I've been waiting for them to go public! I think rkrw was following them noticed he doesn't post here much maybe he'll post some of his thoughts? I'll have to start doing a lot more DD and look for a good price. I think they have 3 drugs that will go against Genzyme including their bread and butter (Cerezyme).

DNDN:

More than likely, the decision will depend on how much they can get—and no one knows that yet.
Well it is about 18 now and rising would be less then 10% dilution for the current shelf. Would you do it now (before the PDUFA)?

>If DNDN management feels the FDA will give an approvable letter pending data from 9902B, then now would be a good time to raise cash…<

If it were up to me, I would probably raise some during the next few weeks.
I thought this would be the survey question (if they'd raise cash before or after their PDUFA)

Thanks for posting that! As a disgruntled TKT Shareholder who strongly opposed the deal I considered joining the group seeking relief according to Delaware law. Not being experienced in these types of matters and being on a relatively basis a small shareholder, I ended up not doing so thinking the time/expense in the end may not justify whatever a new valuation price would show.

The portion about the Warburg executives isn't new information (one reason they bother me on the InterMune board) the potential conflict with Dr. Reddy's Laboratories is something I had not heard before! Of interest Michael Astrue very publicly gave interviews where he was very open about directors switching their vote. I also believe the talks first started when TKT was in the 20's (but this is from memory).

I am curious what Icahn and others end up getting above the $37/share. I saw you post on the IDIX board about Delaware law providing some protection from unfair buyouts. I guess what is decided here may be of interest to IDIX shareholders afraid of Novartis.

EDIT: I caught part of a Shire presentation a little while back and the Hunter drug has been doing very well which may bolster the case for those opposed to the 37/share price.

It seems like not too long ago Wood and Prior were the two hottest pitching prospects. My how times have changed!

http://sports.yahoo.com/mlb/news?slug=ap-cubs-prior&prov=ap&type=lgns

Cubs demote Mark Prior to minors
By RICK GANO, AP Sports Writer
March 28, 2007

MESA, Ariz. (AP) -- Mark Prior, who won 18 games for the Chicago Cubs four years ago before a series of injuries slowed his career, was optioned to Triple-A on Wednesday after his final spring training start.

Prior pitched three innings Wednesday in an exhibition game against the Colorado Rockies that ended in a 4-4 tie. He was limited to nine starts by shoulder problems a year ago when his record was just 1-6.

ADVERTISEMENT
It was just his fourth appearance and third start of the spring. The decision to go with Wade Miller as the fifth starter was announced Tuesday, so there was no place in the rotation for Prior and his final spring outing really had no bearing on his chance to make the team.

Prior gave up two hits and three runs against the Rockies, but they were all unearned because of sloppy play by the Cubs' outfield, which committed three errors.

Notes

Cubs manager Lou Piniella announced his starting lineup and batting order for Monday's opener at Cincinnati: Alfonso Soriano, cf; Matt Murton, lf; Derrek Lee, 1b; Aramis Ramirez, 3b; Jacque Jones, rf; Michael Barrett, c; Mark DeRosa, 2b; Cesar Izturis, ss; Carlos Zambrano, p. ... One day after winning Super Bowl coach Tony Dungy of the Colts sat behind home plate, the losing coach in the game, the Bears' Lovie Smith, was in the same spot.

Thanks. Didn't seem to find what I wanted but always good to have another resource.

Thanks for the links! The (free) search seems very useful I added it to my bookmarks, still trying to get it completely figured out though (maybe it just doesn't have everything as you suggested)!

I was wondering if anyone new about Flolan (Epoprostinil) I know it is available on a limited basis there and I was wondering if it actually has formal approval or is available on some compassionate use basis and if it is actually approved when it received approval.

I am curious because of United Therapeutics which signed a licensing deal with Mochida Pharmaceutical for their Prostacyclin, Remodulin.
http://biz.yahoo.com/prnews/070327/dctu022.html?.v=95

Given United's limited revenue and VERY high price of Remodulin, this could be a very significant source of future revenue especially if it is the only perennial prostacyclin.

Any idea on how long a bridging study needs to run in Japan? I am guessing it is a small number of patients and a couple months (given that US/EU trials for PAH therapies have generally been in the 12-24 week range). Hopefully it doesn't take years to approve after that!

Can anyone tell me of place I can find out when/if a certain drug was approved in Japan? TIA

The official latest is that the 1A portion of the study will be completed in the First Half of this year and that at least top-line results for the 1B will be available in the second half.

In one of the conferences (Susquehana I believe) Larry Blatt or Steve Porter (forget off the top of my head which one spoke) said the 1B did not need to wait for the 1A to be fully completed to start. Also In the update call a few days ago Dan Welch said that InterMune Shareholders may have a higher degree of need then prior Protease companies that combined releasing the 1A and 1B data together. He indicated that would have to be cleared up with Roche. So there is a (I would think slight only) chance we get some 1A data before getting the full top-line results.

My unofficial thinking is the 1B top line results will be out in Q3 (as opposed to Q4). I also think the 1A should be advanced far enough that the 1B could begin within a month or so. Keep in mind I am a bit of an optimist though when it comes to companies I own :)

A very good read. Just because there isn't enough discussion about Dendreon :)... Dew did you write this?
http://biz.yahoo.com/seekingalpha/070326/30574_id.html?.v=1

SeekingAlpha
The Short Case on Dendreon Corporation
Monday March 26, 6:47 am ET

Maxim Jacobs submits: Back in February I wrote how the "if it works, it will be huge" argument was not a very good one for owning Atherogenics (NasdaqGM: AGIX). The same can be said for Dendreon Corporation (NasdaqGM: DNDN), which is currently having a rally thanks to an article by the usually sound Adam Feuerstein which suggested that you should wait for it because 'if it works it will be huge' (okay, more specifically, if Provenge is approved by the FDA, it will be huge). He even goes so far as to put a $27 price target on the then $3.80 stock. As the stock was already tough to borrow, it is no surprise that the end result has been a relatively strong rally. The same thing happened to Genta Inc (NasdaqGM: GNTA) right before its panel meeting in April 2004 - right before it crashed.

ADVERTISEMENT
Why am I so sure DNDN will fail here? Because just like with AGIX, there is no clear evidence that the drug actually works:

First, Provenge has never hit a primary endpoint, a big no-no for the FDA as the primary endpoint is what the trial is designed to test. And while there was a survival benefit in the D9901 trial, it was only a secondary endpoint and therefore was never designed to conclude on whether or not Provenge extends survival.

I've heard arguments that survival is the hardest endpoint out there so if they can show a survival benefit, how can the FDA not approve it. For the simple reason that because of the design of the trial, Provenge might have had very little to do with that survival benefit. After disease progression, patients on placebo were given the option of going on Provenge or not. 68% of placebo patients then crossed over and received Provenge but not chemotherapy. If you were on Provenge and progressed, you had the option of receiving chemotherapy right away. This by itself could account for the entire survival benefit seen between the two arms as it is generally better to get chemotherapy sooner rather than later. The company has even disclosed data that showed that Provenge patients who subsequently received Taxotere had median survival of 34.5 months compared to 25.4 months for placebo patients (most of whom received Provenge before receiving chemo). Considering Provenge only showed a 4.5 month difference, this 9.1 month difference is pretty important.

Given these confounding factors it seems clear that the survival benefit is in question and will very clearly be questioned in the FDA briefing documents which will be released on March 27th. So let's move on to the more important statistic, the one that was unaffected by patient crossover, time to tumor progression. Here Provenge showed only a 1.7 week difference (11.7 versus 10.0), a difference that was not significant. And given the imbalance in the arms with factors like Gleason score (a higher Gleason represents more aggressive disease and DNDN itself has referred to it as "one of the most important prognostic factors") where Provenge had a major advantage which could easily explain the meager 1.7 week benefit. The Gleason score breakdown was:

# 39.0% of Provenge patients and 44.4% of placebo patients had Gleason scores of 8 or higher. These are the patients with the most aggressive disease and worst prognosis.
# 34.1% of Provenge patients and 40% of placebo patients had Gleason scores of 7, which is an intermediate type of score.
# 26.8% of Provenge patients and 15.6% of placebo patients had Gleason scores of 6 or less.
In other words, the Provenge arm had an 11.2% advantage in patients with the best prognosis. And in a small 127 person trial in only takes imbalances of a few patients here and there to manufacture a benefit.

The big question is, what is the company thinking, going in front of the FDA with this sloppy data? Well that was not initially the plan. For those of you following DNDN for years as I have, you will remember that initially they were going to run a 500 patient confirmatory Phase III under an SPA with the FDA (AGIX and Telik (NasdaqGM: TELK) also had SPA's by the way, so that just proves that SPA's don't count for anything in terms of the FDA signing off on a product). They did initiate the trial and were guiding for full enrollment in 2004. Then 2005, then ...

Well, they just decided that it might take years to fully enroll this trial (a very bad sign as doctors appear completely unexcited) so why not just file with what they have. That is not a very good reason in my mind to file with the FDA, because your Phase III isn't enrolling well (and is still not enrolled). It equates to a biotech hail mary pass. And while we are on old management promises, remember how they were in final discussions with 2 or 3 potential partners for Provenge in 2004? What happened with that? I guess the experts in Large Pharma didn't believe the data either.

Besides not trusting management because of promises they have made in the past, I also think the CEO pays himself much too much to be an honest guy. Just like Michael Wick, the CEO of TELK, and Russ Medford, CEO of AGIX, CEO Mitch Gold pays himself a hefty salary of $673,000 (salary + bonus) with an additional $309,000 in restricted stock awards. In other words, DNDN's CEO pays himself over $1 million a year as he erodes shareholder value and can't even enroll a 500 patient Phase III within 5 years.

So what happens with DNDN stock? I think the FDA will do the prudent thing and recommend that they wait for the confirmatory 9902B trial results to come out (DNDN is currently guiding for year end 2007 full enrollment, they really mean it this time) as that would more likely be able to definitively prove whether or not Provenge is a real drug or not. This would effectively mean a 2-3 year delay. The stock should then trade at no more than $2, given DNDN will have around $1 per share in cash (about $80m total as of March 31 by my calculations) and the bulls will likely give it some residual value unless the FDA is as unmerciful as they were with GNTA, in which case it would trade to $1.

And as they are burning through cash faster than a Weimar Republic pensioner (sorry. had a Dennis Miller moment for a second there), they are likely to have to raise cash again in the next six months. At $1 they would dilute shareholders 100% for 1 years worth of cash, at $2, around 50%. So this stock would likely be dead in the water for some time.

In conclusion, yes if it works it could be huge, but most likely it won't and if you are left holding this stock, you will end up with far less money than what you put into it.

Disclosure: Author has a short position in DNDN

Thanks for creating a board on one of my favorite companies! I found this board by chance. I've been a (small) shareholder for some time (good luck adding shares on the cheap) and since reading the Interview and getting more information have really gotten excited about the company and potential and adjusted my position (as much as could reasonably be done with the small float).

I am eagerly awaiting the Q4 results and hopeful of some very good numbers. If there is interest on the board I will post more detailed info. For now I'd suggest anyone interested in the company or even if you enjoy a good "value" investor read to read the interview Mr. Menard gave (it really picks up at the second page or so).

http://www.morocorp.com/news/Moro%20Corp%20-%20Wall%20Street%20Transcript.pdf

If the above link doesn't work then you can get it on the following page:
http://www.morocorp.com/news/index.htm

For those interested in investing in the company be sure to check out their financial reports too:
http://www.pinksheets.com/quote/finance.jsp?symbol=MRCR

This is a pink sheet company but IMHO shouldn't be put in the speculative category with other Pink Sheet companies. This is really a gem of a company!!

drbio45,

are they getting better because they are on the drug or because they know they are on the drug

Yes Photosensitivity and GI issues likely make those who are on drug know they are. "getting better" is defined as slower decline in Forced Vital Capacity in InterMune's CAPACITY trials. My understanding is this is a measure of expiration from the lung that measures both volume and velocity. With several studies now measuring this (including Placebo controlled studies), I believe it has been validated as a clinically meaningful end-point for IPF. Pirfenidone will have been tested in close to 1000 patients (in IPF alone) with the completion of the CAPACITY study. In addition to the Shionogi study showing positive results, there were 2 prior Placebo phase 2 studies that were stopped for efficacy in the Pirfenidone arm. I think it unlikely that all 3 of these Placebo controlled studies favored pirfenidone because the patients new they were taking the drug (the Phase 2 IPF secondary to HPS were multi-year studies too).

You've posted a couple times directly/indirectly on Pipex. I was wondering if you could answer something for me on Coprexa. Why do you see it is a better drug for IPF? It seems to me it is VERY premature to suggest that?

My thinking on it goes like this...
I looked at Pipex (back when they were Sheffield Pharma) and I had some thoughts on why I didn't see Coprexa as viable in the near term for IPF. My understanding is The Phase 1/2 trial they will announce results for shortly is 20 patients and was open label and only measuring safety. I would think that is unlikely to give them enough direction to go into a Phase 3 trial. Further more marketing the drug for Wilsons doesn't seem viable, so I wouldn't count on off label use (plus with just 20 patients I can't see it getting much use even if it were available). The existing therapies are relatively cheap and the very rare nature of the disease does not seem to lend itself to justifying building a mfg/sales infrastructure. Furthermore Pipex doesn't have the financial resources to do. To me the best bet for Pipex is to get a sponsor for a larger trial (in IPF) to really see if this has some therapeutic benefit there. I think it puts them behind several other therapies being investigatetd.

The preclincal work with the drug showing anti-inflamatory effects if I recall were with pretreatments before doxorubicin. I think this is a stretch to go from mice to humans and preventing something to reversing/stopping progression in a disease that is not well understood and likely has many different sub-types.

Don't get me wrong, I haven't ruled out at some point looking to invest in Pipex (under the right circumstances). I think IPF will be treated in combination and perhaps some of its anti-inflamatory effects may be of benefit to patients with IPF which would be synergistic with Pirfenidone.

For those who have watched InterMune for their Protease program here is something to look at as far as Pirfenidone, I posted it on the InterMune board but here is the text. Anyone by chance have access to the report? Would be curious about their model of patients/price and peak sales. TIA

http://www.investorshub.com/boards/read_msg.asp?message_id=18180994

Interesting analysis. Would appreciate if any one has access to the full report. Their Year 1 Pirfenidone revenue is even more optimistic then mine (and I'll admit to generally being overall optimistic on companies I invest in)! I would be interested in what they have in their models for patients/prices. I've posted in general I think it'll be priced a bit less then Tracleer but with more IPF patients then PAH Pirfenidone has the potential to be larger then Tracleer. Of the analysts that follow InterMune I think Adam Cutler does one of the better jobs.

InterMune "market outperform," target price raised - update

http://www.newratings.com/analyst_news/article_1499162.html

Friday, March 23, 2007 3:01:39 AM ET
JMP Securities

NEW YORK, March 23 (newratings.com) - Analyst Adam Cutler of JMP Securities reiterates his "market outperform" rating on InterMune Inc (ITMN.NAS), while raising his estimates for the company. The target price has been raised from $29 to $34.

In a research note published yesterday, the analyst mentions that there is increased optimism regarding the favourable outcome of the company’s Phase III Pirfenidone programme going ahead, in view of the extremely encouraging Shionogi data. Consequently, the Pirfenidone sales estimates for 2010 and 2011 have been raised from $209 million to $223 million and from $384 million to $409 million, respectively. The fully-taxed EPS estimates for 2010 and 2011 have been raised from $0.14 to
$0.43 and from $2.15 to $2.52, respectively.

Interesting analysis. Would appreciate if any one has access to the full report. Their Year 1 Pirfenidone revenue is even more optimistic then mine (and I'll admit to generally being overall optimistic on companies I invest in)! I would be interested in what they have in their models for patients/prices. I've posted in general I think it'll be priced a bit less then Tracleer but with more IPF patients then PAH Pirfenidone has the potential to be larger then Tracleer. Of the analysts that follow InterMune I think Adam Cutler does one of the better jobs.

InterMune "market outperform," target price raised - update

http://www.newratings.com/analyst_news/article_1499162.html

Friday, March 23, 2007 3:01:39 AM ET
JMP Securities

NEW YORK, March 23 (newratings.com) - Analyst Adam Cutler of JMP Securities reiterates his "market outperform" rating on InterMune Inc (ITMN.NAS), while raising his estimates for the company. The target price has been raised from $29 to $34.

In a research note published yesterday, the analyst mentions that there is increased optimism regarding the favourable outcome of the company’s Phase III Pirfenidone programme going ahead, in view of the extremely encouraging Shionogi data. Consequently, the Pirfenidone sales estimates for 2010 and 2011 have been raised from $209 million to $223 million and from $384 million to $409 million, respectively. The fully-taxed EPS estimates for 2010 and 2011 have been raised from $0.14 to
$0.43 and from $2.15 to $2.52, respectively.

Here is a link to Shionogi's Slide presentation from todays R&D Day:
http://www.shionogi.co.jp/ir_en/explanatory/pdf/e_p070322.pdf

I thought the Pirfenidone results on the slides (and InterMune 8-k notes today) are OK especially considering the small sample size. The factor that the low dose group was as good (slightly better but probably not statistically so) is a little interesting but perhaps could be explained by being better tolerated. Overall, I would have liked to see better overall numbers (InterMune noted no improvement in O2 statuation) with a dose related response. But still the results are significant in a very bad disease with no good treatment.

My read on the InterMune PR/Call

1. The company needs to be certain of Pirfenidone success. The power increase ABOVE 90%. The caution to lengthen (note the Shionogi Phase 3 was actually shorter then the original CAPACITY design) to me speaks to the importance of ensuring success as opposed to rushing the results to get the drug to market.
2. The information on trial conduct, enrollment and most importantly the remarks to retain all its territorial rights to pirfenidone to maintain maximum strategic flexibility while not removing the option of partnering speaks to the value the company sees in the drug x-US. Keep in mind Orphan drug in Europe is 10 years vs 7 US so to me even if IP cannot be extended European rights hold more value as one would expect sales to increase over time.
3. The vast majority of the questions on the call were Pirfenidone related. While granted there is only 191 of significance and no new news is expected till 1B results 2H '07. I think the stock should start to pick up steam as analysts start to grasp the potential of Pirfenidone and adjust their models accordingly.
4. This is the first public mention I heard of where a specific reference was made to other preclinical pulmonology work, specifically saying small molecule drugs. In the past the most that was said was vague mention to preclincal work in pulmonology/hepatalogy.
5. It appears the preclincal 2nd HCV target is still moving ahead (along with 2nd generation Protease work with Roche).
6. There were several things I was curious about the were not asked. One interesting happening just a few days ago Resperonics announced a study of Interferon Gamma administered through their Nebulizer for treating IPF (no disclosure on any relationship between Actimmune's Interferon Gamma was announced).

Here is the full PR for archival purposes:
http://biz.yahoo.com/prnews/070320/sftu073.html?.v=92&printer=1

InterMune Updates Expense Forecasts and Development Plans
Tuesday March 20, 7:30 am ET
Reduction of 50% of Staff and $40-$50 Million in Annual Operating Expenses by 2008
Advances CAPACITY Enrollment Timeline and Reinforces Statistical Power
Conference Call Today at 8:30 a.m. EDT

BRISBANE, Calif., March 20 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that it has completed a review of its research and development programs and infrastructure requirements. InterMune will implement a number of operational and infrastructure changes that, when fully implemented by 2008, are expected to reduce annual operating expenses by approximately $40 to $50 million. The expense savings result from: 1) a reduction in staffing levels by 50%, or 116 full-time and contract positions affecting all departments; 2) a reduction of development, clinical and regulatory costs due to the termination of the INSPIRE trial; and 3) a reduction of SG&A expenses related to Actimmune®.

Regarding its development programs, the Company reconfirmed its focus on its Phase 3 CAPACITY program studying pirfenidone in idiopathic pulmonary fibrosis (IPF) and on its HCV protease inhibitor, ITMN-191 currently in Phase 1a development with its partner Roche. InterMune currently projects that enrollment of the CAPACITY trials will be completed several months sooner than previous guidance due to stronger than expected patient enrollment, and that the Company will refine and expand the CAPACITY program to further enhance its ability to demonstrate clinically and statistically significant benefits for IPF patients.

The Company also announced its current intention to retain all its territorial rights to pirfenidone to maintain maximum strategic flexibility.

"We have quickly and aggressively moved to reduce our operating expenses in light of the termination of the INSPIRE trial of Actimmune in IPF," said Dan Welch, President and CEO of InterMune. Mr. Welch added, "We remain very excited about the progress and potential of both ITMN-191 in hepatitis C and our CAPACITY program studying pirfenidone in IPF. With CAPACITY enrollment significantly exceeding our expectations, we are in a position to expand the program and still complete it ahead of our previously announced timeline. We now expect patient enrollment to be completed in July of 2007 and the results of CAPACITY available in Q1 2009, several months ahead of our previous guidance."

Update on Clinical Development Programs

In updating the status and timelines for its clinical development programs, InterMune announced that the Phase 1a program for its HCV protease inhibitor, ITMN-191, remains on schedule. The Company continues to expect to complete the currently running Phase 1a study of ITMN-191 in healthy subjects in the first half of 2007. InterMune plans to evaluate ITMN-191 in a Phase 1b randomized, double-blind, placebo controlled, multiple ascending dose study in patients infected with chronic hepatitis C virus. In this study ITMN-191 will be administered to treatment-naive patients for 14 days; the study will also include a cohort of non-responder patients. InterMune and its partner Roche expect to announce initial viral kinetic results from the Phase 1b trial in the second half of 2007.

The refinements to the two Phase 3 trials in the CAPACITY program follow InterMune's review of two new and unique data sets related to: 1) changes in forced vital capacity (FVC) and other important measures of lung function over time in the placebo group of the recently un-blinded INSPIRE trial and 2) the effect of pirfenidone on vital capacity (VC) and other lung function parameters in the Phase 3 study of pirfenidone in IPF recently concluded by Shionogi & Co. in Japan. The planned changes to the CAPACITY program will increase the power of the studies to demonstrate statistically significant effects on the primary and secondary endpoint analyses. A total of 135 patients will be added to the previously planned 580 patients and the treatment duration will be increased by 12 weeks, from 60 to 72 weeks. The primary efficacy endpoint remains change in forced vital capacity (FVC). The increased sample size and treatment duration will provide in excess of 90% power to detect a 50% reduction in the rate of FVC progression after 72 weeks of treatment with pirfenidone compared to placebo and will also increase the power on the various secondary endpoints. Taking into account these changes, InterMune projects that the two trials will be fully enrolled with a total of 715 patients in July of 2007 and completed in the first quarter of 2009, several months ahead of previous guidance.

Steve Porter, M.D., Ph.D. and Chief Medical Officer of InterMune, said, "We have recently had the unique opportunity to review two new data sets from clinical studies in IPF that directly inform the design of our CAPACITY program: the INSPIRE study and the Phase 3 study of pirfenidone conducted by Shionogi in Japan. Based on our review of these data, we have refined the CAPACITY program to further enhance the probability of meeting its objectives. We are also pleased that as a result of very strong enrollment trends, we expect that we will complete the refined CAPACITY program well ahead of our previous projection. The study conduct in the CAPACITY program, which has experienced a low patient drop-out rate to date, is proceeding according to our plans. We are also making excellent progress on our ITMN-191 Phase 1a program which is proceeding as we expected."

Updated 2007 Financial Guidance and 2008 Expense Outlook

InterMune's revenues are comprised of revenues from our HCV collaboration with Roche and sales of Actimmune®, which is approved for two indications, chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. In the United States, the Company estimates that there are approximately 1,200 patients with CGD and less than 500 patients with severe, malignant osteopetrosis. InterMune believes that substantially all Actimmune® revenues are and have been historically derived from physicians' prescriptions for the off-label use of Actimmune® in the treatment of IPF.

In light of the INSPIRE study results, InterMune expects revenues from physician prescriptions of Actimmune® for the treatment of IPF to significantly decline. Since InterMune does not promote Actimmune® for IPF and has no visibility on revenues in that setting, the Company has no basis on which to forecast revenues for the 2007 fiscal year following the INSPIRE results announced on March 5, 2007. Therefore, InterMune has withdrawn its previous guidance for revenues and Cost of Goods Sold as a percentage of revenues for the year ending December 31, 2007. However, InterMune currently expects that Actimmune® revenues for the first quarter of 2007 will be in a range of approximately $19 to $21 million, assuming that product returns in this quarter are no higher than those observed in previous periods. Revenues recognized during the fiscal year ending December 31, 2007 from the Roche collaboration are expected to be approximately $13 million, based on amortization of previous collaboration payments already received and anticipated collaboration payments during 2007.

InterMune will take a number of steps to reduce operating expenses, which will have the effect, once fully implemented by 2008, of reducing the Company's total annual operating expense levels by $40 to $50 million, compared to the Company's original 2007 financial guidance. The Company will reduce staffing levels by 50%, or 116 full-time and contract positions, primarily in the Clinical, Regulatory, Medical Affairs and Commercial areas. The majority of staffing reductions will occur in April and the remaining reductions will be implemented over the coming months as the INSPIRE trial is closed. The Company will also take additional steps intended to significantly reduce non-personnel related expenses.

For the year ending December 31, 2007, R&D expenses are anticipated to be in a range of approximately $100 to $110 million, and SG&A expenses in a range of approximately $25 to $35 million. These ranges represent reductions in R&D and SG&A of $10 to $15 million and $10 million, respectively, from the original 2007 financial guidance provided on February 8, 2007. InterMune will record charges for restructuring related expenses associated with these operational changes of approximately $3.5 million, which are expected to be recorded during the year. In addition, InterMune may incur charges related to various Actimmune® assets. The Company has recorded a $4.5 million Actimmune®-related impairment as of December 31, 2006.

InterMune currently expects to have between $205 and $210 million in cash, cash equivalents and available-for-sale securities at March 31, 2007.

Conference Call and Webcast

InterMune will host a live webcast of a conference call this morning, March 20, 2007, at 8:30 a.m. EDT to discuss its corporate strategy, clinical development programs and cost-saving initiatives. Interested investors and others may participate in the conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international). A replay of the teleconference will be available approximately three hours after the call.

To access the webcast, please log on to the Company's website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required to hear the call.

The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international) and entering the conference ID# 3401542. The webcast will remain available in the Investors section of the InterMune website for 30 days.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary and fibrotic disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 in Phase 1a, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.

Forward-Looking Statements

Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of InterMune's clinical trials and announcements of results thereof. 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. 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 annual report on Form 10-K filed with the SEC on March 13, 2006 (the "Form 10-K") and updates included in the most recent Form 10-Q filed with the SEC on November 7, 2006 (the "Form 10-Q"), and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (v) risks related to our collaboration agreement with Roche; (vi) the results of the InterMune CAPACITY trials of pirfenidone may differ from those of Shionogi's Phase 3 trial; and (vii) risks related to our intellectual property rights. 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 InterMune's other periodic reports filed with the SEC.

NOTE: Actimmune® is a registered trademark of InterMune, Inc.

Is someone else due a milestone??
My recollection is Aventis is owed a royalty. I haven't followed Shire so I don't know if that is still the case.

Amicus seems like an interesting company. I have been following them (from a distance) for a while now waiting for an IPO but they keep doing private placements! I think rkrw was the one who pointed out Genzyme may be behind their inability to get an IPO going. They certainly seem to pose a potential threat to them on several fronts.

http://biz.yahoo.com/prnews/070316/aqf015.html?.v=7

Amicus Therapeutics Completes Phase 2 Enrollment of Amigal(TM) for Fabry Disease
Friday March 16, 9:00 am ET

CRANBURY, N.J., March 16 /PRNewswire/ -- Amicus Therapeutics, a biopharmaceutical company developing small-molecule, orally administered pharmacological chaperones for the treatment of human genetic diseases, announced today that enrollment has been completed for all ongoing Phase 2 clinical trials of Amigal(TM) (migalastat hydrochloride, AT1001). Amigal is in development for the treatment of Fabry disease.

ADVERTISEMENT
The four open-label, multi-national Phase 2 trials are examining various dose levels and frequencies of Amigal in men and women with Fabry disease. The primary objective of the studies is to evaluate the safety and tolerability of treatment with Amigal. The secondary objective is to evaluate certain pharmacodynamic measures of treatment, including effects on alpha-galactosidase A (alpha-GAL) and globotriaosylceramide (GL-3) levels in various cells and tissues of disease. An additional objective is the preliminary assessment of cardiac, renal and central nervous system function. The results of these clinical trials are expected to be available by the end of 2007.

Amigal is designed to selectively bind to and stabilize alpha-GAL, the enzyme deficient in Fabry disease. This deficiency leads to lysosomal accumulation of GL-3, which is believed to cause the various symptoms of Fabry disease. Amigal facilitates proper trafficking of the enzyme to the lysosomes, the compartments in the cell where it is needed to break down GL-3.

About Fabry Disease

Fabry disease is a lysosomal storage disorder caused by inherited genetic mutations in the GLA gene, which result in deficient activity of the enzyme alpha-galactosidase A (alpha-GAL). Deficient alpha-GAL activity leads to lysosomal accumulation of globotriaosylceramide (GL-3), which is believed to cause the various symptoms of Fabry disease, including pain, kidney failure and increased risk of heart attack and stroke. Fabry disease is estimated to affect approximately 5,000 to 10,000 people in the developed world, but recent evidence suggests that the disease may be significantly underdiagnosed. The U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan designation for Amigal in the United States, and the European Commission has designated Amigal as an orphan medicinal product in the European Union.

About Amicus Therapeutics

Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its two lead compounds, Amigal(TM) for Fabry disease, and AT2101 for Gaucher disease. The company is currently conducting Phase 1 trials with AT2220 for the treatment of Pompe disease.

Good to see a strong InterMune supporter. Feel free to borrow posts (sorry I don't have a paying membership here).

I was surprised when I saw your post on the discount. I remember back in the TKT days, Michael Astrue gave the impression a discount would be modest and it had some potential selling advantages the main being lack of evidence of pure red cell aplasia (though since it was rare hard to know for sure). If this still holds that and the price discount seems to be placing Shire in a strong position. FYI I think Dynepo was valued at about 450 million (if the TKT acquisition fell through that is what they would have paid for Dynepo alone). I believe their is a royalty still to be paid on Dynepo sales.

Do you think JNJ will discount their product?

http://phx.corporate-ir.net/phoenix.zhtml?c=128610&p=conferenceAgendaByTimeJS&id=1350466&...

You can get to it from here if the above doesn't work. It seems the printable version is the only one up to date right now.

http://www.cowen.com/UpcomingConferences.asp

If you had the ability to search the future I think you would have found it (the link wasn't there the other day when I looked)

Maybe someone with a better understanding of the Orphan Drug Law could explain this to me then. If Tercica had their product approved first shouldn't the only way Insmed's been approved was to offer an advantage over Tercica's? Unless for Orphan drug going from 2x to 1x dosing is considered enough? I thought they (Insmed) claimed other advantages too (whether real or not I can't say).

PED:

Allan Greene has made those comments in the past (in the other direction) in reference to segments that are NOT subscription based like their Video/Reproduction and especially Working Values division. Working Values especially had some great quarters then almost nothing for a couple quarters and that is when he (Allan Greene) kept trying to emphasize the quarter to quarter fluctuations from non-subscription divisions. I think he is now trying to be cautious on the other end. Will be interesting to see the K and the breakdown of revenue by segment. The banking/Sage seems to be doing extremely well and the newest deal (couple days ago) was in that segment wonder if that is coincidence or means more.

Seems to be a day for management changes

http://yahoo.reuters.com/misc/PrinterFriendlyPopup.aspx?type=comktNews&storyID=urn%3anewsml%3are...

UPDATE 1-MOVES-HSBC, Acambis, HCM, AIU, Stonehage, UBS
Wed Mar 7, 2007 6:23 AM ET

ACAMBIS PLC <ACM.L>

Biotechnology company Acambis has announced that Ian Garland will replace Gordon Cameron as chief executive officer with effect from June 1. Garland was previously chief financial officer (CFO) at Arrow Therapeutics Ltd., a company engaged in the discovery and development of novel anti-viral products.

In addition, CFO David Lawrence is leaving the firm with immediate effect. He will be replaced by Elizabeth Brown as acting CFO.

OK I'll admit in a few moments of fullishness I actually bought into Celacade and the VP Series. Fortunately I thought it risky and kept it small. I think Elsley is one of the least trustworthy CEO of a company I've owned, my guess is the stock goes up on the news but don't know if it'll do anything for the technology.

http://biz.yahoo.com/prnews/070307/to304.html?.v=15

Vasogen Appoints Terry H. Gregg President & CEO
Wednesday March 7, 7:00 am ET

MISSISSAUGA, ON, March 7 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ:VSGN - News; TSX:VAS - News), a biotechnology Company focused on the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease, is pleased to announce that Terrance H. Gregg has succeeded David G. Elsley as President and Chief Executive Officer of Vasogen. Mr. Gregg joined Vasogen's Board of Directors in 1999, was appointed Vice Chairman in November 2005, and became Chairman of the Board in March 2006. David Elsley, who founded Vasogen, will remain a member of Vasogen's Board of Directors and Mr. Gregg will retain his position as Chairman.

In 1996, Mr. Gregg became President and Chief Operating Officer of MiniMed Inc., now a world leader in insulin pump therapy and continuous glucose monitoring, and was instrumental in Medtronic's US$3.4 billion acquisition of the company in 2001. Mr. Gregg retired as President of Medtronic MiniMed in 2002. He also served in executive positions with Smith & Nephew plc, a diversified healthcare product company, and Allergan, Inc., a leading ophthalmic device and pharmaceutical company. He is currently a Special Venture Partner with Galen Associates, a private equity firm specializing in the healthcare sector, serves on the boards of DexCom, Inc. and LMS Medical Systems, Inc., and is Executive Chairman of Patton Medical Devices, LC. Mr. Gregg also served on the Boards of Amylin Pharmaceuticals, Inc. and Ocular Sciences, Inc., which was purchased by The Cooper Companies, Inc. for US$1.2 billion last year.

"Vasogen has an exciting future and I am pleased to assume the role of President and CEO of a company with a solid scientific team and experienced management who are committed to achieving success," stated Terrance Gregg. "As a founder of Vasogen, David Elsley has provided visionary leadership since the Company's inception and has positioned us well for the future. I look forward to working with David as we transition from a development-stage company to a successful commercial enterprise."

"Terry Gregg's vision and his experience in transforming MiniMed from a development-stage therapeutic device company to a global leader in diabetes management systems will prove invaluable as we prepare for the commercialization phase of Vasogen's Celacade technology," stated David Elsley. "I am confident that the key findings from our ACCLAIM trial provide a strong foundation to move to the next level of Vasogen's evolution and I look forward to my continued involvement as an active member of the Board."

The 2,408-patient phase III ACCLAIM trial of Vasogen's Celacade(TM) technology (Celacade) in patients with chronic heart failure, completed in 2006, demonstrated strong results in two important pre-defined patient subgroups. While the study did not meet its primary endpoint, Celacade was shown to significantly reduce the risk of death or first cardiovascular hospitalization by 39% in patients with NYHA Class II heart failure at baseline (n=689, p=0.0003), and by 26% in patients with no prior history of heart attack at baseline (n=919, p=0.02). The Company is currently pursuing partnering discussions to support the initial commercialization of Celacade in Europe on the basis of these results. The Company is also preparing to meet with the FDA to review the ACCLAIM results for the purpose of determining the next steps in the regulatory pathway for Celacade in the United States.

About Vasogen:

Vasogen is a biotechnology company engaged in the research and development of therapies that target the damaging inflammation associated with cardiovascular and neurodegenerative disorders. The Company's lead product, the Celacade(TM) technology, is designed to trigger the immune response to apoptosis - an important physiological process that regulates inflammation. Celacade(TM) is in late-stage development for the treatment of chronic heart failure. The Company is also developing VP025, an early-stage new drug candidate for the treatment of certain neurodegenerative diseases.

Certain statements contained in this press release or elsewhere in our public documents constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements may include, without limitation, summary statements relating to results of the ACCLAIM trial in patients with chronic heart failure, plans to advance the development of Celacade(TM), plans to fund our current activities, statements concerning our partnering activities and health regulatory submissions, strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "expects", "plans", "anticipates", "believes", "estimated", "predicts", "potential", "continue", "intends", "could", or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of these forward-looking statements, including assumptions about the nature, size and accessibility of the market for Celacade in the treatment of chronic heart failure, particularly in Europe, the regulatory approval process leading to commercialization and the availability of capital on acceptable terms to pursue the development of Celacade, and the feasibility of additional trials. You should not place undue reliance on our forward-looking statements which are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to, the outcome of further analysis of the ACCLAIM trial results, the requirement or election to conduct additional clinical trials, delays or setbacks in the regulatory approval process, securing and maintaining corporate alliances, the need for additional capital and the effect of capital market conditions and other factors on capital availability, the potential dilutive effects of any financing, risks associated with the outcome of our research and development programs, the adequacy, timing and results of our clinical trials, competition, market acceptance of our products, the availability of government and insurance reimbursements for our products, the strength of intellectual property, reliance on subcontractors and key personnel, losses due to fluctuations in the U.S.-Canadian exchange rate, and other risks detailed from time to time in our public disclosure documents or other filings with the Canadian and U.S. securities commissions or other securities regulatory bodies. Additional risks and uncertainties relating to our Company and our business can be found in the "Risk Factors" section of our Annual Information Form and Form 20-F for the year ended November 30, 2006, as well as in our later public filings. The forward-looking statements are made as of the date hereof, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Unless otherwise indicated, numerical values indicating the statistical significance ("p-values") of results included in this document are based on analyses that do not account for endpoint multiplicity.

Thanks. I actually looked at them but thought it was a bit too early for me to speculate and to wait and see how their products advance. I guess I am being a bit hard on the CEO since as I recall their Neupogen product had some (potential) advantages I believe it was faster acting with neutropenia risk I could see that alone as an advantage.

Gee that sounds like something an arrogant CEO might say :)... Maxygen

Updates: Actimmune, IPF competitive landscape

InterMune http://www.intermune.com/

Focus on Pulmonology and Hepatology. In Pulmonology focused on Idiopathic Pulmonary Fibrosis (IPF) and in Hepatology Protease Inhibitor recent collaboration with Roche and an undisclosed preclinical compound (in collaboration with Array).

IPF
• Scarring of lungs, unknown cause
• Median survival from diagnosis 2-5 years
• US Prevalence (for PF) 128,000, Incidence 48,000 each year http://tinyurl.com/u6kgo, journal abstract http://tinyurl.com/tqd6m IPF prevalence incidence 83K US and 30K incidence.
• No approved therapy steroid and immune suppressants used with little effect. Drugs used include: Imuran (Azathioprine), Cellcept (Mycophenolate mofetil), Rheumatrex (Methotrexate), Mucomyst/Parvolex (N-acetylcysteine [NAC]) and Prednisone along with off-label use of Actimmune. Other off-label use include: Remicade (Infliximab), Enbrel (Etanercept) and Gleevec (Imatinib).

Competitive Landscape for IPF
1. Genzyme (collaboration with what was CAT) in Phase 1
2. Bosentan (Tracleer) from Actelion, Phase 2 failed in their endpoint proceeding with Phase III (BUILD-3) believed to be mortality end point 390 patients, event-driven study with SPA, results expected late 2009.
3. Imatinib (Gleevec), I believe it failed Phase 2 not sure of status going forward.
4. Sildenafil (Phase 2) http://www.clinicaltrials.gov/ct/show/NCT00352482
5. Pipex (Tetrathiomolybdate) Phase I-II completed http://clinicaltrials.gov/ct/show/NCT00189176 Company filings say plans to initiate Phase 3
6. FivePrime Collaboration http://tinyurl.com/yz444l
7. Others?

Actimmune
• INSPIRE Trial DSMB stopped at interim analysis for lack of efficacy, http://tinyurl.com/37y9tn
• For more information on Actimmune please see prior ReadMe files

Pirfenidone
• Administration Orally active small molecule 3x day pill of either 267 mg capsules (CAPACITY 1) or 267 mg or 133 mg (CAPACITY 2)
• Acquired NA and EU rights from Marnac, http://www.marnac.com/ for Fibrotic Indications. (PR http://tinyurl.com/yy2qao and 10K’s) In March 2002, we licensed from Marnac, Inc., a privately held biopharmaceutical company, and its co-licensor, KDL GmbH, their worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases, including pulmonary, liver and renal fibrosis. Under the terms of the agreement, we received an exclusive license from Marnac and KDL in exchange for an up-front cash payment of $18.8 million and future milestone and royalty payments.
• Method Of Action (Company presentations) Preferentially binds to and disables the kinase p38-gamma. Significantly inhibits TGF-beta synthesis (fibrosis), Also inhibits TNF-alpha synthesis (inflammation)
• IP Protection (Conference call) Older compound patent from Marnac licensed covering anti-fibrotic uses 2011 expires. Basis of exclusivity more on Orphan drug. Granted in US (7 years) and Europe (10 years) after approval. Company states on Q4 2006 call that it is working on expanding IP and have certain activities and progress (very vague could be anything from follow-on compound to exploring new patents). Also stated at SIGnificant Investment conference 3/07
• Other Indications being studied in a number of trials (not all by InterMune). InterMune is seeking approval in Idiopathic Pulmonary Fibrosis. It is also conceivable that they later seek a broader approval for Fibrotic disease of the lung. Most notably an NIH study in Hermansky Pudlak Syndrome.
• Shionogi Phase 2 Results PR http://tinyurl.com/y5nwel Stopped after 6 months (efficacy). Treatment of 9 month. Observation/ Placebo/ Pirfenidone: Improved Minimal O2 Oximetry/6.1%/24.2% Declined Saturation/33.3/18.2% P=.016 Vital Capacity Improved/0%/9% Vital Capacity Declined/36.4%/13.4% P=.003
• InterMune Phase 2 Results PR http://tinyurl.com/y49zp7
• Journal Articles http://ajrccm.atsjournals.org/cgi/content/full/171/9/1040 (Shionogi Phase 2), http://ajrccm.atsjournals.org/cgi/content/full/159/4/1061
• Shionogi Phase 3 Top Line PR http://www.shionogi.co.jp/ir_en/news/detail/e_061222.pdf


CAPACITY Trials, http://www.capacitytrials.com/
http://www.clinicaltrials.gov/ct/show/NCT00287729
http://www.clinicaltrials.gov/ct/show/NCT00287716 - Three Arm Study
• Primary endpoint is change in forced vital capacity (FVC) after 60 weeks of treatment
• Two concurrent, multi-national trials CAPACITY 1 and CAPACITY 2
• Approximately 585 patients
• Randomized first patient April 27, 2006
• Expect enrollment to conclude Q4 of 2007, with top-line data expected in early 2009
• Exploring European partnering opportunities
• Enrollment proceeding “Very Well” (according to Q4 call) company still maintains enrollment expected to complete in Q4 2007.
• Differences between CAPACITY and Shionogi Phase 3 (Company presentations) Shionogi 250 patients, ours I-260, II-325, roughly same. Length Shionogi-52 ours 60 weeks. Dosing in Shionogi low dose 400mg TID high 600 TID, CAPACITY I-800mg TID, CAPACITY II 800mg and 400mg both TID, if account for avg. body weight of US/EU vs. Japan about 30mg/kg in each. Endpoint Shionogi change in Vital Capacity ours Change in Percent Predicted Forced Vital Capacity. Comparable measures of lung volume. Other difference is the patient population, Shionogi is Japanese ours is mainly NA and EU do not know of any metabolism difference in population or Pirfenidone between two groups.

InterMune 191 / PI Program
• Collaboration began with Array BioPharma http://tinyurl.com/y75d42
• Royalties due Described as “mid-single digits”. Array describes their royalties as 3% (generally speaking about royalty deals they have in past not just 191). As pointed out by rkrw (SI) and Dew other 3rd party royalties Chiron/others (~2%?)
• 191 General Characteristics
1. Active Sight NS3/4 PI
2. High affinity for and stability in the liver
3. Favorable pharmacokinetic profile potential Q12/BID dosing.
4. Good safety margins for: Body weights, organ weights, Clinical chemistry, clotting parameters and hematology, Renal, neurologic, gastrointestinal, immune and cardiovascular systems
5. Potency of ITMN compound is maintained against mutations that show resistance to other protease inhibitors
6. HCV protease selectivity is high
7. There were no significant effects on microscopic histopathology on any organ or tissue, including heart and liver
• 191 more specifics
1. Replicon Potency (genotype 1) EC-50 1.6nM, EC-90 14.1nM, EC-99 155.3, EC-999 1567.3 nM
2. 28 day preclinical tox suggests safe over wide dose range
3. Mutants D168A primary driver of 191 sensitivity. Hypersensitive mutation to Pegasys shift by about order may suggest suggests combo will result in protection against mutation.
4. Rat studies (looking at livers) various dose concentrations including 16 hours above EC 99.9 (3 log drop) 30 mg/kg equiv about 300mg in human to get similar human concentration.
• Some comparisons to VX-950/other PI’s
1. HCV replicon EC50 = ~2nM (VX-950=402nM, SCH-503034=200nM)
2. Mutations resistant to other PI primarily A156T 191 is highly active against mutation indicating complimentary profile with other PI’s in development
• 9/26/06 CTA submitted to the French Medicinal and Biological Products Evaluation Directorate http://tinyurl.com/yevhgh
• For technically oriented suggest listening to Think Equity “Think Tank” presentation by Dr. Blatt on 11/10/06 most technical info in company presentation to date.
• Phase 1A Trial Information http://tinyurl.com/32lvtz
1. One clinical trial site in Europe and will enroll approximately 74 healthy volunteers.
2. First patient dosed early January 2007.
3. Single-dose ascending dose in healthy volunteers.
4. Expects to complete the currently running Phase 1a study of ITMN-191 in healthy subjects in the first half of 2007.
5. Schering and Vertex held 1A until 1B that could be something we’ll do and have not disclosed plans yet.
• Phase 1B Trial Information (Press release/call) “InterMune plans to evaluate ITMN-191 in a Phase 1b randomized, double- blind, placebo controlled, multiple ascending dose study in patients infected with chronic hepatitis C virus. ITMN-191 will be administered to treatment naïve patients for 14 days and the study will include a cohort of non- responder patients. InterMune and its partner Roche expect to announce initial viral kinetic results from the Phase 1b trial in the second half of 2007.”
1. Not disclosing number of patients at this point
2. A specific cohort of non-responders in our mono-therapy studies so we can understand is there any difference in kinetics between non-responders and naïve patients. Ours will be the first in systematic fashion look at those directly.
3. We have very clear definition of what it means to be non-responder as operational defined in protocol. Will be a homogeneous group. (in response to question about type of non-responders)
• Other 191 Information
1. Looking at addition of ribavirin toxicology and PK (preclinical).
2. Plan to move quickly into Phase 2 of a design and duration of what would want to do in Phase 3 which you may imagine would include PEG-Interferon and Ribavirin.

Roche Collaboration http://tinyurl.com/y2e87x
• 60 million on closing, assuming successful develop in US and other countries will receive up to 470 million in milestones. 530 million total. Potentially 35 million (of 470 million) in next 12 months.
• Cost sharing – Roche responsible for 67% global development costs including all related mfg costs.
• Royalties outside US Roche commercializes all products from collaboration InterMune Royalties “mid-high teens %” depending on net sales level
• In US commercialize and share profits on 50/50 basis.
• Same economic terms would cover any 2nd generation PI’s developed and commercialized, roughly doubling value. Note this was clarified to mean excluding the up-front payment.
• Roche responsible for World-wide formulation development and manufacturing any compound.
• InterMune has 3rd party royalty obligations that total in mid single digits. Split 50/50 with Roche in US, InterMune responsible for them outside US
• Development self funding through development. Beyond significant post development milestones.
• Can opt out of either co-development or com-commercialization. If do so would receive higher x-US royalties and same royalties replace profit share in US.
• Expect to close pending Hart-Scott-Rodino around mid November

Other Pipeline/Interests
• Early stage preclinical program partnered with Array (undisclosed indication in Hepatology). Royalty described by Array as high single digits. Array Responsible for creating clinical trial and all synthetic process. InterMune take into clinical development through commercialization.
• Equity interest in Targanta Therapeutics, http://www.targanta.com/ as a result of selling Oritavancin in December 2005. (http://tinyurl.com/yznhod)
• Early stage work on PEGylated version of Actimmune (with Maxygen), does not appear to have much effort as this time. (http://tinyurl.com/yn4e4z)
• PEG-Alfacon (PEGylated version of Infergen) appears unlikely to be further developed.
• Research work in both Hepatology and Pulmonology

Financials
• Cash/securities 214.5 million (end of Q4 2006)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• Shelf registration (http://tinyurl.com/29rsqc) for up to 175 million filed 12/28/2006
• 33 million shares outstanding
• 2007 Guidance
o Revenue 70– 90 million.
o COGS 21-23%.
o R&D 110-125 million. Including 5-10 million for est. FAS 123R.
o SG&A 35-45 million including 5-10 million for FAS 123R.
• Government settlement for past Actimmune promotion (http://tinyurl.com/y3wa8a) . The company will pay $36.9 million plus 5% interest over five years. The first annual installment is $5 million and will be paid this year. Note some acceleration terms exist should InterMune receive 150 million in partnering/licensing (capped at $10 million/year).

Time-Line/Medical Presentations
• Present 8 abstracts from Pulmonology research at ATS in May
• Present 3 abstracts of preclinical experience of 191 at EASL in April
• Submitted several abstracts on preclinical data for 191 for DDW in May
• 2H ’07 Phase 1B data
• Q4 ’07 CAPACITY Trials enrollment targeted completion [I think it will be MUCH earlier]
• Q4 ‘07/Q1 ’08 CAPACITIY (Pirfenidone) treatment period ends
• Q1 ’09 Top line results from CAPACITY

Personally I was hoping that the results wouldn't come till trial completion. Was hoping Pirfenidone would be progressing faster and hopefully good news on 191. In my estimation I had about $10 value for Actimmune (before the 20%+ correction the past week). In addition to obviously not marketing it for IPF, it takes away some significant revenue.

Its certainly more speculative now and more riding on the Protease program then I feel comfortable with but I think Pirfenidone has more value then the market gave it credit.

Its interesting to note that the company put the shelf out in late December (175 million) and never issued also Dan Welch never sold shares. I don't think the company expected this. Though I think the program was appearing less promising.

If the company announces something major in the next day or two I'll update the readme if not I will probably update just the Actimmune stuff. The company cut staff in December '05 while I'd like to see some cut-back more I wouldn't count on a lot now. I also think partnering Pirfenidone is more likely rather then less. I'd put a slight chance on them revealing their mystery preclinical HCV program or perhaps even an inlicensing deal (another IPF compound??)

I was thinking a bit more about this poster presentation at the upcoming EASL meeting:

ADDITIVE TO SYNERGISTIC ANTIVIRAL EFFECTS OF AN NS3/4A PROTEASE INHIBITOR (ITMN-191) AND AN NS5B RNA-DEPENDENT RNA POLYMERASE INHIBITOR (R1479) IN AN HCV REPLICON SYSTEM
S.D. Seiwert 1, H. Tan 1, L.M. Blatt 1
1 InterMune, Inc., Brisbane, CA, USA

Given that the InterMune/Roche collaboration happened mid October it is probably a descent speculation that Roche new this before making the deal.

Then a few days later the FDA advisory committee had those 2 day meetings on future development of HCV therapies (in which Roche was very well represented)

Now I am speculating what if:
1-Roche has high confidence in the synergistic possibility and saw a lower potential of adverse interaction (not an expert here so just speculating based on the low amount of drug needed and high affinity for liver)
2-I believe Roche's Polymerase has already been tested with PEG-Riba
3-191's 1B will include a cohort of PEG nonresponders
What if 191 shows activity and reasonable tolerability in the 1B non-responders and then the companies decide that the Combo PEG-Riba-Portease-Polymerase be tried together in Phase 2 for (amongst other groups) a group of non-responders. Could this provide a route for an accelerated approval given the poor response rates for non-responders??

Yeah helicase sorry about that!

InterMune has not publicly hinted at what it may be this is just my speculation. The closest (I heard) was in response to a question at a conference once Dan Welch was asked about what he thought the HCV market place would look like and in addition to mentioning the PI he said there are also other targets that we and others are working on including Polymerase and Helicase. That is why I thought it could be one of these.

At the Susquehanna SIGnificant Investment Options in Healthcare conference Steven Porter was asked during the panel directly about Cardio Tox and the BI compound similarities. He stated the differences between the two (which InterMune has stated before) but He also stated that BI ran into cardio tox during 28 day Primate studies and went on to say that InterMune had done 28 day studies in Primates and did not see anything of concern. To my knoweldge this is the first time the company has given out this much detail.

Dr. Porter was also asked about combining 191 with Roche's Polymerases Inhibitor. He didn't give a specific answer but two things of note:
1-He said during the FDA Panel meeting they encouraged trying out combinations earlier then might be ordinarily. I wonder if some sort of accelerated approval path would be possible?
[EDIT: Saw this poster at EASL
ADDITIVE TO SYNERGISTIC ANTIVIRAL EFFECTS OF AN NS3/4A PROTEASE INHIBITOR (ITMN-191) AND AN NS5B RNA-DEPENDENT RNA POLYMERASE INHIBITOR (R1479) IN AN HCV REPLICON SYSTEM
S.D. Seiwert 1, H. Tan 1, L.M. Blatt 1
1 InterMune, Inc., Brisbane, CA, USA]
2-Given that InterMune has publicly stated they have a preclinical HCV target (outside of the Protease Roche collaboration) there is a decent chance InterMune has their own preclinical Polymerase. I guess a Helix Inhibitor is a descent possibility as well. Don't know if this would complicate combining 191 with Roche's Polymerase

On Pirfenidone InterMune said Q4 enrollment was ahead of schedule but continued with their Q4 Enrollment Goal. I still think it gets done early. I think I read that lung biopsy is required so this may be part of the reason its not quite as fast as I had thought/hoped.

On the Pharmion call Friday one of the doc's pointed out the same thing. I believe that is one of the drugs that was mentioned he was speaking about Kidney Cancer in general.

Granted this may be biased but there appeared to be general consensus that satraplatin warrants approval just on PFS and also its by no means clear that a survival benefit won't appear.

My 2 cents Overall survival just adds extra for the benefits of an Oral Platinum with a (relatively) benign safety profile. Just to make sure the drug is successful though I'd like to see GPC and Pharmion initiate as many Phase 2's in as many indications as possible ASAP :)

I know some analysts are better then others so its unfair to generalize broad-based but I tend to not think too highly of the Rodman and Renshaw analysts (generally speaking) at least in the stocks I own/follow.

I would be curious as to who (more so then which firms) people on this board think highly of rather then be negative and list those who aren't thought of highly (i'll let someone else suggest that :)).

One that I really like is Martin Auster I believe his new firm is GLG Partners he was with Wachovia (amongst others). The main thing I like about him is he asks insightful questions (even though he doesn't always get a direct/good answer all the time IMHO).

On the negative side the analysts who ask things that you can get if you read the PR or for the Q/K tend to annoy me. They also tend to be the ones that are looking for the company to basically fill out their reports for them (i.e. save them all the "modeling" work they'd need to do).

Just my 2 cents. Really would be interested in whom others would recommend and why. TIA

Webcast Calendar

[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]

NOTE: ANYONE MAY UPDATE THIS FILE


Edits: Susquehanna SIGnificant Investment Options in Healthcare, Bear Stearns 2007 London Healthcare Conference

Bear Stearns 2007 London Healthcare Conference
Tuesday, February 27, 2007
http://cc.talkpoint.com/BEAR002/022707b_cy/agenda.asp?day=Tuesday

SIGnificant Investment Options in Healthcare
Thursday, March 1, 2007
The Omni Berkshire Place
New York, NY
http://www.wsw.com/webcast/sig4/

ACHN 3/1 1:30 pm (SIG)
ALO 2/27 8am
BRL 2/28 8:30 am
EMIS 2/27 10am
GPCB 3/15 8am
GTCB 3/5 10am
HGSI 2/27 5pm
IDIX 3/1 10am (SIG/HCV panel); 3/1 2pm (SIG); 3/2 8am (4Q06)
NSTK 3/7 4:30 pm
OXGN 3/6 10am
VPHM 2/28 9am
VRTX 2/27 6:20 am (BS/London)

--
Procedure For Updating Calendar

When adding or modifying entries, please follow these steps:

1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.

2. Make your additions or modifications, inserting any new items in alphabetical order.

3. Post the updated

Let’s talk biotech!
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”

Dew,

I saw you follow AMD, do you know anything about Othera or this treatment? I believe you (maybe it was someone else) had mentioned a while back about a company working on the dry form of AMD? I was interested in any potential therapy to treat the dry form, aside from delaying the progression to wet. Appreciate any information on therapies/companies. TIA


http://biz.yahoo.com/bw/070226/20070226005633.html?.v=1

Othera Pharmaceuticals Presents New AMD Data at Angiogenesis 2007 Symposium
Monday February 26, 8:00 am ET
Preclinical data demonstrates the potential for a synergistic anti-angiogenic effect of OT-551 (topical eye drop) with Lucentis or Avastin injections to treat the wet form of AMD

EXTON, Pa.--(BUSINESS WIRE)--Othera Pharmaceuticals, Inc. today announced that Dr. Shaker Mousa, Professor of Pharmacology and Executive Vice President and Chairman of the Pharmaceutical Research Institute at Albany College of Pharmacy presented new preclinical data demonstrating the potential for OT-551's synergistic anti-angiogenic effect with either Lucentis or Avastin, the current standards of care for the wet form of age-related macular degeneration (wet AMD). Dr. Mousa's talk was presented at the Angiogenesis 2007 Conference in Key Biscayne, FL, hosted by the Bascom Palmer Eye Institute.

ADVERTISEMENT
click here
In his study, Dr. Mousa employed a well-known model of angiogenesis (the Chick Chorioallantoic Membrane or CAM model) wherein a blood vessel growth factor (i.e., vascular endothelial growth factor, or VEGF) is applied to a chick embryo to rapidly generate neovascularization, a hallmark of wet AMD. Dr. Mousa then studied the effect of either Lucentis or Avastin treatment alone, or in combination with Othera's drug to inhibit the number of new blood vessels formed. The results from this model clearly demonstrate that when the Othera compound OT-551 is added to either Lucentis or Avastin treatment there is a synergistic effect versus either treatment alone.

These results, along with other data, provide sufficient preclinical support for moving OT-551 into a previously-announced Phase II clinical trial to evaluate OT-551 eye drop as an adjunctive therapy to Lucentis injections for the wet form of AMD. That trial, scheduled to begin enrollment in the second quarter of this year, will be conducted at leading eye research institutions across the U.S., with Dr. Philip Rosenfeld of the Bascom Palmer Eye Institute serving as the study's chairman.

"We're encouraged to enter Phase II testing in wet AMD, as these results demonstrate that OT-551 could potentially improve the outcome of patients already on Lucentis by treating the underlying macular degeneration and decreasing the need for frequent Lucentis injections," said Dr. Len Parver, Medical Director of Othera Pharmaceuticals. "Today, retinal specialists only have at their disposal invasive treatments, such as intravitreal needle injections, to use against this disease. Even Lucentis, which showed in its clinical trials superior efficacy to any other approved agent, does not treat the underlying macular degeneration, just the abnormal blood vessels. Our goal would be to use an eye drop like OT-551 to obtain even better visual acuity outcomes with fewer Lucentis intraocular injections. If this could be achieved with a topical medication, it would be a major breakthrough in treating this disease."

AMD is the leading cause of blindness in the U.S. in persons over age 55. AMD is a chronic degenerative disease that is initially classified as a 'dry' form, and which can progress to vision loss via either advanced dry AMD or the so-called 'wet' form of AMD. As many as one million or more Americans currently suffer from the wet form of AMD. Although only 10 percent of all people with AMD have this type, it accounts for 90 percent of all blindness from the disease. As dry AMD worsens, new blood vessels may begin to grow. Because these new blood vessels tend to be very fragile, they will often leak blood and fluid under the macula. This causes rapid damage to the macula that can lead to the loss of central vision in a short period of time. The treatment paradigm for wet AMD today includes repeated needle injections into the eye of biomolecules, such as Genentech's Lucentis and Avastin, which specifically target factors known to promote new blood vessel formation.

In addition to the planned Phase II wet AMD study, Othera also plans to initiate its own Phase II study in 2007 with OT-551 for geographic atrophy, an advanced form of dry AMD that affects about a million Americans. OT-551 is also currently being tested in Othera's Phase II trial for preventing or slowing the progression of post-vitrectomy nuclear cataract.

About Othera Pharmaceuticals

Othera Pharmaceuticals, Inc. is a privately-held, specialty pharmaceutical company located in Exton, PA. Othera is developing treatments for the leading causes of blindness and vision impairment in the world, including age-related macular degeneration (AMD), cataracts and glaucoma. Othera's lead compound, OT-551, an eye drop, is being developed to treat several major eye diseases and conditions, including the dry and wet forms of age-related macular degeneration (AMD), cataracts, and dry eye syndrome. Othera's second lead compound, OT-730, is a novel improved beta-blocker for the treatment of glaucoma. More information on Othera Pharmaceuticals is available on the company's website at www.othera.com.


Contact:

Matt Dallas
Financial Dynamics
Tel: 212-850-5627
matt.dallas@fd.com

I am listening again, and I'm not sure if this is the part your refering to but in response to the Piper analysts' (Sally ??) questions about 47 min. Dr. Seizinger says
... Have seen in early interim analysis positive trend in overall survival which is included as supportive data in NDA filing ...

About 46:45 into it mentions that there are other examples where PFS leads to overall survival and then says
Have to wait for final data but very, very hopeful based on experience seen with my patients.

Saw this on Raging Bull (sorry I was checking out the competition) :). Anyway a nice (long) article on Strawberry, thought I would post the link for anyone interested.
http://www.riverfronttimes.com/2007-02-21/news/being-darryl-strawberry/1

Well it looks like GPC beet SPPI to this PR but they probably had some inside information that they were going to do this :).

I was looking over the license agreement a bit this weekend.
http://www.sec.gov/Archives/edgar/data/831547/000089256902002255/a84976exv10w9.txt

Let me first say I have no legal background and there are parts of the filing that are omitted for confidentiality. But I think I am more convinced GPC will try to settle. A couple of reasons, I think the biggest being the co-promote option Spectrum has included for US rights. Yes I know Co-promote != revenue sharing, however the wording is vague enough that Spectrum could be a pain for GPC if it isn't resolved before as it states the terms need to be negotiated in "good faith". Also the fact that Spectrum has equal representation on the joint development committee AND votes must be unanimous leads me to think it is GPC's interest to settle rather then risk an unfavorable arbitration and I'm sure they'll try to get the wording less vague.