Daewoong Pharmaceutical will export its new drug "Fexuprazan" to the U.S. for gastroesophageal reflux disease.
Daewoong Pharmaceutical announced on June 8 that it has signed a license-out contract with the U.S. company "Neurogastrx". Under the contract, "Neurogastrx" will be in charge of clinical, development and licensing of "Fexuprazan" in the U.S. and Canada, while Daewoong Pharmaceutical will receive a 13.5% stake in "Neurogastrx".
In addition, Daewoong Pharmaceutical receives a total of $430 million in technical fees and up to double-digit running royalties depending on U.S. sales of "Fexuprazan". It will also make profits through exports of finished products manufactured in Korea.
"Neurogastrx" is a company specializing in digestion invested by global healthcare venture capital group "OrbiMed" and "5AM Ventures".
"Fexuprazan" is a new drug for gastroesophageal reflux disease developed by Daewoong Pharmaceutical and is a P-CAB (Potasium-Competitive Acid Blocker) drug that blocks proton pumps that secrete stomach acid from the stomach wall.
In clinical trials, "Fexuprazan" showed immediate heartburn improvement from the beginning of administration and cough, one of the atypical symptoms of gastroesophageal reflux disease.
The two companies will begin phase 3 clinical trials next year and quickly push for approval of items to the FDA.
Through this contract, "Fexuprazan" has achieved a total of more than KRW 1 trillion won ($900 million) in export technology transfer contracts as a single item to China, Latin America and the United States.
The global anti- ulcer drug market is formed with about KRW 20 trillion won ($18 billion), of which the North American market ranks first with about KRW 4.2 trillion won ($3.8 billion), followed by the Chinese market.
Daewoong Pharmaceutical has signed technology export contracts in the U.S., China, Brazil, and Mexico with "Fexuprazan" to establish a base for entering 40% of the world's markets.
"Fexuprazan has succeeded in exporting technologies from China and Latin America and is now in the process of entering the U.S.," said Jeon Seung-ho, CEO of Daewoong Pharmaceutical. "We will develop Pexuprazan as the world's top gastric acid secretion inhibitor in the future."
