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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (9764)	12/15/2003 2:33:12 PM
From: rkrw	Read Replies (2) \| Respond to of 52153

Bank of America take. Their bottom line, no change to est but increased confidence in projections. MLNM announced this morning that the Velcade Phase III APEX trial has been halted early due a statistically significant improvement in time to disease progression (TTP), the primary endpoint, vs. the active control arm of high-dose dexamethasone, in treatmentexperienced multiple myeloma (MM) patients. Positive Surprise. This announcement comes as a positive surprise as the trial had just finished enrolling patients during 3Q03 and final results of the APEX trial were not expected until 2005. MLNM now expects to present results of the trial in 1H04, most likely at ASCO. APEX Trial Results Will Grow Velcade Potential. The APEX data comes from somewhat less treatment-experienced MM patients than the SUMMIT study that led to the initial FDA approval of Velcade earlier this year. With both positive APEX and SUMMIT results, Velcade will now be able to capture a larger portion of all MM patients. We believe that faster than expected penetration into the patient population studied in the APEX trial could provide upside to Velcade sales estimates. Frontline Trial Expected to Begin in 1H04. MLNM will likely initiate a study in FY04 to evaluate the use of Velcade in treatment-naive patients. While MLNM is not obligated to start this trial until 2005 (as part of its post-marketing agreement with the FDA), we expect that the positive result of the APEX trial will lead MLNM to initiate the frontline trial as soon as possible. Millennium has indicated that the proposed trial would compare Velcade to high-dose dexamethasone to a combination of both agents in previously untreated patients. While the front-line indication does not afford Millennium with the greatest number of patients, it is our opinion that it allows the company to capture patients at the earliest stages of their disease. Accordingly, patients can be treated for significantly longer periods of time compared to those in the relapsed/refractory setting. Further, myeloma is similar to lymphoma in that most patients will inevitably relapse. In our view, patients will continue to be treated with Velcade as long as they respond. Reiterate Buy. There are no changes to our FY 2004-2008 estimates but that our confidence in Velcade achieving our estimates is increased. We remain excited about Velcade’s prospects in a variety of blood cancers. We project that Velcade sales along with continued cost cutting will enable MLNM to reach its goal of profitability in 2006.