STOCKHOLM, Sept. 16, 2021 /PRNewswire/ -- Calliditas
Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq
Stockholm: CALTX) (Nasdaq: CALT), a biopharma company focused on
identifying, developing and commercializing novel treatments in
orphan indications, today announced that the European Medicine
Agency's (EMA) Committee for Human Medicinal Products (CHMP)) has
decided to continue the assessment of the marketing authorization
application (MAA) for Nefecon under standard procedure assessment
timelines.
Calliditas was in April, 2021 granted an accelerated assessment
procedure on its MAA for Nefecon in IgA Nephropathy and submitted
the MAA in May of 2021. With the revised standard assessment
timeline Calliditas estimates a potential impact of 3 months on the
previously communicated timelines with an expected decision by EMA
in the first quarter, 2022.
"This is the first time that EMA is assessing an application for
conditional approval in IgA nephropathy and we acknowledge the need
for an in depth review under standard assessment timelines.
We look forward to engaging with the agency to achieve a potential
approval for this very deserving patient population as soon as
possible." said Renée Aguiar-Lucander, CEO at Calliditas.
If approved, Nefecon could be available to patients in
Europe in mid-2022 and would
become the first therapy specifically designed and approved for the
treatment of IgAN, and which has the potential to be disease
modifying.
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
E-mail: renee.lucander@calliditas.com
Marie Galay, Corporate
Communications and IR
Tel.: +44 7955 129 845, e-mail: marie.galay@calliditas.com
The information in the press release is inside information
that Calliditas is obliged to make public pursuant to the EU Market
Abuse Regulation. The information was submitted for publication,
through the agency of the contact persons above, on September 16, 2021 at 14:30 (CEST).
About Calliditas
Calliditas Therapeutics is a biopharma company based in
Stockholm, Sweden focused on
identifying, developing and commercializing novel treatments in
orphan indications, with an initial focus on renal and hepatic
diseases with significant unmet medical needs. Calliditas' lead
product candidate, Nefecon, is a proprietary, novel oral
formulation of budesonide, an established, highly potent local
immunosuppressant, for the treatment of adults with the autoimmune
renal disease primary IgA nephropathy (IgAN), for which there is a
high unmet medical need and there are no approved treatments.
Calliditas read out topline data from Part A of its global Phase 3
study in IgAN in November 2020 and,
if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning
to start clinical trials with NOX inhibitors in primary biliary
cholangitis and head and neck cancer. Calliditas is listed on
Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select
Market (ticker: CALT).
Forward-looking statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding Calliditas' strategy, business plans and focus. The words
"may," "will," "could," "would," "should," "expect," "plan,"
"anticipate," "intend," "believe," "estimate," "predict,"
"project," "potential," "continue," "target" and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, any related to Calliditas' business, operations, the
potential for and timing of EMA approval of its regulatory
marketing application for Nefecon, clinical trials, supply chain,
strategy, goals and anticipated timelines, competition from other
biopharmaceutical companies, and other risks identified in the
section entitled "Risk Factors" in Calliditas' reports filed with
the Securities and Exchange Commission. Calliditas cautions you not
to place undue reliance on any forward-looking statements, which
speak only as of the date they are made. Calliditas disclaims any
obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements. Any
forward-looking statements contained in this press release
represent Calliditas' views only as of the date hereof and should
not be relied upon as representing its views as of any subsequent
date.
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EMA timeline
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