Calliditas partner STADA launches the first drug approved in the European Union for primary IgA nephropathy

StockholmAnd the September 20 2022 /PRNewswire/- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) at present introduced that its European buying and selling associate, STADA Arzneimittel AG, has launched the primary and solely EU-approved remedy for main immunoglobulin nephropathy (IgAN), a uncommon illness Exacerbated renal involvement with elevated unmet want. STADA might be tentatively launched in Germany With different European international locations to observe up.

“We’re excited that STADA is able to launch this product rapidly EuropeBeginning with the German market. Calliditas CEO Rene Aguiar-Losander stated offering an authorised drug to sufferers with this uncommon illness has been our focus since we started this endeavor greater than a decade in the past.”

Calliditas obtained conditional approval in July from the European Fee for the event candidate Nefecon, offering the primary and solely therapeutic different for grownup IgAN sufferers vulnerable to speedy illness development with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. The conditional advertising authorization, now transferred to STADA, is legitimate in all 27 member states of the European Union in addition to IcelandAnd the NorwayAnd the Liechtenstein. That is the primary orphan drug to be provided by means of STADA’s Specialty Care enterprise unit.

“Making this product out there to main IgAN sufferers in Europe brings for the primary time a remedy choice to a gaggle of underserved sufferers,” STADA CEO commented Peter Goldschmidt. “The launch of STADA’s first orphan specialty medication is a testomony to how STADA is creating extra worth for sufferers, healthcare professionals, and well being methods by means of a variety of specialty, fetal and shopper healthcare merchandise.”

in Germanythe first launch market, 3.1 individuals in 100,000 develop IgAN annually, a frequency barely greater than the two.5 per 100,000 estimated world incidence.[1]

For extra info, please contact:

Mary GallayAnd the
IR Director, Calliditas
Telephone: +447955129845
E-mail: marie.galay@calliditas.com

The knowledge was despatched for publication, by means of the company of the aforementioned focal factors, on September 20 2022 in 2:00 PM CET.

About Calliditas

Calliditas Therapeutics is a industrial biopharmaceutical firm based mostly in Stockholm, Sweden He centered on figuring out, creating and advertising new therapies in orphan indications, with an preliminary give attention to kidney and liver illness with important unmet medical wants. Calliditas’ flagship product, developed below the title Nefecon, has been granted accelerated approval by the US Meals and Drug Administration (FDA) below the commerce title TARPEYO.TM Conditional advertising authorization by the European Fee below the commerce title KINPEYGO®. KINPEYGO is marketed within the EU Member States by Calliditas’ associate, STADA Arzneimittel AG. As well as, Calliditas conducts a stage 2 b/3 Medical trial in main cholangitis and a validation section II trial of head and neck most cancers with a candidate NOx inhibitor product, citanaxib. Calliditas’ widespread inventory is listed on the Nasdaq Stockholm (Inventory ticker: CALTX) and the US Depository Inventory is listed on the Nasdaq International Choose Market (Buying and selling image: CALT).

About STADA Arzneimittel AG

STADA Arzneimittel AG is headquartered in Unhealthy Vilbel, Germany. The corporate focuses on a three-pillar technique consisting of generic medication, specialty medication and over-the-counter shopper healthcare merchandise. Worldwide, STADA Arzneimittel AG sells its merchandise in about 120 international locations. In fiscal yr 2021, STADA achieved mass gross sales of 3249.5 million euros and reported earnings earlier than curiosity, taxes, depreciation, and amortization (EBITDA) from 776.5 million euros. From December 31, 2021STADA employs 12,520 individuals worldwide.

forward-looking statements

This press launch accommodates forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995, as amended, together with, however not restricted to, statements relating to Calliditas’ technique, advertising efforts, enterprise plans, regulatory submissions, medical growth plans and focus. . The phrases “might,” “will,” “may,” “will,” “ought to,” “anticipate,” “plan,” “anticipate,” “intend,” “consider,” “estimate,” “anticipate,” intention “Undertaking,” “potential,” “continued,” “goal,” and comparable expressions restrict forward-looking statements, though not all forward-looking statements include such figuring out phrases. Any forward-looking statements on this press launch are based mostly on administration’s present expectations and beliefs and are topic to plenty of important dangers, uncertainties and elements that might trigger precise occasions or outcomes to vary materially from these expressed or implied by any future-research statements contained on this press launch, Together with, with out limitation, any relationship to Calliditas’ enterprise and operations, ongoing European Fee approval of Kinpeygo and market acceptance of Kinpeygo, medical trials, provide chain, technique, goals and projected timelines, competitors from different biopharmaceutical corporations and different dangers recognized within the part entitled “Threat Elements” In Calliditas experiences filed with the Securities and Trade Fee. Calliditas cautions you to not place undue reliance on any forward-looking statements, which communicate solely as of the date they’re made. Calliditas disclaims any obligation to publicly replace or revise any such statements to replicate any change in expectations or in occasions, circumstances or situations on which such statements could also be based mostly, or which will have an effect on the likelihood that precise outcomes might differ from these set forth within the forward-looking statements. . Any forward-looking statements contained on this press launch symbolize Calliditas’ views solely as of the date of this launch and shouldn’t be relied upon as representing its views as of any later date.

[1] O’Shaughnessy MM et al. Glomerular illness frequencies by race, intercourse, and area: outcomes of the worldwide renal biopsy survey. Kidney Transplant 2011; 26 (2): 414-430

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