• 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, 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 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.

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 30,000 new cases pro­jected in the US in 2016 and over 11,000 deaths annually (American Cancer Society Stats, 2016). The rate of ASCT for patients with MM is growing by approx­i­mately 3.3% annually.

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; EVOMELA is the only in­tra­venous mel­phalan prod­uct that is approved for use in the high-dose con­di­tioning indi­ca­tion.

About EVOMELA™

EVOMELA was approved by FDA based on its bioequivalence to the standard mel­phalan formulation (Alkeran) in a Phase 2 clin­i­cal study (Aljitawi et al, Bone Marrow Transplant, 2014) via the 505(b)(2) regu­la­tory path­way. 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 new mel­phalan formulation does not con­tain propylene glycol. The use of the Captisol® tech­nology to reformulate also con­trib­utes to the 4-hour admixture stability of EVOMELA at room tem­per­a­ture. This is in addi­tion to the 1 hour stability of reconstituted EVOMELA drug prod­uct at room tem­per­a­ture and 24 hour stability at refrigerated tem­per­a­ture (5°C).

Please see the Important Safety Information below and the full pre­scrib­ing in­­for­ma­tion, in­­clud­ing BOXED WARNINGS, for EVOMELA at www.evomela.com.

Important Safety Information

WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY

• Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters.
• Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with EVOMELA for serious hypersensitivity reactions.
• Melphalan produces chromosomal aberrations in vitro and in vivo. EVOMELA should be considered potentially leukemogenic in humans.

• History of serious allergic reaction to melphalan.

Warnings and Precautions

• Nausea, vomiting, diarrhea or oral mucositis may occur. Provide supportive care using antiemetic and antidiarrheal medications as needed.
• Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported after treatment with melphalan. Hepatic veno-occlusive disease has also been reported. Monitor liver chemistries.
• EVOMELA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during and after treatment with EVOMELA. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the patient of potential risk to the fetus.
• Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported.

Adverse Reactions

• The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with EVOMELA were neutrophil count decreased (100%), white blood cell count decreased (100%), lymphocyte count decreased (98%), platelet count decreased (98%), diarrhea (93%), nausea (90%), fatigue (77%), hypokalemia (74%), anemia (66%), and vomiting (64%).
• In a single-arm clinical study, twelve (20%) patients with multiple myeloma who received EVOMELA conditioning for ASCT experienced a treatment emergent serious adverse reaction. The most common serious adverse reactions (>1 patient, 1.6%) were pyrexia, hematochezia, febrile neutropenia, and renal failure.
• In a randomized clinical trial studying the palliative treatment of patients with multiple myeloma, severe myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) was more common in the IV melphalan arm (28%) than in the oral melphalan arm (11%).

Drug Interactions

• No formal drug interaction studies have been conducted. When nalidixic acid and IV melphalan are given simultaneously, the incidence of severe hemorrhagic necrotic enterocolitis has been reported to increase in pediatric patients.

Use in Specific Populations

• It is not known whether melphalan is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from melphalan, breastfeeding is not recommended during treatment with EVOMELA.
• Advise females of reproductive potential to avoid pregnancy, which may include the use of effective contraception methods, during and after treatment with EVOMELA.
• For Palliative Treatment, consider dose reduction for patients with renal impairment receiving EVOMELA.

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 Onyx Pharma­ceu­ticals’ Kyprolis®, Baxter Inter­na­tional’s Nexterone® and Merck’s NOXAFIL IV. There are also more than 30 Captisol-enabled prod­ucts cur­rently in clin­i­cal devel­op­ment.

About Spectrum Pharma­ceu­ticals, Inc.

Spectrum Pharma­ceu­ticals is a leading bio­technology com­pany focused on acquiring, devel­op­ing, and com­mer­cial­iz­ing drug prod­ucts, with a pri­mary focus in Hematology and Oncology. Spectrum cur­rently markets six hematology/oncology drugs, and ex­pec­ts an FDA de­ci­sion on another drug in the second half of 2016. Additionally, Spectrum's pipe­line in­cludes two drugs targeting blockbuster markets in ad­vanced stages of clin­i­cal devel­op­ment. Spectrum's strong track record for in-licensing and acquiring dif­fer­en­ti­ated drugs, and expertise 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.

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.® is a registered trademark 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.

© 2016 Spectrum Pharma­ceu­ticals, Inc.