Rubicon Global Research, LLC Announces Investment Opinion on Antares Pharma
Several recent developments demonstrate the significant opportunities with Antares Pharma (AMEX:AIS).
Latest Highlights Include:
The FDA updated its guidance on safety and efficacy for testosterone therapies used to treat Female Sexual dysfunction by removing the major hurdle of requiring long-term safety studies prior to approval. Estimates vary, but the consensus is that the U.S. and European market for these therapies exceeds $7 billion. Currently, there are no approved products that address this unmet need.
The FDA will now allow companies to opt to complete the longer-term safety information "post-marketing". The FDA acknowledged that testosterone is used widely today (off-label) for the problem and it's preferable to have FDA-approved products from pharma companies. Given the FDA's negative decision last year on Procter & Gamble's competing product, we view the revised guidance as substantially positive. Both Proctor & Gamble and Antares have late clinical stage testosterone products and this decision re-opens exciting near-term opportunities.
We further believe that LibiGel offers several advantages over Proctor & Gamble's patch product. The market opportunity is significant and the FDA's decision puts this product back on the front burner as a significant part of the AIS product pipeline. We point out that prior to last year's FDA decision, both AIS and its U.S. partner BioSante (AMEX:BPA) garnered significantly higher valuations as a result of the potential of this single product and the size of the market. Equally important, BioSante has licensing rights on the North American market only, while Antares retains rights outside of North America. That may prove significant as the European markets are well ahead of the U.S. on this effort.
Bioterrorism Initiative - The Company recently announced the ability to leverage its needle-free device technology to aid in various government efforts to combat bioterrorism. While the company did not discuss the size of this opportunity, it's clearly a major government funded program and offers significant upside to our model. We believe this program may contribute to revenues as early as mid-2006. The announcement and potential to participate in this project was an unexpected, positive surprise. It also demonstrates how the Company's delivery technologies can offer advantages in a wide range of applications, suggesting the opportunity for additional positive surprises.
Licensing Partner (BioSante) - BioSante recently provided additional data on its Bio-E gel product. Bio-E gel offers the lowest effective estrogen dose on the market, a significant advantage from both an FDA point of view as well as from a marketing standpoint. We expect BioSante to file its IND application in the coming weeks, which represents a major milestone, and also triggers a milestone payment to Antares. We would also highlight the recent licensing deal announcement by Novavax (NVAX), another gel technology company. The terms of the license are significant, which demonstrates the significant value associated drug delivery systems. Similar to the LibiGel product, BioSante has licensing rights on the North American market only, while Antares retains rights outside of North America.
We believe these recent developments are just the beginning for Antares. Management has been extremely focused over the past year, as it continues to work on its initial development and licensing deals. Consistent with our original investment report, we continue to believe that the prospects for additional exciting, near-term events remain compelling.
A report published on September 1, 2005, by Rubicon Global Research, LLC is currently available for sale or through subscription.
Rubicon Global Research, LLC is a wholly owned subsidiary of Rubicon Global Holdings, LLC, a registered NASD company. For further information contact: info@rubiconglobalresearch.com
