) recently initiated a phase II study on SPI-2012 (LAPS-GCSF).
SPI-2012 is being developed for the treatment of
chemotherapy-induced neutropenia which utilizes partner Hanmi
Pharmaceutical Company's proprietary Lapscovery Technology.
The multicenter, open label, dose-ranging study will evaluate
the effectiveness of SPI-2012 in comparison to a fixed and
standard dose of
) Neulasta (pegfilgrastim) as a concurrent active control to each
dose of SPI-2012.
The study will assess the effectiveness of the test doses of
the candidate on mean duration of severe neutropenia during Cycle
1 in patients suffering from breast cancer and also eligible for
treatment with adjuvant or neoadjuvant chemotherapy.
In its phase I study, SPI-2012 showed an increase in
neutrophil count similar to that of Neulasta, at one-third of the
Though encouraged with the pipeline progress at Spectrum
Pharma, we remain concerned about the company's financial
guidance for 2013. Last month, Spectrum Pharma announced that its
metastatic colorectal cancer (mCRC) drug, Fusilev, is expected to
generate revenues in the range of $80−$90 million in 2013.
In 2012, Spectrum Pharma had recorded total Fusilev sales of
$204.3 million. The shifts in hospital sales to generics are
primarily responsible for the reduced guidance. The company's
total revenues for the year are expected in the range of $160
million to $180 million, whereas it recorded $267.7 million of
total revenue in 2012.
Spectrum Pharma, a biotechnology company, currently carries a
Zacks Rank #4 (Sell). Presently, other biotech companies like
) look more attractive. XOMA carries a Zacks Rank #1 (Strong
Buy), while Agenus carries a Zacks Rank #2 (Buy). Amgen also
carries a Zacks Rank #2.
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