Two Japanese drugmakers eye U.S. market

Japan's Toyama City-based Nichi-Iko Pharmaceutical and Osaka-based Sawai Pharmaceutical plan to expand their products to the U.S. market. Nichi-Iko is looking to sell new drugs there and not the generics it has relied on, while Sawai will release generics in the American market. Nichi-Iko, Japan's largest generics maker, said it plans to apply to the U.S. Food and Drug Administration next year for approval to manufacture one new drug. It anticipates approval being given in 2018 and generating sales of ¥3 billion ($25.2 million). The company did not disclose what type of drug it hoped to have approved in the U.S. but is said to be preparing U.S. sales of biosimilars. Sawai, the second-largest generics maker in Japan, has already applied for approval for its generic version of lipid-lowering Livalo and expects to start sales in March 2018, according to a report by Nikkei news. Report


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.