Mithra CDMO signs up a second Estrogen drug in 20-year Fuji deal

By Dani Bancroft

- Last updated on GMT

Mithra CDMO signs up a second Estrogen drug  in 20-year Fuji deal
Mithra CDMO has entered a second agreement for Fuji Pharma to commercialise Donesta in Asia, another of Mithra’s estrogen-based hormone drugs.

The Belgian reproductive health biotech first entered the 20-year partnership with Fuji Pharma Co., Ltd. for the oral contraceptive pill Estelle back in August 2016.

Currently in Phase II trials, Donesta is a second Estetrol-based drug which Mithra Pharmaceuticals SA has developed, this time indicated for women in menopause.  

Both Estelle and Donesta contain the active pharmaceutical ingredient Estetrol​ (E4), a steroid hormone derivative of estrogen.

Fuji is looking to further expand Estetrol’s market use in women undergoing menopause in Japan, which the firm says is worth €42.6m ($44.8m).

The term sheet contracts Mithra’s independent CDMO business to supply Donesta to Fuji Pharma for the full 20-year term.

Tokyo-based Fuji’s commercialisation rights for Donesta will apply to Japan and countries belonging to the Association of Southeast Asian Nations (ASEAN), such as Thailand, Malaysia, Indonesia and the Philippines.

Jean-Manuel Fontaine, Head of External Affairs for Mithra, told us: “We want to be flexible for our clients and manufacture small and medium sized batches [of hormone therapy tablets].”

“So we may also be able to partner to cover the increased manufacturing needs for Donesta,”​ he added, saying this could be done in different markets through a another CDMO.

Mithra has also submitted two trial protocol changes for Donesta, with the Phase II results expected for Q1 2018.

Upscaling tabletting demand

Mithra CDMO’s GMP-certified facility in is currently undergoing Phase 2 of its unit construction, with completion of its hormonal tabletting arm of the site being projected for 2019.

On completion the Liège, Belgian-based facility will have the production capacity of up to 1.5 million hormone tablets a year. However, Fontaine told us Mithra CDMO will only meet a certain percentage of the worldwide sales.

“On the one hand we want to keep a tight and flexible capacity for polymeric forms – for example our IUDs, sterile injectable and other contraceptive devices,”​ Fontaine explained.

“We will also consider external partners to ramp up the manufacturing demand for our own products if needed.”

The site is also preparing for potential market approval of its intra-vaginal contraceptive​ Myring, which will be filed with regulatory authorities in H1. 

(Feature Image: iStock/Aj_Op)

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