Cambridge, MA-based Merrimack Pharmaceuticals has won FDA approval to market Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, for patients with metastatic pancreatic cancer.
Taiwan's PharmaEngine submitted a New Drug Application to the Taiwan Food and Drug Administration for MM-398 to treat patients with metastatic adenocarcinoma of the pancreas.
With a big corporate split looming ahead, Baxter has stepped in to pick up the ex-U.S. rights to Merrimack Pharmaceuticals' lead cancer therapy, paying $100 million in an upfront fee and committing up to $870 million in additional milestones for the late-stage treatment.
Sanofi is breaking it off with oncology partner Merrimack Pharmaceuticals, handing back full rights to MM-121, a treatment that has three times failed to hit the mark in midstage studies.
Merrimack Pharmaceuticals got roughed up when it went public back in 2012, then took it on the chin--twice--when one of their cancer drugs partnered with Sanofi failed two mid-stage studies. But this morning its stock price sailed up about 90% on the news that its lead drug scored a win in Phase III in a population of patients with advanced pancreatic cancer.
Merrimack Pharmaceuticals and its partners at Sanofi are back with another trial failure to report on the biotech's lead drug, MM-121. Combined with exemestane, the drug failed to improve progression-free survival among a group of ER/PR+, HER2 negative breast cancer patients.
Seven months after a mid-stage cancer drug from Sanofi and Merrimack Pharmaceuticals flunked its first mid-stage test, researchers are back with another failure to report. The Cambridge, MA-based biotech said that MM-121 (SAR256212), partnered with Sanofi in a $530 million deal, failed to hit the primary endpoint on progression free survival for ovarian cancer when combined with Taxol. Once again, though, the investigators are pointing to a subpopulation which benefited from the drug.
Merrimack Pharmaceuticals has nailed down the top-line results for one group of cancer patients in a mid-stage trial of Tarceva combined with its lead drug MM-121, partnered with Sanofi. And it's not good.
After taking a beating in previous years, biotech has been hot sector on Wall Street this year. The Nasdaq Biotech Index has shot up 30% this year compared with 15% growth in the broader market. And the fact that this year's total number of biotech IPOs already matches that of 2011 indicates that there could be a growing appetite for these types of investments. But there's no indication that we're on the verge of, or will ever, return to the go-go years of the 1990s when biotechs more easily went public at lofty values. Here's the full report >>
Supernus Pharmaceuticals came out of the IPO gate this morning, pricing its shares at a hefty discount in order to complete its long-planned effort to go public.