Boy is this board dead. Oh well, no need to go the whole year without at least one post. Here's a few of my notes from IDEC's presentation at the shareholder meeting today. Caution: I'm a notoriously poor note-taker, so I must forsake any claims as to accuracy.
By all measures, Rituxin is doing very well. About 50% sales growth from last year. Currently used in about 19% of B-cell NHL/CLL patients. A breakdown of use is 48% low-grade NHL, 39% aggressive NHL (intermediate and high-grade), and 13% CLL.
34% of current use is for combination therapy with CHOP, compared to 24% last June-July. This is important from a revenue perspective since combo therapy involves 6 treatments of Rituxan compared to 4 for Rituxan alone. One clinical trial involving 40 low-grade NHL patients showed 100% response with 24/40 patients still in remission after 47 months.
Also, are starting to see more "maintenance" use; that is, don't wait for relapse before treating with Rituxan again. This also bodes well for sales growth.
There are about 150 different clinical trials involving Rituxan in progress. This includes a few major randomized trials comparing Rituxan+CHOP to CHOP alone. One large U.S. trial (I believe partly sponsored by the National Cancer Institute) will also evaluate maintenance use. But don't hold your breath on that one - results aren't due until around 2004.
Surveys are showing a steady increase in oncologist awareness about Rituxan, as well as plans to use it more. This includes intent to use as front-line therapy for patients with other than low-grade or transformed NHL. (Note: Rituxan was approved by FDA for relapsed or refractory low-grade or transformed NHL only.)
Of total sales of $262M last year, Idec's share was $93.2M. They have a tiered agreement with Genetech and this fraction will increase in future tiers. Rituxan is not yet approved in Japan, which is very slow in such matters (except in the case of Viagra, which went through the bureaucracy like a missile. But that's another story.)
Regarding Zevalin, IDEC expects the bottom-line impact to be similar to Rituxan. It won't be used as much, and it's more expensive to produce and market, but they have full rights in the U.S. (Shering AG has rights in the rest of the world.) They are very encouraged with the results of Zev trials, and think the randomized trial comparing Zev to Rituxan will be key in getting European approval.
With regard to Coulter's patent for radioconjugate immunotherapies, IDEC's assessment is that there are many patents and substantial "prior art" in this area (much of it involving Idec, who has been working in this area since 1986). Their current opinion at this point is that the CLTR patent will not cover Zev. They are not altering their development plans because of this or other patents.
At the upcoming ASCO conference, there will be 4 Zev and 13 Rituxan papers given.
Bill Rastetter also reviewed the non-cancer drug pipeline, and looking farther ahead, new cancer treatment approaches including therapeutic vaccines for prostate cancer and new Y-90-labeled antibodies for solid tumors (which require much higher radiation doses compared to lymphomas).
Overall, a good solid review of IDEC's past year, and encouraging news for steady increases in Rituxan sales and use in the future.
Rich
Disclosure: I am long IDPH and have worked with the company as a consultant.
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