Antares Pharma, Inc. (NASDAQ: ATRS) today reported operating and financial results for the fourth quarter and full year ended December 31, 2012.
- Announced the submission and acceptance of OTREXUP™ New Drug Application (NDA) by the Food and Drug Administration (FDA). OTREXUP™ is a potential new product under development for subcutaneous self-administration of methotrexate (MTX) to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
- Announced positive results from OTREXUP™ clinical study which was designed to compare the relative systemic availability of MTX. Following administration of OTREXUP™, the systemic availability of MTX increased proportionately at every dose level studied thereby extending the range of exposure significantly compared to patients receiving oral therapy at doses of 15mg to 25mg.
- Conducted a Pre-Investigational New Drug (Pre-IND) meeting with the FDA to discuss a clinical development program for VIBEX ™ QS T (testosterone replacement therapy). Clinical development path forward has been identified and the development plan is designed to target a launch date in 2016.
- Increased total revenue to $5.5 million and $22.6 million for the three months and year ended December 31, 2012, respectively, from $5.4 million and $16.5 million, respectively, in the comparable periods of the prior year.
- Completed a public offering of the Company’s common stock at a purchase price of $4.00 per share with net proceeds of approximately $53.3 million which included the underwriters exercised overallotment option.
- OTREXUP™ NDA filed early, Prescription Drug User Fee Act (PDUFA) fee recorded in fourth quarter operating results.
- Entered into a new commercial agreement with Teva under which we will manufacture and supply a packaged sumatriptan auto injector for the treatment of migraine. Received an upfront cash payment, a potential milestone payment on commercial launch and a 50/50 split of potential net profits.
- Ended the year with $85.2 million in cash and investments and no debt.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are pleased with the progress we’ve made this past year toward becoming a product focused Specialty Pharmaceutical Company. Completing the clinical work required for the OTREXUP™ NDA and filing the application ahead of schedule was a major accomplishment for our shareholders and the future of the Company.” Dr. Wotton continued, “As we start to build up our commercial effort and develop a comprehensive launch plan for OTREXUP™, we will simultaneously accelerate our product development efforts around what we believe to be the next large opportunity for the Company, Vibex QS T for men suffering from symptomatic testosterone deficiency. We have had constructive discussions with the FDA regarding this product candidate and look forward to working closely with the Agency during the clinical and development process.”