Mithra Submits Marketing Approval Application in Japan to Combat Dysmenorrhea

by Sinead Huang
Share To

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.

© All rights reserved. Collaborate with us:
Related Post
Advancing the Frontiers of Cell and Gene Therapy – An Interview with Dr. Shin Kawamata
Ajinomoto to Acquire Forge Biologics for $620 Million to Boost Gene Therapy Capabilities
Japan’s Red Biotechnology and International Business Partnering Take Spotlight on BioJapan 2023
Breakthrough Stem Cell Treatment Shows Promise in Reversing Liver Disease
2023 Taiwan Healthcare Expo: Showcasing Innovative Advances in Biomedical Technology
Absci Accelerates Breakthroughs in AI-Designed Drugs with AstraZeneca and Almirall Collaborations
Saving Lives Through Communication, Heroic Faith Medical Science Showcasing Novel AI Auscultation Tool for Procedural Sedation Patients in PGA 77
AbbVie Invests $10.1 Billion in ImmunoGen, Targeting the Ovarian Cancer Landscape
PRISM BioLab and Eli Lilly Join Forces in Revolutionary Drug Discovery Collaboration
Novel Hydrogel Delivery System Could Reduce Daily Diabetes Injections to Three Times a Year
Scroll to Top