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Development Strategy

Development Strategy

Solasia is focusing on commercializing assets in the oncology/hematology field, by developing products licensed from western pharmaceutical and biotech companies. Solasia has selected oncology/hematology as its strategic therapeutic area due to the high unmet medical needs and fast expanding patient pools in Japan and China. Solasia intends to carry out multinational studies to expedite market approval, and provide valuable medicines to patients in Japan and Asia.

Products in Development(As of December 2016)

Development

SP-01 Granisetron Transdermal Delivery System (Sancuso®)

Initial indication: Chemotherapy Induced Nausea and Vomiting (CINV)

In May 2008, Solasia acquired rights to SP-01 (Sancuso®) from Strakan International Ltd. (currently, ProStrakan) for China and other countries in Asia.
Sancuso® is an extended release transdermal system, delivering the anti-emetic, granisetron, steadily into the patient’s bloodstream over several days. Transdermal delivery is especially beneficial to patients receiving chemotherapy who cannot swallow medicines due to nausea or mucositis. Clinical guidelines recommend the use of the 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron is a 5-HT3 receptor antagonist with well-established efficacy against CINV.
Sancuso® was approved by the U.S. Food & Drug Administration (FDA) in September 2008 for the prevention of CINV in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. Besides the U.S., Sancuso®was approved in 17 countries and areas including U.S., England, Germany, Netherlands, Spain, Denmark.

Development Strategy

A clinical pharmacology study and a randomized, double blind, oral granisetron controlled clinical study in Chinese has been completed in 2014. New Drug Application (NDA) has been submitted to the Chinese regulatory agency in June 2014.

SP-02: Darinaparsin (ZinaparTM, ZIO-101)

Initial indication: Peripheral T-Cell Lymphoma (PTCL)

In March 2011, Solasia acquired the rights to SP-02 (darinaparsin) from ZIOPHARM Oncology, Inc. for Japan, China, Korea and other countries throughout Asia in March 2011, and worldwide rights including USA and European countries in July 2014. Darinaparsin is a novel mitochondrial-targeted agent (organic arsenic) being developed for the treatment of various hematologic and solid cancers. In a Phase II study in the U.S. , intravenous darinaparsin demonstrated evidence of clinical activity in malignant lymphoma,and in particular peripheral T-cell lymphoma (PTCL).

Darinaparsin was granted Orphan Drug Designation in the U.S. and Europe as a treatment of PTCL and Solasia intends to seek similar status in Japan. ZIOPHARM is also currently studying darinaparsin in combination with CHOP (cyclophosphamide,doxorubicin, vincristine, and prednisone), the current standard of care for front line PTCL, to confirm the tolerability of the combination for a possible future trial in the front-line setting. An oral form is in a Phase I trial in solid tumors.

Development Strategy

Asian Multinational Phase II study for the treatment of relapsed and refractory peripheral T-cell lymphoma (PTCL) has commenced in March 2016.

SP-03:(episil® oral liquid)

In March 2015, Solasia acquired exclusive commercialization rights in Japan and China to SP-03 from Camurus. SP-03 represents a unique and innovative concept for local treatment of pain associated with oral mucositis (OM). Developed using the award-winning* Camurus proprietary technology FluidCrystal®, SP-03 is administered as a lipid-based liquid that spreads on the intra-oral mucosal surfaces and transforms to a strongly bioadhesive film that mechanically protects the sensitized and sore epithelium of the oral cavity. Clinically demonstrated, SP-03 has been shown to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. SP-03 is the product for OM that is supplied as a ready-to-use, pocket-sized device helping patients maintain their quality of life while undergoing cancer therapy. SP-03 was first launched in Europe in 2009 and is today commercially available in a number of countries, including the U.S., where it was launched by key global pharmaceutical players. SP-03 is a medical device class 1 in Europe and a 510(k) registered medical device in the U.S..

*FluidCrystal® was awarded the “Best innovation in formulation” prize at the CPhI Worldwide in 2013

Development Strategy

New Medical Device Applications (NMDA) have been submitted to the Chinese regulatory agency in May 2016 and to the Japanese regulatory agency in October 2016.