Mochida and Duchesnay Partner to Bring First Pregnancy Nausea Treatment to Japan
Key Insights
Mochida Pharmaceutical (search) and Duchesnay Inc. have signed a licensing agreement to bring Bonjesta® to Japan, addressing nausea and vomiting of pregnancy (search) affecting over half of Japanese pregnant women.
The partnership responds to Japan's Ministry of Health call to address "drug loss," where treatments approved in the US and Europe remain unavailable in Japan.
Bonjesta®, containing doxylamine succinate and pyridoxine hydrochloride, is already approved in 43 countries worldwide with potential Japanese launch anticipated by 2030.
Mochida Pharmaceutical (search) Co., Ltd. and Duchesnay Inc. have entered into a licensing agreement to bring Bonjesta®, a treatment for nausea and vomiting of pregnancy (search) (NVP), to Japan for the first time. The partnership addresses a significant unmet medical need in a country where more than half of pregnant women experience this condition but have no approved treatment options available.
Addressing Japan's Drug Gap Challenge
The collaboration directly responds to recent calls from Japan's Ministry of Health, Labour and Welfare following a request from the Japan Society of Obstetrics and Gynecology (search) to tackle the issue of "drug loss." This phenomenon occurs when medications approved in Europe and the United States fail to reach the Japanese market, leaving patients without access to established treatments.
Under the licensing agreement, Mochida will conduct the necessary research activities required to obtain regulatory approval from the Pharmaceuticals and Medical Devices Agency (search) (PMDA), with both companies targeting a potential product launch by 2030.
Established Global Treatment Profile
Bonjesta® is an oral combination formulation containing doxylamine succinate and pyridoxine hydrochloride as active ingredients. The treatment has demonstrated its regulatory acceptance across international markets, securing approval in 43 countries and states worldwide. The medication received FDA approval in the United States in 2016, followed by European approval in 2023.
The drug was specifically developed by Duchesnay to manage nausea and vomiting of pregnancy (search), a common condition that significantly impacts quality of life for expectant mothers but has remained without approved therapeutic options in Japan.
Strategic Partnership for Women's Health
"We are very pleased to have concluded a license agreement with Duchesnay for Bonjesta®," said Junichi Sakaki, Ph.D., Representative Director, Senior Executive Managing Officer of Mochida. "By helping to reduce the burden of NVP symptoms for pregnant women and creating an environment in which women can work and live with less stress during their pregnancy, we aim to contribute to the realization of a society in which women enjoy better health and can actively participate."
Suzanne Paszkiewicz, Vice President, Global Partnerships & Business Development, Duchesnay Pharmaceutical Group, emphasized the partnership's significance for international expansion. "This agreement marks a significant milestone for Duchesnay, contributing to our continued international expansion," she stated. "True to our common mission to improve women's health at every stage of life, we are proud to partner with Mochida in anticipation of a possible product launch by 2030."
Company Expertise in Women's Health
Both companies bring substantial experience in women's health to the partnership. Mochida, established in 1913, focuses its pharmaceutical business on cardiovascular medicine, gastroenterology, obstetrics and gynecology, and psychiatry, while also providing medicines for intractable diseases and generics including biosimilars.
Duchesnay Inc., a member of Duchesnay Pharmaceutical Group, operates as a specialty pharmaceutical company with a long-standing commitment to women's health. The company has historically focused on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding, recently expanding its portfolio to address women's health needs across different life stages.