STOCKHOLM, May 18, 2021 /PRNewswire/ -- Filing of New
Drug Application submission to the FDA
"Following the positive top line readout of our pivotal Phase 3
trial NefIgArd, which met both the primary and key secondary
endpoints with results being statistically significant and
clinically relevant we commenced the regulatory filing process
which ultimately resulted in the timely filing of the submission to
the FDA in Q1 as planned. In April, we received the response from
the Food and Drug Administration (FDA) who accepted the submission
and granted Priority Review for the New Drug Application (NDA) for
Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA)
goal date of September 15, 2021.
During Q1, we also submitted a request for accelerated assessment
to the EMA, which was granted on April
23rd. These grants reflect the perceived unmet medical need
in IgAN by regulators and, in my view, also the strength and
overall quality of our dossier.
In Q1, we also reported positive data from the Phase 1 study of
setanaxib, our lead compound in our NOX inhibition pipeline, paving
the way for the use of higher dosing in the pivotal Phase 2/3 study
in PBC. We also hosted an R&D day in January where we laid out
the clinical development strategy for the year, presenting the
plans for our PBC study as well as the Phase 2b proof of concept study in head and neck
cancer, both slated to start in the second half of 2021. The
substantial preclinical work that has been generated shows
compelling data regarding setanaxib's impact on CAF (cancer
associated fibroblasts), paving the way for a significantly
improved reach of checkpoint inhibitors.
We also significantly built our US team during the quarter,
adding a Head of Marketing, VP Medical Affairs and Head of Sales.
We will continue to build our team in order to be ready to
commercialize in Q4, if approved."
Renée Aguiar-Lucander, CEO
Summary of Q1 2021
January 1 – March 31, 2021
No net sales for the three months ended March 31, 2021 were recognized. For the three
months ended March 31, 2020 net sales
amounted to SEK 0.5 million.
Operating loss amounted to SEK 150.8
million and SEK 72.3 million
for the three months ended March 31,
2021 and 2020, respectively.
Loss before income tax amounted to SEK
136.2 million and SEK 63.7
million for the three months ended March 31, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to
SEK 2.51 and SEK 1.65, for the three months ended March 31, 2021 and 2020, respectively.
Cash amounted to SEK 867.3 million
and SEK 728.6 million as of
March 31, 2021 and 2020,
respectively.
Significant events during Q1 2021, in summary
In January 2021, Calliditas
announced a positive readout of the Phase 1 study with setanaxib,
which enables clinical trials with higher dosing levels.
In January 2021, Calliditas shared
the clinical development plan for setanaxib, including planned
trials in Primary biliary cholangitis (PBC) and head and neck
cancer, and additional data from Part A of NeflgArd study at its
R&D Day.
In March 2021, Calliditas
announced the submission of a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for Nefecon in patients
with primary IgA Nephropathy (IgAN).
Significant events after the end of reporting period, in
summary
In April 2021, Calliditas was
granted accelerated assessment procedure by the European Medicine
Agency's (EMA) Committee for Human Medicinal Products (CHMP)
reducing the maximum timeframe for review of the application for
marketing authorization. If approved, Nefecon could be available to
patients in Europe in first half
of 2022.
In April 2021, Calliditas
announced that the FDA accepted the submission and granted Priority
Review for the NDA for Nefecon. The FDA have set a Prescription
Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this
would enable commercialization of Nefecon in the US in Q4,
2021.
Investor presentation May 18,
14:30 CET
Audio cast with teleconference, Q1 2021, May 18, 2021, 14:30 (Europe/Stockholm)
Webcast:
https://tv.streamfabriken.com/calliditas-therapeutics-q1-2021
Teleconference: SE: +46850558366 UK: + 443333009271 US:
18335268381
Financial calendar
Interim Report for the period January
1 – June 30,
2021
August 19, 2021
Interim Report for the period January
1 – September 30, 2021
November 18, 2021
Year-end Report for the period January
1 – December 31, 2021
February 24, 2022
For further information, please contact:
Renée Aguiar-Lucander
CEO at Calliditas
Email: renee.lucander@calliditas.com
Mikael Widell
Investor Relations
Email: mikael.widell@calliditas.com
Telephone: +46 703 11 99 60
The information was submitted for publication, through the
agency of the contact persons set out above, at 07:00 CET on May 18,
2021.
About Calliditas Therapeutics
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 has recently read out topline data from Part A of its
global Phase 3 study in IgAN 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). Visit
www.calliditas.com for further information.
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,
clinical trials, supply chain, strategy, goals and anticipated
timelines, competition from other biopharmaceutical companies, and
other risks identified in the section entitled "Risk Factors"
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.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/calliditas-therapeutics/r/interim-report-q1--2021,c3348312
The following files are available for download:
https://mb.cision.com/Main/16574/3348312/1418439.pdf
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Interim report
January - March 2021
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https://mb.cision.com/Public/16574/3348312/b9c92514ca64f1c8.pdf
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Press release Q1 2021
ENG
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SOURCE Calliditas Therapeutics