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Spectrum Pharmaceuticals, Inc.

Partner : Ligand Pharmaceuticals

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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On November 24, 2015, Spectrum Pharmaceuticals, Inc. (the “Company”) received a letter from the U.S. Food and Drug Administration (the “FDA”) acknowledging the FDA’s receipt on November 9, 2015 of the Company’s November 7, 2015 resubmission of its New Drug Application (“NDA”) for EVOMELA™ (melphalan) for Injection. The FDA letter set a target decision date on the Company’s resubmitted NDA of May 9, 2016.
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Source: Form 8K, 11/25/15. https://www.sec.gov/Archives/edgar/data/831547/000083154715000031/a8-k20...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Melphalan - Captisol-enabled, propylene glycol-freeOncology HematologicMultiple Myelomaalkylating agent (captisol enabled)Adenine N3 - DNA

Mechanism of action: Melphalan - Captisol-enabled, propylene glycol-free - A propylene glycol-free intravenous formulation containing the hydrochloride salt of the nitrogen mustard phenylalanine derivative melphalan complexed with polyanionic sulfobutyl ether beta-cyclodextrin (SBE-CD) with potential antineoplastic activity. Upon administration, melphalan is converted into highly reactive ethylenimmonium intermediates that induce covalent guanine N7-N7 intra- and inter-crosslinks and alkylation of adenine N3 of DNA; RNA and proteins may also be alkylated. Subsequently, RNA transcription and protein synthesis are inhibited, resulting in cell growth arrest. The addition of sulfobutyl ether beta-cyclodextrin to the formulation improves the solubility, stability and ease of use of melphalan; cyclodextrins are cyclic dextrins derived from starch.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-05-09

Results:

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March 15, 2016
FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection
EVOMELA Received FDA Approval for Two Indications:
High-Dose Conditioning Treatment for Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplantation (ASCT)
Palliative Treatment of Patients with MM Who Cannot Take Oral Therapy
EVOMELA Admixture Solution is Stable for 4 Hours at Room Temperature in Addition to the 1 Hour Following Reconstitution
EVOMELA Does Not Contain Propylene Glycol
Company Plans to Launch EVOMELA with Existing Sales Force in a Market Estimated at Approximately $100 Million
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of EVOMELA for use in two indications: 1) use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and 2) for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM.

"I am very proud to announce that Spectrum has been able to bring another new cancer drug to the market," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "This represents the commercialization of our sixth Hematology/Oncology product in the U.S. Our EVOMELA formulation does not contain propylene glycol and is reconstituted and admixed with normal saline. This new formulation also uses Captisol technology, which allows the admixture solution to be stable for 4 hours at room temperature in addition to the 1 hour following reconstitution and has been used in several other FDA-approved products. We are very excited about the approval of EVOMELA as this fits seamlessly into our existing commercial infrastructure. In addition to our five other currently marketed products, we believe revenues from EVOMELA will help us expeditiously develop the potential blockbusters that we have in our late-stage pipeline."

"The approval of EVOMELA marks the first new formulation of melphalan approved by the FDA, since its initial approval in 1964," said Dr. Parameswaran Hari, Armand J. Quick/William F. Stapp Professor of Hematology at the Medical College of Wisconsin, Director of the Adult Blood and Marrow Transplant Program at Froedtert Hospital and the Section Head of Hematologic Malignancies and Transplantation, in the Division of Hematology and Oncology in the Department of Medicine. "Melphalan is extensively used in the treatment of multiple myeloma and is the main drug in conditioning therapy pre-transplant. EVOMELA's new formulation does not contain propylene glycol and is stable for 4 hours at room temperature in addition to the 1 hour following reconstitution."

Spectrum Pharmaceuticals gained global development and commercialization rights to EVOMELA from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013. Spectrum assumed responsibility for completing the pivotal Phase 2 clinical trial, and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.
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Source: press release, 3/15/16. http://investor.sppirx.com/releasedetail.cfm?ReleaseID=960622

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