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

To: rkrw who wrote (9765)	12/15/2003 3:22:07 PM
From: quidditch	Read Replies (1) \| Respond to of 52153

GS comes out to essentially the same place (w/r/t an existing IL rating), with a shorter term view: MLNM announced that its Phase III trial on Velcade to treat multiple myeloma was stopped about 1 year early due to positive results. The study was conducted to support the marketing application of Velcade which was approved by the FDA based on Phase II results. The new data might lead to faster adoption of Velcade, especially in less advanced patients. However, our projected sales potential for Velcade of $200MM− 300MM remains unchanged because we had previously assumed positive data and some off−label use. The potential could exceed $0.5B if usage can be expanded to solid tumors. We maintain our In−Line rating for MLNM based on the momentum from the Velcade launch, a broad pipeline, and good cash position. Risks to our rating include slower sales, failure in clinical development and higher expenses. Our coverage view remains Neutral. The Phase III APEX trial involved 670 multiple myeloma patients who have progressed after receiving 1−3 prior therapies. Patients received either Velcade or high dose dexamethasone (Dex), a standard therapy. The Dex arm was stopped early by an independent Data Safety and Monitoring Board (DSMB) due to statistical significant improvement in time to disease progression (primary endpoint) in the Velcade arm. The secondary endpoints of clinical benefit, safety and survival also supported the overall results. Details will be presented in H1/04, about 1 year earlier than planned. Velcade was approved by the FDA in May 2003 based on two open label Phase II trials in patients who have progressed after at least 2 prior therapies. The efficacy was based on response rates. Therefore, results from the APEX study should provide controlled data on clinical benefit in both advanced and early stage patients. We expect MLNM to submit data to the FDA in support of a broader indication, which should enhance reimbursement and competitive position. There are about 50,000 people with multiple myeloma and 15,000 new cases per year in the United States. We have previously estimated the sales potential of Velcade to be $200−300MM worldwide assuming positive Phase III data and gradual move to usage in earlier patients. We maintain our Velcade forecast of $57MM and $190MM in 2003 and 2004, respectively. quid

To: rkrw who wrote (9765)	12/15/2003 7:55:52 PM
From: Miljenko Zuanic	Respond to of 52153

<<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. >> After APEX DEX as control arm does not make much sense, for front line and second line. Is there anything else that can be good comparator arm?