year and everyone comes out with lists I thought to do the same for what I’d like to see InterMune do. I put tangible things that are in their direct control (or else I would have put things like 1 Billion in sales, sell the company for $100/share, etc. ). The company (primarily at their R&D day) has talked about some things to somewhat along these lines so I don’t think these are a stretch).
1. UTHR Collaboration
a. Remodulin (IV/Sub-q) EU Co-promote
b. Small Phase 2 Combo studies (Pirfenidone + Tyvaso or Oral Treprostinil) in patients with PAH (secondary to IPF)
c. Bigger deal? (Buy 50% of US rights to Pirfenidone, Co-develop IPF candidates in each ones pipeline, etc)
2. Pirfenidone Phase 2/Phase 3 US Trials. I would like to find a partner (UTHR?) to pay a good chunk of the cost and try to reduce risk of ASCEND failing but if no partner I’d still consider doing Phase 2 either company funded or support investigator lead ones.
a. In more advanced IPF patients. If can get a partner I would try to make a registrational study if not perhaps a small Phase 2 (placebo controlled and if data supports maybe trying a slightly higher dose as done in some early studies)
b. NAC+Pirfenidone Trial
c. + ??? I would basically look to test almost any reasonable compound that does not have an material negative impact for the company.
3. Working on extended release Prodrug of Pirfenidone. I would think they could not only improve the dosing considerably but perhaps reduce the GI side effects. Companies always want to do everything themselves but I wouldn’t have a problem with paying some small upfront and development costs along with say a 5-10% royalty if can get a company like XNPT to make a much better drug more quickly than could on own.

Aside from the be careful what you wish for any comments welcome.