Four months after GPC Biotech AG's satraplatin met its endpoint in a pivotal prostate cancer study, the company pulled in €33.6 million (US$43.7 million) to pave the way for the compound's anticipated commercialization.
"We're working very hard to complete the [new drug application] filing as soon as possible," said Laurie Doyle, director of investor relations and corporate communications for GPC. FDA submission is expected "in the next few weeks," she added. If the NDA succeeds in gaining priority review, the agency could reach a decision around the middle of the year, and pending approval, satraplatin "could be on the market shortly thereafter."
Satraplatin, an oral platinum-based compound, demonstrated highly statistically significant results over placebo in progression-free survival as a second-line chemotherapy treatment in 950 hormone-refractory prostate cancer patients.
Data from that Phase III study showed that patients receiving satraplatin in combination with prednisone had a 40 percent reduction in the overall risk of disease progression compared to those receiving prednisone plus placebo. (See BioWorld Today, Sept. 26, 2006.)
With those results in hand, "we were really able to accelerate the building of a commercial infrastructure in the U.S.," Doyle told BioWorld Today. The recent financing "will assist us in aggressively moving forward with those commercialization activities and, in addition, allow us to expand the development of satraplatin in other cancer settings."
GPC privately placed about 1.6 million shares priced at €21.50 each with institutional investors. Those shares, following the placement, represent about 4.5 percent of GPC's total shares outstanding.
The company, which reported a cash position of €114 million as of Sept. 30, was "pretty well funded" prior to the latest financing, Doyle said. "This extra amount will keep us going for a good chunk of time and help us continue to move forward with satraplatin."
More money is expected to come into GPC later this year by way of a milestone payment triggered by the acceptance of a marketing authorization application for satraplatin in Europe by marketing partner Pharmion Corp., as per the companies' potential $270 million licensing agreement signed in 2005. Pharmion, of Boulder, Colo., anticipates filing for European approval sometime in the second quarter. (See BioWorld Today, Dec. 21, 2005.)
GPC retains marketing rights to satraplatin in the U.S., as well as Asian territories, including Japan, though Doyle said the company is not planning to handle any ex-U.S. commercialization itself.
Recently, Spectrum Pharmaceuticals Inc., which licensed satraplatin to GPC in 2002, filed a demand for arbitration against GPC alleging that the company has not used "commercially reasonable efforts" to gain regulatory approval of the product in Japan, and asked to be reimbursed for €9 million in past development expenses. In response, GPC said claims made by Waltham, Mass.-based Spectrum are without merit and denied that it defaulted on any obligation under the licensing agreement.
Pending approval in all territories, worldwide sales of satraplatin are estimated to reach about $500 million in annual peak sales, Doyle said, and GPC also is investigating the compound in other indications, such as non-small-cell lung cancer.
The company has an ongoing Phase II study of satraplatin in combination with Taxol (paclitaxel, Bristol-Myers Squibb Co.) in patients with NSCLC and another ongoing Phase II study of satraplatin plus Tarceva (erlotinib, Genentech Inc. and OSI Pharmaceuticals Inc.) in elderly NSCLC patients.
Behind satraplatin, GPC is working to advance its early stage pipeline of internally discovered compounds, starting with ID09C3, a monoclonal antibody aimed at treating relapsed or refractory B-cell lymphomas, such as non-Hodgkin's lymphoma and chronic lymphocytic leukemia. That product is in Phase I testing, and preliminary results presented last month at the American Society of Hematology meeting in Orlando, Fla., suggested that ID09C3 is well tolerated, with hints of antitumor activity observed in two patients.
"We hope to finish Phase I around the middle of the year," Doyle said, with plans to begin a Phase II trial shortly after that.
GPC, which is based in Martinsried, Germany, with offices in Waltham, Mass., and Princeton, N.J., also has an "active discovery group," she added, with a focus on kinase inhibitors for multiple cancer indications.
Shares of GPC (NASDAQ:GPCB) closed at $28.60 Wednesday, down 22 cents.