Press release

Hanmi Out-Licenses Poziotinib, a Promising, Irreversible, pan-erbB Inhibitor being investigated for the Treatment of Cancer, to Spectrum Pharmaceuticals

  • Poziotinib is a novel, oral, quinazoline-based pan-erbB inhibitor that  irreversibly blocks  signaling through the erbB family of tyrosine-kinase  receptors.
  • Poziotinib has shown promising activity in early clinical trials in patients  with breast  cancer who had previously failed multiple lines of treatment,  including erbB2-directed  therapies with trastuzumab and lapatinib.
  • Currently Poziotinib is being studied in a number of phase 2 clinical  trials.
  • Spectrum receives worldwide rights, excluding Korea and China.

Seoul South Korea – March 5th, 2015 – Hanmi pharmaceutical (128940), Hanmi pharmaceutical announced it has entered into a licensing agreement with Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology,  for Poziotinib, a drug being investigated for the treatment of cancer.

Poziotinib (HM781-36B) is a novel, oral, quinazoline-based pan-erbB inhibitor that irreversibly blocks signaling through the erbB family of tyrosine-kinase receptors including erbB1 (EGFR; HER1), erbB2 (HER2), and erbB4 (HER4), as well as erbB receptor mutations; this, in turn, leads to inhibition of the proliferation of tumor cells that overexpress these receptors.  Mutations or overexpression/ amplification of erbB 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 erbB1-mutant NSCLC (Phase 2, sponsored by National OncoVenture), gastric cancer (Phase 2), head & neck cancer (Phase 2) and erbB2 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 activity with 6 of 10 (60%) patients with breast cancer having responses in Phase 1 clinical trials. These patients were heavily pre-treated and had previously received and failed multiple lines of treatment, and been previously treated with the erbB2-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 on-going collaboration as we work together to bring more treatment options to 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 still 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

Mar 05, 2015 (source : Spectrum Pharmaceuticals)