Silicon Investor - InterMune (nasdaq)ITMN

[Savant] And out from the cracks in the woodwork they rush forth..... Block &...

Savant — 8/26/2014 3:43:09 AM

And out from the cracks in the woodwork they rush forth.....

Block & Leviton LLP Investigates InterMune, Inc. for Possible Breaches of Fiduciary Duty in Connection with Its Merger with Roche

BOSTON, Aug. 24, 2014 /PRNewswire/ -- Block & Leviton LLP (www.blockesq.com), a Boston-based law firm representing investors nationwide, has commenced an investigation into possible breaches of fiduciary duty by the Board of Directors of InterMune, Inc. ("InterMune" or the "Company") (NASDAQ: ITMN) concerning its proposed merger with Roche in an all cash transaction.

InterMune stockholders will receive $74 in cash for each InterMune share held. This represents a premium of barely 38% of InterMune's previous closing price, far below recent premiums for pharmaceutical companies with fully developed treatments akin to InterMune's Pirfenidone. The transaction is expected to be executed as a two stage tender offer, commencing on or before August 29, 2014.

Block & Leviton's investigation seeks to determine, among other things, whether InterMune's Directors breached their fiduciary duties by failing to maximize shareholder value in the proposed merger with Roche and the fairness of the process by which they considered and approved the transaction. The firm is also investigating whether or not Roche's officers and board members aided and abetted such breaches of fiduciary duty.

If you are a shareholder of InterMune and have questions about your legal rights, or if you have information relevant to this investigation, please contact attorney Steven P. Harte, at (617) 398-5600 or email him at Steven@blockesq.com.

Block & Leviton is a Boston-based law firm representing investors nationwide for violations of securities laws. The firm's lawyers have collectively been prosecuting securities cases on behalf of investors for over 70 years. This notice may constitute attorney advertising.<<<<*OH, YA THINK?

[Savant] Roche/ITMN Deal Hoists First Trust Biotech ETF to Record High -- Mar...

Savant — 8/26/2014 3:41:43 AM

Roche/ITMN Deal Hoists First Trust Biotech ETF to Record High -- Market Talk

11:24 EDT - Roche's (RHHBY) $8.3B move to purchase InterMune (ITMN) sends the First Trust Amex Biotechnology Index ETF (FBT) to an all-time high and other biotech-themed ETFs soaring. The latest takeover sends ITMN up 36%. FBT is perhaps less well known than the $5.4B iShares Nasdaq Biotechnology ETF (IBB) or the SPDR S&P Biotech ETF (XBI), but it's soundly beating both this year. FBT is more concentrated than peers, with an equally weighted batch of 20 holdings that tilt toward early-stage companies. FBT up about 32% this year vs 20% for IBB and 22% for XBI.

[Savant] Roche to buy InterMune for $8.3 billionBy Jonathan D. Rockoff...

Savant — 8/25/2014 1:01:31 PM

Roche to buy InterMune for $8.3 billion

By Jonathan D. Rockoff and Hester Plumridge

LONDON -- Roche Holding AG (RHHBY) said Sunday it would pay $8.3 billion for a California biotech firm that has yet to turn a profit on a new drug to treat a deadly lung disease -- the latest gamble by a pharmaceutical giant to buy its way into a lucrative corner of the industry.

The takeover would allow the Swiss company to expand its presence in the treatment of respiratory disorders, one of the world's biggest drug markets. Roche's offer of $74 a share represents a 38% premium over InterMune's (ITMN) closing share price on Friday of $53.80, and a 63% premium before takeover speculation surrounding the biotech started circulating this month.

2014 has been one of the busiest years for pharmaceutical deal makers. Companies notched $87 billion in deals through June, more than all of last year and on pace to exceed the peak in recent years of $152 billion in 2009, according to EvaluatePharma.

Roche remained one of the M&A holdouts during the latest frenzy. Its last big deal was in 2009, when it paid $46.8 billion for the stake in biotech Genentech that it didn't already own. In 2012, Roche gave up a chance to buy gene-sequencing firm Illumina Inc. (ILMN) rather than boost its $6.7 billion offer.

In InterMune, Roche found a suitable target. The biotech had attracted widespread industry interest, according to people familiar with the matter, because it has a drug, Esbriet, already approved in Europe and Canada.

Esbriet aims to treat a lung-scarring condition called idiopathic pulmonary fibrosis, which currently lacks an approved therapy in the U.S. Pharmaceutical executives look for such opportunities because companies can charge high prices for new drugs involving poorly treated diseases.

(An expanded version of this report appears on WSJ:com: online.wsj.com

[Savant] InterMune Receives FDA Breakthough Therapy Designation For Pirfenido...

Savant — 7/28/2014 11:12:44 AM

InterMune Receives FDA Breakthough Therapy Designation For Pirfenidone, An Investigational Treatment For IPF

BRISBANE, Calif., July 17, 2014 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. As described in the FDA Fact Sheet: Breakthrough Therapies, "If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug." In May, InterMune resubmitted its New Drug Application (NDA) for pirfenidone and noted a target FDA review of six months under the Prescription Drug User Fee Act. Pirfenidone is an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IPF).

"The Breakthrough Therapy Designation underscores the significant need to help patients with this irreversible and ultimately fatal disease, particularly as no FDA-approved therapies are currently available," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "We are pleased that the FDA recognized the importance of pirfenidone as a potential new therapy for IPF, a disease with great unmet medical need."

About Pirfenidone

Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet(R) (pirfenidone) for the treatment of adults with mild to moderate IPF. The approval authorized marketing of Esbriet in all 28 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. In 2011, InterMune launched commercial sales of pirfenidone in Germany under the trade name Esbriet, and Esbriet is now also commercially available in various European countries, including key markets such as France, Italy and the UK.

On October 1, 2012, Health Canada approved Esbriet for the treatment of mild to moderate IPF in adult patients. Health Canada designated Esbriet for Priority Review and completed the accelerated review according to target guidelines of 180 days. InterMune launched Esbriet in Canada in January 2013.

Pirfenidone has been marketed as Pirespa(R) since 2008 in Japan and since 2012 in South Korea by Shionogi & Co. Ltd. Under different trade names, pirfenidone is also approved for the treatment of IPF in China, India, Argentina and Mexico.

Pirfenidone is not approved for sale in the United States.

About IPF

Idiopathic pulmonary fibrosis (IPF) is an irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF inevitably causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Periods of transient clinical stability in IPF, when they occur, inevitably give way to continued disease progression. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. IPF typically occurs in patients over the age of 45, and tends to affect slightly more men than women.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, unpredictable and ultimately fatal lung disease. Pirfenidone is approved for marketing by InterMune in the EU and Canada under the trade name Esbriet(R). Pirfenidone is not approved for sale in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.

[Savant] InterMune beats by $0.04, beats on revs; raises FY14 revs in-line wi...

Savant — 5/13/2014 2:35:17 AM

InterMune beats by $0.04, beats on revs; raises FY14 revs in-line with CapIQ consensus

Reports Q1 (Mar) loss of $0.59 per share, $0.04 better than the Capital IQ Consensus Estimate of ($0.63); revenues rose 188.6% year/year to $30.3 mln vs the $28.12 mln consensus.

Commentary: "Our commercial momentum continues, with sequential quarterly revenue growth of 18% in the first quarter of 2014 -- one of the few quarters in which Esbriet was not launched in a new country since the initial launch in September 2011. Based on our solid first quarter results, we today raised our 2014 revenue guidance to a range of $130-$140 million. This represents potential growth of approximately 85-100% from Esbriet revenue of $70.3 million in 2013. With the April 1 approval of pricing and reimbursement in the Netherlands, Esbriet is now reimbursed and launched in 14 of our original 15 top-priority markets in Europe."

Guidance: Co raises guidance for FY14, sees FY14 Esbriet revs of $130-$140 mln vs. $137.18 mln Capital IQ Consensus Estimate. The new range represents potential growth in 2014 of approximately 85-100% from Esbriet revenue of $70.3 million in 2013. The company anticipates the impact on Esbriet revenue in the EU due to the positive ASCEND results announced in late February 2014 to be partially observed in the fourth quarter of 2014, and not meaningfully until 2015 when the European prescribing information is amended to reflect the ASCEND-related data, which is expected to occur around the end of 2014.

Company continues to expect 2014 R&D expense of $110-$120 mln, SG&A expense of $210-$225 mln, and total operating expenses of $320-$345 mln.

[ghmm] I still have a position in ITMN though its not as big as it once was. I think t...

ghmm — 11/6/2013 3:40:43 PM

I still have a position in ITMN though its not as big as it once was. I think their high burn/multiple finances have taken a big chunk of the upside away. I really think they've done a poor job with the EU launch. I expected more of a gradual ramp but didn't expect such issues with reimbursement and more so a long launch process.

I don't have a guess at where their share price will stabilize but if one looks at when they've raised money they've usually done so at some of the worst times (granted in hindsight). I don't know if its Welch's call or Hodgman but I do seem to recall that under the prior CFO raising money was generally at better times.

On the pirfenidone front I think the FDA pretty much has to give them approval if they hit on FVC and survival is trending (when pulled with prior CAPACITY studies). The panel seemed to focus on the acceptance of a 10% decline in FVC is it meaningful or not and I think the consensus was Yes it is and it seems that is the end point of choice in IPF studies now.

I'm biased so my speculation on whether they hit or not is probably meaningless :-)

[Biotech Jim] One Q on ITMN is where will the share price stabilize? Will it be in the low $1...

Biotech Jim — 11/6/2013 3:04:30 PM

One Q on ITMN is where will the share price stabilize? Will it be in the low $12s, or come back to the $10s area? I lucked out and sold my remaining long term shares the day after they announced the secondary (ie, yesterday). I did have a buy order in at $12.48, but cancelled it due to the toppyness of biotech stocks and thought the price might go lower.

The other Q is how the perfenidone (Esbriet) ASCEND trial will do? Pretty straightforward endpoint of FVC at 52 weeks compared to predrug status. hdl, do you a prediction on the ASCEND trial outcome, and whether the FDA will accept the results if positive, since there is no SPA in hand? Dramatic unmet medical need for an IPF drug.

A summary of the previous Capacity studies are provided in this link:

drugs.com

[hdl] secondary killing pps

hdl — 11/6/2013 12:16:36 PM

[Biotech Jim] In the FWIW column, the Baker Bros. Hedge Fund picked up a significant stake in ...

Biotech Jim — 12/12/2012 8:53:03 AM

In the FWIW column, the Baker Bros. Hedge Fund picked up a significant stake in ITMN as of their last SEC filing. Total shares held: 868,181.

[ghmm] Very Interesting study of Pirfenidone. I recall a very early pilot study that t...

ghmm — 12/1/2012 6:54:11 AM

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

clinicaltrials.gov

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

[ghmm] Ian Estepan ?@ianestepan $ITMN May IMS data for Germany released:16% mo/mo growt...

ghmm — 7/5/2012 2:12:13 PM

Ian Estepan ?@ianestepan
$ITMN May IMS data for Germany released:16% mo/mo growth. 13-19% growth required to hit $7.84M cons - so #'s seem achievable...

[ghmm] Interesting article on Pirfenidone. Granted its a meta-analysis but should help...

ghmm — 6/3/2012 6:56:21 PM

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

err.ersjournals.com

[ghmm] The other day Ian Estepan ? @ianestepan tweeted that IMS data showed 2 - 2.3 mi...

ghmm — 6/1/2012 11:53:35 PM

The other day Ian Estepan ? @ianestepan tweeted that IMS data showed 2 - 2.3 million sales for April. I have no idea on the accuracy of the information. I was under the impression IMS data wouldn't be available in Germany because of privacy laws there.

[ghmm] Bosentan in IPF results are posted at clinicaltrials.gov. I am impressed with t...

ghmm — 6/1/2012 11:49:30 PM

Bosentan in IPF results are posted at clinicaltrials.gov. I am impressed with the level of information given (not the results) haven't noticed this much detail in other study results.

http://clinicaltrials.gov/ct2/show/results/NCT00391443

[tnsaf] Title: InterMune to Divest Actimmune® (Interferon Gamma-1b) Date(s): 5/21/12 4...

tnsaf — 5/22/2012 12:44:36 AM

Title: InterMune to Divest Actimmune® (Interferon Gamma-1b)

Date(s): 5/21/12 4:51 PM

For a complete listing of our news releases, please click her

-- To divest Actimmune for $55 million in cash plus a two-year royalty stream --

-- Transaction provides additional financial flexibility --

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

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

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

[Biomaven] I don't think it's all that surprising that if you immune-suppress old patients ...

Biomaven — 5/21/2012 3:26:09 PM

I don't think it's all that surprising that if you immune-suppress old patients with already compromised lung function you are going to run into issues with infections that would likely show up as exacerbations.

It's a bit frustrating that they don't show cause of death in these studies.

Peter

[ghmm] I found the imbalance in acute exacerbation very interesting especially given no...

ghmm — 5/21/2012 1:12:16 PM

I found the imbalance in acute exacerbation very interesting especially given no meaningful difference in FVC. I would suspect this led to the mortal imbalance as well (but I didn't see it mentioned in the paper). I wonder if azathioprine and/or prednisone triggered this in some patients. I've seen theories on these drugs being beneficial in some patients and yet harmful in others (if there are really different underlying diseases that would make a lot of sense).

The NAC arm is continuing and past studies with NAC have shown some promise. I'd still like to see ITMN do some combo trials perhaps a small investigator trial would be a cheap/low risk way to do this. I believe they mentioned in Germany some are already trying this.

[Biomaven] One "standard" treatment turns out to be harmful: BACKGROUNDA combination of p...

Biomaven — 5/20/2012 5:56:18 PM

One "standard" treatment turns out to be harmful:

BACKGROUNDA combination of prednisone, azathioprine, and N-acetylcysteine (NAC) has been widely used as a treatment for idiopathic pulmonary fibrosis. The safety and efficacy of this three-drug regimen is unknown.

Full Text of Background...

METHODSIn this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups — receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo — in a 1:1:1 ratio. The primary outcome was the change in longitudinal measurements of forced vital capacity during a 60-week treatment period.

Full Text of Methods...

RESULTSWhen approximately 50% of data had been collected (with 77 patients in the combination-therapy group and 78 in the placebo group), a planned interim analysis revealed that patients in the combination-therapy group, as compared with the placebo group, had an increased rate of death (8 vs. 1, P=0.01) and hospitalization (23 vs. 7, P<0.001). These observations, coupled with no evidence of physiological or clinical benefit for combination therapy, prompted the independent data and safety monitoring board to recommend termination of the combination-therapy group at a mean follow-up of 32 weeks. Data from the ongoing comparison of the NAC-only group and the placebo group are not reported here.

Full Text of Results...

CONCLUSIONSIncreased risks of death and hospitalization were observed in patients with idiopathic pulmonary fibrosis who were treated with a combination of prednisone, azathioprine, and NAC, as compared with placebo. These findings provide evidence against the use of this combination in such patients. (Funded by the National Heart, Lung, and Blood Institute and the Cowlin Family Fund; ClinicalTrials.gov number, NCT00650091.)

[ghmm] Speaking of Fibrogen here is a link to the changes in their Phase 2 study (just ...

ghmm — 5/16/2012 8:00:21 PM

Speaking of Fibrogen here is a link to the changes in their Phase 2 study (just got the update on my RSS feed). I don't know when they started/will start cohort 2. I never count on the clinicaltrials.gov completion date (they have 12/2013). So assuming they wait for that to finish before pursing a Phase 3 and we're looking at several years behind ITMN.

If it wasn't open label and the results continued to be promising maybe they'd have a shot with exceptional Phase 2 but that seems unlikely.

EDIT forgot link
clinicaltrials.gov

[Biotech Jim] This issue of potential side effects came to mind when I saw the view from PK-PD...

Biotech Jim — 5/16/2012 10:09:01 AM

This issue of potential side effects came to mind when I saw the view from PK-PD modeling that higher dose could be used to display higher efficacy. I agree that in fatal diseases being treated in older adults, like IPF, this should be less of an issue.

Jim

[Biomaven] Jim, do you think that there will be side effects of the CTGF mAb on chondrogen...

Biomaven — 5/16/2012 10:00:58 AM

Jim,

do you think that there will be side effects of the CTGF mAb on chondrogenesis or osteogenesis, such as an increase in bone fractures upon longer term treatment? Knockout mice have shown such signals based on my earlier review of the literature.

I think that only time will tell on a question like this. The effect seems much less in adult mice and the mAb isn't going to abrogate all CTGF action. The issue is obviously less important in fatal diseases such as IPF or pancreatic cancer, but may be more of an issue in liver fibrosis. Worst case is probably patients need to take some drug holidays.

Peter

[Biotech Jim] Below is that PR from Fibrogen. I do not disagree with you on this Peter, but I ...

Biotech Jim — 5/16/2012 8:38:39 AM

Below is that PR from Fibrogen. I do not disagree with you on this Peter, but I also believe that IPF has a significant variety of causes and also have the view of ghmm that a cocktail approach to treatment. We need multiple candidate treatments for the human fibroses.

Peter, do you think that there will be side effects of the CTGF mAb on chondrogenesis or osteogenesis, such as an increase in bone fractures upon longer term treatment? Knockout mice have shown such signals based on my earlier review of the literature.

BJ

fibrogen.com

FibroGen Announces Promising Preliminary Data from an Open-label Phase 2 Study to Evaluate the Safety and Efficacy of FG-3019 in Individuals with Idiopathic Pulmonary Fibrosis (IPF) and Provides Program Update

-FibroGen Expands Clinical Study Based on Preliminary Data Indicating Improvement in Lung Function and Lung Fibrosis in Patients with IPF-

San Francisco, CA - May 3, 2012
FibroGen, Inc., today announced expansion of an ongoing open-label Phase 2 study to evaluate the safety, tolerability, and efficacy of FG-3019, a human monoclonal antibody against connective tissue growth factor (CTGF), in individuals with idiopathic pulmonary fibrosis (IPF). The company’s decision to add a second, higher dose group is based on promising preliminary data from the first dose group as well as dose-escalation data from other clinical trials of FG-3019 indicating that higher doses of FG-3019 appear to be associated with a more robust biological and clinical response. FibroGen has also decided to add on another year of FG-3019 therapy for patients in the first dose group who are exhibiting stable or improved lung function in order to evaluate whether the observed maintenance of lung function continues.

IPF is a chronic, progressive, fatal lung disease for which there are no FDA-approved therapies. FG-3019 was developed to inhibit the activity of CTGF, a matricellular protein that plays a key role in fibrosis. More than a decade of research conducted by FibroGen and others has demonstrated a critical role of CTGF as a final common pathway in chronic fibrotic diseases in which persistent and excessive scarring leads to organ dysfunction and failure.

“This is the first demonstration in humans, to our knowledge, that reversal of fibrosis may be possible using a highly-targeted antifibrotic therapeutic,” said Thomas B. Neff, Chief Executive Officer of FibroGen.

A total of 54 patients having moderate to severe IPF for up to five years and aggressive disease progression have been enrolled into the first dose group in which 15 mg/kg FG-3019 is administered by intravenous infusion every 3 weeks for 45 weeks. Patients are tested every 3 months to assess changes in pulmonary function including measurement of forced vital capacity (FVC), a key indicator of both pulmonary function loss and disease-related mortality in IPF. For reference, based on placebo-treated patients in multiple recent clinical trials, patients with IPF typically experience a loss in lung function of approximately 7% predicted FVC per annum. In addition, patients are evaluated every 6 months by high resolution computed tomography (HRCT) imaging to assess structural changes in the lungs. HRCT assessments are made by pulmonary radiology experts who are using advanced digital imaging methods to quantify extent of and changes in lung fibrosis.
Combined 6-month preliminary pulmonary function and HRCT data are available for over half of the patients who remain in the study. Key preliminary findings from the first dose group include:
Disease severity at baseline, measured as the FVC percent predicted, ranged from 42.5% to 86.0%, with a median of 63%. These data suggest that patients enrolled in the FibroGen trial on average have greater disease severity than those enrolled in several recent IPF clinical trials with other experimental therapies. A substantial proportion of the patients who entered the trial with FVC percent predicted values above the median (i.e., > 63%) are experiencing stable disease or improvement in pulmonary function, as evidenced by increasing or stable FVC measurements during the study and comparable effects on FVC percent predicted values over the same period. Computer-generated HRCT data suggest that patients who entered the trial with disease severity above the median exhibit, on average, an improvement in lung fibrosis compared to baseline in two different measures of the extent of tissue scarring in the lung. Improved FVC appears to correlate with decreased fibrosis.

Pharmacokinetic modeling of clinical data available on FG-3019 from this and other studies suggests that dose increases are likely to generate a more consistent response. FibroGen and its scientific and medical advisors believe that higher doses of FG-3019 as well as extended treatment of patients considered responsive may result in even better clinical outcomes.

Based on the promising preliminary results from the first dose group, as well as data from other clinical trials suggesting that higher doses of FG-3019 are associated with better responses, FibroGen is expanding the Phase 2 IPF clinical trial in two ways. First, those patients from the initial dose group who appear stable or have improving FVC levels will be given the option to continue for another year of treatment with FG-3019. In addition, another group of patients will be enrolled for treatment at a higher dose of FG-3019 (30 mg/kg every 3 weeks) to further assess the safety, tolerability, and efficacy of FG-3019 in IPF patients. FG-3019 has been well tolerated in all clinical studies to date.

“Our decisions now to extend the current study and add a higher dose group are based on the data to date from this initial dose group suggesting that FG-3019 therapy may retard or prevent predicted declines in FVC and, in some cases, may increase lung capacity as measured by FVC,” said Mr. Neff. “These are potentially very important clinical findings and are surprising in light of disease severity of patients enrolled. We are hopeful that those who may be responding to FG-3019 in the current study will continue to maintain lung capacity and show improvements with extended time on treatment, and that the new group will benefit from a higher dose.”

About FG-3019
FG-3019 has been the subject of clinical studies involving over 200 patients to date, including a Phase 1 study of patients with IPF. FibroGen is currently conducting two other clinical studies with FG-3019 in addition to the IPF study. One is a study in Hong Kong in patients with liver fibrosis as a manifestation of hepatitis B. Reversal of liver fibrosis would prevent liver failure and reduce the risk of developing hepatocellular carcinoma. The other is a study in patients with pancreatic cancer, a disease in which extensive fibrosis associated with pancreatic tumors and metastases is thought to make this aggressive form of cancer highly resistant to chemotherapy. FG-3019 has been well tolerated in all clinical studies to date with no apparent safety signals.

About CTGF and IPF
IPF is a debilitating and life-threatening lung disease characterized by a progressive scarring of the lungs that diminishes functional lung volume and hinders oxygen uptake. The cause of IPF is not known. As scarring progresses, patients with IPF experience shortness of breath (dyspnea) and difficulty with performing routine functions, such as activities of daily living. Approximately 40,000 cases of IPF are diagnosed annually in the U.S. and Canada, where the overall prevalence is estimated to be 150,000. A similar prevalence exists for six other idiopathic interstitial lung diseases and systemic sclerosis that may benefit from antifibrotic therapy. There are no FDA-approved treatments for IPF, and approximately two-thirds of patients die within five years after diagnosis. Patients are often treated with corticosteroids and immunosuppressive agents, however, no therapies have been clinically proven to improve survival or quality of life. It is thought that stabilization or reversal of lung fibrosis could stabilize lung function and diminish the impact of this devastating disease.

The development of IPF is not completely understood but is thought to result from repetitive injury to epithelial cells that line the lungs. This initiates an abnormal wound healing process characterized by activation of cells called myofibroblasts, which produce and deposit excessive amounts of extracellular matrix (ECM). ECM deposition and tissue remodeling are key elements in the process of fibrosis that can eventually severely damage the lungs.

While different traumas and multiple biological factors can initiate the fibrotic process, CTGF is the final common element essential for chronic fibrosis.1,2 Studies have shown that CTGF causes transformation of multiple cell types into ECM-producing myofibroblasts and impairs important antifibrotic and proregenerative repair factors.3

Blockade of CTGF, in contrast, has been shown enable regenerative tissue repair:

administration of FG-3019 was reported to reverse fibrotic processes in a model of radiation-induced lung fibrosis at the 2010 annual meeting of the American Thoracic Society ;4 preventative and curative effects resulting from genetic blockade of CTGF using siRNA were reported in a model of liver fibrosis at the 2008 annual meeting of the American Association for the Study of Liver Diseases5 and in a subsequent journal article;6 and reversal of vascular remodeling using FG-3019 in a model of type 1 diabetes mellitus was reported at the 2006 annual meeting of the American Diabetes Association.7 CTGF is implicated as a pathogenic factor in IPF. In patients with IPF, CTGF levels are elevated in plasma,8 in transbronchial biopsy specimens, and in bronchoalveolar lavage fluid.9 Increased levels of CTGF have also been observed in experimental models of lung fibrosis.10 In addition, CTGF can cause susceptibility to experimentally-induced lung fibrosis in otherwise resistant mice.

Independent investigative teams have corroborated the reversal and regenerative effects of anti-CTGF therapy in two models of lung injury using anti-CTGF antibodies. In the first study mentioned above, FG-3019 reversed the process of fibrosis and improved lung function in a model of radiation-induced lung fibrosis.4 This model closely mimics progressive, radiation-induced lung damage in humans in which initial inflammatory stages are followed by extensive tissue remodeling and scar formation. In the second study, hyperoxia altered the development of neonatal rat lungs, inhibiting alveolarization and vascularization and promoting epithelial to mesenchymal transition and hyperplasia. Hyperoxia also induced cardiovascular remodeling leading to pulmonary hypertension, including increased pulmonary artery medial wall thickening and right ventricular hypertrophy. Treatment with FG-3149, an antibody similar to FG-3019, inhibited all of these pathologic changes, resulting in more normal lungs and hearts.11

About FibroGen, Inc.
FibroGen, Inc. was founded to discover and develop antifibrotic therapeutics. Using its expertise in the field of tissue fibrosis, in particular with matricellular proteins, such as connective tissue growth factor (CTGF), and matrix assembly enzymes, such as prolyl hydroxylases, FibroGen is now engaged in clinical development of anti-CTGF therapy and prolyl hydroxylase inhibitors for serious unmet medical needs. A placebo-controlled Phase 2 clinical trial of FG-3019 in Hong Kong addresses reversing advanced liver fibrosis and cirrhosis, the major consequences of chronic hepatitis B and C infections. Another Phase 2 pilot study addresses the ability of FG-3019 to prevent disease progression and reverse the consequences of tissue damage in idiopathic pulmonary fibrosis. Early results from an ongoing dose-escalation study in pancreatic cancer showed bioactivity of FG-3019, which is consistent with preclinical data implicating CTGF mechanistically in pancreatic cancer. From its large proprietary library of prolyl hydroxylase inhibitors, FibroGen is developing clinical and preclinical candidates designed to selectively activate HIF biology for the treatment of anemia and elicit a rapid, multifactorial, cytoprotective response for treating or preventing conditions resulting from acute ischemic injury and/or inflammation, including cardioprotection and inflammatory bowel disease. FibroGen also develops and produces recombinant human collagens and gelatins using proprietary production technology that permits making collagen essentially identical to the native protein. Development of medical devices, such as corneal implants fabricated with recombinant human collagen type III, is ongoing.

For more information about FibroGen, Inc., please visit www.fibrogen.com.

Contact for Patients
Loredie Lugos at 415-978-1353 or llugos@fibrogen.com

Contact for Media
Laura Hansen, Ph.D. at 415-978-1433 or lhansen@fibrogen.com

References

Mori T, et al. (1999) Role and interaction of connective tissue growth factor with transforming growth factor-beta in persistent fibrosis: A mouse fibrosis model. J Cell Physiol 181: 153-159.

Wang Q, et al. (2011) Cooperative interaction of CTGF and TGFß in animal models of fibrotic disease. Fibrogenesis Tissue Repair 4(1):4.

Nguyen T, et al. (2008) CTGF inhibits BMP-7 signaling in diabetic nephropathy. J Am Soc Nephrol 19(11):2098-107.

Huber PE, et al. (2010) Reversal of established fibrosis by treatment with the anti-CTGF monoclonal antibody FG-3019 in a murine model of radiation-induced pulmonary fibrosis. Am J Respir Crit Care Med 181: A1054.

Lawrencia C, Brigstock DR. (2008) Targeted delivery of connective tissue growth factor siRNA to activated hepatic stellate cells resolves experimental liver fibrosis in mice. Hepatology 48:908A.

Brigstock DR (2009) Strategies for blocking the fibrogenic actions of connective tissue growth factor (CCN2): From pharmacological inhibition in vitro to targeted siRNA therapy in vivo. J Cell Commun Signal 3:5–18.

Langsetmo I, et al. (2006) Anti-CTGF human antibody FG-3019 prevents and reverses diabetes-induced cardiovascular complications in streptozotocin (STZ) treated rats. Diabetes 55(Suppl.1): A122.

Kono M, et al. (2011) Plasma CCN2 (connective tissue growth factor: CTGF) is a potential biomarker in idiopathic pulmonary fibrosis (IPF) Clinica Chimica Acta 412: 2211–2215.

Pan LH, et al. (2001) Type II alveolar epithelial cells and interstitial fibroblasts express connective tissue growth factor in IPF. Eur Respir J 17:1220-1227.

Bonniaud P, et al. (2004) CTGF is crucial to induce a profibrotic environment in “fibrosis resistant” Balb/c mouse lungs. Am J Respir Cell Mol Biol. 31(5):510-6.

Alpati S, et al. (2011) Connective Tissue Growth Factor Antibody Therapy Attenuates Hyperoxia-Induced Lung Injury in Neonatal Rats. Am J Respir Cell Mol Biol 45: 1169-1177.

[ghmm] No doubt a second approved drug for IPF would hurt ITMN stock. I've heard Dr. P...

ghmm — 5/16/2012 12:02:30 AM

No doubt a second approved drug for IPF would hurt ITMN stock. I've heard Dr. Paul Noble (and others) speculate and I tend to agree that the disease is likely going to require a cocktail of therapies. I imagine it will be similar but more so than PAH. Unless the Fibrogen drug is extremely efficacious I would think combination may be even more common in IPF given the limited benefit of any one agent and the high mortality. The other likelyhood (in my opinion) is patients try one drug keep declining docs have them try another.

InterMune still has a couple years on anyone and Phase 2/3 failures are numerous. I am more disappointed with their (extremely) slow roll out into other countries. If BI's drug didn't have a similar and much worse tox profile (GI) I would think BI could be a good company to partner (or just take out ITMN) maybe a bigger company could navigate the EU reimbursement better.

I don't know much about the Fibrogen drug's mechanism but would like to see ITMN license (or develop) other complimentary IPF drugs and would hope they are very open to testing Pirfenidone with other agents.

[Biomaven] But the Fibrogen IPF PR does create some new and substantial long-term risk here...

Biomaven — 5/15/2012 10:26:55 PM

But the Fibrogen IPF PR does create some new and substantial long-term risk here.

Peter

[Biotech Jim] In the FWIW column: I like the recent action in the ITMN stock since the latest...

Biotech Jim — 5/7/2012 11:46:49 AM

In the FWIW column:

I like the recent action in the ITMN stock since the latest downgrade. My basis is about $12.50 overall.

[ghmm] On the InterMune call to me the begin negatives were the delay in launch not onl...

ghmm — 4/5/2012 8:13:36 PM

On the InterMune call to me the begin negatives were the delay in launch not only for France but also Italy and Spain to likely Q4 because of price negotiations. The other negative was the problem with Pirfenidone generics being made available in some Latin American countries based on where InterMune was trying to enroll patients ( ascendtrial.com ) and their history in the drug industry Brazil would seem to be the likely country in question. I am not concerned as much the impact it having on enrollment in ASCEND but on (potential) future sales into North America in particular. I still think the delay in enrollment may work out to InterMune's benefit in terms of reimbursement price reassement for Germany and by management comments I think they are in no hurry to rush enrollment I think this may be an unspoken reason.

[ghmm] I have been wondering for some time if it might be in InterMune's best interest ...

ghmm — 4/5/2012 4:29:08 PM

I have been wondering for some time if it might be in InterMune's best interest to have the results of ASCEND delayed. Germany will have yet another review some time (don't recall but it may be considerable I think it may be close to a year) after they hit 50 (or is it 60?) million euro in sales. At that time any new data would be included in the review including ASCEND (if the results would be available). A cautious person by no means would assume positive results so not having negative results in hand may be best for the company. So to me I actually view a delay in enrolling patients as a POSITIVE and not a negative at all!

On a related note I would like to see the company derisk the impact of ASCEND. I can think of a few ways to do that (some I posted here siliconinvestor.com ) but I certainly don't have the expertise or inside knowledge the company has. Overall I think Dan Welch has done a good job with the hand he has been dealt and I am cautiously optimistic he will do that and now we have a bit less than 2 years to do that. Of course having EU sales ramp fast would remove a lot of risk :-).

[IRWIN JAMES FRANKEL] InterMune has added a news release to its Investor Relations website. T...

IRWIN JAMES FRANKEL — 4/5/2012 1:33:07 PM

InterMune has added a news release to its Investor Relations website.

Title: France's Transparency Commission (CT) Issues Favorable Opinion for Reimbursement of Esbriet® (pirfenidone)

Date(s): 4/5/12 1:27 PM

For a complete listing of our news releases, please click here

-- InterMune expresses confidence in ASCEND Phase 3 study outcome; updates timeline --

-- Company to conduct conference call and webcast at 4:30 p.m. EDT today --

BRISBANE, Calif., April 5, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today reported that the Transparency Commission (CT: Commission de Transparence) of the French National Health Authority (HAS: Haute Autorite de Sante) has issued a favorable opinion for the reimbursement of Esbriet® (pirfenidone) by French National Health Insurance.

The CT noted that no other treatment provided evidence of a clinical benefit in IPF and considering all available information, Esbriet was granted an Amelioration du Service Medical Rendu (ASMR) rating of level IV. ASMR is a rating of added clinical value in comparison with existing therapies. The CT focused on the risk/benefit ratio for assessing the actual medical benefit (Service Medical Rendu SMR), and rated it as "Low." Patients suffering with severe, chronic diseases in France are typically reimbursed 100% for all services and medicines associated with the management of their condition, regardless of SMR level other than "Insufficient," (under a specific program for such diseases (Affection de Longue Duree ALD). This program covers more than 8.3 million French citizens.

The CT has recommended that Esbriet be reimbursed as a "medicament d'exception", which means that it will be reimbursed only for the labeled indication, further defined by the CT as IPF patients with forced vital capacity (FVC) > 50% and DLco > 35%. The CT also recommended that InterMune collect information in the form of a patient registry regarding the use of Esbriet in clinical practice. InterMune will now enter the next step in the process, which is to determine the price and any reimbursement conditions of Esbriet in France with the CEPS (Comite Economique des Produits de Sante).

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are pleased to receive the CT's favorable opinion for reimbursement of Esbriet. In the recently more challenging market access environment in France, our rating of ASMR IV is a positive outcome for Esbriet. The SMR and ASMR ratings we secured for Esbriet allow us to advance to the next step in the French process and we are optimistic about successfully concluding negotiations with the CEPS and making Esbriet available to patients in France as soon as possible and practical thereafter."

Based on information published on the HAS website, since early 2011 the CT did not recommend reimbursement in 32% of all its new product appraisals, compared with an historic average of 4%.

ASCEND Phase 3 Trial
InterMune provided an update on patient enrollment in the company's Phase 3 "ASCEND" study, which is designed to confirm the efficacy and safety of pirfenidone and to support an NDA re-submission for FDA approval of Esbriet (pirfenidone) in the United States. The company now expects ASCEND to be fully enrolled around the end of 2012. InterMune's previous guidance was the second quarter of 2012.

Steve Porter, M.D., Ph.D., Chief Medical Officer for InterMune, said, "Our primary mission for ASCEND is to deliver a high-quality result, which we aim to achieve by concentrating on a select number of high-quality sites. While a number of factors have contributed to the extended timeline, we are firmly convinced that the trade-off between data quality and time is a very good one. We believe the trial design and refined entry criteria of ASCEND significantly increase our probability of a successful outcome because they provide that patients enrolled in the study have the characteristics that we know from our many studies in IPF predict disease progression. We are extremely pleased with the continued enthusiasm of IPF physicians for ASCEND and look forward to sharing the results at the end of the study."

InterMune noted that it will discuss the status and projected timing for completion of the ASCEND Phase 3 clinical trial of Esbriet during today's conference call and webcast.

About Esbriet® (pirfenidone) in France

Esbriet is the first-ever drug approved by the EU regulatory authorities in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). In its assessment, the CT cited 7,700 mild-to-moderate IPF patients in France. The CT is the agency in France responsible for assessing medicinal products and advising the health authorities on whether those products provide sufficient benefit to be covered by French National Health Insurance.

About SMR and ASMR

Under the French system, a new medicine may be granted one of four SMR levels. Of these, three are considered "sufficient" for the CT to recommend favorable inclusion on the reimbursed drug list. The three sufficient SMR ratings are: Important, Moderate and Low. Each rating is associated with different levels of reimbursement.

The fourth SMR level, "Insufficient," is a recommendation by the CT that is unfavorable to inclusion on the reimbursed drug list and if assigned to an application, no ASMR rating is given by the CT. In this case, the manufacturer does not proceed to price negotiations with the Pricing Committee (CEPS).

There are five levels of ASMR rating:

ASMR I: Major therapeutic advance

ASMR II: Important improvement as far as effectiveness and/or reduction of side effects are concerned

ASMR III: Moderate improvement as far as effectiveness and/or reduction of side effects are concerned

ASMR IV: Minor improvement as far as effectiveness and/or clinical or pharmacokinetics usefulness are concerned

ASMR V: Absence of improvement but favorable opinion for registration on the reimbursed drugs list

Since the beginning of 2011, with its significantly more challenging reimbursement process, benefit ratings of new medicines have trended significantly lower. Based on information published on the HAS website, since early 2011 the CT has granted an ASMR rating of IV in 23% of applications. A rating of V (absence of improvement) was granted in 33%, no ASMR rating was given (due to an SMR of "Insufficient") in about 32% of applications, and only 11% of applications were granted an ASMR rating higher than IV (I, II or III).

About ALD

In France, diseases requiring a long-term, expensive treatment are defined as ALD (Affection de Longue Duree Long Term Diseases) and patients are fully reimbursed by the National Social Security for all the costs related to this disease (hospitalizations, lab tests, medicines, etc.). More than 8 million French citizens are reimbursed under this scheme. There are 30 broad disease categories including cancer, several cardiovascular diseases and others as well as smaller diseases grouped in a separate category. Most orphan diseases fall into this scheme.

Conference Call and Webcast Details

InterMune will host a live webcast of a conference call today at 4:30 p.m. EDT to discuss the CT's assessment of Esbriet in France, and the ASCEND Phase 3 clinical trial of Esbriet in IPF patients in the United States and other territories. Interested investors and others may participate in the conference call by dialing 800-891-8257 (U.S.) or +1-212-271-4651 (international), conference ID# 21587875. A replay of the webcast and 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.

A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 800-633-8284 (U.S.) or +1 402-977-9140 (international), and entering the conference ID# 21587875.

About ASCEND

ASCEND is a multinational, randomized, double-blind, placebo controlled Phase 3 trial designed to evaluate the safety and efficacy of Esbriet® (pirfenidone) in IPF patients with mild to moderate impairment in lung function. The primary endpoint is lung function, as measured by change in forced vital capacity (FVC) from baseline to Week 52. The trial will enroll a total of approximately 500 patients who are randomly assigned 1:1 to receive oral pirfenidone (2403 mg/day) or placebo.

The primary endpoint in the ASCEND study is change in percent predicted FVC, with the primary outcome analysis a Rank ANCOVA at Week 52. The magnitude of effect will be presented on a categorical basis as the proportion of patients with decrements of less than 0% or greater than 10% at pre-specified study time points.

Patient eligibility criteria for ASCEND include the following:

Centrally confirmed diagnosis by High Resolution Computed Tomography (HRCT) (+/- surgical lung biopsy)

%FVC 50% - 90%

%DLco 30% - 90%

FEV1/FVC ratio greater than 0.80

Time since IPF diagnosis greater than six months and less than four years

Key secondary endpoints include change in six-minute walk test (6MWT) distance and progression-free survival, which will be based on the earliest of time to death, FVC decrement of 10% or greater, or decrement in 6MWT distance of 50 meters or more.

Other secondary endpoints include all-cause mortality, evaluated both independently as well as pooled with the previous CAPACITY data, and on-treatment IPF-related deaths, which also will be evaluated independently and pooled with the CAPACITY data, and dyspnea.

About Esbriet® (pirfenidone)

Esbriet is an orally active drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF. The approval authorizes marketing of Esbriet in all 27 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. Esbriet is commercially available in Germany, Austria, Norway, Denmark and Luxembourg.

Since 2008, pirfenidone has been marketed in Japan as Pirespa® by Shionogi & Co. Ltd.

InterMune is conducting a Phase 3 study, ASCEND, to pursue the registration of Esbriet for the treatment of IPF in the United States.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs, hindering the ability for gas exchange in the lungs. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal. Published epidemiology studies suggest there is a range of between 85,000 and 141,000 IPF patients in Europe, with approximately 113,000 being the median estimate. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.

About InterMune

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

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to our expectation that IPF patients in France will be reimbursed at a 100% level for drugs with an SMR rating other than "Insufficient", statements related to the anticipated timing of commercial launch for Esbriet® (pirfenidone) in France, statements related to anticipated pricing and reimbursement of Esbriet in France and statements related to our ASCEND trial, including projected timing for completion of enrollment of the trial and expectations for improved probability of the results of such trial based in part on refined enrollment criteria. 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 most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 29, 2012 (the "Form 10-K"), and other periodic reports filed with the SEC, including but not limited to the following: (i) risks related to unexpected regulatory actions or delays or government regulation generally; (ii) risks related to the company's manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue; (iii) risks related to government, industry and general public pricing pressures; (iv) risks related to our ability to successfully launch and commercialize Esbriet in the EU, including successfully establishing a commercial operation in the EU and receiving favorable governmental pricing and reimbursement approvals in each EU country; (v) risks related to the timing of enrollment of our ASCEND clinical trial, the results of such trial and the prospects for FDA approval of Esbriet in the United States; and (vi) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections. 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, all of which are available via InterMune's web site at www.intermune.com.

Esbriet® is a registered trademark of InterMune, Inc.

SOURCE InterMune, Inc.

Jim Goff of InterMune, Inc., +00 1 415-466-2228, jgoff@intermune.com

[hdl] i was wondering why it was up. thanks.

hdl — 3/15/2012 8:42:15 AM

[IRWIN JAMES FRANKEL] InterMune, Inc. : Esbriet® (pirfenidone) Benefit Granted by German Federal Joint...

IRWIN JAMES FRANKEL — 3/15/2012 8:23:48 AM

InterMune, Inc. : Esbriet® (pirfenidone) Benefit Granted by German Federal Joint Committee (G-BA)

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BERLIN, March 15, 2012 /PRNewswire/ -- InterMune, Inc. (NADSAQ: ITMN) today reported that Germany's Federal Joint Committee (G-BA) has announced its decision granting the additional benefit of Esbriet® (pirfenidone) in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). Esbriet's additional benefit was classified as stage 4 (not quantifiable benefit) in the rating system established under Germany's AMNOG pharmaceutical law. A non-quantifiable benefit means that the drug has an additional benefit, which will be defined in the future via experience in daily clinical use or clinical studies. Based on this, a stage of 1-3 will be assigned. G-BA is the highest decision-making body of the self-governing healthcare system in Germany.

Today's final assessment of Esbriet's added benefit by the G-BA is improved from the preliminary assessment of the benefits of Esbriet issued by the Institute for Quality and Efficiency in Healthcare (IQWiG) in December 2011. In its preliminary assessment, IQWiG did not determine an additional benefit of Esbriet.

"We are pleased that the G-BA has recognized the additional benefit of Esbriet for patients with IPF," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Esbriet is the first orphan drug to be evaluated under the new German system for assessing the additional benefit to patients of a new medicine. As the only therapy approved for IPF, G-BA determined that there is no appropriate comparator treatment to Esbriet. Today's decision applies to all adult patients with mild-to-moderate IPF and ensures continued reimbursement in Germany for the first drug shown to be efficacious, safe and generally well-tolerated in this relentless and uniformly fatal disease."

Dr. Markus Leyck Dieken, InterMune's Senior Vice President and Country Manager for Germany, said, "We appreciate the input of those who helped to inform G-BA in making its decision, including patients, physicians, the pharmaceutical association and the German pulmonology society. We believe their comments were constructive in helping G-BA to arrive at today's final and positive assessment, and we thank them for their contributions on behalf of IPF patients."

InterMune's next step is to enter price negotiations with the Statutory Health Insurance, the umbrella organization which represents Germany's sickness funds. Sickness funds are the health insurance providers that reimburse the cost of pharmaceutical products in Germany.

Under Germany's AMNOG law, the price charged by a manufacturer for a new pharmaceutical product is reviewed during the 12 months following the medicine's launch. The current price for Esbriet in Germany will remain in effect until the pricing review is completed, which is expected by September 15, 2012.

Esbriet® (pirfenidone) Demonstrates Benefit for Patients

In its written and oral comments to G-BA during the review process, InterMune noted that pirfenidone slows both disease progression and the decline of physical performance. Compared to placebo, the results of a pooled analysis of pivotal trials showed that pirfenidone achieved a 31% relative reduction in the decrease in walking distance from the 6-minute walk test (6MWT) (p<0.001). In addition, a pooled analysis showed that pirfenidone significantly reduced the relative decrease in percent predicted forced vital capacity (FVC) by approximately 23%, compared to placebo (p=0.005). Considering the poor prognosis of IPF, the reversible side effects of pirfenidone are viewed as acceptable.

Conference Call and Webcast Details

InterMune will host a live webcast of a conference call today at 4:00 p.m. EDT to discuss the G-BA's final assessment of Esbriet's additional benefit. Interested investors and others may participate in the conference call by dialing 800-891-8257 (U.S.) or +1-212-271-4651 (international), conference ID# 21582928. A replay of the webcast and 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.

A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 800-633-8284 (U.S.) or +1 402-977-9140 (international), and entering the conference ID# 21582928.

About Esbriet®

Esbriet® (pirfenidone) is an orally active drug, indicated in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). The anti-fibrotic acting pirfenidone inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet® in adults for the treatment of mild to moderate IPF. The approval authorizes marketing of Esbriet® in all 27 EU member states. Esbriet® has since been approved for marketing in Norway and Iceland. In addition to Germany, Esbriet® is commercially available in Austria, Norway, Denmark and Luxembourg.

Since 2008, pirfenidone has been marketed in Japan as Pirespa® by Shionogi & Co. Ltd. In the United States, pirfenidone is currently being evaluated for the treatment of IPF in another clinical trial and is not yet approved by the FDA for this indication.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs, hindering the ability for gas exchange in the lungs. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal. Published epidemiology studies suggest there is a range of between 85,000 and 141,000 IPF patients in Europe, with approximately 113,000 being the median estimate. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.

About InterMune

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

[tuck] Jeffries downgrades, saying they expect a disappointing launch: notablecalls #...

tuck — 8/4/2011 9:56:33 AM

Jeffries downgrades, saying they expect a disappointing launch:

notablecalls # 8:01 AM

Stock is getting whipped on, indeed, near firesale territory.

Cheers, Tuck