West Coast Editor
Three months after word that its licensing partner had finished the first part of its rolling new drug application for the prostate-cancer drug satraplatin, Spectrum Pharmaceuticals Inc. is buying the oncology assets of Targent Inc. in a stock deal worth up to $6.5 million, calculated using Spectrum’s closing price Friday of $5.08.
Under the terms of the agreement, specialty pharma Spectrum will issue to Targent, of Princeton, N.J., 600,000 shares of the company’s common stock at closing. Targent could get undisclosed cash payments as milestones are reached, as well as up to 650,000 more shares. One-third of the issued shares will be registered for resale.
Spectrum’s stock (NASDAQ:SPPI) ended Monday at $5.17, up 9 cents.
Included most notably in the deal are the rights in the U.S., Canada and Mexico to the osteosarcoma therapy levofolinic acid (LFA), for which the NDA has been filed, though the FDA has asked questions about the portion of the filing that deals with chemistry, manufacturing and control.
Irvine, Calif.-based Spectrum did not return phone calls, but said in a press release that it expects to file a response to the FDA’s questions in a year, and the drug could be available in late 2007. A conference call is slated for Wednesday.
An advisory panel recommended 8-0 to approve LFA, the pure active isomer of calcium leucovorin - a component of standard-of-care 5-fluorouracil-containing regimens for colorectal and other malignancies. Already marketed in other parts of the world (where the annual market is estimated at $200 million), the compound has orphan drug status from the FDA when used in the colorectal indication combined with 5-FU, and in bone cancer when used with methotrexate.
Certain rights to other potential drug candidates in the oncology therapeutic area also will be acquired under the terms of the deal, Spectrum said.
In December, GPC Biotech AG, of Tubingen, Germany, filed the chemistry, manufacturing and controls section of a rolling FDA submission for satraplatin, licensed from Spectrum, which is due up to $18 million in milestone payments as the drug makes progress. The Phase III trial had begun about two years earlier, and GPC is first seeking approval of the compound as a second-line treatment for hormone-refractory disease. (See BioWorld Today, Dec. 16, 2005, and Feb. 27, 2006.)