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Calliditas receives notice of allowance for United States patent application covering setanaxib in cancer treatment

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Calliditas Therapeutics (CALT) receives a Notice of Allowance from the USPTO for a patent application related to cancer treatment with setanaxib and PD-1 inhibitors. The patent is anticipated to expire in 2038, providing extended protection for the global setanaxib franchise in oncology.
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The allowance of a patent application, particularly in the pharmaceutical industry, is a pivotal moment for a company. It not only secures the intellectual property of the company's innovation but also adds a layer of defense against competitors. The patent for 'Use of NOX Inhibitors for Treatment of Cancer' is significant as it extends the market exclusivity of setanaxib, potentially until 2038. This exclusivity period is essential for Calliditas to recoup research and development investments and to capitalize on the market without immediate generic competition.

Furthermore, the patent covers a combination therapy, which is increasingly common in oncology. Combination therapies can be more effective than single-agent treatments and may become the standard of care. If setanaxib proves to be successful in clinical trials and gains market approval, the patent could become a cornerstone of Calliditas's revenue stream. It is also important to note that patents can be leveraged in strategic partnerships, licensing deals, or even to enhance the company's valuation in M&A activities.

Resistance to PD-1 inhibitors is a major challenge in treating cancers. Setanaxib's potential to overcome this resistance could address a significant unmet need in the oncology market. This could lead to increased demand and adoption of the drug, contingent upon successful clinical trial outcomes and subsequent regulatory approval. The patent's coverage of the combination therapy with PD-1 inhibitors positions Calliditas to tap into the existing market for PD-1 therapies, which is substantial and growing.

Investors should monitor the progress of setanaxib's clinical trials closely, as the drug's efficacy and safety data will be critical in determining its commercial potential. Additionally, the patent's geographical scope is worth noting. While a U.S. patent is valuable, global protection is important for maximizing returns, hence the significance of corresponding applications in other territories, including Europe.

The announcement of a Notice of Allowance from the USPTO is an indicator of potential future revenue streams for Calliditas. The financial impact of this patent will depend on several factors, including the timeline for setanaxib's clinical development, regulatory approval and market entry. The long-term patent protection until 2038 provides a clear runway for financial planning and return on investment.

Investors should consider the cost implications of ongoing research and development, the scale of investment required for commercialization and potential market size for setanaxib. It's also important to assess Calliditas's financial health and its ability to sustain the prolonged and costly process of bringing a new cancer treatment to market. The patent news may positively impact the company's stock in the short term due to perceived future value; however, the actual financial performance will hinge on successful product development and strategic market positioning.

STOCKHOLM, April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer".  This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.

The allowed claims cover a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by administering setanaxib in combination with a PD-1 inhibitor. The patent, when issued, will have an anticipated expiration date in 2038.

"This is a significant value enhancing event for the global setanaxib franchise and we are delighted that we are able to expand product protection for setanaxib in the important area of oncology," said CEO Renée Aguiar-Lucander.

Calliditas has corresponding applications in several additional territories around the world, including a pending patent application in Europe.

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 April 8, 2023, at 09:00 a.m. CET.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/calliditas-therapeutics/r/calliditas-receives-notice-of-allowance-for-united-states-patent-application-covering-setanaxib-in-c,c3957702

The following files are available for download:

https://mb.cision.com/Main/16574/3957702/2715464.pdf

Setanaxib Patent Press Release_ENG

Cision View original content:https://www.prnewswire.com/news-releases/calliditas-receives-notice-of-allowance-for-united-states-patent-application-covering-setanaxib-in-cancer-treatment-302110165.html

SOURCE Calliditas Therapeutics

The Notice of Allowance signifies that the USPTO has approved Calliditas' patent application for the use of NOX Inhibitors, specifically setanaxib, in combination with PD-1 inhibitors for the treatment of solid tumors resistant to PD-1 inhibitor immunotherapy.

The allowed claims of the patent cover the method of treating solid tumors resistant to PD-1 inhibitor immunotherapy by administering setanaxib alongside a PD-1 inhibitor.

The patent, once issued, is expected to expire in 2038, providing extended protection for the global setanaxib franchise in the field of oncology.

Calliditas has corresponding patent applications in several territories worldwide, including a pending application in Europe.
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About CALT

Calliditas is a clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.