MedinCell Launches Regulatory Development of mdc-WWM Program

MedinCell has designed, tested and selected with the support of the Bill & Melinda Gates Foundation the candidate formulation which can now enter preclinical development

MONTPELLIER, France--()--Regulatory News:

MedinCell (Paris:MEDCL):

  • MedinCell has demonstrated in vivo the feasibility of a contraceptive based on its BEPO® technology, administered by subcutaneous injection, fully bioresorbable and active for six months (mdc-WWM program)
  • The Bill & Melinda Gates Foundation grant of $19 million over four years will fund preclinical activities and an initial clinical study (cf. press release of November 28, 2019)
  • MedinCell owns all commercial rights worldwide, including in the United States, where contraception is a $ 5 billion market
  • It is the sixth product based on MedinCell's BEPO® technology to enter regulatory development

mdc-WWM could be the first contraceptive to combine the following essential features to make it a best-in-class product worldwide: progestin molecule (non-MPA), 6-month duration, subcutaneous injection, full bio-resorption, affordability.

Preclinical activities and phase 1 clinical studies will be fully funded by a up to $19 million over four years grant from the Bill & Melinda Gates Foundation. The grant is structured in advanced installments to cover the costs that will be incurred by the project.

MedinCell owns all marketing rights of the product worldwide, including the United States where the contraceptive market totaled more than $5 billion in 2018. Long-acting reversible contraceptives (LARC) alone (primarily solid implants and intrauterine devices) represented 28% of this market - more than $1.4 billion – with a 5-year CAGR at 7.8%. The mdc-WWM product could capture a significant share of this LARC market and even expand it easing the adoption of this type of contraception1.

In accordance with the Global Access strategy of both partners and to ensure a significant impact on women’s lives, the objective is to make the product widely available. Affordable pricing in emerging economies will help eliminate cost as a barrier to increased availability and voluntary access to the product. High demand among women and girls for long-acting contraceptive options illustrate the potential for market growth and measurably improving maternal, newborn and child health. The Gates Foundation also has a non-exclusive license for non-commercial market in low- and middle-income countries.

Company portfolio – Products based on BEPO® technology - March 2020

About MedinCell

MedinCell is a clinical stage pharmaceutical company that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 130 people representing over 25 different nationalities.

1 Source: IQVIA 2018

Contacts

MedinCell
David Heuzé
Head of Communication
david.heuze@medincell.com
+33 (0)6 83 25 21 86

NewCap
Louis-Victor Delouvrier
Investor relations
medincell@newcap.eu
+33 (0)1 44 71 94 94

NewCap
Nicolas Merigeau
Media relations
medincell@newcap.eu
+33 (0)1 44 71 94 94

Contacts

MedinCell
David Heuzé
Head of Communication
david.heuze@medincell.com
+33 (0)6 83 25 21 86

NewCap
Louis-Victor Delouvrier
Investor relations
medincell@newcap.eu
+33 (0)1 44 71 94 94

NewCap
Nicolas Merigeau
Media relations
medincell@newcap.eu
+33 (0)1 44 71 94 94