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MEDRx (TSE:4586)
H1 FY2024 Business Highlight &
Financial Results
August 22, 2024
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Three Core Transdermal Drug Delivery Platforms
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 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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Pipeline : “Primary Target is US market”
Product name
Development Code
Drug Formulation
Development
Pre
Clinical
Ph-Ⅰ
Ph-Ⅱ
Ph-Ⅲ
NDA
Launch
MRX-4TZT | Phase 1b has got successful result. |
Spasticity | |
Phase 2 to be prepared | |
(Tizanidine, transdermal, ILTS®) | |
MRX-5LBT “Lydolyte” | |
Neuropathic Pain | Receipt of CRL in July 2024 |
(Lidocaine, topical, ILTS®) | |
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®) | |
Alto-101 | |
Schizophrenia | Phase 2 study on-going |
(a PDE4 inhibitor) | |
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Why USA market First?
- USA accounts for approximately half of the global pharmaceutical market and has been maintaining a high growth rate in recent years.
【Sales Share in 2023】Total Drug Sales: $1,458,200M(Data by IQVIA)
USA | EU 5 | China | JP | Emerging | Others |
49.0% | Countries | 7.8% | 4.4% | Countries | 12.2% |
15.2% | 11.4% | ||||
【Compound Annual Growth Rate from 2021 to 2023】
USA 6.1%, EU 5 Countries 3.3%, China ▲ 0.6% and Japan ▲1.8% (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 in the US market with free pricing
- 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.
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1H FY2024 Business Highlight
- P2 study in preparation
- NDA Re-Submission (Jan 2024) → CRL receipt (July 2024)
- USFDA has demanded to submit additional data in a few non-clinical issues
- Re-analysisof existing data is on-going to re-submit NDA
- Completed formulation improvement → P1a study will be started in 3Q
- Successful P1 study with transdermal patch → Receipt of milestone revenue
- P2 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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Pipeline : “Primary Target is US market”
Product name
Development Code
Drug Formulation
Development
Pre
Clinical
Ph-Ⅰ
Ph-Ⅱ
Ph-Ⅲ
NDA
Launch
MRX-4TZT | Phase 1b has got successful result. |
Spasticity | |
Phase 2 to be prepared | |
(Tizanidine, transdermal, ILTS®) | |
MRX-5LBT “Lydolyte” | |
Neuropathic Pain | Receipt of CRL in July 2024 |
(Lidocaine, topical, ILTS®) | |
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®) | |
Alto-101 | |
Schizophrenia | Phase 2 study on-going |
(a PDE4 inhibitor) | |
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MRX-4TZT : Spasticity Treatment
- Transdermal formulation of Tizanidine – the centrally acting muscle relaxant, through ILTS®
- Expected advantages compared to oral route: better durability of effective blood concentration, fewer side effects (drowsiness, etc.)
- Market Size of muscle relaxants in US: $1,519M in 2023 (source: IQVIA)
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MRX-4TZT:Potential, State of the Development & Alliance
- While current annual net sales of oral generic tizanidine in US market is only $64 million USD, MRX-4TZT can achieve much bigger sales. MedRx expects its peak sales in USA at ideal conditions will be able to reach over 300-1,000million USD.
- Volume: over 30-100 million patches (doses) at peak, which represents about 9-30% of 1,000 million doses per year which is actual achievement of oral tizanidine (three times per day) in 2017-2021
- Price: over $10 / patch / day at peak
- P1b study completed with success in USA
- P2 study will be started in 2024
- Execution of mutual termination and settlement agreement with Cipla Tech
- All rights regarding MRX-4TZT return to MedRx
- MRX-4TZTwould like to seek a development / commercial partner globally, especially in USA.
https://www.medrx.co.jp/english/business/iltspipeline/mrx-4tzt/index.html
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Pipeline : “Primary Target is US market”
Product name
Development Code
Drug Formulation
Development
Pre
Clinical
Ph-Ⅰ
Ph-Ⅱ
Ph-Ⅲ
NDA
Launch
MRX-4TZT | Phase 1b has got successful result. |
Spasticity | |
Phase 2 to be prepared | |
(Tizanidine, transdermal, ILTS®) | |
MRX-5LBT “Lydolyte” | |
Neuropathic Pain | Receipt of CRL in July 2024 |
(Lidocaine, topical, ILTS®) | |
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®) | |
Alto-101 | |
Schizophrenia | Phase 2 study on-going |
(a PDE4 inhibitor) | |
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MRX-5LBT “Lydolyte”: Target
- Targeted at the market of Lidoderm®(Lidocaine patch, peak sales of over 1USDbn)
- Indication: Postherpetic Neuralgia
- Lidocaine patch market size in US: $193M in 2023 (source:IQVIA)
- Lidodem GEs: 90% share in volume terms, 60% share in value terms
- Differentiating factors to Lidoderm®(+Generic drugs)
- Same level of effects to small amount of Lidocaine (close to 30%)
- Easy to use as formulated in patch style
“Less skin irritation”, “Good adhesion”, “Adhesion when perspiring”
