- Guidance for 2024 UZEDY Teva’s revenue: ~ $80
million
- Olanzapine LAI ongoing Phase 3: 675 patients (recruitment
completed), 62% of the targeted 3,600 injections performed, no PDSS
(Post injection Delirium/Sedation Syndrome) observed
Regulatory News:
MedinCell (Paris:MEDCL):
About UZEDY
During the Q4 2023 earnings call held today by Teva
Pharmaceutical Industries Ltd., President and CEO Richard Francis
stated that he expects a strong uptake and significant growth for
UZEDY in 2024. He notably provided the annual revenue guidance for
UZEDY, projecting approximately $80 million for 2024.
This revenue projection is aligned with MedinCell's forecasted
earnings from UZEDY, as the company receives royalties on sales and
may earn up to $105 million in commercial milestones.
UZEDY is the first product based on MedinCell's long-acting
injection technology, BEPO, to reach commercial stage
- US marketing authorization obtained from the U.S. FDA on April
28, 2023
- Commercial launch by Teva in May 2023
- MedinCell has already received first royalties of €0.6 million,
calculated on Teva's net sales from mid-May to end of September
2023
About Olanzapine LAI (mdc-TJK)
Eric Hughes, Executive Vice President, Global R&D &
Chief Medical Officer, announced during the call that 62% of the
targeted 3,600 injections have already been performed as part of
the ongoing Phase 3 clinical trial and that no PDSS has been
observed. Full clinical package on efficiency and safety is
expected in the second half of 2024.
mdc-TJK is an investigational once-monthly subcutaneous
long-acting injection of the atypical antipsychotic olanzapine for
the treatment of schizophrenia. It has the potential to be the
first long-acting Olanzapine with a favorable safety profile as
other LAIs of Olanzapine have a FDA black box warning for PDSS that
limits their use.
Teva is fully responsible to lead the development and
commercialization of olanzapine LAI globally.
MedinCell may receive up to $117 million in development and
commercial milestones over the coming years for mdc-TJK, and is
eligible for royalties on all net sales.
Christophe Douat, CEO of MedinCell, says: “The guidance
on UZEDY is very positive. Teva’s ambition reaffirms its confidence
in its potential. Olanzapine LAI Phase 3, potential First-in-Class
product, is progressing impressively and is ahead of schedule with
a major milestone this year. Both illustrate the ability of
MedinCell technology to do breakthrough products. Based on these
news, we confirm our objective to achieve operational profitability
as soon as possible and to generate additional revenue with new
partnerships to extend our cash visibility until this horizon.”
About MedinCell
MedinCell is a clinical- and commercial-stage biopharmaceutical
company developing long-acting injectable drugs in many therapeutic
areas. Our innovative treatments aim to guarantee compliance with
medical prescriptions, to improve the effectiveness and
accessibility of medicines, and to reduce their environmental
footprint. They combine active pharmaceutical ingredients with our
proprietary BEPO® technology which controls the delivery of a drug
at a therapeutic level for several days, weeks or months from the
subcutaneous or local injection of a simple deposit of a few
millimeters, entirely bioresorbable. The first treatment based on
BEPO technology, intended for the treatment of schizophrenia, was
approved by the FDA in April 2023, and is now distributed in the
United States by Teva under the name UZEDY™ (BEPO technology is
licensed to Teva under the name SteadyTeq™).
We collaborate with leading pharmaceutical companies and
foundations to improve global health through new treatment options.
Based in Montpellier, MedinCell currently employs more than 140
people representing more than 25 different nationalities.
UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals
www.medincell.com
This press release contains forward-looking statements,
including statements regarding Company’s expectations for (i) the
timing, progress and outcome of its clinical trials; (ii) the
clinical benefits and competitive positioning of its product
candidates; (iii) its ability to obtain regulatory approvals,
commence commercial production and achieve market penetration and
sales; (iv) its future product portfolio; (v) its future partnering
arrangements; (vi) its future capital needs, capital expenditure
plans and ability to obtain funding; and (vii) prospective
financial matters regarding our business. 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
forward-looking statements and subject to change without notice,
factors beyond the Company's control and the Company's financial
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statement beginning with, followed by or including words or phrases
such as "objective", "believe", "anticipate", “expect”, "foresee",
"aim", "intend", "may", "anticipate", "estimate", "plan",
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"could" and other words and phrases of the same meaning or used in
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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 (the "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 (the "Registration Document"), as well as in the documents
and reports to be published subsequently by the Company. In
particular, readers' attention is drawn to the section entitled
"Facteurs de Risques" on page 26 of the Registration Document.
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Company speak only as of the date they are made. 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
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or a solicitation of an offer to buy or subscribe for the Company's
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this press release does not constitute investment advice and should
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version on businesswire.com: https://www.businesswire.com/news/home/20240131631721/en/
David Heuzé - Head of Communications
david.heuze@medincell.com / +33 (0)6 83 25 21 86
Media Relations Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94
Investor Relations France Louis-Victor
Delouvrier/Alban Dufumier medincell@newcap.eu / +33 (0)1 44 71
94 94
Head of US Financial Strategy & IR Grace Kim
grace.kim@medincell.com / +1 (646) 991-4023
Medincell (EU:MEDCL)
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