West Coast Editor
Aiming to have about two years of operating cash in the bank by the end of this year, beleaguered GPC Biotech AG is saying goodbye to 103 employees - 44 percent of the work force - as the firm deals with satraplatin setbacks, sifting data in hopes of finding use for the failed prostate cancer compound.
The move is part of a revised strategic plan that includes narrowing the focus to certain development-stage oncology projects and boosting efforts to license Martinsried, Germany-based GPC also is exploring merger and acquisition chances on both sides of the Atlantic, an effort that Laurie Doyle, director of investor relations and corporate communications for the company, called "a very important part of the program. We're actively looking into these areas."
Among the internal projects are two cell-cycle inhibitors. "We are hoping to be able to move those forward eventually into the clinic," Doyle said, though GPC has not provided specific guidance regarding when trials might start.
GPC's stock (NASDAQ:GPCB) closed Monday at $3.85, down 53 cents, never recovering from the late October word of disappointing data not only in progression-free survival data but overall survival as well from the Phase III SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial.
"We're still doing subgroup analyses on the data," Doyle said. "Once we have a better grasp on what happened there, we plan to talk with the FDA." Doyle added that she didn't want to "create great expectations, as we originally planned" for the drug, but FDA talks "will, we hope, give us some ideas how we can potentially move satraplatin forward."
The firm is laying off 60 employees in Munich, Germany, and 43 in Princeton, N.J., leaving 56 and 58 at each site, respectively, and the facility in Waltham, Mass., is shutting down in a few weeks. Dismissals already are under way.
"Some have happened; some will happen shortly," Doyle said. The company intends to have €60 million (about US$87.7 million) in cash, cash equivalents and available-for-sale securities at the end of the year.
Earlier this month, GPC won in arbitration its dispute with satraplatin partner Spectrum Pharmaceuticals Inc., of Irvine, Calif., which let GPC out of paying a share of proceeds gained when the drug was licensed to Boulder, Colo.-based Pharmion Corp., which has said it will seek approval in Europe.
First hints of trouble with the oral platinum drug surfaced over the summer, when online FDA documents brought up a handful of issues and suggested an advisory panel might recommend waiting for final survival data from SPARC, or even ask for a new study.
Satraplatin, GPC's pipeline leader, originally came from Johnson Matthey, a London-based precious metals firm, which had a relationship with Bristol-Myers Squibb Co., of New York, and BMS had conducted some trials.
In its third-quarter earnings conference call this month, GPC's management said a data safety monitoring board recommended continuing a Phase II trial testing satraplatin with Tarceva (erlotinib, Genentech Inc. and OSI Pharmaceuticals Inc.) against non-small-cell lung cancer, and the principal investigator of a trial testing the compound with radiation therapy has recommended that study move ahead to Phase II.
GPC also has satraplatin combination trials in progress with Taxotere (docetaxel, Sanofi-Aventis), Xeloda (capecitabine, F. Hoffmann-La Roche Ltd.) and Gemzar (gemcitabine, Eli Lilly and Co.).
Doyle said the company might report data from those trials at the American Society of Clinical Oncology meeting next spring.
Analyst Mark Monane, of Needham & Co., wrote in a report on earnings that, "despite the best efforts and planning of the management team," Needham is keeping its "underperform" rating on the stock, and called an FDA application for satraplatin "very unlikely."