MedinCell’s partner Teva provides additional information regarding the New Drug Application for mdc-IRM
03 Maio 2022 - 4:20PM
Business Wire
> Teva expects a refiling within up to six months followed
by probably a six-month review period
Regulatory News:
MedinCell (Paris:MEDCL):
Kåre Schultz, CEO of Teva, spoke today at the Q1 earnings call
of Teva. He gave information following the Complete Respond Letter
recently issued by the U.S. FDA about the New Drug Application
(NDA) for mdc-IRM.
He first said (extract from the earnings call):
“We communicated some weeks ago that we received a CRL on
risperidone LAI. So, we will be answering the questions that we got
from FDA. We expect that this could cause a delay of a refiling
with some up to six months and then probably a six-month review
period. We still have strong belief in the concept and in the
efficacy. So, we still believe to get this product approved, but
there will likely be a delay of up to 12 months on it”
And he added during the Q&A session:
“[about] the CRL, I can't tell you all the details, but I can
tell that it has nothing to do with the, you could say efficacy and
safety. We have very, very good efficacy data, very good safety
data. We are very confident that the principle works very, very
well.”
“But it's to do with some details around how you could see the
whole execution of the clinical trials have been done and some
details there which we are confident that we can address and
correct and communicate back to FDA within a maximum six months.
And then we expect the review time of six months. So, we still have
high trust in the fact that we can get the product approved at the
end of the day.”
About MedinCell
MedinCell is a pharmaceutical company at premarketing stage 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. MedinCell collaborate 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
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
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", “expect”, "foresee",
"aim", "intend", "may", "anticipate", "estimate", "plan",
"project", "will", "may", "probably", “potential”, "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 (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.
Any forward-looking statements made by or on behalf of the
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
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. Readers are cautioned not to
place undue reliance on these 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 encouraged to inquire about, and required to comply with, these
restrictions.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220503006270/en/
MedinCell David Heuzé Head of communication
david.heuze@medincell.com +33 (0)6 83 25 21 86
NewCap Louis-Victor Delouvrier / Olivier Bricaud 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
Medincell (EU:MEDCL)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Medincell (EU:MEDCL)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024