Enzychem Lifesciences said Tuesday that it struck an 81.5 billion won ($75.3 million) export deal with Taiwan-based InnoPharmax for its magnetic resonance imaging (MRI) contrast medium, Gadobutrol.
The multimillion-dollar deal will begin to generate revenue starting in 2020, pushing up the company’s 2016 sales by up to 370 percent, according to Enzychem.
Under the contract, the Korean pharmaceutical firm will supply raw material to InnoPharmax over the next decade until the end of 2029. The Taiwanese importer will then produce Gadobutrol and export it to the U.S. through an undisclosed U.S. firm that specializes in selling MRI contrast mediums.
The company said it would pursue selling in global markets aggressively.
“We are planning to sell it in Korea and Europe actively and further expand to the U.S. and Japan, as well as Commonwealth of Independent States (CIS) countries such as Russia, after completing the product quality certification,” an Enzychem official said.
Gadobutrol is a Gadolinium-based contrast agent used in diagnostic MRIs in adults and children to highlight areas in the central nervous system that have disrupted blood-brain barriers (BBB) or abnormal vascularity. It also works to expose the presence of breast disease, and detect stroke and tumor perfusion, among others.
“In step with the trends in the MRI contrast agent market, we have decided to commercialize Gadobutrol, which falls into a low-risk category. We are preparing for exports to countries such as the U.S., Europe, and Japan,” the official said.
Enzychem noted that MRI contrast agents remain a necessary diagnostic component despite rising health concerns. Health regulators such as the U.S. Food and Drug Administration issued warning letters and prohibition of specific Gadolinium-based MRI contrast agents with high toxicity that caused human deaths.
Korea’s Ministry of Food and Drug Safety also issued a revision notice of the approval status of eight types of Gadolinium-based contrast agents on Tuesday, which included Bayer’s Gadolinium-based contrast agent “Gadavist” in both pre-filled syringe and vial form.
The health concerns were one crucial reason Enzychem decided to commercialize Gadobutrol despite its high cost. The official noted that it adhered to the category of “low-risk MRI contrast agents” and had little kidney toxicity.
The contract also signified Enzychem’s ability to win over a highly competitive market dominated by large pharmaceutical companies, with the official noting the successful commercialization of Enzychem’s generic product in a market dominated by companies such as Bayer Schering Pharma, Guerbet, and Bracco S.p.A.
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