- 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.
Antares Pharma Reports Fourth Quarter And Full Year 2012 Operating And Financial Results
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