Everest Medicines' Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

Rhea-AI Summary

Everest Medicines' licensing partner, Calliditas Therapeutics, has received a seven-year orphan drug exclusivity period from the U.S. FDA for Nefecon®, a drug to reduce kidney function loss in adults with primary IgAN. This exclusivity covers all adult patients with primary IgAN at risk of disease progression, reflecting a significant clinical benefit on kidney function.

Market Research Analyst

The orphan drug exclusivity granted to Nefecon® by the U.S. FDA is a significant competitive advantage, as it prevents the FDA from approving generic versions of the drug for the same indication until December 2030. This exclusivity could potentially lead to higher pricing power and market control for Calliditas Therapeutics and its licensing partner Everest Medicines in the U.S. market. For investors, this development is promising as it may translate into steady revenue streams over the exclusivity period for the companies involved.

Given the 5 million IgAN patients in mainland China and the drug's successful commercialization in Macau, the imminent launch in mainland China represents a substantial market opportunity. The commercial success in China, however, will depend on factors such as pricing, market access and reimbursement policies. Additionally, the orphan drug status in South Korea could indicate an expansion strategy for Nefecon® in other Asian markets, which could further increase the drug's revenue potential.

Medical Research Analyst

Primary immunoglobulin A nephropathy (IgAN) is a chronic kidney disease that can lead to end-stage renal failure. The therapeutic market for IgAN has been limited due to a lack of effective treatments, making Nefecon®'s FDA approval for this indication a significant breakthrough. The clinical benefit of reducing kidney function loss in adults with IgAN addresses a high unmet medical need, which could lead to a strong uptake among healthcare providers and patients.

The clinical benefit of preserving kidney function and delaying disease progression is critical for patient outcomes and can potentially reduce the long-term healthcare costs associated with kidney transplants and dialysis. This aspect may resonate with payers and insurance companies, possibly facilitating favorable reimbursement decisions.

Financial Analyst

The financial implications of the FDA's orphan drug exclusivity are multifaceted. Firstly, the exclusivity period allows Calliditas and Everest Medicines to recoup R&D investments and capitalize on the drug's market potential without immediate generic competition. Secondly, the approval with a new indication could lead to patent life extension strategies, further strengthening the companies' intellectual property portfolio.

Investors should monitor the adoption rate of Nefecon® in the U.S. and China, as these are key markets that will drive revenue growth. The financial performance of both Calliditas and Everest Medicines could see a significant impact from sales of Nefecon®, which should be reflected in future earnings reports and potentially in the companies' stock valuations.

SHANGHAI, March 11, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon^®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.

Following full approval in December 2023, Nefecon^® is indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression". The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN.

"We congratulate our partner for receiving seven more years of market exclusivity for Nefecon^® in the US, which is a further testament of FDA's recognition of the drug's capability to preserve kidney function and significantly delay disease progression for all adult patients," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Nefecon^® represents a revolutionary first-in-disease therapeutic option for Chinese patients who have more rapid disease progression in IgAN with no effective treatment options. Following its NDA approval in mainland China in November and successful commercialization in Macau in December, we now look forward to Nefecon^®'s imminent commercial launch in mainland China to make the drug available to 5 million IgAN patients as soon as possible."

South Korea's Ministry of Food and Drug Safety granted Orphan Drug Designation status for Nefecon^® in November 2022.

About Nefecon^®

Nefecon^® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon^® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

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SOURCE Everest Medicines

What is the orphan drug exclusivity period granted by the U.S. FDA for Nefecon®?

The U.S. FDA has granted a seven-year orphan drug exclusivity period for Nefecon®, expiring in December 2030.

What is the new indication for Nefecon®?

Nefecon® is indicated to reduce the loss of kidney function in adults with primary IgAN who are at risk for disease progression.

Which countries have granted Orphan Drug Designation status for Nefecon®?

South Korea's Ministry of Food and Drug Safety granted Orphan Drug Designation status for Nefecon® in November 2022.

What is the significance of the FDA's recognition of Nefecon®?

The FDA's recognition reflects the drug's capability to preserve kidney function and significantly delay disease progression for all adult patients with primary IgAN.

When was Nefecon®'s NDA approval in mainland China?

Nefecon® received NDA approval in mainland China in November and was successfully commercialized in Macau in December.