By Randall Osborne

Facing an important court hearing on its ongoing patent battle, CellPro Inc. won FDA approval of an expanded label for the Ceprate SC Stem Cell Concentration System, allowing for selection of peripheral blood progenitor cells and tumor purging.

"We can begin promotion and marketing immediately," said Mark Handfelt, vice president and general counsel for Seattle-based CellPro.

The Ceprate system was first approved in December 1996 for selecting progenitor cells from bone marrow, purifying them in order to replenish cells damaged by cancer chemotherapy. An approvable letter for the label expansion was issued in April.

CellPro is involved in a patent fight related to a similar system being developed by Nexell Therapeutics Inc., a firm jointly owned by Irvine, Calif.-based Vimrx Pharmaceuticals Inc. and Baxter Healthcare Corp., of Deerfield, Ill. In the long-fought case, the district court has ruled against CellPro and it has appealed. (See BioWorld Today, July 9, 1998, p. 1.)

Hearing Slated For Today On $8M In Legal Fees

A district court hearing was scheduled for today over whether CellPro would pay $8 million in legal fees for Baxter, Handfelt said.

If the decision goes against CellPro, "some pretty dramatic consequences" could follow, he added. The company has $13.5 million in cash.

Last month, CellPro cut staff by 11 percent to stay alive while awaiting an appellate court's decision in the case. (See BioWorld Today, June 10, 1998, p. 1.)

However, Handfelt said, if the ruling at the district court level does not favor CellPro with regard to the legal fees, attorneys for the company may be able to push for a quicker ruling on the whole case.

"We would rather know sooner than later," he said.

CellPro's expanded-label approval could help in court, although not as a matter of law, Handfelt added. The FDA's decision shows CellPro's ability to provide the agency with ample data in a timely way, possibly suggesting a more valid product, Handfelt said.

In July, the FDA also issued an approvable letter for CellPro's second-generation device, called the Ceprate SC Instrument II. (See BioWorld Today, July 14, p. 1.)

Nexell, meanwhile, has been asked by the FDA to provide more information related to its premarket approval application. The company's products are the Isolex 300 and Isolex 300i Cell Selection Systems.

CellPro's stock (NASDAQ:CPRO) closed Tuesday at $3.281, up $0.156. *

No Comments