Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

• Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine
• NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine
• Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC

PARIS, FRANCE, 13 February 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

“The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” said Christelle Huguet, EVP and Head of Research and Development, Ipsen. “With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the U.S.”

Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV). Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms, mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year. Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S... Ipsen's Press Release -

Pharnext and Ipsen : exclusive research, development and marketing agreement

Paris (France), 15 June 2009 - The agreement concerns innovative drug candidates issued from the Pleotherapy™ technology intended for the treatment of Charcot-Marie-Tooth disease - Ipsen (Euronext : IPN), an innovation-driven global pharmaceutical Group and Pharnext SAS, a biopharmaceutical company specializing in the development of innovative treatments, announced they have entered into an exclusive research, development and marketing agreement regarding innovative drug candidates intended for the treatment of Charcot Marie-Tooth disease, issued from the Pleotherapy™ technology. According to this agreement, Ipsen has been granted an option to Pharnext programme and subscribes to the issuing of convertible bonds of the company...

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About Ipsen
Ipsen is an innovation-driven international specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,200. Its development strategy is based on a combination of specialty products, which are growth drivers, in targeted therapeutic areas (oncology, endocrinology and neurology), and primary care products which contribute significantly to its research financing. The location of its four Research & Development centres (Paris, Boston, Barcelona, London) and its peptide and protein engineering platform give the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. More than 800 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. This strategy is also supported by an active policy of partnerships. In 2008, Research and Development expenditure was about €183 million, close to 19% of consolidated sales, which amounted to €971 million while total revenues exceeded €1 billion. Ipsen’s shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible to the “Service de Règlement Différé” (“SRD”) and the Group is part of the SBF 120 index.

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About Pharnext
Pharnext is a biopharmaceutical company focused on discovering, developing and licensing new pharmaceutical treatments based on intelligent Pleocompounds™ that form the basis of Pleodrugs™. Pharnext was founded in Paris, France in April, 2007, by Daniel Cohen, MD, PhD, his research group (composed of pioneers in genome science and technology) and Philippe Pouletty, MD (General Partner at Truffle Capital). Thanks to Truffle Capital's founding investment, strong support from OSEO, a grant from AFM (The French Muscular Dystrophy Association) and the benefits of France's research tax credit scheme, Pharnext has developed a new proprietary platform (PleotherapyTM) based on network pharmacology and which may provide a solution for the current 3/3 decline in pharmaceutical pipeline productivity. Pharnext is advised by La Compagnie Financière Edmond de Rothschild... [PDF] Ipsen's Press Release - PDF du communiqué de presse d'Ipsen -

Ipsen, a Biologics License Application (BLA) for Dysport in cervical dystonia

Paris (France), 31 January 2008 - Ipsen (Euronext: FR0010259150; IPN) announced that the Food and Drug Administration (FDA) has accepted the filing of its BLA for Dysport® in the United States to treat patients with cervical dystonia. This acceptance signifies the start of the review process of the dossier... Ipsen's Press Release -