Cambrex Corporation and Ortec International Inc have entered into a multi-year agreement for Cambrex to market and distribute Orcel, a bioactive wound care product to treat chronic and acute wounds such as venous leg ulcers, diabetic foot ulcers, and donor site wounds in burn patients.

The companies have an existing agreement under which Cambrex is the exclusive manufacturer of Orcel. The new agreement expands upon the existing relationship, further aligns Ortec's and Cambrex's goals and provides a unique approach to effectively commercialize Orcel.

Under the terms of the agreement and subject to product approval by the Food and Drug Administration (FDA), Cambrex will provide a dedicated sales force, a multi-million dollar product launch and will manage the entire sales and distribution process in the United States. Cambrex will also provide an ongoing annual marketing commitment to maximize market penetration, according to a release from Cambrex.

A major focus for Cambrex is the continued addition and integration of unique products and services. John R. Leone, Cambrex president and CEO, stated, "The decision to market as well as manufacture Orcel is part of our growth strategy in specialty markets. This is the first agreement of its kind to combine marketing, manufacturing, and distribution services of a cell-based therapeutic. We have given the product launch a high priority and are committed to its success."

"Ron Lipstein, vice chairman and CEO of Ortec, said, " This agreement provides Ortec the ability to more rapidly achieve profitability and reduce Ortec's future cash requirements, thereby enhancing the Company's value. We both have a vested interest in Orcel's success and have established a relationship that has what it takes to succeed."

Orcel, developed by Ortec International Inc, is a frozen, cell-based product for use in skin regeneration and chronic and acute wound healing. Orcel is currently awaiting FDA approval of the PreMarket Approval (PMA) application that was submitted in February 2004 and based on the results of the pivotal clinical trial in venous leg ulcers.

Ortec International Inc is a tissue-engineering company involved in the commercialization of a proprietary and patented technology to stimulate the repair and regeneration of human tissue.