ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma announced that China's NMPA has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® for treating adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This marks the first non-platinum treatment approved in China for this condition in nearly 40 years.

The approval is based on the Phase 3 EV-302 trial results, which showed significant improvements in survival outcomes. The treatment combination achieved a median overall survival of 31.5 months compared to 16.1 months with chemotherapy, representing a 53% reduction in death risk. Additionally, the median progression-free survival was 12.5 months versus 6.3 months with chemotherapy, showing a 55% reduction in cancer progression or death risk.

This approval addresses a significant medical need in China, where over 92,000 people were diagnosed with bladder cancer in 2022, resulting in approximately 41,000 deaths.

Astellas Pharma announced that China's NMPA has approved VYLOY™ (zolbetuximab) for first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma. The approval is specifically for HER2-negative patients whose tumors are claudin (CLDN) 18.2 positive, in combination with chemotherapy.

The approval is supported by Phase 3 GLOW and SPOTLIGHT trials, which showed significant improvements in survival rates. In the GLOW trial, median progression-free survival was 8.21 months with zolbetuximab plus CAPOX versus 6.80 months with placebo. Overall survival was 14.39 versus 12.16 months. The SPOTLIGHT trial showed similar improvements.

This approval is particularly significant as China has the highest number of gastric cancer cases globally, with over 260,000 deaths in 2022. The drug targets CLDN18.2, a biomarker expressed in 35% of Chinese patients with advanced gastric cancer.

Astellas Pharma US has launched 'Cooler Moments' in partnership with Dr. Jen Ashton to address menopausal hot flashes and empower women's health advocacy. The initiative focuses on educating women about moderate to severe vasomotor symptoms (VMS) and available treatment options.

The campaign features Dr. Ashton hosting a video series to debunk menopause myths and discuss VEOZAH, a first-of-its-kind, FDA-approved, hormone-free treatment for reducing moderate to severe hot flashes and night sweats due to menopause. The program includes personal testimonials and aims to encourage open dialogue between women and healthcare providers about menopause management.

Astellas Pharma US has partnered with Desert Oasis Healthcare (DOHC) to pilot DIGITIVA™, a non-invasive digital health solution for heart failure management. DIGITIVA combines the CORE 500™ Digital Stethoscope with a smartphone app featuring AI-driven coaching and educational resources. The system provides clinicians with patient reports highlighting cardioacoustic biomarkers and physiological parameters to enable earlier intervention. The partnership will evaluate DIGITIVA's effectiveness through clinical measures, cost metrics, and patient quality of life assessments using the Kansas City Cardiomyopathy Questionnaire. DIGITIVA received FDA listing in September 2024.

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.