TWi Biotechnology Inc. Announces Development and Commercialization Agreement and Collaboration with Castle Creek Pharmaceuticals, LLC

TAIPEI, Taiwan, Dec. 17, 2015 /PRNewswire/ -- TWi Pharmaceuticals, Inc. (4180.TT) today announced that its subsidiary, TWi Biotechnology, Inc. (TWiB), and Castle Creek Pharmaceuticals, LLC (CCP), a spin off entity from Marathon Pharmaceuticals, LLC, have entered into a development and commercialization agreement for its lead drug candidate AC-203, which is currently in development for the treatment of epidermolysis bullosa (EB). Under the terms of the agreement, TWiB grants to CCP an exclusive license of AC-203, covering a worldwide territory with the exception of Asia but including Australia and New Zealand, to develop, register and commercialize AC-203. TWiB is eligible to receive an upfront payment and milestone payments based on achievement of predefined clinical and regulatory events and will receive double-digit royalties after product launch. TWiB and CCP will collaborate globally for AC-203 product development in any other future indications.

"We are very pleased to enter into the collaboration with CCP for AC-203. With their expertise and capabilities in orphan drug development, CCP is the ideal partner to rapidly advance these promising candidates to the clinic and, ultimately, bring new treatments to EB patients," said Dr. Calvin C. Chen, President and CEO of TWiB. "Epidermolysis Bullosa, or EB, is a very rare genetic connective tissue disorder that affects 1 child out of every 50,000 births. It is estimated that there are approximately 30,000 patients in the US, and close to a hundred children in Taiwan that are suffering from the debilitating disease. Patients with EB are also known as "Butterfly Children" in the United States and "Bubble Dragon Children" in Taiwan due to their extremely fragile skin that blisters and tears from friction or trauma. We hope this collaboration can quickly bring forth a new treatment for EB patients. Current treatments for EB are focused on the relief of symptoms such as itching and pain and wound care to prevent infection, which are expensive and may require frequent visits to hospitals. In contrast, AC-203 is being developed to prevent or reduce the blisters and so, if successful, may alleviate the suffering of the patients and their families from this debilitating disease."

Mr. Michael Derby, CEO of CCP added: "We are excited to begin work on a promising new therapy for the treatment of EB, and to expand on the progress already made by TWiB. EB patients are in dire need of new therapies and AC-203 represents a potential breakthrough in the treatment of this devastating disease." 

About AC-203

AC-203 is a proprietary topical formulation of a first-in-class, small molecule which has shown the ability to inhibit the production and activity of caspase-1 and the cytokine Interleukin-1Beta (IL-1Beta) through the inhibition of the assembly of the NLRP3 inflammasome. Inhibition of the NLRP3 inflammasome associated signaling pathway and IL-1Beta has been demonstrated to be effective in treating a variety of diseases including arthritis, gout, and diabetes mellitus (DM). The active ingredient of AC-203 has been approved for treating patients with chronic rheumatic diseases in France and subsequently in other EU and Middle Eastern countries such as Spain and Italy since the mid-1990s.

TWi Biotechnology holds US and Taiwan orphan drug designations for AC-203 for Epidermolysis Bullosa treatment as well as two US INDs for the oral dosage form of the molecule for type 2 diabetes and gout treatment.

About Epidermolysis Bullosa (EB)

EB is caused by mutations in the DNA code that make up genes. Genes are responsible for making and expressing proteins. EB can result from a mutation in any one of the 18 genes that have been found to cause the disorder. These mutations, or errors in the genetic code, may not allow the affected gene to produce a specific protein, or it may result in the incorrect formation of that protein. Either way, the mutation does not enable the affected protein to work correctly thus resulting in extremely fragile skin, and other manifestations of EB including: anemia, cardiomyopathy, syndactyly (fusion of the fingers and toes), renal insufficiency, dysphagia (difficulty swallowing), malnourishment, cancer, constipation, osteoporosis, muscular dystrophy and pyloric atresia.

About TWi Biotechnology, Inc.

TWi Biotechnology, Inc., a subsidiary of TWi Pharmaceuticals, Inc., is a leading clinical stage biopharmaceutical company based in Taipei, Taiwan, specializing in the development of innovative new drugs for unmet medical needs, especially in the diseases associated with innate immunity. The company is building its product pipeline through in-licensing and internal research. TWi Biotechnology's product development pipeline includes two drug candidates for treating type II diabetes, arthritis, and immunodermatology diseases.

About Castle Creek Pharmaceuticals, LCC.

Castle Creek Pharmaceuticals is a pharmaceutical company that develops and commercializes niche, specialty branded drugs for targeted diseases or conditions with great unmet medical need. Castle Creek was founded in 2015 as a spin off entity from Marathon Pharmaceuticals, with dedicated funding and a team focused on innovative early stage asset creation.

Contact :
Weishu Lu 
Tel: +886-2-2657-1788 #300
Email: weishu.lu@twibiotech.com

SOURCE TWi Pharmaceuticals, Inc.