2014 exemplified our personal motto of “See it big but keep it simple”. Charleston Laboratories succeeded in reaching several key milestones by maintaining its focus on delivering benefits to both patients and our shareholders in 2014. In 2015, we’ve set our sights on the “big” by developing products that are poised to revolutionize the pain management market, but we will continue the “simple” by maintaining our focus on developing cutting edge products, making the right management hires and developing key strategic partnerships.
Our lead asset, CL-108, completed a Phase 3 clinical trial, demonstrating its ability to treat moderate to severe pain and the reduction of Opioid-Induced Nausea and Vomiting (OINV). We’re excited to be filing for FDA approval for CL-108, as we think it will not only change how patients manage their pain, but also change the economics of the hydrocodone market.
Also on the clinical front, we submitted an IND to the U.S. Food and Drug Administration (FDA) for CL-H1T, our novel treatment for patients suffering from migraine pain and migraine induced nausea or vomiting. We were also granted our request for a Type B Pre-IND meeting to discuss CL-AT-313, our novel treatment for the relief of cough and other symptoms associated with upper respiratory allergies or a common cold.
I’m proud to say we fulfilled our goal of identifying a strategic partner that shares our passion for the discovery and commercialization of novel pain therapies. We entered into a strategic collaboration with Daiichi Sankyo, Inc. for the development and U.S. commercialization of CL-108 and other novel hydrocodone products. This partnership showcased Charleston’s tenacity and its potential to be a preeminent company in the pain management space. I’m looking forward to seeing how this collaboration develops and expands Charleston’s profile in the United States.
A key focus in 2015 will remain our commitment to the development of cutting edge, industry-changing second generation products. We’ll also look to continue to drive innovation in our product pipeline and identify opportunities where we can increase shareholder value. Additionally, we’re focused on building out our commercial infrastructure to support the commercialization of our products. As always, we want to thank our shareholders for their commitment and continued support of our company and its vision.
G. Paul Bosse III
President and Chief Executive Officer