Calliditas partner STADA receives European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy

Rhea-AI Summary

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) announced that the European Commission has granted full marketing authorization for Kinpeygo® to treat adults with primary immunoglobulin A nephropathy (IgAN). This approval significantly broadens the label, now covering patients with urine protein excretion (UPCR) ≥ 0.8g/g, based on the two-year data from the Phase 3 NefIgArd clinical trial. The approval triggers a €10 million milestone payment to Calliditas, recognizable as revenue in Q3. Kinpeygo, marketed exclusively by STADA Arzneimittel AG in the EU and UK, now has orphan drug status with 10-year market exclusivity until 2032.

Positive

• Full marketing authorization granted by European Commission for Kinpeygo®
• Expanded label coverage for broader patient population (UPCR ≥ 0.8g/g)
• €10 million milestone payment to be recognized as revenue in Q3
• Orphan drug status with 10-year market exclusivity until 2032
• Positive results from Phase 3 NefIgArd clinical trial published in The Lancet

Negative

• None.

STOCKHOLM, July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).

The European Commission has granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours. This expanded label is based on full two-year data set from the Phase 3 NefIgArd clinical trial, published in leading medical journal The Lancet ^(1).

"This is an important event for patients suffering from IgAN in Europe as Kinpeygo represents the first ever fully approved medication for this rare kidney disease.  The long-term confirmatory trial met its eGFR endpoint with high statistical significance and we are delighted that the European Commission has granted a full approval for the broader population" said Renee Aguiar-Lucander, CEO.

Kinpeygo is marketed in in the EU and UK exclusively by Calliditas' commercial partner, STADA Arzneimittel AG.

The full marketing authorization for Kinpeygo covers the European Union (EU) member states as well as Iceland, Norway and Liechtenstein. Also, Kinpeygo's status as an orphan drug for a rare disease, subject to 10-year market exclusivity running until 2032, was confirmed by the Commission.

This approval triggers a milestone payment of ten million EUR to Calliditas, which will be recognized as revenue in the third quarter.       

1. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomized phase 3 trial - The Lancet

CONTACT:

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 person set out above, on July 26, 2024 at 5:00 p.m. CET.

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https://news.cision.com/calliditas-therapeutics/r/calliditas-partner-stada-receives-european-commission-decision-for-full-approval-of-kinpeygo--for-th,c4019061

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SOURCE Calliditas Therapeutics

FAQ

What is the new approval status for Kinpeygo® in Europe for IgA Nephropathy treatment?

The European Commission has granted full marketing authorization for Kinpeygo® to treat adults with primary immunoglobulin A nephropathy (IgAN), expanding the label to cover patients with urine protein excretion (UPCR) ≥ 0.8g/g.

How does the Kinpeygo® approval affect Calliditas Therapeutics' (CALT) financials?

The approval triggers a €10 million milestone payment to Calliditas Therapeutics, which will be recognized as revenue in the third quarter of 2024.

What market exclusivity does Kinpeygo® have in Europe after the CALT approval?

Kinpeygo® has been granted orphan drug status for a rare disease, subject to 10-year market exclusivity running until 2032 in the European Union, Iceland, Norway, and Liechtenstein.

Who is marketing Kinpeygo® in the EU and UK for Calliditas Therapeutics (CALT)?

Kinpeygo® is marketed exclusively by Calliditas' commercial partner, STADA Arzneimittel AG, in the EU and UK.