- Tergase® poised to capture a fair share of the global
hyaluronidase market.
DAEJEON, South Korea,
July 8,
2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced
that the Ministry of Food and Drug Safety (MFDS) of Korea approved
its New Drug Application (NDA) for Tergase® (recombinant
hyaluronidase).
Tergase® is a recombinant human hyaluronidase developed
utilizing Alteogen's proprietary Hybrozyme™ Technology. Dermal
filler removal is the main product application, but it can also be
used for various purposes, including local anesthetic solution for
eye surgery, and orthopedics pain management. Mainly bovine or
ovine-derived hyaluronidases with lower purity levels are available
on the market, whereas owing to its recombinant source, Tergase®
exhibits over 99% purity with lower immunogenicity. Given the
superior product profile and comparative advantages, it is expected
that the product applications will be extended to fields where
animal-origin hyaluronidases have not been traditionally used.
The NDA submission is supported by a multicenter, 2-arm,
randomized, double-blinded, placebo-controlled pivotal Phase 1
clinical trial involving 244 healthy subjects for the assessment of
safety, tolerability, and pharmacokinetic characteristics. Primary
endpoint - drug allergy response during intradermal administration
– was met as the allergic response rate in
the test group was significantly
lower than the U.S. Food and Drug Administration (USFDA)
recommendation as well as zero incidence of anti-drug antibodies (ADA)
found.
MFDS approval of Tergase® marks a key milestone for Alteogen as
it transitions to become a commercial-stage company and achieves
its goal of delivering better biologics for patients.
"We are pleased to report this important milestone, and look
forward to expanding our partnerships in commercializing Tergase®,"
said Dr. Soon Jae Park, Chief
Executive Officer of Alteogen. "And having excellent safety
profile compared to animal-derived
hyaluronidase products on the market, Tergase® stands to emerge as
a promising alternative in the global hyaluronidase market
estimated to be around $1 billion in
the near future."
About Tergase®
Tergase® (development code name ALT-BB4) is a stand-alone
recombinant hyaluronidase derived from human hyaluronidase PH20,
being investigated for a wide range of applications. Usage includes
tissue permeability modifier indicated as an adjuvant to increase
the dispersion and absorption of other injected drugs and topical
anesthetics by subcutaneous or intradermal injection. Designed to
achieve optimal balance between efficacy and safety, it is
comprised of proprietary, human serum albumin-free liquid
formulation with the presentation of 1,500 IU/mL/vial.
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
US: Vivek Shenoy, Ph.D., MBA
Chief Business Officer
Phone: +18055708998
E-mail: vivek_shenoy@alteogen.com
ROW: Tae-Yon Chun, Ph.D.,
J.D.
Corporate Alliance Officer
Phone: +820428678861
E-mail: alliance@alteogen.com
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SOURCE Alteogen Inc.