Amgen Inc. announced Thursday that it has entered into acollaboration with Amcell Corp. to develop and market cell-separation-based products. The agreement represents Amgen'ssecond collaboration in the area of cell separation; in July 1992,the Thousand Oaks, Calif., company teamed up with CellPro explore cancer treatments combining its recombinant humangranulocyte colony stimulating factor (G-CSF), Neupogen, andCellPro's stem cell purification technology.

Amgen's collaboration with Amcell of Los Altos, Calif., willinvolve similar areas of investigation, Amgen spokesman DavidKaye told BioWorld. As with CellPro, he said, Amcell's cell-separation techniques represent "a technology platform"through which Amgen hopes to discover new therapeuticapplications for Neupogen or its stem cell factor (SCF), which iscurrently in Phase II clinical development.

Amcell has developed a magnetic cell-separation technology, asopposed to CellPro's biologically based technique. Amgen hopesAmcell's device may be able to collect progenitor cells fromperipheral blood, which could be used to increase the efficacyof therapeutics such as Neupogen or SCF. CellPro's Ceprate SCstem-cell concentration system, on the other hand, collectsstem cells from bone marrow.

Amgen also hopes to apply the device to ex vivo expansion ofcells and will investigate the ability of Neupogen to increaseperipheral stem cells that could then be purified through cellseparation.

At this stage in its cell-separation collaborations Amgen ispursuing two distinct means to achieve the same end, Kayesaid. The company may later find that each of the twotechnologies has certain advantages in specific applications,which could lead to the commercialization of products based onboth cell-separation techniques.

CellPro submitted a pre-marketing approval (PMA) applicationto FDA for its Ceprate SC stem cell concentration system lastDecember, said Lee Parker, director of investor relations at theBothell, Wash., company. Phase III trials studying the use ofthe device in autologous bone marrow transplant, which wereco-sponsored by Amgen and involved the use of Neupogen,were concluded last September. Parker added that CellPro iscurrently in the equivalent of a Phase I/II trial with Amgen toevaluate the use of the company's cell-separation technologyand Neupogen in 20 autologous bone marrow transplantpatients in Paris.

CellPro's Ceprate CS device, if approved, will not explicitlyinvolve the use of Neupogen. The two products will likely beused in combination nonetheless, since Neupogen is commonlyused in cancer therapies such as autologous bone marrowtransplant to accelerate replenishment of the granulocytesnecessary to reconstitute the immune system afterchemotherapy.

Amcell reportedly has not yet filed an application with FDA forclinical testing of its products, so the company will apparentlyface a considerable development period before it can marketproducts outside the research market.

Under the terms of the agreement, Amgen will receiveexclusive worldwide rights to clinically develop andcommercialize certain cell-separation products developed byAmcell. In return, Amcell will receive research anddevelopment funding as well as milestone payments fromAmgen. Amcell will manufacture and supply cell-separationproducts for Amgen.

Amgen (NASDAQ:AMGN) has also made an equity investment inprivately held Amcell. No specific financial terms of theagreement have been disclosed, however.

Amcell is the U.S. marketing arm of Miltenyi Biotec GmbH ofGermany. It was founded in 1993 to develop andcommercialize products for human therapeutic and diagnosticapplications based upon Miltenyi's cell-separation technologies.

-- Karl A. Thiel Business Editor

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