Key Developments: Spectrum Pharmaceuticals Inc (SPPI.OQ)

SPPI.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Spectrum Pharmaceuticals announces agreement with FDA on the special protocol assessment
Monday, 17 Aug 2015 07:00am EDT 

Spectrum Pharmaceuticals Inc:Announces that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) of the planned Phase 3 clinical trial of its novel, potent pro-drug, apaziquone.  Full Article

Spectrum Pharmaceuticals Inc files New Drug Application with FDA for Captisol-Enabled (Propylene Glycol-Free) Melphalan
Friday, 26 Dec 2014 07:00am EST 

Spectrum Pharmaceuticals Inc:Says it has submitted New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for approval of Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free).For use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.Spectrum is also seeking approval for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.  Full Article

Spectrum Pharmaceuticals Inc announces issue of new patent for beleodaq for injection with patent term adjustment till 2027
Tuesday, 16 Sep 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Says United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 8835501, which covers Beleodaq (belinostat) for Injection on Sept. 16 with patent term adjustment from May 2026 to Oct. 2027.Says in addition to the existing patent, covering the chemical entity of Beleodaq, this new patent covers the formulation of the product, strengthening and expanding significantly its industrial property protection.  Full Article

Spectrum Pharmaceuticals Inc makes decision to advance SPI-2012, Novel Long-Acting GCSF, to Phase 3 Due to positive phase 2 results in its collaboration program with Hanmi Pharm Co
Tuesday, 9 Sep 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Announced Phase 3 Go/No-Go decision for SPI-2012, its long acting Granulocyte Stimulating Factor (GCSF), and is planning for start of Phase 3 clinical trials next year.Phase 2 trial was multicenter, dose-ranging study that evaluated effectiveness and safety of SPI-2012 relative to fixed, standard dose of pegfilgrastim as a concurrent active control.Primary objective and endpoint of this study was to assess effect of SPI-2012 on mean duration of severe neutropenia during Cycle 1 in patients with breast cancer who received adjuvant or neoadjuvant chemotherapy.Three doses of SPI-2012 were evaluated compared to pegfilgrastim.Company plans to present results for presentation at premier scientific conference in first half of 2015.  Full Article

FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq (belinostat) for Injection
Monday, 7 Jul 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Says U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of Beleodaq for treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response.Says an improvement in survival or disease-related symptoms has not been established.Says Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.Says In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity.PTCL comprises a group of rare and aggressive non-Hodgkin's Lymphomas (NHL) that develop from mature T-cells and accounts for about 10 to 15 pct of all NHL cases in the United States.These patients generally have a poor prognosis with a low response rate (25-27 pct) to available treatment options, and commonly experience repeated treatment failures until drug resistance or death.Therefore, there has been an important unmet medical need for these patients with PTCL for additional new treatment options that are specifically effective for this disease.  Full Article

Spectrum Pharmaceuticals completes enrollment in Phase 2 Trial of SPI-2012
Wednesday, 28 May 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Completes phase 2 study enrollment of long-acting granulocyte stimulating factor analog developed using LAPSCOVERY technology.  Full Article

Spectrum Pharmaceuticals Inc's Pivotal Trial of Captisol-Enabled (Propylene Glycol-Free) Melphalan Meets Primary Endpoint
Wednesday, 23 Apr 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Says its pivotal trial of Captisol-enabled (propylene glycol-free) Melphalan met its primary end points.Phase 2 pivotal trial evaluating CE Melphalan was a multi-center trial evaluating safety and efficacy.Primary objective of study was to determine overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m(2)of CE Melphalan as myeloablative therapy prior to autologous stem cell transplantation (ASCT).Secondary objectives evaluated the efficacy of CE Melphalan in this patient population as measured by multiple myeloma response rate (according to International Myeloma Working Group [IMWG] criteria), and the rates of myeloablation, and engraftment.Primary endpoint of this Phase 2 trial was met, and additional analyses are currently underway.Company plans to file NDA in third quarter.  Full Article

Spectrum Pharmaceuticals appoints Joseph Turgeon as president and chief operating officer - Form 8-K
Thursday, 17 Apr 2014 05:03pm EDT 

Spectrum Pharmaceuticals Inc:Effective April 17, company appointed Joseph Turgeon as president and chief operating officer.On April 17, Ken Keller resigned from his position as executive vice president and chief operating officer.Keller will continue to be employed by company through April 28 in order to assist with the transition.Effective April 17, Tom Riga, currently Vice president, corporate accounts of company, is promoted to position of senior vice president and chief commercial officer.  Full Article

Spectrum Pharmaceuticals Inc announces offering of $100 million of convertible notes
Monday, 16 Dec 2013 04:01pm EST 

Spectrum Pharmaceuticals Inc:Intends to offer $100 million aggregate principal amount of convertible senior notes due 2018.Expects to grant an option to the initial purchasers for up to an additional $20 million aggregate principal amount of Convertible Notes, solely to cover overallotments.Expects to use a portion of the net proceeds from the sale of the Convertible Notes to pay the cost of the convertible note hedge transactions.Expects to use the remainder of the net proceeds for general corporate purposes, which may include working capital, research and development, clinical studies, and business development.Says Jefferies LLC and RBC Capital Markets, LLC are acting as joint book-running managers for the offering of Convertible Notes.  Full Article

Spectrum Pharmaceuticals Inc announces submission of new drug application for Belinostat
Tuesday, 10 Dec 2013 07:00am EST 

Spectrum Pharmaceuticals Inc:Says it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Belinostat, a pan-histone deacetylase (HDAC) inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).Says Belinostat is differentiated from other HDAC inhibitors that selectively inhibit a single class of HDAC enzymes by virtue of its inhibition of all three classes of the zinc-dependent HDAC enzymes (Class I, Class II and Class IV).Says this leads to different alterations in histone and non-histone protein acetylation that, in turn, could importantly influence chromatin accessibility, gene transcription, and activity in different cancer patients, including those who develop drug resistant disease.  Full Article

Judge refuses to block generic version of Spectrum's Fusilev

- A federal judge has refused to block Novartis AG unit Sandoz Inc from making a generic version of Spectrum Pharmaceuticals Inc's drug Fusilev, which is used to counteract the toxic effects of a widely used chemotherapy drug.

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