Daewoong Pharmaceutical said it aimed to sell its flagship product Ursa, a hepatic protector, in the U.S. market.

In a preparatory move, the company is conducting a bioequivalence test on the drug’s ingredient ursodeoxycholic acid (UDCA) in Canada. A bioequivalence test on Ursa in the U.S. is reportedly in the finishing step.

Daewoong said it would request approval for Ursa in the U.S. in the first half of next year. The company hopes to obtain approval as early as in 2019.

If Daewoong’s plan goes as scheduled, the company will be launching another generic drug in the U.S., after Meropenem. If the company also launches Nabota, a botulinum toxin type A, which is currently under the U.S. regulator’s review, Daewoong will release three products in the U.S. alone.

Ursa’s entry into the U.S. is more than just boosting revenue by tapping a new market. Ursa posted 27.5 billion won ($25.3 million) local revenue in 2015, after 27.8 billion won in 2015, and 24.6 billion won in 2014, according to data from IMS Health.

In Korea, Ursa’s dosage is limited to 600 mg per day. However, in the U.S., prescriptions will be available up to 900-1,200 mg. In other words, Ursa can tap the world’s largest drug market where high-dose drugs can be prescribed.

Daewoong also hopes to build a plant in Korea to ship other products to the U.S. market. Once the bioequivalence test gets done next year, the company plans to request the U.S. FDA for an inspection of production facilities, along with approval for Ursa.

Daewoong is currently manufacturing Meropenem, the first Korean generic drug to obtain sales approval from the U.S. FDA in 2015, at a cGMP (Current Good Manufacturing Practices) factory under the partnership with a global company. The company’s another plant in Hyangnam, Gyeonggi Province, which manufactures Nabota, has been inspected by the U.S. FDA last month.

Although the company has not decided on the location of a plant related to sales in the U.S. market, some observers said it could be Osong, North Chungcheong Province, where Daewoong has a factory. If so, the company’s manufacturing facilities for Nabota and Ursa sales in the U.S. are likely to have positive effects on other drugs’ entry in the U.S. market.

“UDCA was the only drug among hepatic protectors to be recognized by the U.S. FDA for its efficacy in preventing gallstone, incurred by a sudden weight loss of obese patients,” a Daewoong official said. “We will do our best Ursa carve out a significant share of the U.S. market, too.”

sjh@docdocdoc.co.kr

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