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Last $5.69 USD
Change Today +0.21 / 3.83%
Volume 544.0K
SPPI On Other Exchanges
As of 8:10 PM 11/25/15 All times are local (Market data is delayed by at least 15 minutes).

spectrum pharmaceuticals inc (SPPI) Key Developments

Spectrum Pharmaceuticals, Inc. Submits IND Application to Food and Drug Administration

Spectrum Pharmaceuticals, Inc. announced that it has submitted an IND application to the U.S. Food and Drug Administration (FDA) and plans to initiate a Phase 2 breast cancer study in the U.S. as soon as possible. The Phase 2 study is planned to be an open-label study that will enroll approximately 70 patients with HER-2 positive metastatic breast cancer, who have failed at least one or more HER-2 directed therapy. The dose and schedule of oral poziotinib will be based on clinical experience from the studies in Korea, and in addition include the use of prophylactic therapies to help minimize known side-effects of HER2-directed therapies.

Eagle Pharmaceuticals, Inc. and Spectrum Pharmaceuticals, Inc. Announce Co-Promotion Agreement

Eagle Pharmaceuticals, Inc. and Spectrum Pharmaceuticals, Inc. announced that they have entered into a co-promotion agreement under which the Spectrum 32-person corporate accounts sales team will dedicate 80% of its time to selling and marketing up to six Eagle products over a period of at least 18 months. Spectrum will continue to maintain a separate sales force to market existing and potential hematology products. The agreement leverages the experience and network of the Spectrum corporate accounts sales team in order to maximize the respective product sales of both companies by targeting infusion centers, hospitals, and oncology purchasing groups. Under the terms of the agreement, the Spectrum corporate accounts sales team will promote up to six products. This will potentially include Eagle’s current pipeline plus products that may be in-licensed over time. Eagle’s approximately 20 direct sales representatives will focus on promoting Eagle products with an initial emphasis on the launch of RTU Bivalirudin and RYANODEX® (dantrolene sodium). As outlined in the agreement, Eagle will pay Spectrum a base fee of $12.8 million over 18 months. Spectrum will also have the opportunity to earn an additional $9 million in specific identified sales milestone payments if its Corporate Accounts Sales Team surpasses sales projections, for a potential total payment of up to $22 million in base fee and specified milestones over 18 months. The agreement grants both companies the opportunity for six-month renewal periods upon mutual agreement.

Spectrum Pharmaceuticals, Inc. Reports Unaudited Consolidated Financial Results for the Third Quarter and Nine Months Ended September 30, 2015; Provides Pipeline Update

Spectrum Pharmaceuticals, Inc. reported unaudited consolidated financial results for the third quarter and nine months ended September 30, 2015. For the quarter, the company's total product sales were $28.5 million in the third quarter of 2015. Total product sales decreased 41% from $47.9 million in the third quarter of 2014. Product sales in the third quarter included: FUSILEV® (levoleucovorin) net sales of $11.1 million, FOLOTYN® (pralatrexate injection) net sales of $8.7 million, ZEVALIN® (ibritumomab tiuxetan) net sales of $4.8 million, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) net sales of $1.3 million and BELEODAQ® (belinostat for injection) net sales of $2.6 million. Net loss was $18.7 million, or $0.28 per basic and diluted share compared to net loss of $11.5 million, or $0.18 per basic and diluted share in the comparable period in 2014. Non-GAAP net loss was $7.9 million, or $0.12 per basic share and diluted share compared to non-GAAP net income of $5.3 million, or $0.08 per basic and $0.07 per diluted share in the comparable period in 2014. Total revenues were $28.627 million against 47.990 million a year ago. Loss from operations was $16.074 million against $4.127 million a year ago. Loss before income taxes was $18.802 million against $8.062 million a year ago. Net loss was $18.724 million against $11.539 million a year ago. For the nine months, the company reported total revenues of $112.226 million against $134.969 million a year ago. Loss from operations was $37.769 million against $29.937 million a year ago. Loss before income taxes was $46.595 million against $40.489 million a year ago. Net loss was $46.632 million against $42.743 million a year ago. Net loss per diluted share was $0.71 against $0.66 a year ago. Non-GAAP net loss was $13.004 million or $0.20 per diluted share against non-GAAP net income of $13.668 million or $0.17 per diluted share a year ago. The company provided pipeline update: Two Potential Blockbusters and One Near-term NDA Submission: SPI-2012, long-acting GCSF: In a Phase 2 dose ranging study, SPI-2012 was shown to be superior at the higher dose tested and non-inferior at the middle dose in decreasing the duration of severe neutropenia compared to the blockbuster drug pegfilgrastim. SPI-2012 was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities. The Phase 2 data will be presented at the San Antonio Breast Cancer Symposium. Spectrum has continued to have productive discussions with the FDA, expects to finalize the pivotal study design this year, and start the study shortly after reaching SPA agreement with the Agency. Over 80 study sites have already been qualified. Apaziquone, a potent tumor-activated pro-drug for non-muscle invasive bladder cancer: By year end, Spectrum expects to file the NDA based on the previous Phase 3 studies. The Company has also initiated enrollment in an additional randomized, placebo-controlled Phase 3 trial under the SPA agreement, and treated the first patient in late October. This Phase 3 study has been specifically designed to address important lessons learned from the previous apaziquone Phase 3 studies, as well as recommendations made by the FDA. EVOMELA, a propylene-glycol free melphalan formulation with improved stability: Spectrum is actively addressing the non-clinical issues raised in the Complete Response Letter regarding the EVOMELA NDA. FDA has granted a Type A meeting for November 6, 2015 and the company believes these issues can be swiftly resolved. Spectrum plans to launch this drug with the company's existing sales force. Poziotinib, a potential best-in-class, novel, pan-HER inhibitor:The Company plans to initiate a breast cancer program in the U.S., based on compelling Phase 1 efficacy data in breast cancer patients who had failed multiple other HER-2 directed therapies. In addition, multiple Phase 2 studies funded by the company's partner, Hanmi Pharmaceuticals, are currently ongoing in South Korea.

TheGrantLawFirm, PLLC Files Class Action Complaint against Spectrum Pharmaceuticals, Inc

TheGrantLawFirm, PLLC announced that it has filed a class action complaint on behalf of all securities holders who purchased the securities of Spectrum Pharmaceuticals, Inc. during the period between May 7, 2015 until October 23, 2015, inclusive. On October 23, 2015, the company announced that the FDA failed to approve the new drug application for one of the company's major potential revenue drivers, Evomela, a drug directed at patients with multiple myeloma. The complaint asserts that during the Class Period, the company, through the Chairman of its Board and Chief Executive Officer, Rajesh C. Shrotriya made repeated false and misleading statements concerning the ability of Evomela to drive the company's revenues, and provided assuring statements to the public that the FDA would approve its NDA, allowing the drug to be marketed immediately. The complaint asserts that Shrotriya and the company violated federal securities laws by disseminating materially false and misleading information and failing to disclose material facts, causing the artificial inflation Spectrum's stock price during the Class Period. The complaint seeks to recover damages on behalf of class members.

Spectrum Pharmaceuticals, Inc., Q3 2015 Earnings Call, Nov 04, 2015

Spectrum Pharmaceuticals, Inc., Q3 2015 Earnings Call, Nov 04, 2015


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