STOCKHOLM, Feb. 2, 2023
/PRNewswire/ -- Calliditas Therapeutics
AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX)
("Calliditas") today announced that the Medicines and Healthcare
products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional
Marketing Authorization (CMA) for Kinpeygo® for the
treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in
adults at risk of rapid disease progression with a urine
protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
Kinpeygo is the first and only approved treatment for IgAN, a
rare, progressive autoimmune disease of the kidney with a high
unmet need, with more than 50% of patients potentially progressing
to end-stage renal disease (ESRD). The MHRA authorization
follows the European Commission (EC) authorization in July of 2022.
Calliditas will transfer the CMA to its partner STADA Arzneimittel
AG, which is commercializing Kinpeygo in the European Economic Area
(EEA) member states, Switzerland
and the UK. STADA launched Kinpeygo in its lead launch market,
Germany, in October 2022.
"We are happy to be able to add another approval in a European
territory, which will lead to patient access to Kinpeygo, a drug
developed specifically to target this disease," said CEO Renée
Aguiar-Lucander.
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on February 2, 2023 at 9:15
a.m. CET.
About Calliditas
Calliditas Therapeutics is a commercial stage 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, developed under the name Nefecon, has been granted
accelerated approval by the FDA under the trade name
TARPEYO® and conditional marketing authorization by the
European Commission under the trade name KINPEYGO®.
KINPEYGO is being commercialized in the European Union Member
States and will be commercialized in the UK by Calliditas' partner,
STADA Arzneimittel AG. Additionally, Calliditas is conducting
a Phase 2b/3 clinical trial in
primary biliary cholangitis and a Phase 2 proof-of-concept trial in
head and neck cancer with its NOX inhibitor product candidate,
setanaxib. Calliditas' common shares are listed on Nasdaq Stockholm
(ticker: CALTX) and its American Depositary Shares are listed on
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 regulatory approval and marketing of Kinpeygo in UK,
Calliditas' strategy, commercialization efforts, business plans,
regulatory submissions, clinical development plans and focus, the
planned transfer of the CMA to STADA, improved patient access to
Kinpeygo and the potential therapeutic benefits of Kinpeygo. 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,
continued regulatory approvals for TARPEYO and Kinpeygo and
additional regulatory approvals for Nefecon, market acceptance
thereof, 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.
The following files are available for download:
https://mb.cision.com/Main/16574/3707636/1822130.pdf
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SOURCE Calliditas Therapeutics