BioWorld International Correspondent
With the completion of a new drug application filing of its cancer drug Satraplatin imminent, GPC Biotech AG capitalized on the current strength of its stock by raising €33.6 million (U.S.$43.7 million) in a private placing with institutional investors.
The company (FSE:GPC; NASDAQ:GPCB) sold 1,564,587 shares at €21.50, which represents a small discount to its closing share price of €22.15 immediately before the transaction was completed. It reported €113.9 million in cash Sept. 30, 2006.
Its shares have doubled in value since September, when the Martinsried, Germany-based company reported eye-catching data from a Phase III clinical trial in patients with hormone refractory prostate cancer.
Those receiving Satraplatin plus prednisone had a 40 percent reduction in the overall risk of disease progression as compared with those receiving prednisone plus placebo. (See BioWorld International, Sep. 26, 2006.)
The company aims to complete its NDA filing in the current quarter. GPC bills Satraplatin as the first orally available platinum drug for cancer. It has a fast-track designation from the FDA and could receive a priority review, leading to a decision within six months of filing and a market launch shortly after that.
"What we reckon is to have around 40 to 50 sales reps on the ground at the time of launch," Martin Braendle, GPC director of investor relations and corporate communications, told BioWorld International. "That should ramp-up, with an increase in sales, to 60 to 80."
"For prostate cancer, that is clearly enough," Daniel Wendorff, analyst at Dusseldorf, Germany-based West LB AG, told BioWorld International. However, if extension studies in several other cancer indications that currently are under way are successful, he added, it could need additional marketing muscle.
The company hasn't closed the door completely on the idea of partnering satraplatin in its lead indication, second-line treatment of hormone refractory prostate cancer patients. "We haven't ruled it out. We are opportunistic here," Braendle said. "[But] we will take the lead role, if we take a partner on board."
"These issues are not decided yet, and most likely, they won't be decided before final approval," Martin Possienke, analyst at Frankfurt-based Equinet Institutional Services AG, told BioWorld International.
Boulder, Colo.-based Pharmion Corp., which acquired European rights to Satraplatin in late 2005, in a deal worth a potential $270 million, is expected to file a Marketing Authorization Application with the London-based European Medicines Agency in the second quarter.
Because of Satraplatin's oral bioavailability and a more benign side-effect profile compared with other commonly used platinum drugs, GPC Biotech also is exploring its potential as a chronic therapy for older patients living with cancer who now are deemed too frail to receive current platinum-based drugs.
The company has a series of combination studies under way in several indications. It is testing Satraplatin in combination with Tarceva (erlotinib), with Taxol (paclitaxel) and with radiotherapy in separate trials in non-small-cell lung cancer.
The Taxol study is due to report data later this year. It also is running separate combination trials of Satraplatin involving Taxotere (docetaxel), Xeloda (capecitabine) and Gemzar (gemcitabine) in advanced solid tumors. An additional trial of Satraplatin, Xeloda plus radiotherapy, is under way in rectal cancer.
Daniel Wendorff had raised his target price on the stock to €26 at the start of the year, based on a 90 percent probability that Satraplatin will reach the market. In the last week, Martin Possienke raised his target price, from €19 to €23, also on the basis that the drug currently has a 90 percent probability of reaching the market.