Mithra Pharmaceuticals SA: CDMO announces a collaboration with MedinCell for the development of injectable products against malaria and transplant rejection

Mithra CDMO announces collaboration with MedinCell for the development of injectable products against malaria and transplant rejection

  • Collaboration for the development of innovative long-acting injectable products to meet major global health challenges

  • Jo MedinCell product candidates within the framework of the collaboration:

    • oh A 3-month long-acting injectable designed as an additional tool to fight malaria, one of the world’s biggest health threats with more than 200 million people infected each year

    • oh A long-acting injectable of tacrolimus for transplant patients aimed at improving efficacy, tolerability and patient compliance

  • Projects that perfectly combine Mithra CDMOit is core business: extensive experience in complex therapeutic polymeric forms and specific know-how in flexible complex liquid injectables

Liège, Belgium, April 26, 2022 7:30 a.m. CEST Mithra (Euronext Brussels: MITRA) today announced a collaboration with MedinCell for the development of two long-acting injectable products at its Liège-based CDMO.

Mithra CDMO offers a full range of solutions from early drug development, clinical batches and commercial manufacturing of complex polymer products (vaginal ring, implants) and complex liquid injectables and biologics in vials, pre-filled syringes or cartridges.

Based in Montpellier (France), MedinCell is developing a portfolio of long-acting injectable products in various therapeutic areas by combining its BEPO® technology with active ingredients already on the market. This technology makes it possible to control the regular delivery of a drug at the optimal therapeutic dose over a period of days, weeks or months, by means of a simple delayed injection. The deposit is completely bioabsorbable and forms immediately after subcutaneous or localized injection. A real alternative to conventional methods of taking medication, MedinCell’s The technology offers a number of benefits to address major global health challenges, potentially improving efficacy, tolerability and patient compliance, as well as rapid development.

1. Malaria treatment supported by global health agency Unitaid

MedinCell’s product candidate “mdcSTM” is a Formulation of ivermectin 3 months aimed at reducing the transmission of the parasite responsible for Malaria, thanks to a killing effect on vector mosquitoes when they bite treated people. Administered at the start of the transmission season, this long-acting injectable product could have a significant epidemiological impact. Malaria remains pandemic in 91 countries representing 50% of the world’s population. According to WHO estimates, 228 million people were infected worldwide in 2018, 93% of them in Africa, resulting in 405,000 deaths. Children under 5 are the most vulnerable, accounting for 67% of malaria deaths.

This R&D program is financially supported by the global health agency Unitaid1. Regulatory preclinical activities started in 2020 with the objective of a first clinical trial in 2023 supported by Mithra CDMO.

2. Treatment to prevent transplant rejection

MedinCell’s product candidate “mdcGRT” is a subcutaneous treatment based on immunosuppressive tacrolimus to prevent transplant rejection in transplant patients. In addition to improving compliance, a major issue in patients who have received a transplant associated with lifelong treatment, this product could reduce the risk of adverse effects. Mithra CDMO will support the development of this product for preclinical and clinical trials in 2023.

Renaat Baes, CDMO Site Manager, Mithra CDMO, commented: We are very pleased to collaborate with MedinCell on complex technology products that perfectly match our combined expertise in polymers and injectables. These technologies based on a sustained and controlled release of the drug offer numerous advantages to patients and offer both effective and affordable alternatives to treat chronic or pandemic diseases, such as malaria. Our Mithra CDMO provides quite specific know-how covering a full range of services in the development and production of these high value-added products and intends to further strengthen its activities in these growing markets.”

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For more information please contact:

Mithra CDMO

Benoît Mathieu (IRO) : +32 473 35 80 18- [email protected] Maud Vanderthommen (Press): +32 473 58 61 04 [email protected]

About Mithras

Mithra (Euronext: MITRA) is a Belgian biotechnology company dedicated to transforming women’s health by offering new choices through innovation, with particular emphasisus about contraception and menopause. Mithra’s goal is to develop products with better efficacy, safety and convenience, meeting the needs of women throughout their lives. scope. Mithra explores the potential of the unique native estrogen, estetrol, in a wide range of applications in women’s health and beyond. After successfully launching the first estetrol product in 2021, the birth control pill Estelle®Mithra is now focusing on its second product Donesta®, the next generation hormone therapy. Mithra also develops and manufactures complex therapies in the fields of contraception, menopause and hormone-dependent cancers. It offers its partners a full spectrum of research, development and specialized manufacturing on its Mithra CDMO technology platform. Active in more than 100 countries around the world, Mithra employs approximately 300 people and is headquartered in Liège, Belgium. www.mithra.com

Important Information

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology,

1 MedinCell press release, 06/14/2021

including the words “believes”, “estimates”, “anticipates”, “expects”, “intends”, “may”, “will”, “plans”, “continues”, “ongoing “, “potential”, “predicted”, “project”, “target”, “research” or “should” and include statements made by the Company regarding the expected results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that these forward-looking statements are not guarantees of future performance. The Company’s actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.

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