Spectrum acquires Targent's oncology drugs, files NDA for osteosarcoma drug

By Elaine Rigoli

Tampa, Fla., March 20 - Spectrum Pharmaceuticals, Inc. said it has agreed to acquire all of the oncology drug assets of Targent Inc., including its key product, levofolinic acid (LFA).

LFA is the pure active isomer of calcium leucovorin, a component of "standard of care" 5-fluorouracil (5-FU) containing regimens for the treatment of colorectal and other malignancies, according to a company news release.

Calcium leucovorin is also used after the administration of high-dose methotrexate in treating certain malignancies.

Spectrum said it has filed a New Drug Application for LFA with the Food and Drug Administration for the osteosarcoma indication.

In addition, LFA has been granted orphan drug status for colorectal cancer in combination with 5-FU and for osteogenic sarcoma in use with metheotrexate rescue, the release said.

"While LFA was recommended for approval by the oncology advisory committee at a vote of 8-0, the chemistry manufacturing and control portion of the submission generated additional questions from the FDA. We believe that it is possible to file a response to these questions in approximately one year and to have this important drug available to patients in late 2007," said Rajesh C. Shrotriya, chairman, chief executive officer and president, in a statement.

Under the agreement, Spectrum has agreed to issue to Targent a total of 600,000 shares of the company's common stock at closing. One-third of these shares will be registered for resale.

The remaining two-thirds of the shares will not be registered and therefore will be subject to restrictions on resale under Rule 144A.

In addition, on achieving certain regulatory and sales milestones, Targent is eligible to receive cash payments as well as up to 650,000 shares of the company's common stock. One-third of these shares will be registered for resale, the release said.

The remaining two-third shares will not be registered and therefore will be subject to restrictions on resale under Rule 144A.

At Spectrum's option, any amounts due in cash may be paid by issuing shares of the company's common stock, one-third of which will also be registered.

LFA is marketed by Wyeth, Sanofi-Aventis and others in certain parts of the world, including Europe and Japan, while Spectrum will obtain the rights in the United States, Canada and Mexico, the release said.

Targent, a specialty pharmaceutical company, is based is Princeton, N.J.

Spectrum, a specialty pharmaceutical company, is based in Irvine, Calif.

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