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Calliditas provides patent update

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Calliditas Therapeutics AB (CALT) secures a new patent for TARPEYO in the US, extending product protection until 2043. The patent covers treatment of IgA nephropathy with NEFECON, showcasing the company's commitment to innovation and global expansion.
Positive
  • Securing a new patent enhances product protection for Calliditas Therapeutics AB.
  • The patent covers a method of treating IgA nephropathy with TARPEYO, showing a focus on therapeutic advancements.
  • Calliditas intends to expand patent coverage to other territories like Europe and China, indicating a global growth strategy.
  • CEO Renée Aguiar-Lucander expresses excitement over the extended product protection and potential in other markets.
  • Filing for listing in the Orange Book signifies a step towards regulatory approval and market access.
Negative
  • None.

Insights

The issuance of patent no. 11896719 by the USPTO to Calliditas Therapeutics AB for TARPEYO is a significant legal milestone. It solidifies the company's intellectual property rights, granting it exclusive control over the commercialization of this treatment for IgA nephropathy until 2043. The strategic move to file for listing in the Orange Book further enhances market exclusivity, as it is a requirement for generic manufacturers to certify that they will not infringe upon the listed patents before their products can enter the market. This patent not only protects the specific pharmaceutical composition but also the method of treatment, creating a robust barrier for potential competitors.

Additionally, the company's intention to file corresponding patent applications in other territories such as Europe and China indicates a global strategy for market protection. This is a common practice to safeguard market share and revenue streams from international sales, which can be substantial, especially in large pharmaceutical markets like the EU and China. The patent's international expansion could deter generic competition abroad and provide a competitive advantage in global markets.

From a market perspective, the extended patent protection for Calliditas' TARPEYO until 2043 is likely to have a positive impact on the company's financial outlook. It ensures a longer period without generic competition, potentially resulting in sustained revenue from the drug. This is particularly important given that IgA nephropathy is a chronic disease and a stable market presence can lead to consistent treatment demand.

The market exclusivity also provides Calliditas with a predictable revenue stream that can be reinvested into further research and development, which is critical in the pharmaceutical industry for maintaining a competitive edge. Investors often view extended patent protections favorably as they can lead to higher valuations due to the increased certainty and potential for long-term profitability.

Calliditas Therapeutics AB's announcement of the US patent issuance might be reflected in the company's stock performance as investors digest the implications for long-term revenue generation. The protection against generic competition for an additional period is a key factor in maintaining the drug's pricing power, which is a significant driver of profitability in the pharmaceutical industry.

However, it is also important to note that patent protection alone does not guarantee commercial success. The company must continue to execute effective marketing strategies and maintain a strong sales infrastructure to capitalize on the patent's potential. Furthermore, the cost of filing and defending patents in additional territories must be weighed against the expected increase in revenue from those markets. The financial health of the company and the potential return on these investments are critical considerations for stakeholders.

STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no. 11896719, entitled "New Pharmaceutical Compositions, on January 24, 2024 with validity as of today, February 13, 2024.  This is Calliditas' second patent for TARPEYO in the United States, and provides product protection until 2043.

The patent covers a method of treating IgA nephropathy with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name "NEFECON®". Filing for listing in the Orange Book has thus been made.

Calliditas intends to file corresponding patent applications in additional territories around the world, including Europe and China.

"We are delighted with the additional product protection and longer runway until patent expiration with regards to TARPEYO and look forward to successful processes also in other geographies", said CEO Renée Aguiar-Lucander.

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 persons set out above, on February 13, 2024 at 17:15 p.m. CET.

The following files are available for download:

https://mb.cision.com/Main/16574/3927929/2601842.pdf

Patent PR_ENG

Cision View original content:https://www.prnewswire.com/news-releases/calliditas-provides-patent-update-302060856.html

SOURCE Calliditas Therapeutics

FAQ

What is the ticker symbol for Calliditas Therapeutics AB?

The ticker symbol for Calliditas Therapeutics AB is CALT.

What is the new patent issued by the USPTO for Calliditas?

The USPTO issued patent no. 11896719 for 'New Pharmaceutical Compositions' on January 24, 2024, providing product protection until 2043.

What does the new patent cover for Calliditas Therapeutics AB?

The new patent covers a method of treating IgA nephropathy with TARPEYO® (budesonide) delayed release capsules, developed under the name 'NEFECON®'.

Which territories does Calliditas Therapeutics AB plan to file corresponding patent applications in?

Calliditas intends to file corresponding patent applications in additional territories worldwide, including Europe and China.

Who commented on the new patent issuance for Calliditas Therapeutics AB?

CEO Renée Aguiar-Lucander expressed delight over the extended product protection and potential in other geographies.

What does filing for listing in the Orange Book signify for Calliditas Therapeutics AB?

Filing for listing in the Orange Book indicates a step towards regulatory approval and market access for the company's product.

Calliditas Therapeutics AB American Depositary Shares

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