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