STOCKHOLM, Jan. 7, 2024 /PRNewswire/ -- Calliditas
Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX)
("Calliditas"), a commercial biopharma company focused on rare
diseases today announced that Maria Törnsén has been
appointed to the position of President North America. Ms
Törnsén will be responsible for all US based operations and
will report to the CEO.
Maria Törnsén has broad commercial leadership experience having
spent more than 20 years in the biopharma industry in senior
commercial roles. Most recently Ms Törnsén held the position of
Chief Commercial Officer at Passage Bio, prior to which she was SVP
General Manager US at Sarepta Therapeutics. Prior to joining
Sarepta she served as VP Global Therapeutic Area Head at Sanofi
Genzyme and held several senior commercial roles at Shire including
VP Head of US Sales. Ms Törnsén will replace Mr Andrew Udell, who has held the position since
2020.
"We are pleased to welcome Ms Törnsén to the executive
management team as President of our US operations. She brings
invaluable experience from building commercial organisations,
driving growth and profitability in the area of rare diseases,
which will be critical as we target the next step in our
development." said CEO Renée Aguiar-Lucander. "I also want to thank
Mr Udell for his valuable contribution to the build-up of the US
organisation and its early commercial success."
"I am delighted to join Calliditas at this exciting time in the
company's history, with the recent full FDA approval of
TARPEYO® and an innovative late-stage pipeline in rare
diseases. I look forward to working with the Calliditas team to
continue advancing the TARPEYO® launch and develop our
capabilities to support further growth." said Maria Törnsén.
Calliditas received full FDA approval of
TARPEYO®(budesonide) delayed release capsules, a
targeted treatment to reduce the loss of kidney function in
patients with primary IgA nephropathy (IgAN) at risk of disease
progression on December 20, 2023; the
product has been granted conditional approval in Europe and China and is being commercialized by partners
under the brand names of Kinpeygo and Nefecon, respectively.
Calliditas is targeting top line read out of several Phase 2
clinical trials with setanaxib, its lead product candidate from its
proprietary and novel NOX platform, in 2024.
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on January 7, 2024 at 5:00
p.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma company headquartered in
Stockholm, Sweden, focused on
identifying, developing, and commercializing novel treatments in
orphan indications with significant unmet medical needs.
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). Visit Calliditas.com for
further information.
Important Safety Information
Contraindications: TARPEYO is contraindicated in
patients with hypersensitivity to budesonide or any of the
ingredients of TARPEYO. Serious hypersensitivity reactions,
including anaphylaxis, have occurred with other budesonide
formulations.
Warnings and Precautions
Hypercorticism and adrenal axis suppression: When
corticosteroids are used chronically, systemic effects such as
hypercorticism and adrenal suppression may occur. Corticosteroids
can reduce the response of the hypothalamus-pituitary-adrenal (HPA)
axis to stress. In situations where patients are subject to surgery
or other stress situations, supplementation with a systemic
corticosteroid is recommended. When discontinuing therapyor
switching between corticosteroids, monitor for signs of adrenal
axis suppression.
Patients with moderate to severe hepatic impairment (Child-Pugh
Class B and C respectively) could be at an increased risk of
hypercorticism and adrenal axis suppression due to an increased
systemic exposure to oral budesonide. Avoid use in patients with
severe hepatic impairment (Child-Pugh Class C). Monitor for
increased signs and/or symptoms of hypercorticism in patients with
moderate hepatic impairment (Child-Pugh Class B).
Risks of immunosuppression: Patients who are on drugs that
suppress the immune system are more susceptible to infection than
healthy individuals. Chickenpox and measles, for example, can have
a more serious or even fatal course in susceptible patients or
patients on immunosuppressive doses of corticosteroids. Avoid
corticosteroid therapy in patients with active or quiescent
tuberculosis infection; untreated fungal, bacterial, systemic
viral, or parasitic infections, or ocular herpes simplex. Avoid
exposure to active, easily-transmitted infections (e.g.,
chicken pox, measles). Corticosteroid therapy may decrease the
immune response to some vaccines.
Other corticosteroid effects: TARPEYO is a
systemically available corticosteroid and is expected to cause
related adverse reactions. Monitor patients with hypertension,
prediabetes, diabetes mellitus, osteoporosis, peptic ulcer,
glaucoma or cataracts, or with a family history of diabetes or
glaucoma, or with any other condition where corticosteroids may
have unwanted effects.
Adverse reactions: In clinical studies, the most
common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO
treated patients, and ≥2% higher than placebo) were peripheral
edema (17%), hypertension (12%), muscle spasms (12%), acne (11%),
headache (10%), upper respiratory tract infection (8%), face edema
(8%), weight increased (7%), dyspepsia (7%), dermatitis (6%),
arthralgia (6%), and white blood cell count increased (6%).
Drug interactions: Budesonide is a substrate for
CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as
ketoconazole, itraconazole, ritonavir, indinavir, saquinavir,
erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice
with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4
activity, can increase the systemic exposure to budesonide.
Use in specific populations
Pregnancy: The available data from published case
series, epidemiological studies, and reviews with oral budesonide
use in pregnant women have not identified a drug-associated risk of
major birth defects, miscarriage, or other adverse maternal or
fetal outcomes. There are risks to the mother and fetus associated
with IgAN. Infants exposed to in-utero corticosteroids, including
budesonide, are at risk for hypoadrenalism.
Please see Full Prescribing 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 the development of Calliditas' pipeline. 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, intellectual
property of the NEFECON franchise globally, competition from other
companies, pipeline development, revenue and product sales
projections or forecasts 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/16574/3905099/2525032.pdf
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