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SPPI Seeks U.S. Approval for Belinostat

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Spectrum Pharmaceuticals (SPPI - Free Report) 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. , Forest Laboratories Inc. and Jazz Pharmaceuticals (JAZZ - Free Report) . All these stocks hold a Zacks Rank #1 (Strong Buy).

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