Business Services Industry
E-Z-EM Inc. Proceeding With Plans To Market New MRI Contrast Agent
Business Wire, Jan 7, 1997
WESTBURY, N.Y.--(HealthWire)--Jan. 7, 1997--
Approvable Letter From FDA On New Drug Application Received By Manufacturer of GADOLITE(R) Oral Suspension
E-Z-EM Inc. (AMEX: EZM.A and EZM.B) today announced that Pharmacyclics Inc., the manufacturer of GADOLITE(R) Oral Suspension, has received a letter from the Food and Drug Administration indicating that its New Drug Application for use of the product as an MRI contrast agent to enhance delineation of the bowel is approvable. GADOLITE(R) is to be marketed in North America and Europe by E-Z-EM, who will share profits on net sales of the product with Pharmacyclics. The FDA letter is approvable subject to the submission by Pharmacyclics of additional information and final product labeling, and review and approval of that filing by FDA. The product was recently approved by the Medicines Control Agency for sale in the United Kingdom.
"Use of GADOLITE(R) as a bowel marker has been shown to improve bowel visibility and the diagnostic quality of MRI pelvic and abdominal procedures," said E-Z-EM's President and CEO, Daniel R. Martin. "In clinical trials, GADOLITE(R) permitted radiologists to distinguish the gastrointestinal tract from surrounding tissues, which is critical for improving the certainty of diagnosis under Magnetic Resonance Imaging, E-Z-EM should be able to leverage its 34 years' experience marketing contrast agents worldwide to successfully promote GADOLITE(R) in our North American and European markets," said Martin.
Dr. Andrew A. Zwarun, E-Z-EM's Vice President of MRI added that, "E-Z-EM was the first company to develop and commercialize MR-compatible interventional devices, such as biopsy needles. An MRI bowel marker such as GADOLITE(R) that will enhance the conspicuity of lesions and diseases in the body cavity should also provide a synergy for increasing interventional MRI procedures and the use of our MR-compatible devices."
GADOLITE(R) Oral Suspension consists of a synthetic crystalline compound formulated as an aqueous, orange-flavored suspension. Gadolinium, a member of the lanthanide series of metals that exhibits powerful magnetic properties, and water molecules are held together in a crystalline lattice structure. The inert agent gives an intense MRI signal and, when the stomach and intestines are filled, provides more definitive differentiation of the GI tract from adjacent tissues. Without such a contrast agent, bowel fluid in the GI tract can mimic tumors or other diseases.
Pharmacyclics Inc., headquartered in Sunnyvale, Calif., is developing patented pharmaceutical products to facilitate and improve existing treatments for certain cancers, atherosclerosis and other diseases and to improve existing diagnostic imaging procedures. These proprietary products are based upon small molecules that bind metals in a unique way and are capable of capturing and focusing forms of energy used in a variety of medical applications.
E-Z-EM Inc., is the world leader in developing and manufacturing contrast agents for gastrointestinal radiology. Headquartered in Westbury, New York, E-Z-EM had fiscal 1996 sales of $92 million. The Company's common stock trades on the American Stock Exchange under the symbols EZM.A and EZM.B. For additional information on E-Z-EM, including a copy of our latest Annual Report, please contact Frank Kerrigon at 1-800-544-4624, ext. 325. For additional information, consult the E-Z-EM corporate web site at www.ezem.com.
The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from the Company's expectations. In addition to the matters described in this release, future actions by the Food and Drug Administration, results of pending or future clinical trials, as well as the risk factors listed from time to time in the Company's SEC reports, including but not limited to, its report on Form 10-Q for the quarter ending Aug. 31, 1996, as well as its Annual Report on Form 10-K, may affect the actual results achieved by the Company.
CONTACT: Andrew A. Zwarun
Vice President - MRI
1-800-544-4624, ext. 329
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