• The FDA did not identify any clin­i­cal deficiency in the CRL
• Company plans to meet with FDA and seek clarification on the CRL

Henderson, NV (Press Release) – 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 it has received a Complete Response Letter from the U.S. Food and Drug Admin­istra­tion (FDA). A Complete Response Letter is a communication from the FDA that informs com­pa­nies that an appli­ca­tion cannot be approved in its present form. In the letter, the FDA did not identify any clin­i­cal deficiency in Spectrum’s NDA package.

“We will work swiftly with the FDA to address the Complete Response Letter,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharma­ceu­ticals. “We remain committed to bringing EVOMELA to the market for patients and plan to work closely with the FDA.”

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.

About Spectrum Pharma­ceu­ticals, Inc.

Spectrum Pharma­ceu­ticals is a leading bio­technology com­pany focused on acquiring, devel­op­ing, and com­mer­cial­iz­ing drug prod­ucts, with a pri­mary focus in Oncology and Hematology. Spectrum and its affiliates market five on­col­ogy drugs─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; ZEVALIN® (ibritumomab tiuxetan) Injection for in­tra­venous use, for which the Company has world­wide market­ing rights; MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for in­tra­venous infusion, for which the Company has world­wide market­ing rights; and BELEODAQ® (belino­stat) for Injection in the U.S. Additionally, Spectrum's pipe­line in­cludes three drugs targeting block­buster markets in ad­vanced stages of clin­i­cal devel­op­ment. Spectrum's strong track record in in-licensing and acquiring dif­fer­en­ti­ated drugs, and expertise and proven track record in clin­i­cal devel­op­ment have generated a robust, di­vers­i­fied, and growing pipe­line of prod­uct can­di­dates in ad­vanced-stage Phase 2 and Phase 3 studies. More in­­for­ma­tion on Spectrum is avail­able at www.sppirx.com.

About Multiple Myeloma

Multiple Myeloma is a systemic malig­nan­cy of plasma cells that accumulate in the bone marrow, usually asso­ci­ated with mono­clonal anti­body secretion, and results in bone marrow failure and bone destruction. It is the second most common hema­to­logic disease with nearly 27,000 new cases pro­jected in the U.S. in 2015 and over 11,000 deaths annually (American Cancer Society Stats, 2015). The rate of ASCT for patients with MM is growing by approx­i­mately 3.3% annually.

While MM is usually sensitive to cytotoxic chemo­therapy, most responses are transient and patients fre­quent­ly relapse. The dem­onstrated superiority of high-dose chemo­therapy with ASCT over conventional chemo­ther­apy for the treat­ment of MM has made trans­plant the current standard of care for patients, particularly the young, with adequate organ function. Melphalan is the most commonly used IV agent for high-dose con­di­tioning for patients undergoing ASCT for MM. The current IV mel­phalan market is approx­i­mately $100 million annually, with predominant use in ASCT.

About EVOMELA™

EVOMELA is a new, propylene glycol-free mel­phalan formulation that dem­onstrated bioequivalence to the standard mel­phalan formulation (Alkeran) in a Phase 2 clin­i­cal study (Aljitawi et al, Bone Marrow Transplant, 2014). EVOMELA has been granted Orphan Drug Designation by the FDA for its use as a high-dose con­di­tioning regi­men for patients with MM undergoing ASCT.

EVOMELA’s formulation elim­i­nates the need to use a propylene glycol con­taining custom diluent, which is required with other in­tra­venous mel­phalan formulations, and has been reported to cause renal and cardiac side effects. The use of the Captisol^® tech­nology to reformulate mel­phalan also im­proved its stability, extending its use time to five hours, which is antic­i­pated to simplify preparation and admin­istra­tion logistics, and allow for slower infusion rates and longer admin­istra­tion durations for pre-transplant chemo­ther­apy.

About Captisol®

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug devel­op­ment and formulation. This unique tech­nology has enabled six FDA-approved prod­ucts, in­­clud­ing Amgen’s Kyprolis^®, Baxter Inter­na­tional’s Nexterone^® and Merck’s NOXAFIL IV. There are also more than 30 Captisol-enabled prod­ucts cur­rently in clin­i­cal devel­op­ment.

Forward-looking state­ment — This press release may con­tain forward-looking state­ments regarding future events and the future per­for­mance of Spectrum Pharma­ceu­ticals that involve risks and un­cer­tain­ties that could cause actual results to differ materially. These state­ments are based on man­agement's current beliefs and ex­pec­ta­tions. These state­ments in­clude, but are not limited to, state­ments that relate to our business and its future, in­­clud­ing certain com­pany mile­stones, Spectrum's ability to identify, acquire, develop and com­mer­cial­ize a broad and diverse pipe­line of late-stage clin­i­cal and commercial prod­ucts, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any state­ments that relate to the intent, belief, plans or ex­pec­ta­tions of Spectrum or its man­agement, or that are not a state­ment of historical fact. Risks that could cause actual results to differ in­clude the possibility that our existing and new drug can­di­dates may not prove safe or effective, the possibility that our existing and new appli­ca­tions to the FDA and other regu­la­tory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug can­di­dates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop addi­tional drug can­di­dates may fail, our lack of sustained revenue history, our limited market­ing ex­peri­ence, our dependence on third parties for clin­i­cal trials, manu­fac­tur­ing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Com­mis­sion. We do not plan to update any such forward-looking state­ments and expressly disclaim any duty to update the in­­for­ma­tion con­tained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.^®, FUSILEV^®, FOLOTYN^®, ZEVALIN^®, MARQIBO^®, and BELEODAQ^® are registered trademarks of Spectrum Pharma­ceu­ticals, Inc and its affiliates. REDEFINING CANCER CARE™, EVOMELA™ and the Spectrum Pharma­ceu­ticals logos are trademarks owned by Spectrum Pharma­ceu­ticals, Inc. Any other trademarks are the property of their re­spec­tive­ owners.

Source: Spectrum Pharma­ceu­ticals.