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Biotech / Medical : InterMune (nasdaq)ITMN

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To: Secret_Agent_Man who started this subject4/25/2002 10:05:55 PM
From: IRWIN JAMES FRANKEL  Read Replies (3) of 508
 
ITMN CC 4/24/02

This summary is organized logically rather than in the order the information was presented. Info in the PR of the same data is often left out to avoid duplication.

Presenters:

Scott Harkonen
Tim Lynch
Jim Pennington
The marketing guy

Actimmune for IPF

- PIII is due to complete in August ‘02
- Data from the PIII should be released in November ‘20
- Granted Fast Track by FDA
- Data Safety medical board OK’ed continuing trial
- Average person in study will have been treated 60 weeks by end of study
- 85% of days in study are now complete
- less than 5% of patients have dropped out prior to meeting end point
- drug appears more effective in early and mid-stage disease
- at least 6 months and perhaps 12 months on treatment is necessary to determine if the drug is effective
- Actimmune has been detailed to all pulmonologists
- Disease severity distribution/drug-use; 1/3 early, 1/3 mid-stage, 1/3 severe
- Registry data suggests about 5% discontinuation
- Reimbursement running 65% to 70%

Financial Data

- Actimmune revenues up 28% sequentially (1Q over 4Q)
- Cash on hand 3/31/02 $413 million
- On track to do $100 mil rev ’02 and $200 ‘03
- Actimmune revenue $85-90 in ‘02
- Increased pricing of Actimmune 7.5% at the beginning of ‘02
- Price increase did not result in a distortion to inventory levels

Oritavancin

- PIII results in Skin infection due by EOY
- Will be doing PIII for pneumonia with 850 in study
- Goal to file NDA by EOY ‘03
- Optimistic that it will become the standard of care, 50% treatment time
- Needs broad strong label, meet with FDA in 4 to 8 weeks

American Thoracic Society in Atlanta

- IMTN will host a reception at the High Museum presenting a study on the incidence and prevalence of IPF which may be currently understated
- New 5 year mortality data on the NEJM PII will show statistically significant result on survival of those treated over the control group

Infergen

- 36 specialists have been trained to relaunch
- Many thought leaders believe it is best-in-class molecule
- Started meeting with 3,500 Hepatologists
- Is a second chance for treatment failures

Milestones

- 17 clinical trials underway
- 9 clinical milestones will be reached in the next 12 months
- Announce PEG Infergen partner & start trials w/i 12 months
- Present clinical results of pirfenidone at the ATS

Positive ATS abstracts

- encouraged by possibility that nitrous oxide is a surrogate marker in pulmonary fibrosis in patients treated for 4 months with Actimmune
- King Schwartz and Brown study correlated positively changes in lung function with mortality, thus supporting the ultimate FDA application

Pirfenidone

- We were impressed with animal data and pilot trial data in humans

Misc

- No comment on the number of patients being treated with Actimmune
- IMS data is not accurate during the switch to specialty distributors
- ITMN working with specialty distributors to get the IMS data accurate
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