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"Japan is the second largest pharmaceutical market in the world. By gaining commercial rights in Asia, and global rights to all indications, we believe we have created significant new opportunities for ranolazine," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. "We also plan to utilize the data we have developed to secure approval in the U.S. to support our potential commercialization efforts around the world."
Under the terms of the amendment, CV Therapeutics will pay an upfront fee and will make royalty payments associated with product sales in the added Asian markets. Milestone payments would be due to Roche upon approval in Japan and approval of the first additional non-cardiovascular indication.