Spectrum Pharmaceuticals In-Licenses Poziotinib, a Novel pan-HER Inhibitor With Clinical Activity in Several Solid Tumors, From Hanmi Pharmaceuticals

  • Poziotinib is a novel oral, pan-HER inhibitor that has shown single agent clinical activity in breast cancer, gastric cancer, lung cancer, and colorectal cancer, and is currently being studied in several Phase 2 clinical trials.
  • Poziotinib has shown a remarkable 60% response rate in early clinical trials in patients with breast cancer who had previously failed multiple lines of treatment, including HER2-directed therapies trastuzumab and lapatinib.
  • Spectrum receives worldwide rights, excluding Korea and China.

Data from Poziotinib will be highlighted at Spectrum's upcoming Analyst Day on March 13th in New York.
March 04, 2015 07:00 AM Eastern Standard Time
HENDERSON, Nev.--(BUSINESS WIRE)--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 it has entered into a licensing agreement with Hanmi Pharmaceuticals for poziotinib, a drug being investigated for the treatment of cancer.

"Despite the availability of a number of HER2-directed therapies, most patients with metastatic breast cancer relapse and die because of progressive disease"

Poziotinib (HM781-36B) is a novel, oral, quinazoline-based pan-HER inhibitor that irreversibly blocks signaling through the HER family of tyrosine-kinase receptors including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), as well as HER receptor mutations; this, in turn, leads to inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of HER family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, gastric cancer, etc. Currently, poziotinib is being investigated by Hanmi in EGFR-mutant NSCLC (Phase 2, sponsored by National OncoVenture), gastric cancer (Phase 2), head & neck cancer (Phase 2) and HER2 positive breast cancer (Phase 2, sponsored by National OncoVenture). National OncoVenture is a funding initiative by the Korean government's National Cancer Center.

"We continue to make progress on achieving our goal of becoming leaders in Oncology, and we believe that this late clinical stage drug acquisition continues to build and further strengthen our oncology portfolio," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "Poziotinib has shown promising early clinical activity with 60% (6/10) of patients with breast cancer having responses in Phase 1 clinical trials. These patients were heavily pre-treated, had previously received and failed multiple lines of treatment, and had been previously treated with the HER2-directed therapies, trastuzumab and lapatinib. In addition, tumor responses were also seen in patients with gastric cancer, colorectal cancer, and lung cancer. We are pleased to continue to work closely with Hanmi Pharmaceuticals and further our ongoing collaboration as we work together to bring more treatment options to cancer patients."

"Despite the availability of a number of HER2-directed therapies, most patients with metastatic breast cancer relapse and die because of progressive disease," said Dr. Francisco Esteva, Professor of Medicine, Director, Breast Medical Oncology Associate, Director of Clinical Investigation, Laura and Isaac Perlmutter Cancer Center New York University Langone Medical Center. "Therefore, there is a critical need for new treatments to improve the outcome for these patients. The fact that breast cancer patients previously treated with trastuzumab and lapatinib have shown responses to poziotinib is very exciting. If these early data are confirmed in additional clinical trials, poziotinib could become a very important treatment option for patients with breast cancer."

Under the terms of the agreement, Spectrum received exclusive license to develop, manufacture and commercialize worldwide excluding Korea and China. Hanmi shall remain responsible for the cost of the ongoing Phase 2 studies through completion.

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 Pharmaceuticals Co., Ltd

Hanmi Pharmaceuticals is a Korea-based global pharmaceutical company focused on the development and commercialization of new pharmaceutical products. The Company is fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The Company invests over 16% of its sales in R&D and has over 20 programs in clinical development in three main areas: 1) novel long-acting biologics based on the Company's LAPSCOVERY™ platform that aim to shift treatment paradigm of diabetes and obesity with weekly insulin, weekly to monthly GLP-1, and their combinations (Quantum Project); 2) novel targeted agents against cancer and autoimmune disorders; and 3) fixed-dose combination programs. The Company has collaboration with global partners 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.