Cell>Point and HYUN IMC Expand License in South Korea to Include Hanmi
Pharmaceutical Co., Ltd for Cancer and Heart Disease Imaging
Third License Completes the Company’s Initiative to Secure a Strong
Pharmaceutical Partner for the South Korean Market
CENTENNIAL, Colo. -- March 11, 2013
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.
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.
Terry Colip, 303-689-9693
Vincent Dipas, 303-591-7919
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