Sandoz Pharmaceuticals Corp. has decided not to pursuedevelopment of calcitonin in Emisphere Technologies Inc.'s oraldelivery system.

Emisphere announced that it had been informed by Sandoz ofBasel, Switzerland, that "for strategic business reasons they arenot moving forward with this particular product at this time."

Emisphere (NASDAQ:EMIS) said the feasibility studiesconducted by both Emisphere and Sandoz in two primatespecies were successful, illustrating that the system can orallydeliver a protein with appropriate pharmacokinetics in aprimate model. Emisphere's vice president of research anddevelopment, Robert Baughman, said the bioavailability is onthe order of that reported with the nasal system. Thecompound tested is a salmon calcitonin.

Emisphere's oral delivery system encapsulates therapeuticcompounds in microscopic spheres composed of compoundsmade from amino acids. The microspheres change configurationaccording to pH conditions. They remain closed in an acidicmedium, such as the stomach, and open under neutralconditions, such as in the intestines or bloodstream. Themicrospheres thus allow a therapeutic to pass intact throughthe gastrointestinal tract and be released into the bloodstream.

Baughman said Emisphere has encapsulated more than 20compounds in its delivery system, assessed the formulation forstability, and dosed it in animals. These compounds includevaccines, monoclonal antibodies, peptides and proteins.Baughman noted that every compound in the delivery systemdemonstrated a therapeutic response, sometimes at a very highdose, while the compounds had no response withoutEmisphere's carrier. The molecular weight of the compoundstested ranged from 400 to 2.5 million daltons.

Emisphere of Hawthorne, N.Y., has development agreementswith six companies, including Schering-Plough for delivery ofan unspecified compound; Upjohn for insulin delivery; Enzonfor use of the delivery system with PEG technology; J3Biologicals (the for-profit arm of the non-profit Coalition forHemophilia B) to create a Factor IX product; Main Biologicals (adivision of the poultry vaccine manufacturer Ghen Corp.) fororal delivery of a veterinary vaccine; and SciClonePharmaceuticals for delivery of thymosin alpha 1. Emisphere isnot in clinical development for any of these compounds.

In addition, Emisphere has its own research programs using thedelivery system for heparin and vaccines. One of the vaccineproducts, monoclonal antibody IgG 2A has successfully beendelivered to 20 percent oral bioavailability, Baughman said.

Emisphere presented results of an initial human safety study oflow molecular weight heparin (LMWH) in the delivery systemlast November at the annual meeting of the AmericanAssociation of Pharmaceutical Scientists. LMWH was deliveredto 20 percent bioavailability.

Emisphere's stock lost $1.13 a share on Wednesday to close at$9.38.

-- Brenda Sandburg News Editor

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