GNT Pharma announced on the 5th that it has signed a comprehensive cooperation agreement with Pfizer CentreOne, a subsidiary of Pfizer, to produce finished pharmaceuticals according to current Good Manufacturing Practice (cGMP) standards for advanced pharmaceuticals, aiming to enter overseas markets with its canine cognitive dysfunction syndrome treatment, Jedacure. Pfizer CentreOne is a contract development and manufacturing organization (CDMO) with production facilities in over 30 locations worldwide and is a subsidiary of the global big pharma Pfizer.
Currently, the active ingredient of Jedacure, 'crisdesalazine,' is contract manufactured (CMO) by GNT Pharma through Apelloa Pharmaceuticals of the Hengdihan Group in China. Based on the produced crisdesalazine, Pfizer CentreOne plans to provide contract manufacturing and quality control services for Jedacure that meet global veterinary pharmaceutical standards to enter markets such as the United States and Europe.
Jedacure is a treatment for canine cognitive dysfunction syndrome, which is similar to human Alzheimer's dementia. It was approved in February 2021 as the first synthetic new animal drug in Korea and is prescribed at over 1,800 animal hospitals through Yuhan Corporation. Since the full-scale prescription began, inquiries for purchase have been received from 21 countries including the United States, Japan, the United Kingdom, and Brazil.
Lee Jin-hwan, Head of Animal Health Business Division at GNT Pharma, said, “Currently, there is demand for Jedacure supply in Russia, Taiwan, and Southeast Asia,” adding, “Once production of Jedacure is completed at Pfizer CentreOne, we plan to expand sales regions to overseas markets such as the United States and Europe.”
According to the American Pet Products Association (APPA), out of approximately 89.7 million pet dogs in the United States in 2020, about 10 million are estimated to suffer from cognitive dysfunction syndrome. This estimate is based on the proportion of senior dogs (52%) and the incidence rate (21.4%). In Europe, it is estimated that about 8 million out of 72 million pet dogs suffer from the syndrome. GNT Pharma explained, “If Jedacure is sold in the U.S. market, applying the pet insurance subscription rate (4%), annual sales of approximately 57.4 billion KRW are expected. In Europe, due to a relatively higher pet insurance subscription rate, annual sales of about 114 billion KRW are anticipated.”
Gwak Byung-joo, CEO of GNT Pharma, stated, “The therapeutic effect of Jedacure, where senior dogs with cognitive dysfunction syndrome recover memory and regain the ability to perform daily activities after taking the drug, has been confirmed through clinical trials and post-marketing surveys,” adding, “Since its efficacy and safety have been sufficiently demonstrated in domestic animal hospitals, we will accelerate Jedacure’s overseas expansion for pets and pet families worldwide.”
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