Calliditas partner STADA launches the first medicine authorized in the EU for treating primary IgA nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that its European commercial partner, STADA Arzneimittel AGhas launched the first and only approved treatment in the EU for primary immunoglobulin A nephropathy (IgAN), a rare, progressive kidney disease with a high unmet need.

STADA will initially start in Germany with even more European countries to follow.

‘We are excited that’ STADA is able to quickly launch this product in Europe, starting with the German market. Our focus has been to bring an approved drug to patients suffering from this rare disease since we started this more than a decade ago,” said Calliditas CEO. Renée Aguiar-Lucander.

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Calliditas received conditional approval from the European Commission for the developmental candidate Nefecon, the first and only approved treatment alternative for adult patients with IgAN at risk of rapid disease progression, with a urine protein-to-creatinine ratio (UPCR) of 1.5 g/gram. The conditional marketing authorisation, which has since been transferred to STADAapplies in all 27 European Union both Member States and Iceland, Norwayand Liechtenstein. This is the first orphan drug introduced through STADAs Business Unit Specialist Care.

‘Making this product available to primary IgAN patients in’ Europe brings for the first time a therapeutic option to an undertreated patient population,” noted STADA Director Peter Goldschmidt. ‘The launch of’ STADAs first orphan Specialized medicine is proof of how STADA adds value to patients, healthcare professionals and health systems through a broad portfolio of Specialty, Generic and Consumer Healthcare Products.’

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In GermanyIn the lead launch market, 3.1 people per 100,000 develop IgAN each year, a frequency slightly higher than the 2.5 per 100,000 that is the estimated global incidence.[1]


Marie Galay

Phone: +44 79 55 12 98 45

Email: [email protected]

About Calliditas

Calliditas Therapeutics is a commercial biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing new treatments for orphan indications, with an initial focus on kidney and liver diseases with significant unmet medical needs. Calliditas’ lead product, developed under the name Nefecon, has received accelerated approval from the FDA under the trade name TARPEYOTM and a conditional marketing authorization from the FDA. European Commission under the trade name KINPEYGO. KINPEYGO is commercialized in the European Union Member States by Calliditas’ partner, STADA Arzneimittel AG. In addition, 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 stock is listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).

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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 pharmaceuticals and non-prescription consumer health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In fiscal year 2021, STADA achieved group turnover of EUR 3,249.5 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 776.5 million. From December 31, 2021, STADA 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, commercialization efforts, business plans, regulatory filings, clinical development plans and focus. The words ‘may’, ‘will’, ‘could’, ‘should’, ‘expect’, ‘plan’, ‘anticipate’, ‘plan’, ‘believe’, ‘estimate’, ‘forecast’, ‘project’, ‘potential’, ‘continue’, ‘target’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All 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 could cause actual events or results to differ materially from those expressed or implied by any forward-looking looking to statements in this press release, including, but not limited to, all relating to Calliditas’ business, business, continued EC approval for Kinpeygo, market acceptance of Kinpeygo, clinical trials, supply chain, strategy, objectives and anticipated timelines, competition from other biopharmaceutical companies and other risks identified in the “Risk Factors” section of Calliditas’ reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise such statements to reflect a change in expectations or in events, conditions or circumstances on which such statements may be based, or that could affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements in this press release represent the views of Calliditas only as of the date of this posting and should not be relied upon as a representation of Calliditas’s views as of a later date.

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