Astellas Completes Acquisition of Propella Therapeutics

TOKYO – WEBWIRE

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) announced today that it has completed the acquisition of Propella Therapeutics, Inc. (President and CEO: William Moore, Propella), and has become a wholly owned subsidiary of Astellas as of U.S. Eastern Time December 21, 2023.

Through the acquisition of Propella, Astellas has acquired PRL-02 (abiraterone decanoate), a next-generation androgen biosynthesis inhibitor being developed by Propella to treat prostate cancer. PRL-02 is a novel, long-acting prodrug* of abiraterone that, following intramuscular injection, is expected to achieve high concentrations in target tissues where the active moiety, abiraterone, is continuously released. PRL-02 may provide improved efficacy and safety compared to existing treatment options by high CYP17 lyase inhibition selectivity. PRL-02 is currently in a Phase 1 clinical trial and is expected to enter Phase 2a clinical trials in 2024.

Under the agreement, Astellas paid approximately US $175 million to acquire all of the outstanding common stock and equity interests in Propella.

The impact of this transaction on Astellas financial results in the fiscal year ending March 31, 2024, will be limited.

* Prodrug: drugs with increased bioavailability by utilizing metabolic reactions in the body

About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on managements current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

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Astellas Completes Acquisition of Propella Therapeutics

Astellas and PeptiDream Enter into Research Collaboration and License Agreement to Discover Novel Targeted Protein Degraders

TOKYO and KANAGAWA – WEBWIRE

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) and PeptiDream Inc. (TSE: 4587, President and CEO: Patrick C. Reid, PeptiDream) today announced a research collaboration and license agreement to discover novel protein degraders for two targets selected by Astellas. Under the agreement between the two companies, Astellas will have the option to select up to three additional targets to be included in the collaboration.

Astellas focuses on targeted protein degraders directed to undruggable targets that are difficult to approach with conventional technologies. Under the terms of the agreement, the companies plan to combine PeptiDreams PDPS (Peptide Discovery Platform System) technology*1 with Astellas drug discovery capabilities to discover multiple next-generation protein degraders targeting diverse targets that go beyond existing technologies. Astellas will be responsible for the development and commercialization of products created from this collaborative research.

Astellas will provide PeptiDream with an upfront payment of 3.0 billion. PeptiDream is eligible to receive discovery, development and commercial sales milestones of up to 20.6 billion per target. PeptiDream is also eligible to receive single-digit percent royalty payments on net sales of any products arising from the collaboration.

Adam Pearson, Chief Strategy Officer, Astellas
Targeted Protein Degradation is one of the Primary Focuses of Astellas*2. We hope this collaboration will bring synergies between the two companies cutting-edge research and will ultimately lead to the expansion of Astellas portfolio and development of new therapeutics for patients with significant unmet medical needs.

Keiichi Masuya, Chief Operating Officer, PeptiDream
This transaction further validates the potential of our PDPS technology to obtain highly selective peptides, which enables creative approaches in the area of targeted protein degraders. We believe that through this research collaboration, we can leverage the strengths of both companies to advance the development of innovative drugs.

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Astellas and PeptiDream Enter into Research Collaboration and License Agreement to Discover Novel Targeted Protein Degraders

Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers

TOKYO – WEBWIRE

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japans Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.

Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer, said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. Astellas submission of a New Drug Application to Japans Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan.

The NDA is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

In both SPOTLIGHT and GLOW, approximately 38% of patients screened for the trials had tumors that were CLDN18.2-positive (≥75% of tumor cells with moderate-to-strong membranous CLDN18 staining intensity), as determined by a validated immunohistochemistry assay.1,2

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Astellas Submits New Drug Application for Zolbetuximab in Japan

Japan – Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging

Astellas Pharma Inc. (TSE: 4503), Eisai Co., Ltd. (TSE: 4523), Daiichi Sankyo Company, Limited (TSE: 4568) and Takeda Pharmaceutical Company Limited. (TSE: 4502/ NYSE:TAK) today announced that the four companies have agreed the collaboration to reduce environmental burden in the field of pharmaceutical packaging.

Based on the agreement, the four companies will aim to promote the use of more environmentaly friendly packaging for pharmaceutical products by sharing knowledge on packaging technologies to reduce environmental burden, such as blister packs made of biomass-based plastic instead of petroleum-derived plastic, compact packaging, recycled packaging materials, and recyclable packaging materials.

Astellas, Eisai, Daiichi Sankyo, and Takeda aim to ensure that society benefits from this collaboration to harmonize corporate activities with the global environment. In the future, the four companies expect to expand this collaboration beyond the four companies by calling on other companies in order to reduce further environmental burden.

Initiatives for Sustainability (Environment) of Each Company

Astellas has set “Deepen our engagement in sustainability” as one of the strategic goals in its Corporate Strategic Plan 2021. The reduction of environmental burden is one of Astellas’ priority themes within sustainability. For more information on specific initiatives, please visit our website.

Eisai established the “Eisai Environmental Management Vision” this fiscal year, and in addition to climate change countermeasures aimed at achieving carbon neutrality by fiscal 2040, Eisai has formed a medium- to long-term plan for environmental issues including efficient use of water and recycling of resources, and will work to further advance these efforts. To learn more about our environmental initiatives, please visit our website.

As a healthcare company with the Purpose “to contribute to the enrichment of quality of life around the world,” Daiichi Sankyo considers global environmental conservation, which is the basis of life and livelihood, as a key management issue (Materiality) and promotes environmental management. For more information on specific initiatives, please visit our website.

At Takeda, “Purpose-led Sustainability” is about creating both business and societal value through its core business. Takeda continues to reduce our operational carbon footprint and are now committed to achieving net-zero GHG emissions for scopes 1 and 2 before 2035 and for Scope 3 before 2040. For more information, see our Annual Integrated Report.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en.

About Eisai

Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter @Eisai_SDGs

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world- class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit www.daiichisankyo.com.

About Takeda

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit www.takeda.com.

Contacts for inquiries or additional information:

Astellas Pharma Inc.
Corporate Advocacy & Relations
+81 3 3244 3201

Eisai Co., Ltd.
Public Relations Department
+81 3 3817 5120

Daiichi Sankyo Co., Ltd.
Corporate Communications Department
+81 3 6225 1126

Takeda Pharmaceutical Company Limited Global External Corporate Communications
+81 3 3278 2314


Sectors: BioTech

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