Spectrum Pharmaceuticals, Inc .'s SPPI new drug application (NDA) for Captisol-enabled melphalan (CE-melphalan) was accepted by the FDA for review. 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 FDA is expected to give a final decision on the approval of the candidate by Oct 23, 2015.
The NDA for CE-melphalan, submitted last December, was filed under the FDA's 505(b)(2) regulatory pathway based on data from a pivotal phase II study. If approved, Spectrum Pharma intends to launch the drug, towards end of this year with help from its existing hematology/oncology sales force. Needless to say, CE-melphalan's addition to the company's portfolio will boost its top line.
We remind investors that Spectrum Pharma acquired the global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals Inc. LGND in Mar 2013. Per the agreement terms, Spectrum Pharma was responsible for the pivotal study on the candidate and for filing the NDA. Ligand Pharma already 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.
CE-melphalan enjoys orphan drug designation in the U.S. for the multiple myeloma transplant setting.
The company has progressed well with its pipeline. We expect investor focus to remain on pipeline updates from the company.
Spectrum Pharmaceuticals currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Cytokinetics, Inc. CYTK and Affymetrix Inc. AFFX - both carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
