Peptron announced on the 15th that it has received approval from the Ministry of Food and Drug Safety for its bioequivalence test (BE) of PT105, a prostate cancer and precocious puberty drug.
Peptron is scheduled to begin clinical development in March and complete the clinical development of PT105 by September. The goal is to submit a new drug license application (NDA) and launch it on the market in the second half of 2022.
PT105 is a 1-month-long prostate cancer treatment developed with Peptron’s proprietary drug development platform SmartDepot technology.
It is characterized by remarkably enhancing the ease of administration by implementing a mass production process that not only matches the bioequivalence of Takeda’s’Luprin’, which is a reference drug, but also improves the particle size of the drug. Accordingly, it is expected that the product’s great competitiveness will be that the patient’s pain can be significantly reduced by using a 26-gauge needle instead of a thick needle, which is pointed out as a disadvantage of existing products.
This clinical trial is conducted in a cross-over (2×2 crossover) method to compare and evaluate the safety and pharmacokinetic characteristics of PT105 compared to Lufrin, and the clinical trial is conducted at Chungnam National University Hospital.
Lufrin is a blockbuster drug with sales of about KRW 53 billion in Korea and KRW 900 billion in global sales as of 2019.
Peptron expects that the commercialization of PT105 produced at the Osong Biopark GMP facility as a generic product will drive the company’s stable sales and facilitate entry into the global market as a first generic drug with the same PK (pharmacokinetics) profile as the original product . In October last year, the selection of preferred negotiators for the domestic copyright contract was also finished.
Meanwhile, in addition to PT105, Peptron has a variety of pipelines that utilize SmartDepot, a platform technology based, and plans to gradually release each drug to the market. PT320, a treatment for Parkinson’s disease, has completed the recruitment of clinical patients and is currently undergoing phase 2 clinical trials smoothly.
An official from Peptron said, “Clinical trials are in progress as planned without any specially reported side effects so far,” and “We are also discussing CDMO (consignment development and production) business with global partners who are interested in SmartDepot-based technology.”