STOCKHOLM and BAD VILBEL,
Germany, July 21, 2021 /PRNewswire/ -- Calliditas
Therapeutics AB (Nasdaq: CALT), (Nasdaq Stockholm: CALTX)
("Calliditas") and STADA Arzneimittel AG ("STADA") announced today
that they have entered into a license agreement to register and
commercialize a novel specialty drug candidate for the treatment of
the chronic autoimmune kidney disease Immunoglobulin A Nephropathy
(IgAN) in the European Economic Area (EEA) member states,
Switzerland and the
UK.
Under the terms of the agreement, Calliditas is entitled receive
an initial upfront payment of 20M EUR
($24m) upon signing and up to an
additional 77.5M EUR ($91m) in future payments linked to pre-defined
regulatory and commercialization milestones. STADA is also
obligated pay tiered royalties on net sales expressed as a
percentage between the low twenties and the low thirties.
The partnership relates to a novel oral formulation, developed
under the project name 'Nefecon', of a potent and well-known active
substance – budesonide – designed to target down regulation of IgA1
with a view to be disease modifying. If approved, this value-added
specialty medicine, which received an EU orphan-drug designation in
2016, would be the first treatment authorized in the European Union
for IgAN, a rare autoimmune disease. IgAN, also known as Berger´s
disease, is a serious progressive autoimmune disease in which up to
50% of patients end up at risk of developing end stage renal
disease and thus requiring dialysis or a kidney transplant.
Prevalence in Europe is estimated
at 4 in 10,000, translating into approximately 200,000
patients.
"We are excited to be entering into this partnership with STADA
to bring this IgAN therapy to market in Europe, where there is a significant unmet
medical need for this patient population. We look forward to
working in close collaboration with STADA to pursue marketing
authorization with the goal of bringing the first ever EU-approved
medication in IgAN to patients as soon as possible, utilizing
STADA's extensive marketing and sales platform throughout
Europe," said Renée
Aguiar-Lucander, CEO of Calliditas.
"This partnership, which leverages Calliditas' drug-delivery
expertise and clinical data in this under-served patient
population, further validates STADA's position as a go-to-partner
for specialty pharmaceuticals, as well as for generics and consumer
health products," commented STADA CEO Peter
Goldschmidt. "This value-added novel formulation for a large
orphan indication will complement STADA's offerings in nephrology,
where we have built strong expertise over more than a decade
through our epoetin zeta biosimilar and where we continue to place
a clear strategic focus on seeking further opportunities to bring
new options to patients."
The novel 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. The
formulation uses a unique two-step 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 ileum in the lower small intestine. In addition to its
potent local effect, another advantage of using this active
substance is that it has very low bioavailability, with around 90%
being inactivated in the liver before it reaches the systemic
circulation. This means that a high concentration can be
applied locally where needed, whilst limiting systemic
exposure.
On May 28, 2021, Calliditas
announced that the company had, under the drug-development
candidate name Nefecon, submitted a Marketing Authorisation
Application (MAA) to the European Medicines Agency (EMA) for a
novel oral formulation of budesonide targeting down regulation of
IgA1 for the treatment of primary IgAN. The company also
filed an application for accelerated approval in the US on
March 15, 2021 and was granted
priority review in April 2021. The
commercial brand name for this therapy in Europe will be determined and disclosed at a
later date.
Calliditas´ oral formulation has been granted Accelerated
Assessment procedure by the Committee for Human Medicinal Products
(CHMP) within the European Medicines Agency, which is intended to
expedite access to drugs that the CHMP considers to be of major
therapeutic interest from the point of view of public health and in
particular from the viewpoint of therapeutic innovation.
Accelerated assessment reduces the maximum timeframe for review of
the MAA to 150 days (excluding clock-stops).
IgAN is designated as an orphan disease in both the US and
Europe. In Europe, an orphan disease is defined as a
disease or condition affecting no more than five in 10,000 European
citizens with no satisfactory method of diagnosis, prevention or
treatment. Orphan incentives consist of ten years of market
exclusivity from the grant date of marketing approval in the EU,
protocol assistance and scientific advice, fee reductions on EMA
procedural activities and eligibility for EU grants.
If approved, the product could be available to patients in
Europe in the first half of 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.
Torreya acted as exclusive financial advisor to Calliditas on
the transaction.
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel.: +44 79 55 12 98 45, email:
marie.galay@calliditas.com
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel - Germany
Phone: +49 (0) 6101 603-165
Fax: +49 (0) 6101 603-215
For Media Relations, email: press@stada.de
Or visit us on the Internet at www.stada.com/press
For Investor & Creditor Relations, email: ir@stada.de
Or visit us on the Internet at www.stada.com/investor-relations
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 Calliditas contact person set out above, on
July 21, 2021 at 8:45 a.m.
CET.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel,
Germany. The company focuses on a
three-pillar strategy consisting of generics, specialty pharma and
non-prescription consumer healthcare products. Worldwide, STADA
Arzneimittel AG sells its products in approximately 120 countries.
In financial year 2020, STADA achieved group sales of EUR 3,010.3 million and adjusted earnings before
interest, taxes, depreciation and amortization (EBITDA) of
EUR 713.3 million. As of December 31, 2020, STADA employed 12,301 people
worldwide.
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 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, regulatory
submissions and focus, as well as Calliditas's partnership with
STADA, the parties' plans with respect to registration and
commercialization of the specialty therapy, the terms of the
collaboration and the intended benefits therefrom, the regulatory
pathway and interactions for Nefecon, including timing of review
and assessment of the candidate, and the intended benefits of
regulatory designations such as Accelerated Assessment and orphan
disease. 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
conduct of Calliditas's partnership with STADA, the potential for
regulatory acceptance for and the success and timeline 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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SOURCE Calliditas Therapeutics