RHEI receives Chinese SFDA acceptance letter for MuGard

RHEI receives Chinese SFDA acceptance letter for MuGard

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, announced that its MuGard partner in China, RHEI Pharmaceuticals has received the acceptance letter from the State Food and Drug Administration (SFDA) of China acknowledging all necessary documentation for the MuGard has been submitted and accepted.

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP),a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi,announced that its MuGard partner in China, RHEI Pharmaceuticals has received the acceptance letter from the State Food and Drug Administration (SFDA) of China acknowledging all necessary documentation for the MuGard has been submitted and accepted.  Together with its marketing partner Jian An, RHEI Pharmaceuticals completed the required process required to satisfy all requirements to receive marketing approval in China and its other South East Asian territories.  RHEI has advised Access of the next steps the SFDA will take to grant approval in its territories and anticipates receiving marketing approval in the second half of this year.

As part of its licensing agreement with Access, RHEI is responsible for obtaining the necessary regulatory approvals for MuGard.  Access and RHEI recently signed a $30 million supply agreement for MuGard to ensure manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. In addition, Access also approved a sub-license agreement between RHEI Pharmaceuticals and Jian An Pharmaceuticals ("Jian An") Limited in Shenzhen, China to leverage Jian An's extensive sales, marketing and regulatory infrastructure for the launch of MuGard in China and Taiwan. Jian An is headquartered in Shenzhen, China and has a 25-year history of selling pharmaceutical and other medical products in the China market.  Jian An has 1400 sales representatives covering all majors centers in China through 169 sales offices.  

With Jian An's sales and marketing infrastructure, the supply agreement and the letter of acceptance, Access Pharmaceuticals' commercialization efforts remain on track in China. Access retains its existing milestone and royalty structure for the territory.  

"The acceptance of MuGard submission is a critical step in receiving marketing approval for MuGard in China and South East Asian territories," said Phillip Wise, Vice President of Business Development and Strategy, Access Pharmaceuticals, Inc.  He continued, "We knew that the SFDA would perform a significant amount of due diligence before it would accept our MuGard submission.  Receiving the acceptance letter helps us, as a company, gauge more accurately the timeline to marketing approval.  We are pleased with RHEI and Jian An's ability to streamline the process thus far and their continued progress and commitment to advancing the marketing approval."  

Source:

Access Pharmaceuticals, Inc.

Source: www.news-medical.net