Mixed news on Immunomedics patent

June 9, 2003

Immunomedics has received a patent from the European Patent Officefor its technetium-labeled monoclonal antibody agent for cancerimaging and therapy. In a setback for the Warren, NJ company,however, the office reversed a prior decision that gave

Immunomedics has received a patent from the European Patent Officefor its technetium-labeled monoclonal antibody agent for cancerimaging and therapy. In a setback for the Warren, NJ company,however, the office reversed a prior decision that gave Immunomedicsa broader patent for the use of monoclonal antibodies in cancerimaging.

The more specific patent granted to Immunomedics covers itsImmuRaid-CEA product for colorectal, breast and lung cancer imagingand therapy. The product labels antibodies with technetium totarget carcinoembryonic antigens produced by certain cancers.

Clinical trials for ImmuRaid-CEA have been split into separategroups:

  • The colorectal cancer product has completed phase threetrials and is under review with the Food and Drug Administrationand the Committee for Proprietary Medicinal Products in Europe.

  • ImmuRaid-CEA for breast and lung cancer is in phaseone and two trials in the U.S.

The reversal of the broader patent was based on "priorart," which restricts the granting of a patent if a partyother than the one applying for the patent has published or mentionedthe product for which an application is being made, accordingto Joseph T. Schepers, manager of investor relations for Immunomedics.

The U.S. has a one-year statute of limitations on prior art,according to Schepers, so Immunomedics' North American patentswill not be affected. ImmuRaid-CEA has already received patentsin the U.S. and Canada for colorectal, breast and lung cancerapplications.

With the reversal of the broader patent, Immunomedics willrely on patents for specific products, such as the one just grantedfor ImmuRaid-CEA, to protect its properties. The ImmuRaid-CEApatent is not affected by the reversal.

"We have a number of patents pending for other antibodiesthat we're using (as well as) our methods of labeling the radioisotope,"Schepers said. "Those are key elements of our products."

Immunomedics has signed an agreement with Adria Laboratoriesof Columbus, OH, for sales and marketing of ImmuRaid-CEA in NorthAmerica. Adria is a division of pharmaceutical firm Erbamont,which in turn is owned by the Italian conglomerate Montedison(SCAN 7/31/91).

Immunomedics tried to reach an agreement with Boehringer IngelheimInternational for European marketing, but talks ended withouta final agreement (SCAN 5/22/91 and 2/27/91). Immunomedics isstill negotiating for a marketing partner in Europe. CompetitorNeoRx signed a wide-ranging marketing and manufacturing agreementwith Boehringer Ingelheim last week (see story, page one).

Immunomedics is involved in a patent dispute with NeoRx overproduct licensing for melanoma and small-cell lung cancer agents.Seattle-based NeoRx filed suit against Immunomedics in July 1991,charging breach of contract and patent infringement (SCAN 9/11/91).NeoRx claims that a licensing agreement signed with Immunomedicsfor the melanoma agent allowed it the option to sign similar licenseswith Immunomedics for other products.

NeoRx is also charging that Immunomedics has infringed on NeoRxpatents relating to the direct labeling of proteins used in imagingand therapy. Immunomedics disputes the claims, and the case iscurrently before a federal court in New Jersey.

In other Immunomedics news, Russell C. McLauchlan has resignedas president and COO of Immunomedics for the position of presidentand COO at U.S. Bioscience of West Conshohocken, PA. McLauchlan'sdeparture was a mutual decision, according to Amy Factor of Immunomedics.McLauchlan had been with Immunomedics for two and a half years;he was previously vice president and general manager of LederleLaboratories (SCAN 11/22/89).

The move to U.S. Bioscience gives McLauchlan the opportunityto become more involved in product marketing, he told SCAN. U.S.Bioscience has an ovarian cancer therapy product on the marketand several others in advanced clinical trials. Immunomedics hasyet to bring a product to market.

Immunomedics has selected a new president, but the companyis delaying an announcement because of the candidate's contractualobligations with another company, according to Factor.

BRIEFLY NOTED:

  • MRI contrast developer Metasyn of Cambridge, MA, formedits first strategic alliance last month, which will be targetedat Japan and other Far East markets. Nippon Shoji Kaisha of Osakasigned a $3.5 million agreement to develop and market MRI liveragents based on Metasyn's patented metal ion-chelate technology.

The Japanese medical manufacturer will have exclusive rightsto sell resulting MRI contrast products in Japan and certain othercountries in the region. Sumitomo of Tokyo helped negotiate thealliance. Both firms have taken an equity position in the smallerU.S. developer.

Two-year-old Metasyn signed a licensing agreement last yearwith Massachusetts General Hospital pertaining to certain contrasttechnology developed at MGH since 1983. Metasyn chairman and CEODr. Randall B. Lauffer supervised the initial development workas director of the NMR Contrast Media Laboratory of MGH.

Metasyn's technology surrounds an organic chelator that bindsmetal ions to specific proteins in the body. This binding activatesa magnetic effect that enhances the MRI signal (SCAN 2/13/91).

The world market for MRI contrast amounts to about $285 millionin annual sales, primarily in brain and spine imaging applications.The MRI contrast market is expected to grow to over $1 billionby 1996, the company said.