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news.AnGes MG has announced an agreement with Mitsubishi Tanabe Pharma for exclusive marketing rights of Collategene in the US.
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Upon the conclusion of the agreement, AnGes will earn upfront payments and milestone payments. AnGes expects to maximize the asset value of Collategene by conducting a prompt global Phase III study centered in the US.
AnGes president and CEO Ei Yamada said that it is estimated that there are more than five hundred thousand patients with CLI in the US alone, with a market size estimated at $5bn.
"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," Yamada added.
"We aim to obtain the marketing approval at an early date by promptly advancing the development of this project."
The drug is naked plasmid DNA which does not use virus vector thereby preventing the adverse effects caused by a virus vector.
Collategene, which is different from the existing drugs which are symptomatic treatment, and improves ischemic condition by angiogenesis, is expected to become a new treatment medicine that is effective to intractable Peripheral Arterial Disease.