AnGes MG, Inc. has announced that it has concluded a basic agreement with Mitsubishi Tanabe Pharma Corporation for the exclusive marketing rights of Collategene® (DNA Plasmid with HGF gene) as a treatment for Peripheral Arterial Disease (PAD) in the United States.
AnGes has been seeking for a partner to pursue the global Phase III study regarding Collatege® as a treatment for Critical Limb Ischemia (CLI), the severe stage of arteriosclerosis obliterans and Buerger's disease.
AnGes has announced that it has reached the basic agreement regarding the exclusive marketing rights as stated above.
Once the contract regarding the exclusive marketing rights is concluded, AnGes will receive upfront payments and milestone payments.
AnGes believes that it can maximize the asset value of Collategene® by conducting a prompt global Phase III study centered in the United States which has the biggest market in the world.
Ei Yamada, President and CEO of AnGes commented, “It is estimated that there are more than 5 hundred thousand patients with CLI in the United States alone, with a market size estimated at 5 billion US dollars. For the global development of Collategene®, it is crucial to proceed with the development in the United States, which has the main market for Collategene®. AnGes through its US subsidiary AnGes, Inc. has been conducting discussions with the Food and Drug Administration (FDA) and has already reached agreement on SPA (Special Protocol Assessment) for the Phase III global clinical study as well as obtaining Fast Track Drug Development Program which is designed to facilitate the development and expedite the review of new drugs. We aim to obtain the marketing approval at an early date by promptly advancing the development of this project.”
AnGes will continue to take proactive steps for the development of Collategene® to provide a new treatment option for patients with CLI.
The effect of this event on AnGes’s business performance for the fiscal term ending in December 2012 is currently under calculation, and it will be published as soon as the result becomes clear.