DAEJEON, South Korea, July 1, 2024
/PRNewswire/ -- Alteogen Inc. (KOSDAQ: 196170) announced on
July 1st that its
subsidiary, Altos Biologics Inc. has submitted Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) for an aflibercept biosimilar ALT-L9, developed by
Alteogen.
The Phase 3 clinical trial for ALT-L9 commenced with initial
clinical trial approval in 2022, involving over 400 subjects across
12 countries. The study compared efficacy, safety, and
immunogenicity against Eylea® in the indication of wet Age-related
Macular Degeneration. Conducted in Europe, South
Korea, and Japan, the trial
evaluated changes in Best-Corrected Visual Acuity (BCVA) over an
8-week period as the primary endpoint. The study demonstrated
therapeutic equivalence between ALT-L9 and Eylea®, prompting the
submission of the Marketing Authorization Application.
Altos Biologics expects to receive approval from EMA by 2025,
aligned with the substance patent expiration, and intends to
negotiate License Agreements with potential distributors
worldwide.
Dr. Soon Jae Park, Chief
Executive Officer of Alteogen, emphasized, "The submission of
Marketing Authorization Application for ALT-L9, developed by
Alteogen and clinically tested by Altos Biologics, mark significant
milestones in commercializing our proprietary products and gaining
global clinical experience." He added, "This represents a crucial
moment for Alteogen's growth as a global pharmaceutical
company."
"Following the European Marketing Authorization Application for
ALT-L9, we plan to pursue product approvals in target markets
including Korea," added Dr. Hyi Jeong
Ji, Chief Executive Officer of Altos Biologics. Altos
Biologics also aims to leverage its expertise gained from this
trial in ophthalmic diseases to develop a novel multi-specific
fusion protein therapeutic incorporating Tie2 regulators, in
addition to anti-VEGF mechanisms similar to Eylea®, aimed at
stabilizing blood vessels. This initiative aims to position the
company as a leading developer of Best-in-Class treatments in the
expanding market driven by aging demographics and related eye
conditions.
About Alteogen Inc.
Alteogen Inc. is a South
Korea-based biopharmaceutical company that focuses on the
development and commercialization of novel biologics such as
Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars.
Alteogen's portfolio includes clinical-stage long-acting
therapeutic proteins and next-generation ADCs, developed by its
proprietary NexP™-fusion and NexMab™ platform technology,
respectively. It also developed a proprietary recombinant human
hyaluronidase enzyme utilizing Hybrozyme™ technology, which enables
the large volume subcutaneous administration of drugs that are
typically administered as an IV infusion. The company was founded
in 2008 and listed in KOSDAQ (196170.KQ).
Contacts
Altos Biologics: Issac Hwang
U.S. Attorney
Phone: +821024007530
E-mail: issac.hwang1221@altosbio.com
Alteogen: Tae-Yon Chun, Ph.D.,
J.D.
Corporate Alliance Officer
Phone: +820428678861
E-mail: alliance@alteogen.com
View original
content:https://www.prnewswire.com/news-releases/altos-biologics-files-approval-of-aflibercept-biosimilar-302186707.html
SOURCE Alteogen Inc.