Upcoming FDA PDUFA: Oct 14 2013 - Antares Pharma - Otrexup for Rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis

Antares Pharma (ATRS) is awaiting an FDA approval decision on Oct 14 2013 for Otrexup (Methotrexate - combination product for use with Medi-Jet™ self-injection technology) for the treatment of Rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis. 

Date of FDA Decision (PDUFA): October 3, 2013

Company name: Antares Pharma

Stock ticker: (ATRS)

Location: Ewing, NJ

Type of application: First Submission; combination of previously approved drug with novel self-injection technology

Indication: Rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis

01 Oct 2013:

Market Cap	$516.26 Mln
52-week range	3.35 – 4.67
Avg. volume	926,105

Q2 2013:

Net loss	$0.02 per share
Cash	$75.0 mln

Antares Pharma is a developer of parenteral technologies, specializing in self-injectable drug delivery. Among the company’s proprietary products are Jet-injectors, Auto-injectors and Pen injectors which can be used with a wide array of oral and injectable medications. Among the companies to which Antares has licensed its technologies are Pfizer, Teva and Jazz Pharmaceuticals. Teva is Antares’s largest source of revenue, having licensed three technologies from the company.

Although Antares normally engages in risk-diluting partnerships with Big Pharma, it is developing Otrexup (methotrexate) on its own. Methotrexate is a rheumatoid arthritis (RA) drug used in 70% of 1.3 million RA cases in the US. Commonly, the drug is taken orally, but complications exist with this mode of delivery, namely poor absorption and gastrointestinal side effects.  A self-injectable formulation of methotrexate would lower the necessary dosage of the drug, and reduce side effects. In clinical studies, Antares found that 98% of patients found the self-injectable system easy to use. In addition to RA, the company intends to market Otrexup for moderate to severe psoriasis, an autoimmune skin pigmentation disorder, for which methotrexane is also commonly prescribed. The global psoriasis market was worth US$ 3.9 billion in 2010.