Soligenix, Inc. (SNGX), SciClone Pharma (SCLN) Enter SGX942 Development, Distribution Agreement

September 12, 2016 7:21 AM EDT

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Soligenix, Inc. (OTC: SNGX) and SciClone Pharmaceuticals, Inc. (Nasdaq: SCLN) announced that the companies have entered into an exclusive license agreement granting rights to SciClone to develop, promote, market, distribute and sell SGX942 (dusquetide), a novel, first-in-class therapy being developed for the treatment of oral mucositis in patients with head and neck cancer. The licensing agreement includes the People's Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam (the "Territory"). This exclusive agreement builds on an existing collaboration between the two companies, in which SciClone provided its complete oral mucositis clinical and regulatory data library to Soligenix in exchange for certain, previously undisclosed, commercialization rights to SGX942 in the Greater China market.

Under the terms of the agreement, SciClone will make a $3 million upfront equity investment in Soligenix for 3,529,412 shares of Soligenix common stock. In addition, SciClone will be responsible for all aspects of development, product registration and commercialization in the Territory, having access to data generated by Soligenix. In exchange for exclusive rights, SciClone will pay to Soligenix royalties on net sales, and Soligenix will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.

Friedhelm Blobel, PhD, President and Chief Executive Officer of SciClone, commented, "We believe that SGX942 can be an excellent fit within our growing oncology portfolio, and expands our strategy to in-license programs that can potentially utilize accelerated development and regulatory pathways in China. SciClone has a well established commercial presence in China, and key to driving our long-term growth is the expansion of our pipeline with innovative product candidates. We believe that oral mucositis represents an unmet medical need and is a frequent complication of anticancer treatment, including chemotherapy and radiation therapy. We appreciate the strong performance of the Soligenix clinical team in advancing this potentially important therapeutic, and are looking forward to developing SGX942 for potentially multiple Asia markets."

"We are very pleased to expand on our partnership with SciClone," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "SciClone has a significant commercial presence and expertise in China, and their clinical and regulatory contribution to the dusquetide oral mucositis program has the potential to bring high quality development and potential commercialization of SGX942 in the Territory. In the US, our multi-center, double-blind, placebo-controlled, Phase 2 clinical study in oral mucositis in head and neck cancer patients is currently ongoing with completion of long-term follow-up expected by the end of 2016."

This exclusive license agreement builds on an existing collaboration, wherein SciClone provided its significant oral mucositis clinical and regulatory data library, thus increasing the probability of success for the Soligenix SGX942 Phase 2 exploratory clinical study. By analyzing data available from the placebo subjects in the SciClone trials, Soligenix acquired essential insight into disease progression, along with quantitative understanding of its incidence and severity in the head and neck cancer patient population. This information assisted with the design of the SGX942 Phase 2 clinical trial, in which positive preliminary results were announced in December 2015.

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