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Strategies & Market Trends : Galapagos Islands -- Ignore unavailable to you. Want to Upgrade?


To: Jorj X Mckie who wrote (15829)12/9/2002 2:59:27 PM
From: Techplayer  Read Replies (1) | Respond to of 57110
 
There was a comment about higher than expected toxicity in briefing.com....



To: Jorj X Mckie who wrote (15829)12/10/2002 12:46:50 PM
From: tuck  Read Replies (1) | Respond to of 57110
 
Jorj,

Interesting situation with MLNM. Management has essentially added fundamental volatility by going for accelerated approval. Drop out rate was overblown by bears; the adverse effects in such a sick population are due more to patient condition and prior therapy than to Velcade. I think Velcade will ultimately be approved, but I am not so sure of MLNM's time table. Pazdur of CBER -- the FDA branch in charge of approving new drugs -- has indicated recently they would be moving away from accelerated approval a la Gleevec. I don't think it has been tried in multiple myeloma, either.

So MLNM warrants watching from a traders perspective. Plenty of news flow from this company in the upcoming months. Velcade in solid tumors, NDA for Velcade, etc. Watch for a partnership deal for Velcade, too, featuring a non-U.S. co-marketer (MLNM might distribute in the U.S. with its own sales force). That should also be tradable.

I am slightly bearish intermediate term, as I think the accelerated approval will not happen. The negative reaction will be worse if MLNM signs a partner, ramps sales and manufacturing capability, etc. This would be a great time to buy for the long haul, IMO. For even if Velcade is forced down the normal regulatory path, it has two advantages over CELG's Revimid: a) it's at least a year ahead -- two if it gets acccelerated approval; b) though it's an IV drug and less pleasant to take than Revimid -- which is a pill -- Medicare does not reimburse oral cancer drugs.

Pay close attention to the solid tumor data coming out in the first half '03. MM isn't a huge market, MLNM's success depends on being able to expand the label.

Somewhat nearer term, watch for '03 Integrilin guidance. Some analysts think there has been inventory build up and that MDCO's Angiomax might take share.

As I said, plenty of tradable angles on MLNM.

Cheers, Tuck