spectrum pharmaceuticals inc (SPPI) Key Developments
Spectrum Pharmaceuticals, Inc. Announces Results of Clinical Study of the Stability of Captisol-Enabled Melphalan
Apr 22 15
Spectrum Pharmaceuticals, Inc. announced results of a clinical study of the stability of Captisol-enabled Melphalan versus the currently marketed, propylene glycol-containing melphalan formulation entitled, 'Solution Stability of Captisol-enabled Melphalan vs Marketed Melphalan Products'. This is but one of the company's products that has a diversified portfolio of commercial, late-stage and early-stage development stage products. Data from the study show that EVOMELA has significantly better stability in solution compared to the marketed melphalan formulations. Reconstituted solution in vials is 17X more stable, and the admixture solution in bags is 5X more stable, respectively, than the same solutions prepared using currently marketed formulations.
Spectrum Pharmaceuticals, Inc. Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014
Mar 13 15
Spectrum Pharmaceuticals, Inc. reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, the company reported total revenues of USD 51.861 million compared to USD 41.518 million a year ago. Loss from operations was USD 1.632 million compared to USD 6.510 million a year ago. Loss before income taxes was USD 3.044 million compared to USD 3.623 million a year ago. Net loss was USD 2.976 million compared to USD 39.372 million a year ago. Basic and diluted loss per share was USD 0.05 compared to USD 0.63 a year ago. Non-GAAP income from operations was USD 8.385 million compared to USD 3.454 million a year ago. Non-GAAP net income was USD 7.523 million compared to USD 3.470 million a year ago. Diluted non GAAP income per share was USD 0.09 compared to USD 0.05 a year ago.
For the year, the company reported total revenues of USD 186.830 million compared to USD 155.854 million a year ago. Loss from operations was USD 31.569 million compared to USD 38.785 million a year ago. Loss before income taxes was USD 43.533 million compared to USD 36.636 million a year ago. Net loss was USD 45.719 million compared to USD 62.134 million a year ago. Basic and diluted loss per share was USD 0.71 compared to USD 1.02 a year ago. Non-GAAP income from operations was USD 24.886 million compared to non GAAP loss from operations of USD 4.919 million a year ago. Non-GAAP net income was USD 21.358 million compared to non GAAP net loss of USD 5.641 million a year ago. Diluted non GAAP income per share was USD 0.27 compared to diluted non GAAP loss per share of USD 0.09 a year ago.
Spectrum Pharmaceuticals, Inc. Presents at 12th Annual BIO Asia International Conference, Mar-24-2015 01:00 PM
Mar 12 15
Spectrum Pharmaceuticals, Inc. Presents at 12th Annual BIO Asia International Conference, Mar-24-2015 01:00 PM. Venue: Grand Hyatt Hotel, Tokyo, Japan.
Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for Captisol-Enabled™ (Propylene Glycol-Free) Melphalan
Mar 9 15
Spectrum Pharmaceuticals announced that its New Drug Application (NDA) for Captisol-Enabled Melphalan (CE-Melphalan), has been accepted by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 23, 2015 for the CE-Melphalan NDA, which is 10 months from the filing date. Spectrum is seeking FDA approval for its use as a high-dose conditioning treatment prior to autologous hematopoietic (progenitor) stem cell transplantation (AHCT) in patients with multiple myeloma (MM), an orphan drug designation. Spectrum is also seeking approval for the palliative treatment of patients with MM for whom oral therapy is not appropriate. The drug's improved solubility and stability should make it an attractive treatment option for both transplant conditioning and the palliative treatment of patients with MM. Eliminating the need for propylene glycol in the preparation of CE-Melphalan eliminates the risk of the toxicities associated with this excipient. In addition, CE-Melphalan's increased stability simplifies the logistics for pharmacies and nursing staff, and is anticipated to allow for longer infusion times which may permit the administration of higher dose intensities. The company anticipates these characteristics of CE-Melphalan will facilitate rapid adoption. The company looks forward to bringing this drug to market and providing additional treatment options to patients suffering with cancer. The Phase 2 pivotal trial evaluating CE-Melphalan was a multi-center trial evaluating safety and efficacy. The primary objective of the study was to determine the overall safety and toxicity profile in MM patients receiving 200 mg/m2 of CE-Melphalan as myeloablative therapy prior to AHCT. The secondary objectives evaluated the efficacy of CE-Melphalan in this patient population as measured by Multiple Myeloma Response Rate, and the rates of myeloablation and engraftment. Study results support the safety and efficacy of high-dose CE-Melphalan as a high-dose conditioning treatment prior to AHCT in patients with MM. CE-Melphalan led to successful myeloablation and subsequent engraftment in all (100%) of the MM patients studied with no mortality or unexpected transplant-related toxicity. Overall, 95% of subjects (n=61) responded to high dose CE-Melphalan, and 67% VGPR or better responses were achieved in the subgroup of high risk patients (15%). There were no deaths by Day 100, and the most common Grade 3 and 4 toxicities were the expected hematologic events (neutropenia, leukopenia, lymphopenia, thrombocytopenia and anemia). The most frequent non-hematologic adverse events included diarrhea, nausea, and fatigue. Importantly, the incidence of severe mucositis was low (Grade 3/4; 10%).
Spectrum Pharmaceuticals, Inc. Presents at RBC Capital Markets Healthcare Conference 2015, Feb-24-2015 09:30 AM
Feb 20 15
Spectrum Pharmaceuticals, Inc. Presents at RBC Capital Markets Healthcare Conference 2015, Feb-24-2015 09:30 AM. Venue: The New York Palace Hotel, New York, New York, United States. Speakers: Rajesh C. Shrotriya, Chairman, Chief Executive Officer, Chairman of Product Acquisition Committee and Chairman of Placement Committee.