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    4597   JP3436500007

SOLASIA PHARMA K.K.

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Solasia Pharma K K : Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan

06/30/2021 | 02:32am EST

NEWS RELEASE

Solasia Announces Submission of New Drug Application for Anti-cancer Drug

DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan

  • NDA filed in Japan ahead of anywhere else in the world
  • New anti-cancer drug with a novel mechanism of action
  • Darinaparsin is designated Orphan Drug in the US and EU as a treatment of peripheral T-cell lymphoma (PTCL)

TOKYO, JAPAN, June 30, 2021 - Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan,

President & CEO: Yoshihiro Arai, hereinafter "Solasia") today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW). Based on positive results of R&D on darinaparsin, centered primarily on the results of the Asian Multinational Phase 2 Study (study results released in June 2020), Solasia filed an NDA for the drug with the regulatory authority in Japan ahead of anywhere else in the world.

Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year. If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.

Mr. Yoshihiro Arai, President and CEO of Solasia, commented as follows:

"No standard treatment has been established for relapsed or refractory PTCL as of yet. I firmly believe that darinaparsin, with its novel mechanism of action that differs from those of already approved drugs, will contribute to patients and healthcare providers at clinical sites as a new treatment option for relapsed or refractory PTCL. Since founding, Solasia has conducted R&D on five pipeline drugs. Of the five, we have successfully developed and brought to market two drugs, i.e., began providing them to patients, and today, we submitted an NDA for our first anti-cancer drug. Under our mission to provide patients with 'Better Medicine for a Brighter Tomorrow', we will continue aiming to contribute to patients' treatment and enhanced quality of life. "

About darinaparsin (SP-02)

Darinaparsin, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. Darinaparsin is believed to exert anticancer effect by inducing cell cycle arrest and apoptosis. Darinaparsin has been granted orphan drug designation in the US and EU.

For more information, please visit at https://solasia.co.jp/en/pipeline/sp-02.html

About Asian Multinational Phase 2 Study

The Asian Multinational Phase 2 Study was a multinational, multicenter, single-arm,open-label, non- randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in patients with relapsed or refractory PTCL conducted in Japan, Korea, Taiwan, and Hong Kong. (CT.gov Identifier: NCT02653976).

Solasia plans to present the results of the study at an international academic conference to be held in the near future.

About peripheral T-cell lymphoma (PTCL)

PTCL is a type of malignant lymphoma. Malignant lymphoma is largely classified into Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL), and non-Hodgkin lymphoma is further divided into two main categories of B-cell lymphoma and T-cell lymphoma. PTCL is a subtype of T-cell lymphoma with a relatively high incidence rate among other subtypes of T-cell lymphoma. No standard treatment has been established for PTCL, and the National Comprehensive Cancer Network guidelines recommend as front-line treatment participation in clinical trials or multidrug chemotherapy such as CHOP therapy.

1

NEWS RELEASE

For relapsed or refractory PTCL patients, in addition to participation in clinical trials, multidrug chemotherapy or recently approved drugs are recommended. However, as with the newly diagnosed cases, no standard therapy has been established. As prognosis for PTCL may be poor and its treatment difficult, it is one of the diseases with high unmet medical needs for which the development and introduction of new therapies and drugs are much anticipated.

About Solasia

Solasia is a specialty pharmaceutical company based in Asia, with a mission to provide "Better Medicine for a Brighter Tomorrow." To address the unmet medical needs in the oncology field, Solasia develops innovative medicines to contribute to the better health and brighter future of patients. Please visit the company website at https://solasia.co.jp/en/for more information.

###

For further information, please contact:

Solasia Pharma K.K.

Rie Toyoda, Public Relations and Investor Relations,

Tel. +81 3 5843 8049

info@solasia.co.jp

Disclaimer:

The forward-looking statements, including earnings forecasts, contained in this press release are based on information currently available to the Company and on certain assumptions deemed to be reasonable. Such statements should not be construed as representing commitments on the part of the Company. Please be aware that actual performance may differ for a variety of reasons. Major factors affecting the Company's actual performance include the economic conditions in which it operates, exchange rate fluctuations, the competitive situation and other factors. Information contained in this press release is for informational purposes only and should not be considered as investment solicitation. Information with regard to pharmaceuticals and medical devices (including products under development) is not provided for the purposes of advertising or medical advice. We do not have any obligation to update or revise any information in this press release, and any update or revision may occur anytime without notice.

2

Disclaimer

Solasia Pharma KK published this content on 30 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 June 2021 06:31:10 UTC.


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Financials
Sales 2020 454 M 3,96 M 3,96 M
Net income 2020 -4 127 M -36,0 M -36,0 M
Net cash 2020 1 904 M 16,6 M 16,6 M
P/E ratio 2020 -3,30x
Yield 2020 -
Capitalization 13 484 M 118 M 118 M
EV / Sales 2019 13,3x
EV / Sales 2020 27,1x
Nbr of Employees 77
Free-Float -
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Yoshihiro Arai President & Representative Director
Toshio Miyashita CFO, Director & General Manager-Administration
Stanley E. Lau Independent Outside Director
Norikazu Eiki Independent Outside Director
Jiro Mizukawa Independent Outside Director
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