mdc-TJK has the potential to be the first long-acting
injectable of olanzapine with a favorable safety profile
MedinCell’s partner, Teva Pharmaceuticals, highlighted
mdc-TJK as one of their three promising late-stage assets poised to
accelerate growth during their Investor Day on May 18, 2023
(replay and presentation available here)1
mdc-TJK is the second product developed by Teva based on
BEPO® (licensed under the name SteadyTeq™ to Teva), MedinCell’s
long-acting injectable technology, which has a proven safety
profile as established with UZEDY™ (FDA approved on April 28,
2023)
Regulatory News:
As announced on May 4, 2023, MedinCell’s (Paris:MEDCL) partner
Teva Pharmaceuticals communicated an original presentation
describing pharmacokinetic characteristics of an investigational
long-acting subcutaneous formulation of olanzapine (mdc-TJK) at the
2023 Schizophrenia Investigational Research Society (SIRS) on
Friday, May 12.
Data came from a 127-participant phase 1 clinical study
evaluating, among other things, the pharmacokinetics of single
ascending doses of mdc-TJK in healthy volunteers and single and
multiple once-monthly doses in patients with schizophrenia or
schizoaffective disorder.
mdc-TJK exhibited favorable characteristics of an
extended-release profile:
- Reaching clinically relevant therapeutic olanzapine plasma
concentrations (≥ 10 ng/mL) within a 1 to 2 day and maintaining
them during the 28-day dosing interval
- At steady-state conditions over a 28 dosing interval, the
systemic exposure of mdc-TJK at doses 318, 425 and 531 mg were
comparable to oral daily corresponding doses 10 mg, 15 mg, and 20
mg respectively
- No burst or uncontrolled rise in olanzapine plasma
concentrations following mdc-TJK subcutaneous administration was
observed
The results of this study supported dose selection of mdc-TJK in
the ongoing Phase 3.
The phase 3 study is designed to establish both efficacy and
safety, including to identify PDSS (post-injection
delirium/sedation syndrome) event occurrence. Both MedinCell and
Teva believe that BEPO® technology and subcutaneous administration
will allow olanzapine LAI to have a favorable safety profile.
Richard Malamut MD, CMO of MedinCell, comments: “We are hopeful
that the safety profile of mdc-TJK will be favorable compared to
other long-acting injections available for olanzapine. With the
long-acting product already available, patients have to be
monitored for 3 hours after injection because of risk of PDSS. An
improved long-acting injectable of olanzapine could answer a
significant unmet medical need.”
“We are very excited to see both UZEDY™ and mdc-TJK highlighted
as having the potential to drive long-term growth of Teva at their
recent investor day presentation.”, adds Christophe Douat, CEO of
MedinCell.
mdc-TJK is the second antipsychotic (following approval of
UZEDY™) based on MedinCell’s BEPO® technology. MedinCell is
eligible for development milestones, royalties on net sales, and
future commercial milestones.
1.https://ir.tevapharm.com/Events-and-Presentations/events-and-presentations/event-details/2023/Teva-Pharmaceutical-Industries-2023-Investor-Day--2023-QP7tTiob5U/default.aspx
UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals
About MedinCell
MedinCell is an innovative pharmaceutical company, from
development to market, with a portfolio of long-acting injectable
products in various therapeutic areas by combining its proprietary
BEPO® technology (licensed to Teva under the name SteadyTeq™) 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. MedinCell collaborates with tier
one pharmaceuticals companies and foundations to improve Global
Health through new therapeutic options. Based in Montpellier,
MedinCell currently employs more than 140 people representing over
25 different nationalities.
www.medincell.com
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MedinCell David Heuzé Head of Communications
david.heuze@medincell.com +33 (0)6 83 25 21 86
NewCap Alban Dufumier / 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
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