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Biotech Stock Mailbag: Amarin, Spectrum, Arena

3. Management did their last financing in January 2011 before the second AMR101 data set at a price of around $7 per share. Then management didn't raise any money when their stock was $15 to $18 for many months! How stupid are they?

My investor source's bottom line:

A. Something is going really badly here from a fundamental perspective (which we haven't figured out yet); or

B. Amarin does have a very good opportunity in front of them, but we will look back on this just as we looked back on Fred Price's misadventures and needless Orapred-related dilution at BioMarin Pharmaceuticals several years ago: A really awful management team robbing biotech investors of a portion of what turned out to be home run longer term.

Either way, he bailed on Amarin.

Paolo M. writes: "You said a lot about Spectrum Pharmaceuticals' (SPPI - Get Report) current cancer drugs, but I haven't seen you write about what is more important to the company, which is the pipeline products with trial results this year. What about these drugs? Are they growth opportunities for Spectrum? I think so."

Spectrum has two drugs in late-stage studies: belinostat for peripheral T-cell lymphoma (PTCL) and apaziquone (Eoquin) for non-invasive bladder cancer. Results from these pivotal studies are expected this year.

I'll discuss belinostat today and save apaziquone for a future Mailbag.

The pivotal phase II "BELIEF" study of belinostat enrolled 120 patients with PTCL that has failed to respond to at least one prior therapy. All patients in the study are being treated with belinostat -- there is no control arm. The primary endpoint of the study is overall response rate. Spectrum plans to seek approval for belinostat using the data from this study when it's completed.

Spectrum conducted a previous, small phase II study of belinostat in patients with PTCL and cutaneous T-cell lymphoma (a related cancer.) In the PTCL subgroup of 20 patients, the overall response rate to belinostat was 25% with a median duration of response of 5.2 months.

Another study conducted by Spectrum partner Topotarget of 19 PTCL patients yielded a 32% response rate and a median duration of response of 9 months.

If belinostat yields a similar 25-30% response in the pivotal phase II study, will that be strong enough for FDA approval?

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