QualityStocks News - Access Pharmaceuticals Partner Receives China Regulatory and Marketing Approval for MuGard

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Regulatory nod from China’s State Food and Drug Administration provides “Transformative Milestone” for Access’ global program.

QualityStocks would like to highlight Access Pharmaceuticals, Inc., a publicly traded biopharmaceutical company focused on developing and commercializing proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (http://www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum in Phase 2 clinical testing of patients with ovarian cancer, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas.

In the company’s news yesterday,

Access Pharmaceuticals announced that its MuGard partner in China, Rhei Pharmaceuticals HK Ltd., has received regulatory approval from the State Food and Drug Administration (SFDA) to market MuGard in China.

China’s regulatory agency approved MuGard to treat cancer patients afflicted with oral mucositis a debilitating side effect of many anticancer treatments. The approval provides Access the opportunity to tap into an expansive market with a largely unmet medical need. Access will soon begin manufacturing MuGard in the United States to meet demand created by Jian An Ltd., Rhei’s sales and marketing partner in China.

“Receiving final marketing approval from the SFDA of China is a transformative milestone for our global MuGard program. China represents a key target market with its large and increasingly affluent population and its desire for improved oncology care,” Jeffrey B. Davis, president and CEO of Access stated in the press release. “With the approval process now complete, we look forward to moving as quickly as we can to complete manufacturing so Rhei and Jian An can launch MuGard through their well-established sales and marketing infrastructure in China.”

“China is one of the fastest growing oncology markets and cancer supportive care has been improving throughout recent years,” said Sven De Backer, CEO of Rhei. “Rhei and Jian An are proud to bring MuGard to patients and physicians as we believe it is a critical and valuable product that addresses a significant unmet need for a large and growing patient population.”

Access and Rhei last year signed a supply agreement for MuGard, which ensured manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. Access also approved a sub-license agreement between Rhei and Jian designed to leverage Jian An’s sales, marketing, and regulatory infrastructure for the launch of MuGard in China and Taiwan.

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Forward-Looking Statement:

This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.


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