) announced encouraging results from a phase II pivotal study on
captisol-enabled melphalan. The candidate is being developed as
an intravenous formulation of melphalan (a well-known
conditioning therapy). Spectrum Pharma gained over 4% following
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The candidate met the primary objective of the study of an
overall safety and toxicity profile before autologous stem cell
transplantation (ASCT) in patients suffering from multiple
myeloma. The study also evaluated the efficacy of
captisol-enabled melphalan in these patients as measured by the
multiple myeloma response rate (as per International Myeloma
Working Group criteria) and the rates of myeloablation and
Spectrum Pharma is conducting additional analyses on the
candidate. The company intends to file a New Drug Application
(NDA) for captisol-enabled melphalan in the U.S. in the third
quarter of this year.
In Mar 2013, Spectrum Pharma acquired the development and
commercialization rights to captisol-enabled melphalan from
Ligand Pharmaceuticals Inc.
). Ligand Pharma will receive license fees, milestone payments
and royalties from Spectrum Pharma following potential
commercialization of the candidate.
Spectrum Pharma has Beleodaq (relapsed or refractory peripheral
T-cell lymphoma) under review in the U.S. A final decision from
the FDA on the approval of Beleodaq is expected by Aug 9, 2014.
The successful development and commercialization of both the
candidates will be beneficial for Spectrum Pharma.
Spectrum Pharma currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
Biogen Idec Inc.
). While ImmunoGen carries a Zacks Rank #1 (Strong Buy), Biogen
holds a Zacks Rank #2 (Buy).