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     276  0 Kommentare MedinCell Receives Funding for the Second Formulation Phase of Its 6-Month Injectable Contraceptive

    Regulatory News:

    MedinCell (Paris: MEDCL)

    The Bill & Melinda Gates Foundation has made the payment of the second tranche of a grant to fund the second formulation research phase of a best-in-class long acting contraceptive.

    This payment is based on promising in vivo results that have been obtained during the first 12 months of the project and substantiates the feasibility potential.

    The Gates Foundation is supporting MedinCell to develop a product for women most in need in emerging countries.

    MedinCell is evaluating ways to extract the product’s potential in developed countries, especially in the US where the contraceptive market is worth €4.7bn.

    Project highlights

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    Following positive results of in vivo studies, the Bill & Melinda Gates Foundation has confirmed its support to pursue the formulation research of a 6-month active contraceptive. The objective is to enter non-clinical development in 2020 and then clinical development.

    MedinCell has been awarded a $3.5m grant by the Bill & Melinda Gates Foundation to fund the formulation research phase of this program. A first tranche of $2m was received at the start of the program in November 2017, and the second of $1.5m has just been received following promising first in vivo results.

    The product should be the first contraceptive to combine the following essential features that would make it a best-in-class product both in developing and developed countries.

    • Progestin molecule (non-MPA)
    • 6-month duration
    • Subcutaneous injection
    • Full bio-resorption
    • Affordability

    The Foundation aims at making the product available to most in need women in emerging countries.

    The product could indeed address major challenges such as low affordability, weak distribution systems or cultural barriers. Unlike most other Long-Acting Reversible Contraceptives (LARC) such as contraceptive implants, no surgical or specialist intervention will be necessary with the product of MedinCell. After a simple subcutaneous injection, a depot is formed that acts as a virtual-pump up for 6 months and then disappears completely.

    Studies have shown that the risk of contraceptive failure for women using oral contraceptive pills or other methods is 17 to 20 times higher than the risk for those using LARCs mostly due to the lack of patient adherence to contraceptive treatments1.

    MedinCell is evaluating ways to leverage the product’s potential in developed countries, especially in the US where contraceptive market worth €4.7bn.

    In 2017, LARCs represented 30% of the €4.7bn US contraceptive market with 10% 5 years-CAGR (mainly composed of solid implants and intrauterine devices)2.

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    MedinCell Receives Funding for the Second Formulation Phase of Its 6-Month Injectable Contraceptive Regulatory News: MedinCell (Paris: MEDCL) The Bill & Melinda Gates Foundation has made the payment of the second tranche of a grant to fund the second formulation research phase of a best-in-class long …

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