The annual meeting of the American Society of Hematology kicks off Saturday, Dec. 4, and will attract thousands of doctors to hear the latest medical research on blood-related disease, including cancer.

This year's meeting, taking place in San Diego over four days, also draws the attention of Wall Street. Unlike past confabs, ASH 2004 lacks a singular, high-profile biotech event, but that doesn't mean investors will be tuning out this year. There will be important clinical updates from the likes of:

And as always, biotech heavyweights


(AMGN) - Get Report




will make their presence felt.

These players will provide some of the more compelling investment stories to keep an eye on.

Celgene in the Spotlight

Celgene has a full slate of presentations inside the San Diego Convention Center, but the company's activities outside the hall will grab more of the spotlight. On Sunday, Dec. 5, Celgene will hold an analyst meeting where it will make public data from its phase II study of Revlimid in patients with the so-called 5q minus form of myelodysplastic syndrome, or MDS, a cancer-like disease of the blood marrow.

These data are important for two reasons: First, Celgene has told investors that it expects to use data from this phase II study to seek marketing approval for Revlimid from the Food and Drug Administration during the first quarter of 2005.

But as I reported recently, a spate of

patient deaths in this study has raised safety questions about Revlimid's use as a treatment for patients with this low-risk, low-grade form of MDS. The ASH meeting will be the first complete airing of Revlimid's efficacy and safety in this patient population, which will provoke a lot of discussion and debate about the drug's chances for approval.

Head-to-Head With Millennium Pharmaceuticals

Celgene currently derives the bulk of its revenue and profit from the off-label sale of the leprosy drug Thalomid as a treatment for patients with advanced multiple myeloma, a type of cancer formed by malignant plasma cells found in bone marrow. Data to be presented at ASH this year will explore the use of Thalomid in newly-diagnosed multiple myeloma patients.

Millennium Pharmaceuticals, with its multiple myeloma drug Velcade, represents the major challenge (and comparator) to Celgene's Thalomid. At this year's meeting, Millennium will present midstage clinical data on Velcade use in newly-diagnosed multiple myeloma patients. Millennium also will make a detailed, formal presentation of Velcade data in more advanced patients, although many of these data were previously released.

Data Discussions

Earlier this month, Genta said its phase III Genasense study in chronic lymphocytic leukemia met its primary endpoint of tumor response, but failed to help patients live longer or even delay the progression of their cancer. On Monday, Dec. 6, the data from this study will be presented at the ASH meeting, which will give insight into whether Genta has any realistic chance of gaining FDA approval for Genasense. Data from a phase III multiple myeloma study also will be presented, but Genta already has disclosed that this study failed.

Maxim Pharmaceuticals has claimed that its drug Ceplene was responsible for a survival advantage in a phase III study in patients with acute myeloid leukemia, but the company has yet to offer much in the way of detail. Those details finally will be presented Monday, Dec. 6. Expect that they will be scrutinized to determine whether Ceplene has a chance at the FDA.

SuperGen and partner

MGI Pharmaceuticals


already have filed their drug Dacogen with the FDA, seeking approval as a treatment for MDS. Data from a pivotal phase III study have been widely disseminated already, but another complete presentation will be made at the ASH meeting.

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send your feedback to