EPIX Medical Inc. filed its first new drug application along with partner, Schering AG, for a blood-pool agent called MS-325 for vascular imaging with magnetic resonance angiography.
Reaching the regulatory filing phase is particularly exciting for EPIX, the Cambridge, Mass.-based company that developed MS-325 from "PowerPoint slide to the FDA," Peyton Marshall, EPIX's chief financial officer, told BioWorld Today.
Indeed, Marshall said EPIX is the first company to seek FDA approval for a magnetic resonance (MR) blood-pool agent designed to stay in the blood, and the first to request approval for an agent used in angiography or magnetic resonance angiography (MRA), a subset of magnetic resonance imaging (MRI).
MR blood-pool agents, a new class of imaging agents, are expected to expand the clinical use of MRIs by giving patients and doctors new ways of diagnosing vascular abnormalities. The gold standard is the X-ray angiography.
"What we are setting out to do is to provide an agent with imaging quality that is every bit as good [as the gold standard] with a better safety profile," Marshall said.
Of its first regulatory filing, Michael Webb, the company's president and CEO, told BioWorld Today the event is an "enormous achievement because this is a molecule that we discovered in our own laboratories in 1994 and we've taken it through the stages of development and submitted the NDA by ourselves. This is an extraordinary achievement for any small company with fewer than 100 people."
Based on FDA history, unless the company receives priority-review status, action on the application likely will take about a year.
MS-325 binds reversibly to human serum albumin, brightening the blood for a prolonged period and allowing doctors to collect more meaningful clinical data using MRI equipment to diagnose and characterize vascular disease, EPIX said.
EPIX and former partner Mallinckrodt Imaging, of Hazelwood, Mo., worked on MS-325 for several years, until Mallinckrodt was purchased by Tyco Healthcare Group, of Mansfield, Mass. (a unit of Tyco International Ltd. & Co.). Marshall said Schering AG, of Berlin, became interested in the EPIX project in 2000, and essentially took over partnership duties while Mallinckrodt stepped aside.
The EPIX-Schering relationship basically is a 50-50 partnership. Marshall declined to discuss specific financial details about the deal. However, he said his company has spent about $85 million over eight years in discovery and development efforts associated with MS-325.
Schering is expected to handle most regulatory issues and sales overseas.
Aside from MS-325, EPIX and Schering are advancing EP-2104R, a thrombus detection product, and developing other new compounds to be used with MRIs. EP-2104R is expected to enter the clinic in 2004. (See BioWorld Today, May 28, 2003.)
Webb said MS-325 and EP-2104R, in addition to several other compounds, are based on the company's RIME, or receptor-induced magnetic enhancement, technology.
The NDA is based on four successful Phase III trials conducted in 83 clinical sites on four continents involving 782 patients. In all four trials, based on blinded interpretation of nearly 4,000 vessels, MS-325 provided significant improvement in diagnostic efficacy compared to non-contrast MRA, and the overall accuracy of MS-325-enhanced MRA was similar to the individual X-ray reader's inter-reader accuracy, the company said.
EPIX's stock (NASDAQ: EPIX) rose 26 cents Tuesday to close at $15.95.