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”) today announced that its European trading partner, STADA Arzneimittel AG, has launched the first and only EU-approved treatment for primary immunoglobulin nephropathy (IgAN), a rare disease Exacerbated renal involvement with elevated unmet need. STADA will be tentatively launched in Germany With other European countries to follow up.

“We are excited that STADA is in a position to launch this product quickly EuropeStarting with the German market. Calliditas CEO Rene Aguiar-Losander said providing an approved drug to patients with this rare disease has been our focus since we began this endeavor more than a decade ago.”

Calliditas received conditional approval in July from the European Commission for the development candidate Nefecon, providing the first and only therapeutic alternative for adult IgAN patients at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. The conditional marketing authorization, now transferred to STADA, is valid in all 27 member states of the European Union as well as IcelandAnd the NorwayAnd the Liechtenstein. This is the first orphan drug to be offered through STADA’s Specialty Care business unit.

“Making this product available to primary IgAN patients in Europe brings for the first time a treatment option to a group of underserved patients,” STADA CEO commented Peter Goldschmidt. “The launch of STADA’s first orphan specialty medicine is a testament to how STADA is creating additional value for patients, healthcare professionals, and health systems through a wide range of specialty, fetal and consumer healthcare products.”

in Germanythe primary launch market, 3.1 people in 100,000 develop IgAN each year, a frequency slightly higher than the 2.5 per 100,000 estimated global incidence.[1]

For more information, please contact:

Mary GallayAnd the
IR Director, Calliditas
Phone: +447955129845

The information was sent for publication, through the agency of the aforementioned focal points, on September 20 2022 in 2:00 PM CET.

About Calliditas

Calliditas Therapeutics is a commercial biopharmaceutical company based in Stockholm, Sweden He focused on identifying, developing and marketing new therapies in orphan indications, with an initial focus on kidney and liver disease with significant unmet medical needs. Calliditas’ flagship product, developed under the name Nefecon, has been granted accelerated approval by the US Food and Drug Administration (FDA) under the trade name TARPEYO.TM Conditional marketing authorization by the European Commission under the trade name KINPEYGO®. KINPEYGO is marketed in the EU Member States by Calliditas’ partner, STADA Arzneimittel AG. In addition, Calliditas conducts a stage 2 b/3 Clinical trial in primary cholangitis and a validation phase II trial of head and neck cancer with a candidate NOx inhibitor product, citanaxib. Calliditas’ common stock is listed on the Nasdaq Stockholm (Stock ticker: CALTX) and the US Depository Stock is listed on the Nasdaq Global Select Market (Trading symbol: CALT).

About STADA Arzneimittel AG

STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generic drugs, specialty drugs and over-the-counter consumer healthcare products. Worldwide, STADA Arzneimittel AG sells its products in about 120 countries. In fiscal year 2021, STADA achieved mass sales of 3249.5 million euros and reported earnings before interest, taxes, depreciation, and amortization (EBITDA) from 776.5 million euros. From December 31, 2021STADA employs 12,520 people worldwide.

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, but not limited to, statements regarding Calliditas’ strategy, marketing efforts, business plans, regulatory submissions, clinical development plans and focus. . The words “may,” “will,” “could,” “will,” “should,” “expect,” “plan,” “expect,” “intend,” “believe,” “estimate,” “expect,” aim “Project,” “potential,” “continued,” “objective,” and similar expressions limit forward-looking statements, although not all forward-looking statements contain such 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 significant risks, uncertainties and factors that could cause actual events or results to differ materially from those expressed or implied by any future-research statements contained in this press release, Including, without limitation, any relationship to Calliditas’ business and operations, ongoing European Commission approval of Kinpeygo and market acceptance of Kinpeygo, clinical trials, supply chain, strategy, objectives and projected 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, circumstances or conditions on which such statements may be based, or that may affect the possibility that actual results may 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 of this release and should not be relied upon as representing its views as of any later date.

[1] O’Shaughnessy MM et al. Glomerular disease frequencies by race, sex, and region: results of the international renal biopsy survey. Kidney Transplant 2011; 26 (2): 414-430

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