SciClone To Pursue Development Of SGX942 In China Following Soligenix' Report Of Positive Phase 2 Preliminary Results In Oral Mucositis

Dec 21, 2015, 06:00 ET from SciClone Pharmaceuticals, Inc.

FOSTER CITY, Calif., Dec. 21, 2015 /PRNewswire/ -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced plans to pursue development and registration of SGX942 in the Greater China market, for the treatment of oral mucositis. SGX942 is being developed by Soligenix, Inc. (OTCQB: SNGX), which recently reported positive preliminary results from its Phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer. SGX942 is an innate defense regulator (IDR), a new class of short, synthetic peptides, with a novel mechanism of action in that it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. The Phase 2 preliminary results reported by Soligenix showed a significant reduction in the duration of severe oral mucositis in patients receiving chemoradiation therapy for treatment of their head and neck cancer.

In April 2013, SciClone and Soligenix established a commercial collaboration in which Soligenix received access to SciClone's oral mucositis clinical and regulatory data library in exchange for commercialization rights to SGX942 in the People's Republic of China, including Hong Kong and Macau. The data library derived from SciClone's development of SCV-07 for the treatment of oral mucositis caused by chemoradiation therapy in head and neck cancer which targeted the same patient population Soligenix is pursuing in its oral mucositis program. SciClone discontinued development of SCV-07 in 2012.

Friedhelm Blobel, PhD, SciClone Chief Executive Officer, commented: "The positive results demonstrated in the Phase 2 study of SGX942 are compelling, representing promise for an intervention for patients with head and neck cancer treated with chemoradiation who are suffering with oral mucositis. Cancer is one of China's most pressing healthcare challenges. We have significant development, regulatory and commercial expertise in the China oncology market, and believe that SGX942 could be a valuable addition to our oncology portfolio in the future. Our plans are to develop SGX942 for the Greater China market, and to work with Soligenix to define both a business and development path forward toward that goal."    

"We were very excited with the outcome of the Phase 2 clinical study of SGX942, as oral mucositis is a devastating side effect of chemoradiation and represents a significant unmet medical need and commercial opportunity worldwide," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Access to SciClone's data library was of significant value to Soligenix in designing our Phase 2 program. We are delighted that SciClone intends to pursue development of SGX942 in the China market, where they have a significant commercial presence, and look forward to our companies continuing to work in collaboration."

Specific terms of the collaboration between SciClone and Soligenix have not been disclosed at this time.

About SciClone

SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious diseases and cardiovascular disorders. SciClone's proprietary lead product, ZADAXIN® (thymalfasin), is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. The Company has successfully in-licensed and commercialized products with the potential to become future market leaders and to drive the Company's long-term growth, including DC Bead®, a novel treatment for liver cancer. Through its promotion business with pharmaceutical partners, SciClone also markets multiple branded products in China which are therapeutically differentiated. SciClone is a publicly-held corporation based in Foster City, California, and trades on the NASDAQ Global Select Market under the symbol SCLN. For additional information, please visit www.sciclone.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the development of SGX942, the prospects for SGX942 in the Greater China market and other matters.  Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties relating to risks relating to the product development and clinical trial process, including uncertainties regarding the time and costs related thereto,  and risks relating to performance by us and by Soligenix of obligations under the agreement with Soligenix, as well as well as risks and uncertainties relating to: the course, cost and outcome of regulatory matters, including regulatory approvals and future pricing decisions by authorities in China; the on-going regulatory investigations and expenses related thereto, including potential fines and/or other remedies.  Please also refer to other risks and uncertainties described in SciClone's filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.

SciClone, SciClone Pharmaceuticals, the SciClone Pharmaceuticals design, the SciClone logo and ZADAXIN are registered trademarks of SciClone Pharmaceuticals, Inc. in the United States and numerous other countries.

 

Corporate Contacts



Wilson W. Cheung

Jane Green

Chief Financial Officer

Investors/Media

650.358.3434

650.358.1447

wcheung@sciclone.com

jgreen@sciclone.com

 

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SOURCE SciClone Pharmaceuticals, Inc.



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