- Peptron's PT105, a sustained-release Leuprolide, established
the bioequivalence with Takeda's Leuplin.
- Global and regional deal to be initiated.
- PT105 represents Korea's first commercialized generic drug of
Leuplin, applied with SmartDepot technology.
- Development of 3- and 6-month generic Leuprolide for the global
market soon to be initiated.
DAEJEON, South Korea,
Nov. 28, 2022 /PRNewswire/ --
Peptron, Inc. (KOSDAQ: 087010), a leading company in the
development of peptide-based sustained-release drug products,
announced on November 17 that it has
successfully established bioequivalence of "PT105," once-a-month
injectable Leuprolide for the treatment of prostate cancer, breast
cancer, endometriosis, and precocious puberty.
Takeda's Leuplin, the original drug for PT105, is one of the
biggest blockbuster drugs that has achieved a total of $1.34 billion in sales and the largest global
market share over the past 30 years. Material, Composition and Use
patents have expired, but Peptron obtains full equivalence due to
the difficulty in generic drug development of emulating Takeda's
manufacturing process and technology.
"Compared to Takeda's Leuplin, PT105 has reduced particle size
and smaller needle gauge, which will improve patients'
convenience," said an official of Peptron. "Together with
comparative advantage and large-scale producibility in our Osong
GMP facility, we will quickly expand and strengthen our
"After the launch of PT105 in the domestic market, we will enter
the global market with potential partners based on established
bioequivalence and international standards." said Ho-il Choi, CEO
of Peptron. "Together with PT320 that secured the FDA's Phase 3
clinical trial IND approval, PT105 is a success milestone that
proves the superiority of Peptron's SR formulation technology and
Peptron aims to enter into the domestic and global market with
1-, 3- and 6-month formulations of generic Leuprolide.
- about PT320(Presendin):
In August 2022, Peptron and Invex
Therapeutics received phase 3 IND approvals from the U.S. FDA, MHRA
and others for Presendin (PT320). Currently, there is no treatment
available for idiopathic intracranial hypertension (IIH), the main
target of Presendin, and the global market size of IIH is
approximately $1.5 billion USD.
Peptron expects a significant revenue potential and increased
demands in contract development and manufacturing services.