Spectrum Pharmaceuticals ( SPPI ) announced its intention to initiate a phase III study on SPI-2012 next year. SPI-2012, Spectrum Pharma’s long acting granulocyte stimulating factor, is being developed for the treatment of neutropenia utilizing the proprietary Lapscovery technology of its partner Hanmi Pharmaceutical Company.
Spectrum Pharma plans to meet with the U.S. regulatory authorities by the end of 2014 to discuss the phase III study design. SPI-2012 was successful in a phase II multicenter, dose-ranging study which assessed the effectiveness and safety of the candidate in comparison to a fixed, standard dose of Amgen Inc.’s ( AMGN ) Neulasta (pegfilgrastim) as a concurrent active control.
The main objective of the study was to evaluate the effects of the candidate on the mean duration of severe neutropenia during cycle 1 in patients suffering from breast cancer who received adjuvant or neoadjuvant chemotherapy.
We are encouraged by Spectrum Pharma’s progress with SPI-2012. The neutropenia market is highly lucrative, worth in excess of $6 billion as per the company. However, the neutropenia market currently has players like Amgen. Moreover, several other companies are looking to enter the market. We expect investor focus to remain on updates regarding the development of SPI-2012 in this indication.
We are also pleased with the company’s efforts to expand its product portfolio over the past few quarters. Spectrum Pharma has several candidates in its pipeline including Captisol-enabled melphalan (multiple myeloma).