STOCKHOLM, April 23, 2021 /PRNewswire/ -- Calliditas
Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX)
("Calliditas") today announced that its lead product candidate
Nefecon, a novel oral formulation targeting down regulation of IgA1
for the treatment of primary IgA Nephropathy (IgAN), has been
granted accelerated assessment procedure by the European Medicine
Agency's (EMA) Committee for Human Medicinal Products
(CHMP).
Accelerated assessment, which may be granted when the CHMP
concludes that the product is of major public health interest and
major therapeutic innovation pursuant to Article 14 (9) of
Regulation (EC) No 726/2004, reduces the timeframe for the EMA to
review a marketing authorization application (MAA.) Typically,
evaluating an MAA can take up to 210 procedure days, but
accelerated assessment reduces the maximum timeframe for review of
the application for marketing authorization to 150 days (excluding
clock-stops). Calliditas expects to submit an MAA to the EMA in Q2
2021.
"We are very excited that CHMP has decided to grant us
accelerated assessment, which supports the significant unmet
medical need in IgAN. We look forward to engaging with EMA
over the coming months with the goal to be able to bring the first
approved product to patients with IgAN as soon as possible," said
CEO Renée Aguiar-Lucander.
If approved, Nefecon could be available to patients in
Europe in H1 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:
Marie Galay
IR Manager
Calliditas
Tel.: +44 79 55 12 98 45
email: marie.galay@calliditas.com
The information in the press release is information that
Calliditas is obliged to make public pursuant to the EU Market
Abuse Regulation. The information was sent for publication, through
the agency of the contact persons set out above, on April 23, 2021 at 8:30
a.m. CET.
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 the autoimmune renal
disease IgA nephropathy, or IgAN, for which there is a high unmet
medical need and there are no approved treatments. Calliditas is
running a global Phase 3 study within IgAN and, if approved, aims
to commercialize Nefecon in the United
States. Calliditas is listed on Nasdaq Stockholm (ticker:
CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit
www.calliditas.com for further information.
About Nefecon
Nefecon is a patented oral formulation of a potent and
well-known active substance – budesonide – for targeted release.
The formulation is designed to deliver the drug to the Peyer's
patch region of the lower small intestine, where the disease
originates, as per the predominant pathogenesis models. Nefecon is
derived from the TARGIT technology, which allows for the substance
to pass through the stomach and intestine without being absorbed,
and to be released in a pulse like fashion only when it reaches the
lower small intestine.
The combination of dose and optimized release profile is
required to be effective in patients with IgAN, as shown in a large
Phase 2b trial, completed by
Calliditas. In addition to its potent local effect, another
advantage of using this active substance is that it has very low
bioavailability, i.e. around 90% of it is inactivated in the liver
before it reaches the systemic circulation. This means that a high
concentration can be applied locally where needed but with only
very limited systemic exposure and side effects.
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, including
the therapeutic potential of Nefecon, our plans for regulatory
submissions in Europe, the
intended benefits of the EMA's accelerated assessment procedure and
the availability of Nefecon to patients in Europe, if approved. 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, our planned applications to seek
marketing approvals from regulatory agencies in the U.S. and
Europe, acceptance by regulatory
agencies with respect to the filing and approval of our regulatory
marketing applications for Nefecon, our additional planned studies
of Nefecon due to our intended use of the accelerated approval
pathway with the FDA and the conditional approval pathway with the
EMA, the potential launch and commercialization of Nefecon, if
approved, 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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SOURCE Calliditas Therapeutics