Spectrum Pharmaceuticals Makes Decision to Advance SPI-2012, a Novel Long-Acting GCSF, to Phase 3 Due to Positive Phase 2 Results in its Collaboration Program with Hanmi Pharm. Co.

  • SPI-2012 met the primary endpoint in a multicenter Phase 2 study that evaluated the effectiveness and safety of SPI-2012 compared to a standard dose of pegfilgrastim.
  • The Company plans to meet with the FDA to discuss its Phase 3 design before year-end and submit Phase 2 results for presentation at a premier scientific conference in the first half of 2015.
  • The Company has identified more than 50 clinical sites for the Phase 3 Trial.
  • SPI-2012 is a Long-Acting GCSF that utilizes a proprietary platform technology of Hanmi Pharm. Co., LAPSCOVERY™, designed to maximize pharmacological activity of GCSF.
  • The worldwide commercial opportunity for neutropenia treatments totals over $6 billion.

HENDERSON, Nev.--()--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced the Phase 3 Go/No-Go decision for SPI-2012, its long acting Granulocyte Stimulating Factor (GCSF), and is planning for the start of Phase 3 clinical trials next year.

“We are pleased with the Phase 2 results (N= 156) that we have seen and have strong conviction that we can have a very exciting novel biologic drug in this very large market,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “SPI-2012 is built upon the 3rd generation LAPSCOVERY technology of Hanmi Pharm. Co. that differentiates our drug from the existing drugs used to treat neutropenia, and it could potentially have advantages relating to more rapid and potent granulocyte (white blood cell) recovery compared to pegylated filgrastim. SPI-2012 is one of the highest priorities at Spectrum because of the value of this opportunity with its successful commercialization. We will use the learnings from our Phase 2 enrollment to accelerate Phase 3 enrollment and, if SPI-2012 is approved, use our specialized commercial expertise to get this drug to market as soon as possible. The decision to go into Phase 3 with SPI-2012 is a landmark decision in Spectrum’s history, and significantly enhances the future growth prospects of the company.”

Spectrum’s Phase 2 trial was a multicenter, dose-ranging study that evaluated the effectiveness and safety of SPI-2012 relative to a fixed, standard dose of pegfilgrastim as a concurrent active control. The primary objective and endpoint of this study was to assess the effect of SPI-2012 on the 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. The company plans to present results for presentation at a premier scientific conference in the first half of 2015.

In January 2012, Spectrum entered into a co-development and commercialization agreement with Hanmi Pharm. Co., Korea, gaining rights for SPI-2012.

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. Spectrum's strong track record in 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.

About Hanmi Pharm. Co., Ltd.

Hanmi Pharm. Co., Ltd. is a Korea-based pharmaceutical company focusing on new drug development. It is a top R&D investor in the local pharmaceutical industry by investing over 15% of its annual revenue in the research and development. To date, the company has 23 global R&D programs, consisting of (1) the novel long acting biologics based on LAPSCOVERY™ platform including weekly Insulin, weekly to monthly GLP-1, and their combination for diabetes and obesity (collectively referred as Quantum Project); (2) the novel targeted anti-cancer drugs with improved tolerance and safety profile; and (3) the incrementally modified drugs and fixed-dosed combination drugs. Hanmi has been collaborating with global companies on various co-development and business opportunities. More information on Hanmi is available at www.hanmipharm.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.®, FUSILEV®, FOLOTYN®, ZEVALIN®, and MARQIBO® are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. BELEODAQ™, REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

Contacts

Spectrum Pharmaceuticals
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com

Release Summary

Spectrum Pharmaceuticals Makes Decision to Advance SPI-2012, a Novel Long-Acting GCSF, to a Phase 3 Due to Positive Phase 2 Results in its Collaboration Program with Hanmi Pharm. Co.

Contacts

Spectrum Pharmaceuticals
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com