CMC Contrast Granted Orphan Drug Designation by the FDA for its Liver Specific MRI Contrast Media CMC-001
LUND, Sweden, November 27, 2013 /PRNewswire/ –
CMC Contrast AB, a privately owned drug development company that is developing a
targeted contrast agent for Magnetic Resonance Imaging (MRI), announced today that Orphan
Drug Designation has been granted by the US Food and Drug Administration (FDA) for its
liver specific contrast agent CMC-001. The Orphan Drug Designation has been granted for
CMC-001 for use as a targeted contrast agent for diagnostic MRI for detection and
localization of focal liver lesions in patients where gadolinium-based contrast agents are
contraindicated or cannot be administered.
Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to novel
drugs intended to treat a rare disease or condition affecting fewer than 200,000 people in
the U.S. The designation confers special incentives to the drug developer, including tax
credits towards the cost of clinical trials, prescription drug user fee waivers and may
entitle a period of seven years U.S market exclusivity upon FDA approval.
Magnus Corfitzen, Chairman of CMC Contrast AB “The diagnostic benefits of enhanced MRI
liver imaging in detecting and localizing focal liver lesions are well established.
However, a small subset of patient groups cannot undergo enhanced liver MRI procedures due
to the risks of severe side effects associated with currently used gadolinium based
contrast agents. For these patients, including patients with severe chronic renal
insufficiency, important diagnostic information may be missed due to lack of contrast
enhanced MRI. CMC-001 will allow radiologists to obtain the best possible diagnostic
information in these subsets of patients, enabling clinicians to select the optimal
treatment option for these patients. This is not possible today as clinicians only have
access to data from an unenhanced imaging procedure on which they will base their disease
management decisions for these patients”
The FDA decision to grant the Orphan Drug Designation to CMC-001 is an important
milestone for CMC Contrast AB. The company is now planning a pivotal phase III clinical
program which in conjunction with the completed phase I and II clinical studies should
enable CMC-001 to obtain regulatory approval and marketing authorization in the US.
CMC-001 will then become available to patients in need of a liver MRI procedure for whom
gadolinium based contrast agents are contraindicated or cannot be administered.
About CMC Contrast
CMC Contrast AB is a privately owned drug development company that specializes in
developing targeted contrast agents for Magnetic Resonance Imaging (MRI). CMC Contrast
AB’s product CMC-001 is the world’s first oral contrast agent for MRI of the liver.
CMC-001 is an oral manganese-based contrast agent which enables safe liver enhancement in
MRI, in patients for whom gadolinium based contrast agents are contraindicated or cannot
be administered. A liver MRI scan is a specialized radiology procedure used to examine the
liver to identify certain conditions or diseases which can be malignant cancerous or
CMC Contrast is based in Lund, Sweden, and funded by prominent VC investors including
Sunstone Capital, Industrifonden and Oresund Healthcare. http://www.cmccontrast.com
Contact Magnus Corfitzen Chairman, CMC Contrast AB Email: firstname.lastname@example.org Tel: +45-40-80-48-63
SOURCE CMC Contrast