Omrix, FFF enter into a letter of agreement concerning Omrigam NF

By Elaine Rigoli

Tampa, Fla., Aug. 16 - Omrix Biopharmaceuticals, Inc. said it entered into a letter of agreement with FFF Enterprises, Inc. amending two agreements between FFF and Omrix, the supply and distribution agreement investigational phase and the supply and distribution agreement commercial phase, each dated as of Dec. 21, 2005.

These agreements relate to the approval and distribution in the United States of Omrigam NF, an intravenous immunoglobulin manufactured by Omrix, for primary immune deficiency. On the same date, Omrix had entered into a related plasma supply agreement with DCI Management Group LLC to supply plasma to Omrix.

Omrix did not have any material obligation under these agreements until the letter of agreement amended the terms of the investigational agreement, according to a news release.

Under the investigational agreement, FFF has agreed to take over sponsorship of the active Investigational New Drug application for Omrigam NF from Omrix and to complete a phase 3 clinical trial with Omrigam NF in the United States for the treatment of patients with primary immune deficiency.

FFF has agreed to purchase Omrigam NF for use in the clinical trial from Omrix at the price specified in the investigational agreement. Under certain circumstances, FFF may receive a credit for amounts paid to Omrix for purchases of Omrigam NF for use as an investigational drug in the clinical trial.

The investigational agreement will automatically end upon the approval of the Biologics License Application for the use of Omrigam NF to treat primary immune deficiency, the release said.

In addition, FFF may terminate the investigational agreement if out-of-pocket expenses for conducting the clinical trial exceeds an agreed upon amount; the BLA is not approved by Sept. 1, 2007 due to the fact that the clinical trial has not demonstrated the effectiveness of Omrigam NF; or Omrix has not completed the limited expansion of its facility to enable expanded production of Omrigam NF by an agreed upon date.

Further, either party may terminate the agreement if the Food and Drug Administration withdraws the Investigational New Drug application or places it on clinical hold.

Omrix is a pharmaceutical company with U.S. headquarters in New York.

FFF is a pharmaceutical company based in Temecula, Calif.

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