Replies to post #71288 on Biotech Values

[DewDiligence]

>Is it coincidence that the two [VRUS and ITMN] reported news today?<

No, it’s not a coincidence. The first day of the JPM conference is typically the busiest news day of the year for biotech companies.

[ghmm]

InterMune Reports Results from Triple Combination Study of ITMN-191
#msg-33779887 may be a useful reference to compare Telaprevir and TMC 435. InterMune has previously said that they believe they could get to BID in several ways one that they mention is formulation. So perhaps getting improved BID (closer to TID) are possible with improved formulation. There is a CC at 8:30 http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-EventDetails&EventId=2068481

http://finance.yahoo.com/news/InterMune-Reports-Results-prnews-14027322.html

- Q12h and Q8h Regimens Deliver Robust Antiviral Effects and Strong Safety Profile -

- Phase2b Study Anticipated to Begin in Q2 2009 -

- Conference call today at 8:30 a.m. EST -

BRISBANE, Calif., Jan. 12 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today reported top-line results from all six completed dosage cohorts of its Phase 1b clinical trial of ITMN-191 (R7227) in combination with standard-of-care Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin) for 14 days of treatment in hepatitis C virus (HCV) treatment-naive patients infected with HCV genotype 1. ITMN-191 is being developed in collaboration with Roche (SWX: ROG - News). Viral kinetic performance and safety results were reported for three cohorts each of ITMN-191 given every 12 hours (q12h) and every eight hours (q8h).

Viral Kinetic Performance

After 14 days of triple combination therapy, the median change in HCV RNA from baseline exceeded 5 logs in five of the six cohorts and was -5.4 log and -5.7 log in the best performing q12h and q8h cohorts, respectively. Considering all cohorts, HCV RNA was below the limit of quantification in nearly three-quarters (71%, or 32 of 45) of patients who received treatment with ITMN-191 after only 14 days of treatment. In all q12h and q8h cohorts, reductions in HCV RNA occurred rapidly and there was no evidence of viral rebound during ITMN-191 treatment.

Safety and Tolerability Profile

ITMN-191 was generally safe and well tolerated. There were no serious adverse events (SAE) or Grade 4 adverse events (AEs) during treatment with ITMN-191. AEs reported during study treatment (ITMN-191 or placebo) were predominantly mild to moderate in severity, typically consistent with the well-described AE profile of standard of care (SOC) and none led to treatment discontinuation.

Only four Grade 3 AEs were reported during study treatment, two of which (sciatica and back pain) were deemed by the investigator to be unrelated to ITMN-191. The other two were neutropenia and indirect bilirubin elevation. Neutropenia occurred with a similar pattern, frequency and severity in the placebo and ITMN-191 groups. Minor and transient elevations in indirect bilirubin levels were observed in a small number of placebo and ITMN-191 patients and were deemed not clinically significant by the investigator. There were no other laboratory or ECG findings during study treatment that were attributable to ITMN-191.

 
            Summary of Viral Kinetic Assessments Following 14 Days of Treatment 
  
  
                             Median Change 
                              HCV RNA at 
                             EOT(1),(2)           BLQ           BLD 
                                Log10         (<25 IU/mL)  (<9.3 IU/mL) 
           Dose        N       (IU/mL)            (%)           (%) 
  
          Placebo      12        -2.2           1/12 (8%)     0/12 (0%) 
        100 mg q8h      8        -5.5           6/8 (75%)     1/8 (13%) 
        200 mg q8h      8        -5.7           7/8 (88%)     4/8 (50%) 
        300 mg q8h      7        -5.6           5/7 (71%)     4/7 (57%) 
        400 mg q12h     7        -4.7           4/7 (57%)     1/7 (14%) 
        600 mg q12h     8        -5.4           6/8 (75%)     1/8 (13%) 
        900 mg q12h     7        -5.3           4/7 (57%)     1/7 (14%) 
  
       (1)  EOT = End of Treatment 
       (2)  Values below Limit of Quantification (LOQ) of 25 IU/mL were 
            assigned value of 1.236 log10;   values below Limit of Detection 
            (LOD) of 9.3 IU/mL were assigned value of 0.667 log10 
 

A chart of the median log10 HCV RNA changes from baseline to Day 14 for each dose cohort is available on the investor relations page of InterMune's corporate website at www.intermune.com.
http://media.corporate-ir.net/media_files/irol/10/100067/TripleComboStudyChart.pdf


Dr. Stefan Zeuzem, Professor of Medicine, Chief of the Department of Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany and protocol chair of this study said, "Based on the totality of the viral kinetic data, in particular BLQ, a robust predictor of virologic outcome, the q12h and q8h regimens delivered very convincing viral kinetic results and appeared to perform very comparably in this 14-day study. The safety and tolerability profile of ITMN-191 in both the earlier monotherapy study and in the present triple combination study was also encouraging, as no issues of concern were observed. We look forward to the completion of the planned Phase 2b study to determine if the very promising profile of ITMN-191 observed will be confirmed."

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "We are very pleased to report that in this 14-day study, both the q12h and q8h regimens of ITMN-191 delivered viral kinetic performance that we believe is very competitive with that reported to date for other protease inhibitors in similar experiments. In addition, the strong safety and tolerability profile of ITMN-191 observed in prior Phase 1 experiments was reinforced in this study, even in the presence of standard-of-care therapy and at doses significantly higher than those used in monotherapy." Mr. Welch continued, "We believe that the viral kinetic and safety results reported today provide evidence that ITMN-191 has the potential to deliver superior sustained virologic response (SVR) rates on an intent-to-treat basis. In pursuit of this goal, our Phase 2b study, anticipated to begin in the second quarter of 2009, will study both q12h and q8h regimens and both 12 and 24-week treatment durations."

Phase 1b Triple Combination Trial Design

The Phase 1b randomized, double-blind, placebo-controlled, 14-day triple combination study in treatment-naive patients chronically infected with HCV genotype 1 was designed to inform the dose selection and study design of the ITMN-191 Phase 2 program. The study objectives were to assess the safety, pharmacokinetic and viral kinetic effects of various doses and regimens of ITMN-191 for 14 days in combination with Pegasys and Copegus compared to treatment with Pegasys and Copegus alone. Patient follow-up continues for 30 days following the completion of study treatment.

INFORM-1 Progress (All-oral STAT-C study)

In November 2008, Roche, InterMune and Pharmasset initiated the first all-oral combination study of direct anti-virals in the absence of interferon or ribavirin, known as the INFORM-1 study. That study has completed the first dose cohort. Results of INFORM-1 are expected to be reported at a major medical conference in the second quarter of this year.

Conference Call and Webcast Details

InterMune will host a conference call today at 8:30 a.m. EST to discuss the results of the 14-day triple combination study of ITMN-191. Interested investors and others may participate in the conference call by dialing 888-799-0528 (U.S.) or 973-200-3372 (international), conference ID# 80676348. 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.

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# 80676348.

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 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 new targets in hepatology. 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 anticipated product development timelines. 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 SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. 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.

[mcbio]

Feuerstein Re: ITMN-191 data

Feuerstein isn't too thrilled with the ITMN-191 data today. See: http://www.thestreet.com/_yahoo/newsanalysis/biotech/10457281.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

"A 600 mg dose of ITMN-191 given twice daily and combined with the current standard of care therapy for hepatitis C reduced the amount of virus below detectable levels in 13% of patients treated for 14 days.

Using a less stringent measure of efficacy, 75% of these patients had no detectable virus in their system. InterMune reported the new data on ITMN-191 ahead of the start Monday of the J.P. Morgan Healthcare Conference.

InterMune said it was pleased with the data and that the company and partner Roche plan to move ahead with new ITMN-191 studies in the second quarter. However, Wall Street's biotech investors never evaluate hepatitis C drugs in a vacuum, and in this case, Monday's ITMN-191 data doesn't stack up very well against Vertex's telaprevir.

In a similar 14-day "triple combination" study done in 2006 by Vertex, 25% of telaprevir patients had undetectable levels of virus in their system. That number jumped to 92% when using a less stringent measure of efficacy.

Now, patients in the Vertex study had to take telaprevir every 8 hours, or three times a day, which is less convenient than the twice-daily dosing for InterMune's ITMN-191. If InterMune wins on convenience, Vertex still appears ahead on potency.

The study reported Monday by InterMune also treated groups of patients with a three-times-daily dose of ITMN-191 for 14 days. In the best of these groups, 57% of patients treated with ITMN-191 and standard of care had undetectable levels of the hepatitis C virus in their system under the most stringent measures.

These data on ITMN-191 top the performance of Vertex's telaprevir, however, InterMune and Roche will have a hard time pushing ahead with a three-times-daily dose of ITMN-191 because they are well behind Vertex in the race to get new hepatitis C drugs approved.

Vertex announced Monday morning that it has already completed enrollment in two pivotal phase III studies of telaprevir in treatment-naïve patients, with data expected in 2010. InterMune and Roche, on the other hand, are still planning phase II studies to start next quarter.

Furthermore, other hepatitis C competitors such as Schering-Plough, Johnson & Johnson, Boehringer Ingelheim are also ahead of InterMune, with some of these drugs dosed once a day."

What do you all make of his arguments? I guess my takeaway is why will ITMN-191 have problems ultimately competing against Telaprevir if a similar dosing schedule for ITMN-191 (i.e. 3 times/day) ultimately proves more potent than Telaprevir? I understand it's nice to be first to market and all but if someone comes along with a more potent drug eventually, whether that's 1 year later, 3 years later, or whatever, won't the new drug be able to effectively compete given a similar (or better) safety profile?