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Mithra Submits Marketing Approval Application in Japan to Combat Dysmenorrhea

by Sinead Huang
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Mithra Pharmaceuticals, a Belgian biotech company dedicated to Women’s Health, announced a significant development in its partnership with Fuji Pharma Co., Ltd. on October 23 as they submitted a marketing approval application for ESTELLE® in Japan. This strategic move is part of a broader mission to address dysmenorrhea, a common women’s health issue.

Related article: FDA Approves Astellas’ Non-hormonal Menopause Treatment After Extended Review

Building on a Strong Partnership

In 2016, Fuji Pharma secured commercialization rights for both ESTELLE® and DONESTA® in Japan and the ASEAN region, a market that could potentially reach 330 million patients. ESTELLE® features Mithra’s core asset, Estetrol (E4), a unique native estrogen produced during pregnancy, known for its selective action on estrogen receptors, minimal impact on the liver, and the coagulation cascade. This distinct profile positions E4 as a potential game-changer in the women’s health landscape, offering multiple advantages to patients.

Fuji Pharma’s application submission triggers an important milestone as Mithra is set to receive a EUR 2.5 million payment. The collaboration between the two companies has already yielded significant results. Fuji Pharma began selling the product in Thailand under the name NEXTSTELLIS™ in April 2023. This successful partnership further strengthens Mithra’s global presence and underscores its dedication to revolutionizing women’s health.

Addressing Dysmenorrhea – A Crucial Women’s Health Issue

Dysmenorrhea, commonly referred to as menstrual cramps, affects millions of women, with symptoms ranging from lower abdominal pain, back pain, and nausea to irritability and depression. Mithra’s proactive move is in response to the growing demand for innovative solutions. The global dysmenorrhea market, valued at €257 million (approximately $271 million) in 2022, reflects the pressing need for effective treatments. As Mithra takes significant steps in Japan, its mission to redefine women’s health gains momentum.

In conclusion, Mithra’s partnership with Fuji Pharma and the submission of the ESTELLE® marketing approval application in Japan represents a pivotal moment in the company’s journey. Their commitment to addressing women’s health challenges, such as dysmenorrhea, is reinforced by their ongoing collaborations and innovative solutions, and it sets the stage for potential breakthroughs in women’s health worldwide.

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