Spectrum Pharma Jumps on FDA Orphan Designation

Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) saw its shares rise early on Wednesday after earning an Orphan designation. The company announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) granted seven years of Orphan Drug exclusivity for Evomela for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.

Spectrum gained global development and commercialization rights to Evomela from Ligand Pharmaceuticals in March 2013. The company assumed responsibility for completing the Phase 2 clinical trial and was responsible for filing the New Drug Application (NDA).

Under this license agreement, Ligand received a license fee, and NDA approval milestone, and still is eligible to receive further potential milestones and royalties in connection with commercialization.

Rajesh C. Shrotriya, MD, chairman and CEO of Spectrum, commented:

We are pleased to receive FDA Orphan Drug Exclusivity for Evomela, another important regulatory milestone for Spectrum. Evomela is reconstituted with normal saline and does not contain propylene glycol. Evomela’s formulation is based on Captisol technology and is stable at room temperature for 1 hour following reconstitution and for an additional 4 hours after further dilution. We believe Evomela has the potential to become an important therapy for multiple myeloma patients undergoing high-dose conditioning treatment prior to hematopoietic stem cell transplantation and fits very well with our existing Hematology/Oncology infrastructure. Revenues from our niche products like Evomela help us develop our late-stage drugs that target blockbuster markets.

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Recently, Evomela has also been listed in the Orange Book, including two composition of matter patents that do not expire until March 2029.

Shares of Spectrum rose 3.1% to $7.48 early Wednesday, with a consensus analyst price target of $9.25 and a 52-week trading range of $4.14 to $7.74.