Cell>Point and HYUN IMC Expand License in South Korea to Include Hanmi Pharmaceutical Co., Ltd for Cancer and Heart Disease Imaging

CENTENNIAL, Colo.--(BUSINESS WIRE)--Cell>Point announced today that it entered into a license agreement on December 17, 2012 with Hanmi Pharmaceutical Co., Ltd (Hanmi) who is headquartered in Seoul, Korea. The license agreement also includes HYUN IMC as a party (who Cell>Point previously entered into a license with in February 2012 and subsequently amended and restated the license agreement with HYUN IMC on December 4, 2012). The license agreement with Hanmi covers the kit manufacture, marketing and distribution of Cell>Point’s cancer and cardiology imaging product based on its Ethylenedicysteine-Glucosamine (EC-G) technology platform. The initial product will be technetium-99m labeled EC-G (^99mTc-EC-G) for SPECT and SPECT/CT imaging. Downstream, the license agreement will cover gallium-68 labeled EC-G (⁶⁸Ga-EC-G) for PET/CT imaging. In addition, Hanmi has been granted a Right of First Refusal regarding Cell>Point’s cold metallic therapeutic products Platinum-EC-G and ¹⁸⁷Rhenium-EC-G, and two imaging products, ^99mTc-EC-Annexin V to image tumor cell apoptosis, and ^99mTc-EC-Metronidazole to image tumor cell hypoxia.

Cell>Point receives upfront payments, milestone progress payments, and a royalty on commercial sales.

“We are pleased to associate with such an outstanding pharmaceutical company whose vision is to bring imaging technology to South Korea that has the potential to make high quality cancer imaging more affordable and accessible at a time when the cost of healthcare is becoming a national priority, as it is in many other countries around the world. In addition, Hanmi Pharmaceutical Co. is committed to making available cardiovascular imaging technology that has the potential to increase diagnostic accuracy, drastically shorten the time that the patient has to devote to a cardiovascular study, and make the study considerably easier for the patient,” said Cell>Point CEO Greg Colip.

^99mTc-EC-G, invented at The University of Texas M.D. Anderson Cancer Center and acquired by Cell>Point, is a target-specific molecular imaging radiopharmaceutical that has moved into a Phase 3 lung cancer imaging trial and Phase 2 cardiology imaging trial.

^99mTc-EC-G is injected intravenously and then imaged using a Single Photon Emission Computed Tomography (SPECT) camera (sometimes referred to as a gamma camera) or a combination SPECT/Computed Tomography (SPECT/CT) camera system. The current standard of care in cancer molecular imaging is fluorine-18 FluoroDeoxyGlucose (¹⁸F-FDG) imaged using a combination Positron Emission Tomography /Computed Tomography (PET/CT) camera system.

^99mTc-EC-G Phase 3 lung cancer imaging trial

For the Phase 3 lung cancer study, all patients will be imaged with ^99mTc-EC-G on SPECT/CT and separately imaged with ¹⁸F-FDG on PET/CT cameras. Where combination SPECT/CT cameras are not available, a special workstation will be used to integrate the patient images taken from the stand-alone SPECT and CT cameras. Using a workstation to integrate the images allows the medical site to take full advantage of ^99mTc-EC-G without the need for a new combination SPECT/CT camera on the premises. This should significantly expand the utilization of the installed SPECT camera base in the United States and the rest of the world, which is already substantially greater than the PET and PET/CT camera base. The lung cancer trial will be followed by Phase 4 trials in lymphoma, breast, liver, colorectal, prostate, and head and neck cancers.

^99mTc-EC-G Phase 2 cardiology imaging trial

In a separate clinical trial, ^99mTc-EC-G has moved from a Phase 1 to a Phase 2 cardiovascular imaging study. The product is the same as that used in the oncology trials. ^99mTc-EC-G exhibits minimal uptake in the normal heart; however, it exhibits very high uptake in heart cells that are ischemic (i.e., deprivation of blood flow), such as from atherosclerotic heart disease. The Phase 2 cardiovascular trial involves patients who have suspected coronary artery disease and compares ^99mTc-EC-G images of the heart with images obtained from the standard of care nuclear cardiology procedure, a full “stress/rest” Myocardial Perfusion Imaging (MPI) protocol.

One of the clinical objectives is to compare the results from the “rest” only portion of the ^99mTc-EC-G study to the results from the full “stress/rest” MPI study. Based on clinical evidence from the Phase 1 study, Cell>Point believes clinical information from the ^99mTc-EC-G “rest” study has the potential for greater diagnostic accuracy in less study time than that required from conducting the full “stress/rest” MPI study. The standard MPI study uses either ^99mTc-sestamibi or thallium 201 for the “stress/rest” images. The traditional “stress/rest” MPI study can take up to 5 to 7 hours to complete, whereas the “rest” only ^99mTc-EC-G study can be completed in 30 to 45 minutes. This has the potential to dramatically change the logistics of nuclear cardiovascular imaging by providing more comfort and convenience for the patient, by eliminating the need for a stress test and the shorter time required to complete the imaging.

About Cell>Point

Cell>Point is a commercialization-stage biopharmaceutical company developing universal molecular imaging agents and molecular therapeutics for the diagnosis, treatment and treatment monitoring of cancer, heart, and other diseases. Cell>Point has exclusive license to five drug-development platforms covering cancer imaging and therapy, cardiovascular imaging, high-yield radio/chemotherapy delivery system for treating inoperable and unresectable tumors, neuroendocrine disease imaging and therapy, diabetes imaging, and dual compound imaging in cancer for SPECT/CT, SPECT/MRI, PET/CT, and PET/MRI, all from The University of Texas M.D. Anderson Cancer Center in Houston, a world leader in cancer research and care. Information on Cell>Point’s drug candidates and licenses, recent press releases, and patents and patent filings can be obtained through its website at www.cellpointweb.com. The company is headquartered in Centennial, Colo., and has additional offices in San Francisco and Houston.

About Hanmi Pharmaceutical Co., Ltd

Established in 1973, Hanmi Pharmaceuticals has risen to be one of the top 5 pharmaceutical companies in Korea, and has been the most R&D focused company with the highest R&D investment for several years. Hanmi Pharmaceuticals has worldwide offices in major countries such as, but not limited to, China, Japan, Europe, and the U.S. The company’s long-term strategy has been to remain highly flexible, to recognize the need to continuously change and adapt its market and development strategy from its beginnings as a generic pharmaceutical company to Incrementally Modified Drug and Fixed Dose Combination Drugs, and to new drug development including innovative small molecules and biologics. The company has more than 10 FDC pipelines including collaboration projects with Merck, Glaxo SmithKline and Sanofi. During the period of open innovation, Hanmi Pharmaceuticals made multiple strategic collaborations with multinational companies and biotech companies. The company is actively conducting clinical trials for new drug pipelines such as biobetter drugs with LAPSCOVERY (Long Acting Protein-Peptide Discovery Platform Technology) and small molecule oncology pipelines in global markets.

About HYUN IMC

HYUN IMC is a South Korean company with interests throughout the Pacific Rim. The company’s core business is in the manufacture and distribution of various medical isotope generators, the production and installation of hot cells, and trading in pharmaceutical raw materials. Through its affiliation with and support from Korean pharmaceutical companies, HYUN IMC made the decision to expand its nuclear medicine business by moving into radiopharmaceutical manufacturing and distribution.