Immunomedics Inc. has received an approvable letter for itscolorectal cancer imaging diagnostic and a U.S. marketing partner.

CEA-Scan, an in vivo diagnostic containing an antibody fragmentagainst the carcinoembryonic antigen (CEA) tumor marker, will bethe first product for the Morris Plains, N.J., company. Last Octoberthe FDA's Oncologic Drugs Advisory Committee deferred arecommendation on CEA-Scan, saying the product might be moresuitable for review by the Medical Imaging Advisory Committee.That panel recommended approval in February. (See BioWorldToday, Feb. 16, 1995, p. 1.)

Specifically, the product was deemed approvable for use inconjunction with standard diagnostic evaluations for detecting thepresence, location and extent of recurrent and/or metastatic colorectalcarcinoma involving the liver and extrahepatic abdomen and pelvis inpatients with histologically confirmed disease. Final approval iscontingent mostly on final labeling issues.

The same product is in a Phase III trial for non-small cell lung cancerand Phase II studies for breast cancer.

Immunomedics also put in place a marketing and distributionagreement for CEA-Scan with the Mallinckrodt Group Inc., of St.Louis, which will market, sell and distribute the product on aconsignment basis. Immunomedics already had a deal withMallinckrodt Medical B.V., a Petten, the Netherlands, unit ofMallinckrodt, for marketing the product in Western Europe and partsof Eastern Europe. That European deal is more of a traditionallicensing arrangement.

Paul Herron, director of finance for Immunomedics, saidMallinckrodt will commit financial resources to marketing anddistribution of CEA-Scan, and Immunomedics will participate in themarketing. He said guidance from Mallinckrodt, which has expertiseand presence in the nuclear medicine and oncology areas, will be abig help. n

METRA BIOSYSTEMS RAISES $27M IN SECONDARYOFFERING

By Jim Shrine

Metra Biosystems Inc.'s already strong cash position was boosted bya secondary offering of two million shares Tuesday that grossed $27million for the Mountain View, Calif., company. Company officialssaid the stock was an easy sell.

Metra had $30.2 million on Dec. 31, 1995 _ the end of its secondquarter, and lost $2.7 million in that six-month period. Revenueswere $3.5 million. The shares sold at $13.50, the same price the stock(NASDAQ:MTRA) closed at Tuesday. The company went public inJune 1995 at $10 per share.

Metra has three Pyrilinks bone-resorption products on the market andAlkphase-B, an assay for helping in the management of Paget'sdisease of the bone.

"The secondary we went through and the road show itself was quiteextraordinary," Metra President and CEO George Dunbar said. "Wehad a very good reception from our shareholders, which was reflectedin the fact the deal was significantly oversubscribed."

He attributed the interest to investors' confidence that the companywill do what it says it is going to do.

"Metra has met and delivered every single milestone we've laid out;we've gotten our FDA clearances in the time frames suggested; andwe've launched products according to the timelines promised,"Dunbar said. On the road show Metra also talked about three newcollaborations, and that the company's revenue performance remainson track.

"We're forecasting we're going to hit break-even and begin to gocash-flow positive in late 1997," Dunbar said.

In January Metra completed the acquisition of Beaverton, Ore.-basedOsteo Sciences Corp., a private company that uses ultrasoundtechnology in developing hand-held products that evaluate bonecharacteristics associated with weakness. That deal was done for $10million in Metra stock.

Dunbar said the launch of an ultrasound machine for bone diagnosticsis expected later this year. Next year the company plans to introducea cartilage test for arthritis. n

UROCOR, DIATIDE PROPOSE INITIAL PUBLIC OFFERINGS

By Jim Shrine

Two diagnostics companies that have been around awhile are underregistration for initial public offerings.

Diatide Inc., formerly Diatech Inc., is proposing the sale of 2.5million shares at $10 to $12 each. And UroCor Inc., which hassignificantly changed it focus since its founding in 1985, filed to sell2.8 million shares at $8 to $10.

UroCor, of Oklahoma City, originally was involved in machine-driven testing of bladder cancer. The company changed direction afew years later with a broader focus on urology diagnostics.

In 1995 UroCor had a net income of $533,000, its first profitableyear, on sales of nearly $20 million. The company providesdiagnostic services and information products to urologists, primarilyin the bladder and prostate cancer areas. UroCor is in the process ofscaling up a therapeutics division to leverage its existing urology-based sales force.

After the offering the company will have 9.4 million sharesoutstanding. Its cash position at the end of March 1996 was $1.3million. San Francisco-based companies Montgomery Securities andVolpe, Welty & Co. are underwriting the offering, and have anoption on 420,000 additional shares.

Diatide, of Londonderry, N.H., uses peptide and radio-labelingtechnologies in nuclear medicine imaging procedures. The company,founded in 1990, has six products in development, five of which arebased on Techtides, or technetium-99m labeled synthetic peptides forimaging conditions such as deep vein thrombosis, infections andtumors. It also is developing a therapeutic product for bone painpalliation.

After the offering Diatide will have 10.5 million shares outstanding.The New York firms Dillon, Read & Co. Inc. and Oppenheimer &Co. Inc. are underwriting the offering, and have an option on anadditional 375,000 shares. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.