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ITMN - Intermune Inc

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Thread Starter 
chart.ashx?t=itmn&ta=1&p=d&s=l

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development 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 for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research 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.
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Thread Starter 
Gapping up on good Phase 1 results
post #3 of 153
Man....I think there's good things to come for this one...hang on tight!

Stay tuned...more to follow.
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Form 8-K for INTERMUNE INC

14-Apr-2008

Change in Directors or Principal Officers, Financial Statements and Exhibits

ITEM 5.02. DEPARTURE OF DIRECTORS OR CERTAIN OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT OF CERTAIN OFFICERS; COMPENSATORY ARRANGEMENTS OF CERTAIN OFFICERS.
(b) On April 11, 2008, the Chief Scientific Officer of InterMune, Inc. (the "Company"), Dr. Lawrence Blatt, has indicated his intention to resign as an executive officer and employee from the Company effective May 16, 2008 in order to take on the role of President and Chief Executive Officer of a biotechnology company that he founded. Upon Dr. Blatt's resignation, it is anticipated that Dr. Blatt will serve as an ongoing consultant to the Company for a period of twelve months thereafter.
(e) On April 11, 2008, in connection with the impending departure of Dr. Blatt, the Company entered into a Separation Agreement with Dr. Blatt providing for the separation of Dr. Blatt from the Company to be effective May 16, 2008. The Separation Agreement, in conjunction with the terms of his Employment Agreement, provides for (i) a separation payment equal to twelve months' salary for a gross separation pay of $328,101.45, (ii) COBRA premium payments through May 31, 2009 (or until Dr. Blatt becomes eligible for employer-provided health insurance, whichever occurs first) and (iii) an extended period until December 31, 2008 to exercise vested shares of equity securities ("Separation Payments"). The Separation Payments are in addition to Dr. Blatt's regular compensation through the effective date of his separation. The terms and conditions of Dr. Blatt's separation from the Company are fully defined and set forth in their entirety by the Separation Agreement filed as Exhibits 10.1 to this Current Report on Form 8-K, and incorporated herein by reference.



ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits The following exhibits are furnished with this report on Form 8-K:

Number
10.1

Description
Separation Agreement between InterMune, Inc. and Lawrence Blatt dated
April 11, 2008.
post #5 of 153

Source: InterMune, Inc.

Press Release

InterMune Announces Progress on Pirfenidone in IPF
Monday April 21, 8:00 am ET
- Initiating planned roll-over study for CAPACITY patients in Q3 -
- Patient retention and conduct of Phase 3 CAPACITY program remain excellent to date -
- Abstract of Shionogi Phase 3 pirfenidone study now available on ATS website -


BRISBANE, Calif., April 21 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that it will initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The roll-over study will be open to patients who complete one of the two concurrent Phase 3 CAPACITY studies of pirfenidone in IPF. InterMune expects that the first patient will enter the roll-over study in August 2008. Additional information regarding the design and objectives of the pirfenidone roll-over study will be available at http://www.clinicaltrials.gov within approximately one week. The anticipated 2008 costs of conducting the study are included in InterMune's expense guidance of February 7, 2008.


Regarding the progress of CAPACITY, the company noted that patient retention and overall study conduct remain excellent, with a low rate of patient dropouts to date. InterMune anticipates that top-line results from CAPACITY will be available in January 2009. Data from the CAPACITY trials will remain blinded during the extension study enrollment period.

The company also provided an update on the publication plans of Shionogi concerning its Phase 3 study of pirfenidone in IPF performed in Japan. The abstract of the Tuesday, May 20 presentation by Shionogi of the results of this study at the American Thoracic Society (ATS), entitled, "A Phase III, Double-Blind, Placebo-Controlled Clinical Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis in Japan" [Session C95], is now posted at http://www.thoracic.org.

Conclusion of PR here:
http://biz.yahoo.com/prnews/080421/aqm021.html?.v=42
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Source: InterMune, Inc.

Press Release

InterMune to Release First Quarter 2008 Financial Results on May 1
Thursday April 24, 8:00 am ET

BRISBANE, Calif., April 24 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today that it will release first quarter 2008 financial results on Thursday, May 1, 2008 at 4:00 p.m. Eastern time. A live conference call and webcast will be hosted by InterMune at 4:30 p.m. Eastern time that same day.

To access the live teleconference, dial 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID#44837583. To access the webcast, please log on to the company's website at http://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.

A replay of the webcast and teleconference will be available approximately three hours after 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#44837583.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development 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 for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research 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.
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InterMune Inc. Earnings Conference Call (Q1 2008)
Scheduled to start Thu, May 1, 2008, 4:30 pm Eastern

To participate, follow link:
http://biz.yahoo.com/cc/0/92810.html
post #8 of 153

The Motley Fool

Betting on Approval for This Orphan Drug
By Brian Lawler | April 22, 2008

There's nothing more exciting in pharma investing than the release of new clinical trial data. Let's take a look at InterMune's (Nasdaq: ITMN) newest data for its lead drug, pirfenidone, and see if it's up to muster.

Pirfenidone is being tested in two phase 3 studies as a potential treatment for idiopathic pulmonary fibrosis (IPF).

IPF is a chronic, incurable condition of scarring of the lungs that makes breathing very difficult and has no known cause. Many patients die from the disease several years after being diagnosed.

I've previously covered InterMune's overview of pirfenidone and its market opportunity. Results of InterMune's phase 3 pirfenidone studies are due out early next year, but we recently got a glimpse of what sort of data they could produce. Yesterday, InterMune pointed investors to the abstract of a phase 3 study run by the holder of the marketing rights to pirfenidone in Japan, Shionogi; for those following along at home, here's the abstract.

The exciting news for InterMune investors is that there appear to be many similarities between the Shionogi phase 3 study (and the phase 2 study, as well) and InterMune's phase 3 pirfenidone studies. But there are also some key differences between the InterMune and Shionogi studies, and it is the differences that often trip up a drug in clinical trials.

Differences can spell defeat or victory
As any good pharma investor will tell you, it becomes harder to replicate study results as the number of differences between the clinical trials increases. In the case of InterMune's phase 3 studies and the Shionogi studies, any differences between the trials are bad news, because both Shionogi studies appear to have been successful.

The Shionogi phase 2 pirfenidone study, for example, was stopped early by a data-monitoring committee because of the preponderance of positive data (pirfenidone patients' reduced number of acute IPF exacerbations) favoring the drug versus placebo. In the Shionogi phase 3 study, pirfenidone met its primary and most important secondary study endpoints. The drug increased patients' progression-free survival and also showed benefits in lung functioning in what is called a "vital capacity" breath test.

Here are the main areas in which InterMune's phase 3 pirfenidone studies differ from Shionogi's, based on Shionogi's phase 2 study and the abstract details of Shionogi's phase 3 study:


1. InterMune's phase 3 pirfenidone studies are of a different patient population.

Shionogi's studies tested the drug in Japanese patients, whereas InterMune's trial sites are in North America and throughout Europe. Undoubtedly, patient composition will be very different, and it's anyone's guess whether these demographics will mean better or worse odds for success with InterMune's studies. Japanese IPF sufferers could have an easier (or tougher) version of the disease, for instance, or they could be otherwise healthier than North American and European sufferers of IPF, causing them to respond better to pirfenidone (or, for that matter, worse).

2. InterMune's phase 3 studies use a different maximum dosage than Shionogi's.

InterMune chose to test pirfenidone at a 33% higher dose in most patient groups than Shionogi used for its studies (2,400 mg daily for InterMune phase 3 studies, versus 1,800 mg daily for Shionogi studies). This decision was likely made because North American and European IPF sufferers weigh more than Japanese IPF sufferers. Nonetheless, this higher dosage strength in a different patient group does open the door for more unexpected, serious adverse events to occur in some patients -- although pirfenidone was previously tested at even higher doses in an open-label phase 2 study, so this may be a minor issue.

3. InterMune's phase 3 studies are for a different length of time.

Shionogi's phase 2 study was cut short by its data-monitoring board after most patients had only received nine months of pirfenidone, and in its phase 3 study, Shionogi tested the drug over 52 weeks of dosing. InterMune's phase 3 studies will give patients pirfenidone for 72 weeks. If pirfenidone truly is superior to placebo, then these longer studies will highlight its efficacy even more. But this also means the possibility for new, more serious adverse events that only occur over longer-term dosing.

4. InterMune's phase 3 studies are much larger than Shionogi's.

InterMune's two phase 3 studies will are composed of 400 and 320 patients, and Shionogi's phase 2 and 3 studies recruited 109 and 275 patients, respectively. For one thing, a larger study increases the probability that a drug that truly works will be successful in clinical testing (a phenomenon that's referred to as "the power of a study"). Also, regulatory agencies and doctors always appreciate the extra clarity on adverse events and efficacy in subgroups of patients (women vs. men, for example) that a larger study provides.

5. InterMune's phase 3 studies use a slightly different primary endpoint than Shionogi's phase 3 study did.

Some may consider it a negative that InterMune is using "forced vital capacity" (essentially a measure of how powerfully a patient can breathe) as its pulmonary-functioning primary endpoint in its phase 3 studies, compared to the "vital capacity" pulmonary-functioning primary endpoint Shionogi used in its phase 3 study.
Cont...
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Cont...

When drugmakers switch primary endpoints between trials, bad study results are sometimes more likely. This was the case with AtheroGenics (Nasdaq: AGEN) last year, when it switched endpoints between phase 2 and phase 3 trials. In the case of InterMune's very slightly tweaked pulmonary-functioning primary endpoint, I don't have any major concerns about the minor difference between tests, though.

This list is just a subset of the differences between InterMune's phase 3 studies and the Shionogi clinical trials. I'm sure we'll learn about other clinically important differences when Shionogi presents the full results from its phase 3 pirfenidone study at the American Thoracic Society conference in late May.

Enterprising investors can further compare InterMune's pirfenidone studies to the previously linked Shionogi studies by clicking on the InterMune phase 3 pirfenidone study overviews at clinicaltrials.gov (here and here).

Betting on an orphan


Specialty-pharma analysts often set themselves up for embarrassment by predicting positive study results for a drug too soon. Since only one out every five drugs that begins human clinical study testing goes on to receive FDA marketing approval, drug failures and analyst embarrassment happen quite often. (Exhibit A: my prediction about GPC Biotech's (Nasdaq: GPCB) Satraplatin eventually getting FDA approval last year.)

Even with InterMune's weak patent estate surrounding pirfenidone, what makes the drug exciting is that Shionogi (and others in previous studies) have produced consistently positive clinical studies with it.

Admittedly, there is an infinite number of ways for drugmakers to run a clinical study poorly and mess up its results. But I still have to say that the evidence that pirfenidone works, and that it will work in InterMune's phase 3 studies, is in its favor.

I'll even go out on a limb (something pharma and biotech analysts hate to do) and predict that InterMune's pirfenidone studies will be a success and will go on to get FDA and EMEA regulatory approval. That said, no clinical trial is ever a lock to produce good data, and even a drug that works can fail in clinical testing because of statistical chance.

Currently, there are no FDA-approved drugs to treat IPF. Considering that other drugmakers like United Therapeutics (Nasdaq: UTHR), BioMarin (Nasdaq: BMRN), Alexion Pharmaceuticals (Nasdaq: ALXN), and Actelion will likely see (or have seen) impressive profits after gaining regulatory approval for drugs to treat small orphan indications, I have little doubt that Rule Breakers pick InterMune will make boatloads of cash from pirfenidone if it is successful in phase 3 testing. Thankfully, we have the Shionogi studies to give us a better idea whether this success will occur next January.

Entire Article Here: http://www.fool.com/investing/high-g...phan-drug.aspx
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www.intermune.com/




Corporate Overview

InterMune, Inc. is a biotechnology company focused on developing and commercializing innovative therapies in pulmonology and hepatology.

Our pulmonology pipeline includes the fully enrolled Phase 3 “CAPACITY” program, evaluating pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis, or IPF. IPF is a progressive disease, characterized by inflammation and scarring (fibrosis) of the lungs. InterMune also has a research program focused on small molecules for pulmonary disease.

In hepatology, we are focused on expanding treatment options for patients suffering from hepatitis C virus (HCV) infections. Our portfolio includes the HCV protease inhibitor compound ITMN-191, currently in Phase 1b development. We also have a second-generation HCV protease inhibitor research program and a research program evaluating a new target in hepatology.

InterMune additionally markets Actimmune® (interferon gamma-1b), approved for the treatment of severe, malignant osteopetrosis and chronic granulomatous disease.

Actimmune® (interferon gamma-1b) is a bioengineered interferon gamma, a naturally occurring human protein that acts as a biologic response modifier that stimulates the immune system and has direct effect on various cells in the body.

Actimmune is indicated for reducing the frequency and severity of serious infections associated with chronic granulomatous disease (CGD). Actimmune is also indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis.

The most common adverse events observed in patients with CGD were flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Similar safety data were observed in patients with severe malignant osteopetrosis. Please refer to the Actimmune package insert for more complete safety and prescribing information.


PIPELINE
Development Pipeline:
Our core development programs are focused in the areas of pulmonology and hepatology. In pulmonology, we are developing therapies for the treatment of idiopathic pulmonary fibrosis. In hepatology, we are developing therapies focused on expanding treatment options for patients suffering from chronic hepatitis C.


  • Corporate Headquarters:
    3280 Bayshore Blvd.
    Brisbane, CA 94005

    Tel: (415) 466-2200
    Fax: (415) 466-2300


post #11 of 153


Form 8-K for INTERMUNE INC

13-May-2008

Change in Directors or Principal Officers

Item 5.02 Departure of Directors or Certain Officers; Election of Directors;

Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(c) On May 12, 2008, the Board of Directors ("Board") of InterMune, Inc. ("Company"), upon recommendation of the Board's Corporate Governance and Nominating Committee, approved the creation of the position of Lead Independent Director of the Board and elected Dr. Lars Ekman, a current nonemployee Board member, to serve as Lead Independent Director effective as of May 13, 2008. The Lead Independent Director, among other things, will coordinate the activities of the independent directors, serve as liaison between the Chairman of the Board, senior management of the Company and the independent directors, and preside at the executive sessions of the independent directors of the Company. In addition, the Board, upon recommendation of the Board's Corporate Governance and Nominating Committee, approved the appointment of Daniel G. Welch, currently the Company's President and Chief Executive Officer, as Chairman of Board effective as of May 13, 2008. Mr. Welch's new title will be Chairman, Chief Executive Officer and President. Mr. Welch will be replacing Mr. William R. Ringo who is the Company's current Chairman of the Board and who has elected not to stand for reelection to the Board during the Company's May 13, 2008 Annual Meeting of the Stockholders. Further, upon recommendation of the Board's Corporate Governance and Nominating Committee, the Board approved changes to the cash compensation to be paid to Dr. Lars Ekman in connection with Dr. Ekman's assumption of the role of Lead Independent Director of the Board. In consideration for the additional responsibilities and risks being assumed by Dr. Ekman in taking on the role of Lead Independent Director of the Board, Dr. Ekman's annual retainer for his Board participation will be increased from $50,000 to $75,000 effective as of May 13, 2008. No other changes were made to the cash compensation of nonemployee members of the Board.
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Tuesday, May 13, 2008 - 9:28 AM EDT
R&D expenses, new drug submission fuel higher Targanta losses
Boston Business Journal - Boston Business Journal

Targanta Therapeutics Corp. faced higher research and development expenses in its fiscal 2008 first quarter as the company geared up to submit its lead antibiotic for FDA approval. But its overall net losses actually dipped compared to last year.

The Cambridge, Mass., company (Nasdaq: TARG) said on Tuesday that it lost $17.6 million during the quarter ending March 31, compared to an $18.7 million net loss in the fiscal 2007 first quarter.

Net losses over the same period last year were higher because of a one-time, $9.5 million milestone-related expense under its partnership with InterMune Inc.

Targanta's year-over-year research and development expenses, however, jumped from $5.4 million in the fiscal 2007 first quarter to nearly $14.3 million a year later. That increased spending fueled Targanta's approval application to the FDA for its intravenous drug oritavancin.

Targanta said it had more than $73 million in cash and short-term investments on hand as of March 31, with 21 million shares outstanding.
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AP
InterMune shares rise on FDA drug designation
Monday May 19, 5:21 pm ET
InterMune shares rise as FDA gives drug candidate special designation for review process

NEW YORK (AP) -- Shares of InterMune Inc. rose Monday after the Food and Drug Administration gave the biotechnology company's developing lung disease treatment fast-track status, allowing for a quicker regulatory review.

The stock gained 18 cents, or 1.2 percent, to end at $15.11. Shares have traded between $11.72 and $28.07 over the last 52 weeks.

Early Monday, the company said the FDA gave pirfenidone the special review designation. The drug is being developed as a treatment for idiopathic pulmonary fibrosis.

A fast-track designation means the company can submit clinical trial data to the FDA as it becomes available, rather than having to wait to submit it all at once. The status is reserved for drugs aimed at treating serious conditions for which there are few or no available treatments.

There are currently no approved treatments for idiopathic pulmonary fibrosis.

"Top-line pirfenidone results from InterMune's pivotal Phase III CAPACITY (study) program are expected in January 2009, and assuming positive data, we believe this morning's announcement will likely accelerate the regulatory and commercialization timelines," Thomas Weisel Partners analyst Stephen Wiley said in a note to investors.

He reaffirmed a $26 price target and "Favorable" rating on the stock.
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post #15 of 153
AWsome today!
post #16 of 153
post #17 of 153
Watch for 10.50 close
post #18 of 153
Huge premium on the options, but good volitility and high delta
post #19 of 153
Quote:
Originally Posted by binks View Post
Watch for 10.50 close

Got it, 10.88 close but down after hours. The short interest is huge, over 30% with 29 days to cover. Any news could rocket this in either direction, but earnings are due next and if they are not as bad as expected then there could easily be a squeeze.
post #20 of 153

good one binks

Quote:
Originally Posted by binks View Post
AWsome today!
a close thurs over 11.06 and this could have more to run...sorry i'm late but i am here now...if its up tomorrow i will likely PTT...
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