Prior to the open of U.S. markets yesterday morning, biopharmaceutical firm Merrimack Pharmaceuticals Inc. (MACK:NASDAQ), announced that Ipsen SA (IPN:EPA; IPSEY:OTCMKTS) issued a news release regarding "its primary analysis of the results of its Phase III NAPOLI 3 trial of Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a treatment of first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)."
According to Merrimack Pharmaceuticals, the Ipsen report indicated that during the Phase 3 study, a regimen of Onivyde successfully achieved its primary endpoint by demonstrating "statistically significant improvement in overall survival in previously untreated (mPDAC)."
Additionally, Onivyde met several other key secondary objectives, including improvements in progression-free survival (PFS) and favorable results versus the comparator arm. Ipsen stated that it intends to present the clinical trial results at an upcoming medical conference.
Based upon the data from the trial, Ipsen indicated that it is planning to submit a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for the use of "Onivyde in combination with oxaliplatin plus 5- fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC." The company listed that the FDA granted Fast Track Designation for this particular use in 2020.
Merrimack's Chairman and CEO Gary Crocker commented, "We are encouraged by these results, which indicate progress toward a potential future milestone payment from Ipsen . . . We congratulate the Ipsen team and look forward to continuing to await further public announcements from Ipsen regarding progress with this important program."
Merrimack claims that "it is entitled to receive up to US$450.0 million contingent milestone payments related to its sale of ONIVYDE® to Ipsen S.A. in April 2017."
Ipsen SA's EVP and Head of R&D Howard Mayer remarked, "The positive results from the NAPOLI 3 trial demonstrate that compared with the standard-of-care, the investigational Onivyde treatment regimen extended the lives of people living with metastatic pancreatic ductal adenocarcinoma who were previously untreated…The prognosis for people diagnosed with pancreatic cancer is extremely poor, and we plan to submit these new findings to the regulatory authority as, if approved, we believe this regimen could offer up an important new treatment option for people living with an aggressive and hard-to-treat cancer."
Ipsen explained in its announcement that "PDAC is the most common type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally."
Since the disease does not display noticeable symptoms in the early stages, it is frequently discovered after spreading to other organs and parts of the body. In part due to late discovery, less than 20% of those diagnosed with this form of cancer survive past one year following detection.
The Phase 3 NAPOLI trial is a randomized study of patients that is evaluating an Onivyde treatment regimen in patients diagnosed with metastatic pancreatic ductal adenocarcinoma who have not been previously treated with chemotherapy.
The study included approximately 770 patient subjects who were administered Onivyde plus oxaliplatin and 5 FU/LV twice monthly. Those given the injections were compared with others who had been given an injection of nab-paclitaxel and gemcitabine three times monthly. The primary endpoint in the trial was overall survival. Several other secondary endpoints were considered, including PFS, objective response rate (ORR), and quality of life assessment.
Onviyde is described as a liposomal topoisomerase inhibitor designed to enter and interrupt DNA replication in cancer cells via a naturally occurring process.
Ipsen SA is a global, biopharmaceutical firm headquartered in Paris, France that focuses on the development and commercialization of transformative medicines in the areas of neuroscience, oncology, and rare diseases. The company employs more than 4,500 people worldwide and sells its medicines in over 100 countries. Ipsen has a market capitalization of approximately US$8.4 billion and in FY/21 firm had specialty care sales totaling €2.6 billion (euros).
Merrimack is a biopharma firm based in Cambridge, Mass. The company has no active ongoing operations or employees and is not presently conducting any ongoing research or development activities. Merrimack claims that "it is entitled to receive up to US$450.0 million contingent milestone payments related to its sale of ONIVYDE® to Ipsen S.A. in April 2017."
The milestone payments are tied to Ipsen securing U.S. FDA approval for Onivyde for certain specific clinical indications. Under the terms of the agreement, Ipsen is not obligated to share any information from the clinical trials with Merrimack other than publicly available data.
Previously, the FDA granted approval for Onivyde in combination with fluorouracil (5-FU) and leucovorin (LV) for use in treating patients diagnosed with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Merrimack has another similar outstanding agreement with Elevation Oncology, where it could receive up to another US$54.5 million in contingent milestone payments for selling its anti-HER3 programs in July 2019.
Merrimack Pharmaceuticals started off yesterday with a market cap of around US$53.64 million with approximately 13.41 million shares outstanding. MACK shares opened 215% higher yesterday at US$12.63 (+US$8.63, +215.75%) over the previous day's US$4.00 closing price and reached a new 52-week high price yesterday morning of US$13.66. The stock traded yesterday between US$11.19 and US$13.66 per share and closed for trading at US$12.51 (+US$8.51, +212.75%).
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