Spectrum Pharmaceuticals, Inc. (SPPI) announced the submission of a new drug application (NDA) to the FDA for Captisol-enabled melphalan (CE-melphalan) HCl for injection (propylene glycol-free). The company is looking to get CE-melphalan approved for a high-dose conditioning treatment prior to stem cell transplantation in patients suffering from multiple myeloma and for the palliative treatment of multiple myeloma patients for whom oral therapy is not appropriate.
The NDA for CE-melphalan filed under the FDA's 505(b)(2) regulatory pathway consists of data from a pivotal phase II study. The FDA review is expected to take approximately 10 months. If approved, Spectrum Pharma intends to launch the drug next year with help from its existing hematology/oncology sales force.
We remind investors that Spectrum Pharma acquired the global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals Incorporated (LGND) in Mar 2013. Per the agreement terms, Spectrum Pharma was responsible for the pivotal study on the candidate and for filing the NDA. Under the deal, Ligand Pharma received a license fee of $3 million and is eligible to receive milestone payments and royalties from Spectrum Pharma following the potential commercialization of the candidate.
We note that CE-melphalan has orphan drug designation in the U.S. for the multiple myeloma transplant setting.
Meanwhile, Spectrum Pharma continues to progress with its pipeline. The company intends to initiate a phase III study on SPI-2012 (long acting granulocyte stimulating factor) next year for the treatment of chemotherapy induced neutropenia.
We expect investor focus to remain on pipeline updates from the company.
Spectrum Pharmaceuticals currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Biodel Inc. (BIOD) and Cubist Pharmaceuticals Inc. (CBST). Both stocks carry a Zacks Rank #1 (Strong Buy).
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