Cosette Pharmaceuticals has launched Prochlorperazine Edisylate injection, marking its first injectable product introduced in the U.S.. This product is the generic version of Compazine® Injection, with an annual sales estimate of approximately $15M as of December 2021. The launch aligns with the company's strategy to diversify its offerings and enhance its portfolio, complemented by the recent acquisition of eight branded products from Daiichi Sankyo. Prochlorperazine is primarily used for severe nausea and vomiting and for treating schizophrenia.
The pivotal DESTINY-Breast04 phase 3 trial demonstrated that ENHERTU® (trastuzumab deruxtecan) significantly improves progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer, compared to standard chemotherapy. This trial is historic as it marks the first HER2 directed therapy to show benefits in this patient group, potentially redefining breast cancer treatment classifications. Both Daiichi Sankyo and AstraZeneca are planning global regulatory submissions based on these promising results.
Cosette Pharmaceuticals has acquired the US sales and distribution rights to eight branded cardiovascular products from Daiichi Sankyo. This strategic move expands Cosette's portfolio, which now includes over 45 commercial products. The transition, lasting 30 months, will see both companies manage the integration of these products, which generated approximately $123 million in US annual sales as of November 2021. Cosette aims to strengthen its market position while ensuring continued access to these vital medications for patients.
Daiichi Sankyo has entered an agreement with Cosette Pharmaceuticals for the divestiture of rights to several U.S. medications, including AZOR and BENICAR. This move aligns with Daiichi's strategy to focus on patented drugs and oncology, aiming to become a top 10 global leader in oncology by 2030. The transition will take 30 months, ensuring that legacy medicines remain accessible to patients. No layoffs are anticipated at Daiichi as a result of this agreement.
The phase 3 DESTINY-Breast03 trial presented at ESMO Symposium highlighted ENHERTU's superior efficacy in previously treated HER2 positive metastatic breast cancer. ENHERTU showed a 72% lower risk of progression/death compared to T-DM1, with a median progression-free survival (PFS) not reached versus 6.8 months for T-DM1. Nearly 94% of ENHERTU patients survived one year. The trial also indicated a strong trend in overall survival (OS). Updated DESTINY-Breast01 results showed a median OS of 29.1 months with ENHERTU and consistent safety profiles.