Biotech Values

[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?