Cytogen files PLA for ProstaScint MoAb agent

Firm inks deal with Du Pont for Samarium

Cytogen is a company on the comeback trail. The monoclonal antibodydeveloper had a bruising 1994, with sales of its OncoScint CR/OVproduct below expectations, its marketing relationship with KnollPharmaceutical on the rocks and a sibling spat with sister companyCytoRad distracting its product development efforts.

Things have changed in recent months. While OncoScint salesare still flat, the company is moving additional products closerto market, has inked a distribution deal with Du Pont and hassettled a class-action lawsuit. Cytogen's stock was even recommendedby an analyst who said in December that its share price couldclimb "dazzlingly higher."

And in a major milestone, the Princeton, NJ, company fileda product license application (PLA) in January for ProstaScint,a monoclonal antibody-based imaging agent developed to detectthe presence and extent of prostate cancer. ProstaScint was formerlyknown as OncoScint PR, but on the advice of the FDA, the product'sname was changed to ProstaScint to differentiate it from OncoScintCR/OV.

Cytogen believes that the market potential of ProstaScint islarger than that of OncoScint.

"There are more points for management of prostate cancerat which imaging would be useful," according to Thomas McKearn,Cytogen president. "It is lower dose and lower HAMA (humananti-mouse antibody) than OncoScint. The various places wherewe could improve (relative to OncoScint), we did."

Cytogen hopes that the FDA's review of ProstaScint will gomore quickly than that of OncoScint CR/OV, which took three yearsand three months, McKearn said.

With regard to OncoScint, Cytogen has officially ended itssales and marketing relationship with Knoll Pharmaceutical andis in "substantive talks" with a potential new partner,McKearn said. Cytogen agreed to pay Knoll $3 million over fouryears to reacquire rights to OncoScint. Knoll agreed to pay Cytogen$5 million over four years for expenses incurred under the agreement.

Cytogen has applied for FDA approval for repeat administrationsof OncoScint. FDA approval is needed for repeat doses becauseof concerns about HAMA response. Cytogen plans to relaunch OncoScintwhen repeat dosing approval is granted. Sales of OncoScint in1994 were about the same as in 1993, according to the company.

In the therapy arena, Cytogen signed a deal in December withDu Pont Merck Pharmaceutical for U.S. manufacturing and marketingof Samarium 153 EDTMP, a therapy agent for treatment of patientswith bone cancer. Du Pont paid Cytogen a $1 million up-front payment,bought $4 million in Cytogen stock, and contributed $4 milliontoward additional clinical research to expand the use and marketingof Samarium. Du Pont also agreed to pay Cytogen $2 million onSamarium's receipt of FDA approval. Cytogen is working on filinga new drug application (NDA) for the product.

Finally, Cytogen's proposal to acquire sister company CytoRadis before the Securities and Exchange Commission. CytoRad wasformed to fund Cytogen R&D, but the two companies began feudinglast year over their business relationship (SCAN 6/29/94 and 4/20/94).Cytogen hopes to have final approval on that deal by the end ofthis month.

McKearn said Cytogen is on track with a business plan the companyimplemented in 1993 after OncoScint failed to produce heavy salesvolume. That plan included a painful restructuring and the abandonmentof some products in its R&D pipeline (SCAN 10/6/93).

"We are very much on the plan that we laid out for ourselvesto address what we saw as some of the deficiencies in our ownperformance," McKearn said. "We had to take some toughsteps to fix those problems."