SPPI Seeks U.S. Approval for Belinostat - Analyst Blog
11 Décembre 2013 - 11:00PM
Zacks
Spectrum
Pharmaceuticals (SPPI) submitted a New Drug Application
(NDA) for its pipeline candidate, belinostat, to the U.S. Food and
Drug Administration (FDA). Spectrum Pharma is looking to get
belinostat approved in the U.S. for the treatment of patients
suffering from relapsed or refractory peripheral T-cell lymphoma
(R/R PTCL).
The NDA submission was based on positive results from a clinical
study (BELIEF trial) on belinostat. Results revealed an acceptable
safety profile and clinical efficacy of the candidate. An overall
response rate of 26% was also observed in the heavily pre-treated
patients including patients who had received allogeneic or
autologous stem cell transplant.
The company expects to launch belinostat next year. In 2010,
Spectrum Pharma entered into a licensing and collaboration
agreement with TopoTarget A/S for the development and
commercialization of belinostat.
Apart from belinostat, Spectrum Pharma also has captisol-enabled
melphalan in its pipeline. The candidate is being developed as a
conditioning agent for stem cell transplant and multiple myeloma.
The company expects to report top-line data from a pivotal study on
captisol-enabled melphalan in the second quarter of 2014. Spectrum
Pharma intends to file an NDA for the candidate soon after.
We remind investors that in late third quarter 2013, Spectrum
Pharma launched Marqibo in the U.S. The drug is approved for the
treatment of adults suffering from Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia (ALL). Spectrum Pharma gained
worldwide rights to Marqibo following the completion of the
acquisition of California-based Talon Therapeutics in Jul 2013.
Marqibo is also being developed for the treatment of non-Hodgkin's
lymphoma.
We are encouraged by the addition of Marqibo in Spectrum Pharma’s
portfolio. The drug is expected to boost the company’s top-line
further. We are also encouraged by the company’s efforts to expand
its product portfolio and pipeline.
Spectrum Pharma currently carries a Zacks Rank #3 (Hold). Some
better ranked stocks include Actelion Ltd.
(ALIOF), Forest Laboratories Inc. (FRX) and
Jazz Pharmaceuticals (JAZZ). All these stocks hold
a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
FOREST LABS A (FRX): Free Stock Analysis Report
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report
SPECTRUM PHARMA (SPPI): Free Stock Analysis Report
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