【Pharmaceutical Network Enterprise NewsRecently, Ipsen, a leading pharmaceutical company, announced its financial results for the first half of the year. In constant currency, its total sales growth rate was 9.5% (reported at 8.0%). The growth was driven by two factors: the performance increase of Cabometyx® (Cabozantinib) and Dysport® (Botulinum Toxin Type A), as well as the contributions from Bylvay® (Odevixibat) and Onivyde.
According to reports, Cabometyx® was approved for marketing in the United States as early as 2012 for the treatment of medullary thyroid cancer. It has now been approved for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, medullary thyroid cancer, metastatic colorectal cancer, renal cell carcinoma, and other types of cancers. In 2023, the drug's sales reached approximately $1.629 billion.
Gysmo® is a highly purified botulinum toxin protein that has been widely used in many countries around the world. Its advantages include fast onset, long duration, high safety, and low resistance.
BYLVAY® is an oral, once-daily, non-systemic ileal bile acid transporter (IBAT) inhibitor. On July 16, 2021, BYLVAY® was approved by the European Medicines Agency (EMA) for the treatment of patients aged 6 months and older with progressive familial intrahepatic cholestasis (PFIC). On July 20, 2021, it received approval from the U.S. FDA for the treatment of pruritus in patients aged 3 months and older with progressive familial intrahepatic cholestasis (PFIC). On August 13, 2021, the Boao Lecheng WeHealth Rare Disease Clinical Medical Center successfully introduced BYLVAY® for the treatment of "progressive familial intrahepatic cholestasis" in China.
Onivyde is a liposome-encapsulated chemotherapy drug, mainly used for the treatment of pancreatic cancer. In 2022, Ipsen announced that the Phase III clinical trial NAPOLI3 of Onivyde + 5-FU/LV as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (MPDAC) had reached its primary endpoint, showing a significant extension in overall survival (OS) compared to the control group. It also achieved key secondary endpoints, with progression-free survival (PFS) significantly prolonged. Additionally, the combination of Onivyde with oxaliplatin, fluorouracil, and leucovorin has been approved by the U.S. FDA as a first-line treatment regimen for adult metastatic tumors. This marks the second approval of an Onivyde regimen for metastatic pancreatic cancer following the FDA's 2015 approval of Onivyde combined with fluorouracil and leucovorin for treating disease progression after gemcitabine-based therapy.
Ipsen's core operating profit margin for the first half of 2024 was 32.4% of total sales, a decrease of 1.6 percentage points, mainly due to the acceleration of R&D investment. The operating profit margin under International Financial Reporting Standards (IFRS) remained unchanged at 19.2%.
Currently, the company has raised its financial guidance for 2024: total sales growth of more than 7.0% at constant exchange rates (previous guidance: total sales growth of >6.0% at constant exchange rates). Based on the average exchange rate level in June 2024, it is expected that exchange rates will have an adverse impact of approximately 1% on total sales; the core operating profit margin will exceed 30.0% of total sales (previous guidance: approximately 30%).
Recently, there has been a constant flow of updates on the company’s R&D pipeline, including: the accelerated approval by the U.S. FDA of Iqirvo 80 mg tablets for use in combination with Ursodeoxycholic Acid (UDCA) to treat Primary Biliary Cholangitis in adult patients with an inadequate response to UDCA; the expansion of collaboration with Exelixis, Inc. and extension of the licensing agreement to develop Cabometyx® (Cabozantinib) for the treatment of advanced pancreatic neuroendocrine tumors and advanced non-pancreatic neuroendocrine tumors; and the announcement of a licensing agreement with Foreseen Biotechnology for FS001, an antibody-drug conjugate with first-in-class potential.
Public information shows that Ipsen is an international biopharmaceutical group dedicated to drug innovation and specialty treatments. The group researches and commercializes innovative drugs in three key therapeutic areas: oncology, neuroscience, and rare diseases. Its commitment to the field of oncology is reflected in the continuous expansion of its critical treatment portfolio in prostate cancer, neuroendocrine tumors, renal cell carcinoma, and pancreatic cancer.
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