Highlights of the fourth quarter of 2013 and subsequent two months include:
•Reported positive interim data from the two-year, open-label extension study of ARIKAYCE, or liposomal amikacin for inhalation, to treat Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients, which demonstrated long-term safety and durability of effect at 12 months;
•Entered into a contract manufacturing agreement with Therapure Biopharma Inc. for the manufacture of ARIKAYCE;
•Received Orphan Medical Product Designation in the European Union for ARIKAYCE to treat lung infections caused by NTM;
•Secured another European patent allowance, thereby strengthening the Company's intellectual property position;
•Appointed David W.J. McGirr to its Board of Directors. Mr. McGirr is the former Chief Financial Officer of Cubist Pharmaceuticals, Inc.; and
•Appointed Peggy Berry as Vice President of Regulatory Affairs. Ms. Berry has more than 25 years of experience in the pharmaceutical industry and began her career at the U.S. Food and Drug Administration. Ms. Berry has secured ten drug approvals during her career. She will be reporting to Will Lewis, President and Chief Executive Officer (CEO).
"2013 was a transformational year, one in which we laid the foundation to build Insmed (INSM) into a leading biopharmaceutical company operating at the intersection of orphan, pulmonary and infectious diseases," stated Will Lewis, President and CEO of Insmed. "Most significantly, we advanced the ARIKAYCE clinical programs to treat NTM lung disease as well as Pseudomonas aeruginosa in CF patients. We also expanded our leadership team with talented executives in key regulatory and commercial roles. Our collective talents are focused on advancing the regulatory strategy and filings for ARIKAYCE for the treatment of NTM lung infections and CF patients with Pseudomonas."
This release tells me the company has done everything and said everything it can to tell us Arikayce is on the way and everything is positive to move forward. So the SP is down on low volume- what's that all about?