Although previously denied approval by the FDA for the use of Fusilev in treating colorectal cancer, Spectrum Pharmaceuticals (NASDAQ:SPPI) is expecting to hear later this month as to whether the FDA will allow its use with chemotherapy treatments.
SPPI has been trading higher during the first quarter of 2011, and has doubled in price since December as the pipeline has advanced and the mid to long term potential of the company is uncovered.
Fusilev is already approved by the FDA for the treatment of Osteosarcoma, and after receiving the denial for the colorectal indication, the company filed additional data, hence the hope for reverse of course from the regulators.
Another catalyst set to take place this year is the removal of the bioscan criteria that currently accompanies treatment with Zevalin, Spectrum's treatment for non-Hodgkins Lymphoma. It's expected that the bioscan removal would make Zevalin treatment less of burden on both doctors and patients, and the belief is that doctors would be inclined to recommend the treatment more.
A final decision on the bioscan removal is expected later this year. recent press release has announced that the FDA is expected to act on this issue by November 30th.
In addition to the above-mentioned milestone decisions, sales of both Fusilev and Zevalin have increased significantly on year-over-year, combined basis, according to the last quarterly report, so continued growth should be expected throughout 2011.
If that turns out to be the case, then the current market cap would still have room to increase, in my opinion, especially if the pending FDA decisions pan out in favor of Spectrum.
In additional good news for Spectrum, an independent data monitoring committee tracking the ongoing BELIEF trial for Belinostat in the treatment of peripheral T-Cell Lymphoma found no issues concerning safety and recommended that the trial move forward to its planned goal of 100 patients enrolled.
Data from the trial should be available later this year with an NDA expected in 2012.
The bladder cancer treatment Apaziquone is also in late stage trials, and an NDA for that product may also be possibility at some point in 2012.
The Spectrum story is still evolving, and the growing potential of the pipeline and the upcoming milestone events still have SPPI looking like an attractive mid to long term pick.
Additionally, with big pharmlooking to boost their own pipelines, it's possible that Spectrum is on the radars as buyout target.
Keep an eye on it.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.