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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Bob L who wrote (1569)5/21/1998 5:26:00 PM
From: Richard Belanger  Read Replies (1) of 1762
 
Bob - Dr. Grillo-Lopez gave some data at the shareholder meeting. If I recall correctly, both the overall response and the mean time to relapse is somewhat better for Rituxan compared to CHOP. For low-grade refractory patients, the mean time to relapse is about 13 mo. for Rituxan compared to 8-10 mo. for CHOP. Of those treated with Rituxan that have not relapsed (a significant %), some have been disease free for 30 mo. No data are yet available beyond that time.

For the Phase II Rituxan plus CHOP, 28 of the 38 patients (including intermediate and high-grade) are still in complete remission, with the longest being 46 mo. 24 mo. to relapse is typical of CHOP and other conventional therapies.

VP Bill Rohn indicated that 4,692 patients have been treated with Rituxan from the commercial launch through mar. 31. Clinics and individual physicians offices account for about 37% of sales, while large cancer centers, hospitals, etc. make up bulk of remainder. Idec is anticipating broad Pan European approval in the 2nd or 3rd quarter of this year, and that market is estimated to represent about 70-80% of the U.S. market for NHL. Genentech has recently benn approved by FDA for large-scale manufacturing of Rituxan, which is necessary to support the European launch. He also added that analysts have estimated European sales should add about $0.40/share to the bottom line.

Dr. Rastatter indicated that form now on, only quarterly (not monthly) sales figures will be released.

I asked about the competition to Rituxan and Y2B8 from Bexxar. Idec firmly believes they (Idec) have a better product, and they jumped at the chance to elaborate. They believe the antibody is better, the isotope is better, and the practical aspects (clinic/doctor's office administration, for example) are much better. They regard radio-labelled treatment as "salvage therapy" for those cases that do not respond to the cold antibody. Dr. Gillo-Lopez emphasized that Idec has a lot of experience with I-131 and they strongly favor Y-90.

All in all, it was a very good meeting. The only bad part was getting back to the office and finding IDPH down $3!

Rich
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