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Ligand Pharmaceuticals, Inc.

Partner : Spectrum Pharmaceuticals

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Spectrum Pharmaceuticals received a Complete Response Letter from the FDA for EVOMELA® as a conditioning treatment prior to hematopoietic stem cell transplant for patients with multiple myeloma. In the letter, the FDA did not identify any clinical deficiency in Spectrum’s NDA package. Spectrum resubmitted the EVOMELA NDA on November 7, 2015 and has received a targeted NDA decision date of May 9, 2016.
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Source: press release, 2/10/16. http://investor.ligand.com/press-releases/detail/286/

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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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Ligand to receive $6 million milestone related to EVOMELA’s approval

SAN DIEGO-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, received approval from the U.S. Food and Drug Administration (FDA) of EVOMELA™ (melphalan) for use in two indications: 1) as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with 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. Spectrum plans to launch EVOMELA with its existing sales force.

“We extend congratulations to our partner Spectrum Pharmaceuticals on achieving FDA approval for EVOMELA in these two indications and look forward to the commercial launch of this product,” said John Higgins, Chief Executive Officer of Ligand. “Through partnerships such as this one, Ligand is able to share in the economic success of important, innovative new drugs across a range of indications and patient populations.”

Spectrum Pharmaceuticals licensed global development and commercialization rights to EVOMELA from Ligand Pharmaceuticals in March 2013. Spectrum assumed responsibility for completing the pivotal Phase 2 clinical trial, and was responsible for filing the New Drug Application (NDA). Under the license agreement, Ligand received an upfront fee and earned a $6 million milestone payment on EVOMELA approval, as well as royalties on net sales.
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Source: press release, 3/15/16. http://investor.ligand.com/press-releases/detail/287

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