Replies to post #51054 on Biotech Values

[DewDiligence]

>I agree with your statement. And your "why" is well stated. However, being "inconsistent" will not destroy the clinical trial system, IMHO. Drug trials face that same problem today when the drug at issue is approved for other uses or there are reasonable alternative drugs.<

I respectfully disagree. The difficulties companies face enrolling clinical trials today would be immensely greater, IMO, if the Abigail Aliance’s demands became government policy.

[rkrw]

You may recall Intermune was sued by a wealthy patient wanting access to pirfenidone....

InterMune and Joseph L. Stendig Announce Settlement of Lawsuit

BONITA SPRINGS, Fla. and BRISBANE, Calif., Sep 5, 2003 /PRNewswire-FirstCall via COMTEX/ -- Joseph L. Stendig and InterMune (Nasdaq: ITMN) announced today the settlement of Mr. Stendig's pending litigation in the San Francisco Superior Court concerning his complaint demanding that InterMune's investigational anti-fibrotic compound, pirfenidone, be made available to patients suffering with idiopathic pulmonary fibrosis (IPF). As part of the settlement, InterMune is providing substantial designated funding for certain research and development efforts relating to IPF.

The settlement followed agreement by InterMune to move toward establishing a limited early access program for the drug based on a recently completed review of Phase II proof of concept data for pirfenidone in the treatment of IPF. "Based upon this evaluation, we have decided to permit limited early access in the United States within the context of current U.S. Food and Drug Administration (FDA) regulations and industry practice," said Randall Kaye, M.D., Vice President of Medical Affairs at InterMune. InterMune is in the planning stages of this program. Dr. Kaye added, "InterMune is grateful to Mr. Stendig for his efforts in helping us to better understand the value of establishing an early access program for pirfenidone for IPF."

Patients and healthcare professionals who would like to receive updated information as more details become available are encouraged to logon to www.intermune.com/pirfenidone where they can submit their contact information.

"InterMune continues to be committed to developing pirfenidone for the treatment of IPF and ultimately hopes to gain FDA approval for the treatment of this debilitating condition," stated Dr. Kaye. Mr. Stendig declared himself "delighted with InterMune's undertakings regarding development of pirfenidone. Pirfenidone appears to offer considerable hope to IPF patients. If pirfenidone proves itself in clinical trials, thousands of patients who had no hope of surviving this horrible disease may be helped. I also applaud InterMune for its willingness to put in place an early access program for pirfenidone."