Excaliard has in-licensed a series of antisense oligonucleotides (ASO), from Isis Pharmaceuticals, Inc. (NASDAQ: ISIS: http://www.isispharm.com/ which target various genes known to regulate fibrosis and scarring. The agreement with Isis Pharmaceuticals was announced in November 2007, adding Excaliard to Isis Pharmaceuticals’ growing list of pharmaceutical partners, which currently includes Eli Lilly, Bristol-Myers Squibb, Ortho Division of Johnson & Johnson, as well as Genzyme. Excaliard anticipates early definitive proof of concept in clinical studies in 3-4Q2010.
Skin scarring
Excaliard has focused its initial clinical programs on unsatisfactory skin scarring. The American Society for Aesthetic Plastic Surgery reports that well over 1.5 million cosmetic surgical procedures and over 5 million reconstructive procedures were performed in the US in 2009. Over $1.2 billion was spent on breast cosmetic procedures alone. In addition, market opportunities exist in other non-cosmetic surgical scars such as Caesarian sections (1.3 million/yr in the US), as well as trauma and burn patients. In the USA alone, there are over 40 million surgical procedures annually. Despite the best surgical technique and post-operative wound care, many procedures result in undesirable skin scarring. In addition to fine line scarring, scars can be raised (hypertrophic) or even grow beyond the original site of injury (keloids). The prevalence of hypertrophic scarring has been reported to be between 15-60% for Caucasians and as high as 70% in Asian populations, creating significant and expanding market opportunities in both the USA and Worldwide. Keloids have an incidence of 5-15% in the U.S. population alone, and occur in a particularly high incidence in individuals of African, Hispanic and Asian origin.
There are currently no FDA approved drugs specifically designed to prevent scarring. Studies carried out by the Mattson Jack Group estimate the U.S. market for to be over $4 billion/yr. A preliminary 2010 market analysis indicated a high level of interest in EXC 001 as an anti-skin scarring therapy with a conservative projected sales of $750m in the US alone.
Technology
Excaliard has in-licensed from Isis and has internally developed an anti- scarring drug program, including multiple drug candidates, both clinical and pre-clinical, against multiple drug targets. The company has Exclusive IP composition of matter patents filed on lead candidates including EXC001, extending protection until 2028. Through a separate research agreement, the company also has broad access to ISIS’s technical expertise in oligonucleotide discovery and informatics, pharmacology, toxicology and broad non-exclusive licenses to ISIS’s antisense IP estate.
Excaliard Business Development Goals
The company is currently conducting three Phase 2 trials in elective surgical procedures. While final data analysis will not be complete until Q4 2010, the 12 week data from the first of these studies shows dramatic efficacy of the lead compound, EXC 001, in improving the appearance of skin scarring following surgery. Post successful completion of these studies, Excaliard will seek a strategic partner for further clinical development of EXC 001 and its anti-scarring drug platform.
