ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma Inc. announced FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of advanced gastric and gastroesophageal junction (GEJ) cancer in adults with CLDN18.2-positive tumors. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S.

The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials, which met primary endpoints of progression-free survival and overall survival. Approximately 38% of patients screened had CLDN18.2-positive tumors. An FDA-approved companion diagnostic test from Roche is used to identify eligible patients.

VYLOY is now approved in five markets worldwide, including Japan, the UK, EU, South Korea, and the U.S. Astellas has reflected the impact of this approval in its financial forecast for the fiscal year ending March 31, 2025.

iota Biosciences, a subsidiary of Astellas Pharma, has received FDA approval for an Investigational Device Exemption (IDE) to conduct an Early Feasibility Study (EFS) on a novel implantable bladder device. The device aims to treat underactive bladder (UAB) by delivering electrical stimulation to induce bladder contractions. The FDA granted a staged approval, initially allowing enrollment of three participants, with potential expansion to 10 participants upon successful safety outcomes.

UAB affects up to 28% of men over 50 and 45% of older women with lower urinary tract symptoms. The condition impacts millions worldwide, with current treatment options. This innovative approach could provide an alternative to clean intermittent catheterization, which can be burdensome and risky. The study marks a significant step in Astellas' commitment to expanding treatment options beyond traditional pharmaceuticals through bioelectronic technologies.

Astellas Pharma Inc. announced that VEOZA™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, will be featured in four oral and two poster presentations during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22.

The presentations will cover a range of topics, including:

• Patient-reported sleep outcomes and impact on work productivity from the SKYLIGHT 1 and 2 studies
• Response and quality of life in women treated with fezolinetant who are unsuitable for hormone therapy from the DAYLIGHT study
• Analyses showing no association between fezolinetant treatment and incidence of malignant neoplasm
• Study design for the HIGHLIGHT 1 phase 3 clinical study evaluating fezolinetant for VMS in breast cancer patients

The data presented aims to expand knowledge about fezolinetant beyond pivotal trials, highlighting its safety, efficacy, and positive impact on patient-reported outcomes.

AviadoBio and Astellas Pharma have announced an exclusive option and license agreement for AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development for patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Under the agreement, Astellas will have the option to receive worldwide exclusive license for development and commercialization rights to AVB-101 in FTD-GRN and other potential indications.

Astellas will make a $20 million equity investment and up to $30 million in upfront payments for the option to license AVB-101. AviadoBio is eligible to receive up to $2.18 billion in license fees and milestone payments plus royalties if Astellas exercises its option. The collaboration aims to address the unmet need in frontotemporal dementia, combining AviadoBio's gene therapy candidate and delivery expertise with Astellas' global capabilities in development and commercialization of gene therapies.

Astellas Pharma Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with radically unresectable urothelial carcinoma. This approval is based on the EV-302 clinical trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-containing chemotherapy.

Key findings from the EV-302 trial include:

• Median overall survival: 31.5 months for the combination therapy vs. 16.1 months for chemotherapy
• 53% reduction in risk of death
• Median progression-free survival: 12.5 months for the combination therapy vs. 6.3 months for chemotherapy
• 55% reduction in risk of cancer progression or death

This approval offers an alternative to platinum-containing chemotherapy, the current standard of care for first-line treatment of radically unresectable urothelial cancer in Japan.

Astellas Pharma Inc. announced that the European Commission has approved VYLOY™ (zolbetuximab) in combination with chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. Zolbetuximab is the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer.

Phase 3 clinical trials showed that treatment with zolbetuximab provided statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard of care chemotherapies. The European Marketing Authorization is valid in all 27 EU member states, Iceland, Liechtenstein, and Norway. This approval follows recent approvals in the UK and Japan, with further applications submitted to other regulatory agencies worldwide.

Astellas Pharma Inc. (TSE: 4503) has announced the FDA listing of DIGITIVA™, a non-invasive digital health solution for heart failure management. This Class I Software as a Medical Device (SaMD) is exempt from 510(k) premarket submission and marks Astellas' first digital health offering in the U.S. DIGITIVA comprises three components: the CORE 500™ Digital Stethoscope by Eko Health Inc., a smartphone app built on Welldoc, Inc.'s platform with American Heart Association content, and a dedicated clinical review team.

DIGITIVA aims to place patients at the center of their care, allowing for at-home disease monitoring and facilitating physician intervention when needed. The solution targets the growing heart failure prevalence in the U.S., expected to reach 8.5 million by 2030. Astellas has incorporated the impact of this FDA listing into its financial forecast for the fiscal year ending March 31, 2025.

Astellas Pharma Inc. (TSE: 4503) will present eight abstracts at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, showcasing data from its oncology portfolio and pipeline. Key highlights include:

1. EV-302 study results on enfortumab vedotin with pembrolizumab for first-line treatment of urothelial cancer.

2. Five-year follow-up data from the EV-103 DE/A study on enfortumab vedotin with pembrolizumab in first-line cis-ineligible urothelial cancer.

3. Final pooled overall survival data from SPOTLIGHT and GLOW trials on zolbetuximab plus chemotherapy for gastric/GEJ adenocarcinoma.

4. EMBARK post-hoc analyses on enzalutamide for non-metastatic hormone-sensitive prostate cancer.

5. Phase 1 data on ASP3082, a KRAS G12D protein degrader, and ASP1570, a novel DGKζ inhibitor.

Astellas Pharma Inc. (TSE: 4503) has unveiled its new Astellas Life Sciences Center (ALSC) in Cambridge, Massachusetts. This LEED-certified facility aims to accelerate the discovery of breakthrough therapies through collaboration and innovation. Key features include:

1. The first U.S.-based SakuLab™, an open innovation incubator space for external partners.
2. Home to the Engineered Small Molecules (ESM) unit, focusing on targeted protein degradation research.
3. Workspace for approximately 400 Astellas employees from various departments.
4. Designed to foster collaboration with local academic institutions and biotech innovators.

The ALSC joins Astellas' growing presence in Massachusetts, complementing the Astellas Institute of Regenerative Medicine (AIRM) in Westborough, launched in 2020.