These materials are distributed directly by MEDRx Co., Ltd. and are available only through direct distribution. MEDRx retains all copyrights to these materials. These materials may not be copied or reused in any other way, electronically or mechanically, for any purpose without prior consent. Moreover, these materials were prepared based on the plans of MEDRx at the time of disclosure. Actual results may differ from the statements in these materials.
Three Core Transdermal Drug Delivery Platforms
2
Ionic Liquid
Nano-sizedColloid
Microneedle
Transdermal System
Transdermal System
(MN)
These materials are distributed directly by MEDRx Co., Ltd. and are available only through direct distribution. MEDRx retains all copyrights to these materials. These materials may not be
copied or reused in any other way, electronically or mechanically, for any purpose without prior consent. Moreover, these materials were preparedCo, ltdbased. All rightson thereservedplans of MEDRx at the time 2of disclosure. Actual results may differ from the statements in these materials.
Pipeline : "Primary Target is US market"
Product name
Drug Formulation
Pre
Ph-Ⅰ
Ph-Ⅱ
Ph-Ⅲ
NDA
Launch
Development Code
Development
Clinical
CPN-101(MRX-4TZT)
Worldwide licensing agreement (except for
East Asia) with Cipla USA Inc.
Spasticity
Phase 1b has got successful result.
(Tizanidine, transdermal, ILTS®)
Phase 2 to be prepared
MRX-5LBT "Lydolyte"
Receipt of Complete Response Letter
Neuropathic Pain
Completion of additional study
(Lidocaine, topical, ILTS®)
Expected to get NDA approval in 2023
MRX-9FLT
Fast Track designation
Moderate-Severe Pain
Clinical Study on-going
(Fentanyl, transdermal, ILTS®)
MRX-7MLL
Alzheimer's Disease
IND acceptance
(Memantine, transdermal, NCTS®)
MRX-6LDT
Chronic Pain
(Diclofenac-lidocaine, ILTS®)
4
Why USA market First?
USA accounts for more than 40% of the global pharmaceutical market and has been maintaining a high growth rate in recent years.
【Sales Share in 2021】Total Drug Sales: $1,286,900M(Data by IQVIA)
USA 44.7%
EU 5 Countries
16.1%
China 9.2%
Japan
6.1%
Emerging
Countries米国
11.2%
40.8%
Others 12.7%
【Compound Annual Growth Rate from 2017 to 2021】
USA 6.2%, EU 5 Countries 7.1%, China 8.5% and Japan 0.7% (Data by IQVIA)
In particular, regarding new dosage forms that MEDRx mainly develops (e.g. oral form to topical/transdermal delivery system), MEDRx believes that
The higher values added by new dosage forms, such as the increase efficacy, the decrease side effects and the improvements of QOL and convenience, easily reflect to Drug Prices.
On the other hand, it is likely difficult to reflect the additional values of new dosage forms in prices compared to the US market as there are financial constraints in Japan and Europe, where public insurance and public funds cover the majority of medical costs and public drug prices are set. The drug price of new dosage forms trends to be set as the similar price with the previous dosage forms.
This document is distributed only by the way provided directly by MEDRx Co., Ltd. Please use only those who are provided. All rights to any part of this material belong to MEDRx, so please do not
reproduce it for any purpose without permission, whether electronically or mechanically. In addition, this document was prepared based on the current internal plan and is subject to change in the future.
5
FY2022 Business Highlight (1)
<CPN-101(MRX-4TZT)>
Phase 2 study in preparation
Cipla and Medrx under discussion regarding the future plan of clinical development
<MRX-5LBT "Lydolyte">
Agreement with USFDA regarding the detail of the additional study and Successful Completion of the additional study
Plan to refile in 1H 2023 and get NDA approval in 2H 2023
<MRX-9FLT "Lydolyte">
Fast Track designation granted by the USFDA
MRX-9FLT'scapability of preventing accidental use
Clinical study on-going
These materials are distributed directly by MEDRx Co., Ltd. and are available only through direct distribution. MEDRx retains all copyrights to these materials. These materials may not be copied or reused in any other way, electronically or mechanically, for any purpose without prior consent. Moreover, these materials were prepared based on the plans of MEDRx at the time of disclosure. Actual results may differ from the statements in these materials.
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Medrx Co. Ltd. published this content on 02 March 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 March 2023 09:55:00 UTC.
Medrx Co., Ltd. is a Japan-based Company principally engaged in the research and development of pharmaceutical products. The Company produces new medicines based on percutaneous absorption formulation technology. The Company has pharmaceutical formulation technology, including percutaneous absorbent technology of ionic liquid transdermal system (ILTS) using characteristics of ionic liquid, and percutaneous absorbent technology of nano-sized colloid transdermal system (NCTS) using Nano colloidization technology of drug. Based on the technology, The Company aims to maximize drug efficacy, reduce side effects, prevent forgetting to drink, and to administer to patients who are difficult to orally administer, and to produce medicines with new added value.