ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

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.

Astellas Pharma Inc. (TSE: 4503) will present data on VEOZAH™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, at the 2024 Annual Meeting of The Menopause Society in Chicago. The presentations will include:

1. Pooled analyses from SKYLIGHT™ studies on sleep disturbance and mood improvements
2. Safety and tolerability data in Hispanic/Latina women from three SKYLIGHT™ studies
3. Responder analysis from DAYLIGHT™ study on VMS frequency reduction in women unsuitable for hormone therapy

The data will highlight VEOZAH's efficacy as a nonhormonal treatment for VMS, commonly known as hot flashes and/or night sweats. Additional research on VMS experiences among Black or African American women will also be presented.

Astellas Pharma Inc. (TSE: 4503) announced that the European Commission has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of adult patients with unresectable or metastatic urothelial cancer. This approval is based on the Phase 3 EV-302 trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-containing chemotherapy. The combination nearly doubled median overall survival to 31.5 months versus 16.1 months with chemotherapy, representing a 53% reduction in death risk. It also extended median progression-free survival to 12.5 months compared to 6.3 months with chemotherapy. This approval aligns with updated clinical guidelines from European medical associations and follows similar approvals in the U.S.

Astellas Pharma has initiated the HIGHLIGHT 1™ Phase 3 clinical study for fezolinetant, an investigational oral, nonhormonal compound aimed at treating moderate to severe vasomotor symptoms (VMS) in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy. VMS, including hot flashes and night sweats, affect up to 97% of breast cancer patients and are a major side effect of adjuvant endocrine therapies. The study is significant as there are currently no approved treatments for moderate to severe VMS in this patient population. Breast cancer is the most common cancer in women globally, with about 2.3 million new cases in 2022, and approximately 77% of breast cancers can be treated with adjuvant endocrine therapies.

Astellas Pharma Inc. announced that China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) for treating adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have previously received platinum-based chemotherapy and PD-1/L1 inhibitors. The approval is based on the global EV-301 and China EV-203 trials, which showed significant improvements in overall survival and objective response rate, respectively.

This approval provides a new treatment option for la/mUC patients in China, where over 92,000 people were diagnosed with bladder cancer in 2022. The EV-203 trial met its primary endpoint, demonstrating a statistically significant objective response rate of 37.5% in Chinese patients. The efficacy and safety data from this trial are consistent with global findings.

Astellas Pharma has received a positive CHMP opinion for zolbetuximab, a first-in-class CLDN18.2-targeted monoclonal antibody, in combination with chemotherapy for the treatment of advanced gastric and gastroesophageal junction cancer. If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy available in the EU. The recommendation is for adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2 positive.

The positive opinion is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials. A decision on EU marketing authorization is expected by October 2024. Gastric cancer is the sixth most common cause of cancer-related mortality in Europe, with over 135,000 new cases diagnosed in 2022.

Astellas Pharma Inc. (TSE: 4503) has received a positive opinion from the CHMP recommending approval of PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of advanced bladder cancer. This recommendation is based on the Phase 3 EV-302 clinical trial results, which showed the combination nearly doubled median overall survival compared to platinum-containing chemotherapy. The trial demonstrated a median OS of 31.5 months for the combination versus 16.1 months for chemotherapy, representing a 53% reduction in risk of death. If approved, this combination will be the first alternative to platinum-containing chemotherapy for unresectable or metastatic urothelial cancer. The European Commission will now review the positive opinion for potential approval in the EU and associated countries.