MedinCell Provides a Portfolio Update for J.P. Morgan Healthcare Conference 2020

MedinCell is attending the J.P. Morgan Healthcare Conference 2020 San Francisco, 13-16 Jan., 2020

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

MedinCell’s (Paris:MEDCL) portfolio of long-acting injectable products progresses well. All innovative products are based on its proprietary BEPO® technology combined with active ingredients already known and marketed.

MedinCell’s portfolio includes three products at clinical stage:

  • Interim analysis of the current phase 3 clinical trials of the lead asset (mdc-IRM, maintenance treatment of schizophrenia) is expected during the second half of 2020
  • The phase 2 clinical trials of a second asset (mdc-CWM, post-operative pain and inflammation management) are ongoing
  • The third asset (mdc-TJK, antipsychotic) is in phase 1

Several candidates for clinical development are at formulation or preclinical stage. In particular, results of the ongoing studies of four programs should make it possible to select their candidate formulations in 2020: mdc-GRT, organ transplant ; mdc-WWM, contraception ; mdc-NVA, pain ; mdc-KPT, pain / animal health.

PROGRAMS AT CLINICAL STAGE

Subcutaneous injection

 

mdc-IRM

Maintenance treatment of schizophrenia

Partner: Teva Pharmaceuticals

The phase 3 clinical trials are ongoing with an interim analysis in the second half of 2020 contingent upon the projected recruitment rate and patient relapse events.

(Press release of December 3, 2019)

mdc-TJK

Antipsychotic

Partner: Teva Pharmaceuticals

The first-in-human study for the investigational long-acting injectable antipsychotic mdc-TJK has started in Q4 2019. The results of this study, expected during 2021, will inform future development.

(Press release of December 3, 2019)

Intraarticular injection

 

mdc-CWM

post-operative pain and inflammation

Partnered program

The 20 participants have completed their 3-month follow-up visit last Summer. The analysis of the data is being completed by our partner and its subcontracted clinical research organization. 12-month trial completion is scheduled in March 2020. Our partner plans to meet with the FDA in the meantime to discuss the current findings and how to progress in the next trial moving forward.

(Press release of September 25, 2019)

NEXT POTENTIAL CANDIDATES FOR IND/IMPD

Subcutaneous injection

mdc-ANG

Antipsychotic

Partner: Teva Pharmaceuticals

Current status: Preclinical

Preclinical work continues to progress and will inform a decision on further development expected in the second half of 2020.

Press release of July 9, 2019

mdc-GRT

Organ transplant

MedinCell program

Current status: Formulation

Full results of ongoing studies should make it possible to select the candidate formulation in 2020.

mdc-WWM

Contraception

Partner: Bill & Melinda Gates Foundation

Current status: Formulation

Full results of ongoing studies should make it possible to select the candidate formulation in 2020.

mdc-STG

Indication: confidential

MedinCell program

Current status: Formulation

mdc-KPT (animal health)

Pain

Partner: Cornerstone Animal Health

Current status: Formulation

Full results of ongoing studies should make it possible to select the candidate formulation in 2020.

 

Perineural injection

The two products are the first in MedinCell’s portfolio with perineural administration

mdc-CMV

Pain

MedinCell program

Current status: Preclinical

The first preclinical studies are ongoing. The results of this study will inform future development and updated timelines. The clinical phase 1 may not start in Q2 2020.

mdc-NVA

Pain

MedinCell program

Current status: Formulation

Full results of ongoing studies should make it possible to select the candidate formulation in 2020.

MedinCell news on the last 12 months (press releases available on invest.medincell.com)

MedinCell receives $19 million grant from the Bill & Melinda Gates Foundation for mdc-WWM program - November 28, 2019

mdc-CWM progresses as planned - September 25, 2019

The General Meeting votes to include the “Raison d’être” of the Company in its articles of association- September 10, 2019

New grant from the Bill & Melinda Gates Foundation to develop a best-in-class long acting injectable product for HIV prevention (PrEP) - September 5, 2019

MedinCell partners to address the untapped financial potential in Animal Health - August 28, 2019

Long-acting injectable antipsychotic receives FDA IND clearance to initiate clinical activities - August 26, 2019

MedinCell receives 7,5 M€ from the European Investment Bank (EIB) - July 23, 2019

Third long-acting injectable antipsychotic using MedinCell’s technology enters preclinical development - July 9, 2019

MedinCell demonstrates in vivo the efficacy of the first injectable combining surgical anesthesia and 3 days opioid free postoperative pain management - March 11, 2019

MedinCell receives 2nd part of the grant from the Bill & Melinda Gates Foundation - January 24, 2019

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.

www.medincell.com

This press release may contain forward-looking statements, especially on the Company’s progress of its clinical trials. Although the Company believes that its expectations are based on reasonable assumptions, any statements other than statements of historical facts that may be contained in this press release relating to future events are subject to change without notice, factors beyond the Company's control and the Company's financial capabilities.

These statements may include, but are not limited to, any statement beginning with, followed by or including words or phrases such as "objective", "believe", "anticipate", "foresee", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", "should", "could" and other words and phrases of the same meaning or used in negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that may, if any, cause actual results, performance or achievements to differ materially from those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including the Company's registration document, registered with the AMF on September 4, 2018 under number I. 18-062, as well as in the documents and reports to be published subsequently by the Company. In addition, these forward-looking statements speak only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company does not undertake any obligation to publicly update these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated by the forward-looking statements, including in the event that new information becomes available. The Company's update of one or more forward-looking statements does not imply that the Company will make any further updates to such forward-looking statements or other forward-looking statements.

This press release is for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for the Company's shares in any jurisdiction, in particular in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not related to the investment objectives, financial situation or specific needs of any recipient. It should not deprive the recipients of the opportunity to exercise their own judgment. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be subject to legal restrictions in certain jurisdictions. Persons who come to know about this press release are required to inquire about and comply with these restrictions.

Contacts

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

NewCap
Louis-Victor Delouvrier / Alexia Faure
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
Communication leader
david.heuze@medincell.com
+33 (0)6 83 25 21 86

NewCap
Louis-Victor Delouvrier / Alexia Faure
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