Demand for angiography is booming in the U.S., according to Epix Medical. The Cambridge, MA, developer of an MR angiography agent now in review at the FDA is banking on it staying that way.In a teleconference April 29, the company's chief executive
Demand for angiography is booming in the U.S., according to Epix Medical. The Cambridge, MA, developer of an MR angiography agent now in review at the FDA is banking on it staying that way.
In a teleconference April 29, the company's chief executive described strong growth in the diagnostic angiography market, where total procedures increased last year by 12%. Between 2000 and 2003, the compound annual growth rate for cerebral, carotid, and peripheral angiography was 24%, according to Michael D. Webb, Epix president and CEO, who cited data compiled by Arlington Medical Resources (AMR).
MRA procedures in the U.S. increased last year from 2.2 million to 2.6 million, as cerebral and carotid procedures increased by 260,000 and peripheral vascular exams increased by 140,000. All these were conducted off-label, Webb said, as the agents typically used in MR angiography are FDA-approved for uses only in the central nervous system.
"We are convinced that after FDA approval, MR angiography with MS-325 will be an attractive alternative to x-ray angiography and current MRA exams," he said. "In addition, MS-325 has the potential to expand the MRA market by providing a high-resolution, minimally invasive, and cost-effective method for diagnosing vascular disease."
AMR data indicate that 4.6 million of the 8.4 million angiography procedures conducted in the U.S. last year involved x-ray angiography (XRA). About 2.6 million involved MR, and another 1.2 million in-volved CT.
MR had its greatest utility in cerebral and carotid imaging, in which some two million procedures were performed, easily outdistancing CTA, which registered 0.2 million, and XRA, which accounted for 0.5 million. In peripheral imaging, MRA accounted for 0.7 million procedures, compared with 1.5 million for XRA and one million for CTA. XRA was the only modality capturing angiographic data of the coronaries, driving 2.6 million such procedures in 2003.
MS-325, also known as gadofosveset, is in review at the FDA for peripheral MRA. The company is conducting clinical trials to assess its utility in coronary angiography. Webb expects that MRA enhanced by MS-325 could expand extensively into angiographic applications now served primarily by x-ray and CT.
"When a reliable, less invasive, and easy-to-use diagnostic tool becomes available, medical professionals generally find that to be attractive," he said. "MRA of the cerebral and carotid arteries, areas where the use of MR is less technically challenging, has followed this pattern."
MS-325 provides a one-hour imaging window for MR angiography. Agents now being used in contrast-enhanced MRA last only seconds, which has limited the value of this technique.
"This longer imaging window should allow visualization of the lumen as well as the vessel walls and existing plaques, providing vivid 3D images," Webb said. "MS-325 also has the potential to be used for imaging multiple vascular beds with one dose in a single imaging session."
MS-325 is still a ways from being commercially available. The company submitted a new drug application (NDA) for this agent in December 2003. The FDA accepted the application within two months but is not expected to draw any conclusions regarding the NDA until mid-October, at the earliest.
During the review process, Epix is "interacting frequently and constructively" with the FDA, according to Webb. One manufacturing facility has been inspected. An inspection at the other should happen sometime in the next few months. The company is further preparing for the product's launch and commercialization in collaboration with its worldwide sales and marketing partner, Schering.
"Epix is an active member of the U.S. launch team, which is driving all key marketing initiatives, such as product positioning, pricing, market research, phase IIIb/4 planning, publications, and reimbursement strategy," Webb said.
Work is also under way to generate the data needed to support an NDA for extended clinical applications. The company plans to initiate Phase II cardiac clinical trials for MS-325 in the second quarter of this year.
Clinical trials could also begin in the second half of 2004 on EP-2104R, which is designed to help visualize blood clots. Schering is participating in the development of this agent. The German maker of imaging agents is also in a research partnership with Epix to discover novel compounds for MR. Schering has an option to the late-stage development and worldwide marketing rights for EP-2104R and for all development candidates emerging from the MRI research collaboration.
During the quarter, Epix received a U.S. patent granting composition-of-matter claims for the chemical structure of MS-325. The patent, entitled Diagnostic Imaging Contrast Agents with Extended Blood Retention, provides protection from duplication by competitors through August 2015. This term might be extended upon FDA approval under the provisions of the Hatch-Waxman Act, according to Webb.
During the teleconference, Webb and CFO Peyton Marshall presented financial results for the first quarter ended March 31, showing a net loss of $3.9 million compared with a net loss of $5.4 million in the year-earlier period. The company generated revenues of $3.6 million in the first three months of 2004 compared with $3.5 million during the same quarter in 2003. Product development revenue increased in regard to the company's other MR agent, EP-2104R. Revenue came from development and research agreements with Schering. Total revenues were partially offset by decreases in MS-325 product development revenue and license fee revenue, as both companies await a decision from the FDA.
Total operating expenses in the quarter were down about 15% to $7.7 million compared with $9 million for 2003. The decrease resulted primarily from reduced research and development costs related to the completion of the phase III clinical trial program for MS-325. This decrease was offset slightly by increased R&D expenses for EP-2104R and MR research and increased general and administrative expenses arising from increased marketing and other corporate expenses. Cash, cash equivalents, and marketable securities totaled $74.9 million as of March 31, 2004.
In a proxy statement issued April 26, the company proposed changing its name to Epix Pharmaceutical. Webb said the time is right for such a change.
"In the imaging and radiology community, companies having the term 'medical' in their names most often are in the hardware, software, or services business," he said. "With our lead imaging pharmaceutical MS-325 approaching commercialization, we believe this to be an opportune time to change our name to clearly identify our business and products as pharmaceuticals."