Will InterMune's Hepatitis C Drug Compete?

[Guest guest]

Will InterMune's Hepatitis C Drug Compete?

By Lawler April 3, 2008

http://www.fool.com

The wait was a little longer than anticipated, but investors finally

got a healthy first look at data from InterMune's (Nasdaq: ITMN)

hepatitis C treatment, ITMN-191, on Tuesday.

ITMN-191 is InterMune and partner Roche's antiviral protease

inhibitor to treat hepatitis C virus (HCV) infections. It was

discovered by Array BioPharma (Nasdaq: ARRY) and subsequently out-

licensed to InterMune, which then out-licensed it again to Roche.

Almost six years ago the FDA approved an important new compound to

help treat HCV, which is very dangerous and can lead to liver cancer.

Without a doubt there will be more in the coming years. With the

success of other, similar antiviral compounds in clinical testing,

many people have been eagerly awaiting ITMN-191's first study results.

ITMN-191 against the competition

Thankfully InterMune released enough clinical trial data on Tuesday

and Wednesday for us to be able to make initial comparisons of ITMN-

191 against its brightest competition.

So how strong is the ITMN-191 data? Here's how its 14-day phase 1

study results compare to some other hepatitis C antiviral agents

after their phase 1 14-day monotherapy studies in genotype 1 HCV-

infected patients.

Company Drug HCV mean

viral

load

reduction (VLR)

InterMune and Roche ITMN-191 3.8 log* median VLR

Vertex Telaprevir 4.4 log**

median VLR

Pharmasset and Roche R7128 2.7 log*** mean VLR

Roche R1626 4.1 log*

median VLR

Schering-Plough Boceprevir 2.1 log^*** mean VLR

*In previously untreated patients only.

**Both previously untreated and treatment-experienced patients. ***In

treatment-experienced patients only.

^Not necessarily at end of study.

This is not a full list of top HCV drug treatments in development.

Other compounds, such as privately held ViroChem's polymerase

inhibitor, have produced similarly strong study data.

Another important factor is that all these phase 1 studies used at

least slightly different patient groups in various locations.

Differences such as age, sex, or ethnicity affect how well a drug

performs. All these drugs were tested in very few patients in these

studies; some cohorts had fewer than 10 patients.

It is still too early to guess which drug candidate looks most

effective. Based on these results, all I'd be confident to say is

that they all exhibit some activity in fighting hepatitis C. Even a

2.0 log reduction in a patient's HCV loads represents a 99% reduction

in the amount of the virus in the bloodstream.

The reason I compare ITMN-191 to the other leading anti-hepatitis C

treatment candidates is to show that the drug's phase 1 results are

at least comparable to other similar compounds that are much closer

to approval. (If telaprevir doesn't get approved I will be beyond

shocked.) InterMune has now officially validated ITMN-191 as a viable

anti-hepatitis C drug candidate at this stage of the game.

InterMune will start testing ITMN-191 in another phase 1b study this

quarter, this time in combination with Roche's Pegasys and ribavirin.

The real test for ITMN-191 will be in how the drug performs in long-

term testing, and whether it can produce HCV cure rates as high as

some of its advanced rivals.

Investors shouldn't forget that other HCV antivirals from Wyeth

(NYSE: WYE), Achillion, and Gilead Sciences (Nasdaq: GILD) have been

derailed due to negative safety signals. ITMN-191's long-term safety

in humans is still unknown.

Quality, not quantity

ITMN-191 is not InterMune's only exciting pipeline candidate, and

investors will hear more about its potential idiopathic pulmonary

fibrosis treatment, pirfenidone, by January next year when InterMune

releases phase 3 results for the drug.

InterMune doesn't have the biggest drug pipeline; only two compounds

are in clinical stage testing. Its two drug candidates don't treat

the biggest potential markets in the world. But I can say with

confidence that InterMune does have two very viable shots on goal

with ITMN-191 and pirfenidone, and both have produced very exciting

data so far.