Spectrum Pharmaceuticals In-Licenses a Novel, Long-Acting GCSF Drug in U.S. Clinical Trials from Hanmi Pharmaceuticals

  • SPI-2012, Spectrum's Third Biological Drug, Is a Long-Acting GCSF That Utilizes Hanmi’s Proprietary Platform Technology, LAPSCOVERY™;
  • SPI-2012 Could Have Potential Advantages for More Rapid and Profound Granulocyte Recovery in Patients with Chemotherapy Induced Neutropenia, A Multibillion Dollar Worldwide Market;
  • In a U.S. Based Phase 1 Study in Healthy Volunteers, SPI-2012 Demonstrated Activity Similar to Neulasta® (pegfilgrastim) at One-Third the Dose;
    • Spectrum Expects to Initiate Phase 2 Trials In Collaboration With Hanmi in 2012;
  • If SPI-2012 is Ultimately Commercialized, Spectrum Shall Own Worldwide Rights Except For Korea, China, and Japan.

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced that it has entered into a co-development and commercialization agreement with Hanmi Pharmaceutical Company for SPI-2012 (formerly known as “LAPS-GCSF”), a drug for the treatment of chemotherapy induced neutropenia based on Hanmi’s proprietary LAPSCOVERY™ Technology.

Granulocyte colony-stimulating factor (GCSF) stimulates the production of white blood cells by the bone marrow. A recombinant form of GCSF is used in appropriate cancer patients to accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens to be given at full-dose and on schedule. Chemotherapy can cause myelosuppression and unacceptably low levels of white blood cells, making patients prone to infections, hospitalizations, and interruption of additional chemotherapy treatments. The worldwide market for GCSF-related drugs was over $5 billion in 2011.

LAPSCOVERY™ (Long Acting Protein/Peptide Discovery) is a platform technology that can be applied to various molecules including glycosylated proteins, modified or artificial peptides with unnatural amino acid sequences. LAPSCOVERY™ can select the optimal conjugation sites from the proteins or peptides to minimize the structural hindrance and maximize the pharmacological activity.

“We were very impressed by Hanmi's platform technology and are delighted to add SPI-2012, our third biologic drug, to our mid-stage pipeline,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Early evidence suggests that there could be advantages of SPI-2012 over currently approved therapies in increasing the rate and intensity of neutrophil recovery. We believe this agreement is consistent with our strategy of acquiring promising drug candidates at reasonable upfront and developmental costs, while maintaining significant economics for our shareholders in the long-term.”

“Spectrum Pharmaceuticals has a proven history in in-licensing, developing and commercializing drugs. As a result, we expect this collaboration to help significantly advance SPI-2012 through the clinical and regulatory pathways, and commercial success,” said Dr. Gwan-Sun Lee, Chief Executive Officer and President of Hanmi Pharmaceuticals.

About Hanmi Pharmaceuticals

Established in 1973, Hanmi Pharmaceutical has now become the 2nd largest Korean pharmaceutical company with sales up to $558 million in 2008. Hanmi Pharmaceutical was successful in developing competitive products through ‘First Generic → IMD (Incrementally Modified Drug) → New drug’ Korean type R&D strategy. By investing the cash from this success into new product development, Hanmi was able to become a competitive pharmaceutical company in the global market. While other Korean pharmaceutical companies focused only on in-licensing products from foreign companies, Hanmi concentrated on developing domestic products through in-house API synthesis. This allowed Hanmi to be successful in developing the competitive modifying technology.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® (levoleucovorin) for Injection and ZEVALIN®(ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, apaziquone and belinostat, in late stage development with a goal of filing New Drug Applications (NDAs) with the U.S. Food & Drug Administration in 2012. The Company also has a diversified pipeline of novel drug candidates. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.

Neulasta® is a registered trademark of Amgen Inc.

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 may not receive approval, and other regulatory agencies 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.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.


Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
Paul Arndt
Senior Manager, Investor Relations

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INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Oncology  Pharmaceutical