Immunomedics Inc.'s stock soared 43 percent Monday on news theFDA cleared the company's first product, a monoclonal antibodyfragment for detecting colorectal cancer in combination with standarddiagnostic techniques, such as computed tomography (CT) scans.
Immunomedics, of Morris Plains, N.J., received an approvable letterfrom the FDA for the cancer test, called CEA-Scan, in April 1996,five years after submitting a product license application (PLA) for theimaging agent.
In addition to being Immunomedics' inaugural product, companyfinance director Paul Herron said, "There are several firsts associatedwith this approval.
"It's the first technetium-labeled product approved in the U.S.," hesaid. "It's the first small antibody fragment approved and it's the firstapproval under the FDA's new guidelines," which are designed tospeed clearance of biologics by eliminating the need for approval ofan establishment licensing application (ELA) along with the PLA. AnELA required companies to get approval of manufacturing facilitiesbefore marketing a product.
Immunomedics' stock (NASDAQ:IMMU) jumped $3.62 Monday toclose at $12.
CEA-Scan is an in vivo imaging agent composed of a monoclonalantibody fragment labeled with technetium-99m for detection of thecarcinoembryonic antigen (CEA), which is expressed by colorectalcancer cells and those of many other tumors.
Immunomedics also is evaluating CEA-Scan as a diagnostic in PhaseIII trials for lung cancer. Another Phase III study for breast cancer isexpected to start soon.
A humanized monoclonal antibody to CEA is nearing completion ofpreclinical trials for treatment of cancers. The therapy would involveusing the antibody to carry a toxic radioisotope directly to cancercells to shrink the tumor.
Clinical trial findings to support the PLA for the CEA-Scancolorectal cancer test demonstrated the imaging agent can detectcancer cells the CT scan misses, such as malignancies that havemetastasized.
In conjunction with the standard diagnostic tools, CEA-Scan, Herronsaid, gives physicians the ability to better assess the benefits ofsurgery for cancer patients and avoid unnecessary operations. It alsois expected to reduce reliance on biopsies and laparotomies to detectthe cancer and extent of its spread.
In 1994, Immunomedics received a non-approvable letter from theFDA for CEA-Scan, but the agency several months later agreed to re-evaluate the marketing application.
Herron said he could not estimate the potential market for CEA-Scanor the company's anticipated first year sales. CEA-Scan will sell inthe range of $500 to $700 for a single test and will be available thisfall.
Immunomedics, which has U.S. and European marketing agreementsfor the product with Mallinckrodt Group Inc., of St. Louis, completeda $10 million equity financing last week with international investorsto help launch CEA-Scan. Immunomedics ended the first quarter ofthis year with $21.8 million and a three-month net loss of $3.4million.
In the U.S., 134,000 new cases of colorectal cancer are diagnosedannually and 55,000 people are killed each year by the cancer. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.