MedinCell Receives Funding for the Second Formulation Phase of Its 6-Month Injectable Contraceptive - Seite 2

1. Winner, B; Peipert, JF; Zhao, Q; Buckel, C; Madden, T; Allsworth, JE; Secura, GM. (2012), “Effectiveness of Long-Acting Reversible Contraception”, New England Journal of Medicine, 366 (21): 1998–2007, doi:10.1056/NEJMoa1110855, PMID 22621627

2. Source: IQVIA data in € at constant exchange rates in ex-manufacturer prices

About MedinCell

MedinCell is a 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.

Glossary

Formulation research

Formulation research is the first stage for all programs. It enables a prototype of the product to be obtained that complies with the targeted specifications, notably the duration of action and the dose of active ingredient to be regularly released. For each product, a new combination of polymers is created, thus making each formulation unique and exclusive.

Non-clinical development

Launched after the development of the prototype, non-clinical development includes a series of studies and operations aimed at confirming the product's viability, testing its safety and establishing the scientific bases and regulatory strategy necessary for all applications for clinical trial approval.

Clinical development

Clinical development includes three major trial phases undertaken on human cohorts:

• Phase I includes healthy volunteers to assess their tolerance to the treatment.
• Phase II is carried with a limited group of sick patients to assess the treatment's efficacy, the drug's optimal dose and any side effects.
• Phase III is undertaken with a large number of sick patients to compare the treatment's efficacy to that of a placebo or standard of care. If successful, this is the final step before the marketing of the product.

NB: as the products developed by MedinCell use active ingredients that are already widely known and marketed, they can be exempt from certain clinical studies.