Stars lining up for Vyteris

Last week, we alerted our subscribers to the incredible comeback story developments at Vyteris (OTCBB: VYTR). Since our published alert, the stock has doubled in value as investors took Tuesday's company released data as a confirmation of the rumors we have been reporting.

The company is the developer of the first FDA-approved active transdermal patch and on Tuesday, they announced positive results from a Phase II clinical trial evaluating the safety and efficacy of a pulsatile delivery system for the treatment of female infertility.

The Phase II trial enrolled 350 women between 18 and 38 years of age with ovulatory dysfunction. The trial assessed the safety and efficacy of three dosage strengths of pulsatile gonadotropin releasing hormone (GnRH) delivered from an iontophoretic patch compared to oral treatment with another leading infertility drug, and placebo.

GnRH is a naturally occurring hormone that is currently approved by the U.S. Food and Drug Administration to induce ovulation in patients with hypothalamic amenorrhea, which is relatively rare and affects three to five percent of the women with ovulatory dysfunction.

"The positive outcome of our Phase II trial in female infertility represents a significant milestone for Vyteris and a promising development for the women worldwide who suffer from infertility," said Michael Reidy, Ph.D., Chief Technology Officer at Vyteris. "These data underscore the potential of Vyteris' smart patch technology to meet the growing demand for controlled drug delivery in major therapeutic areas."

As we told you last week, finance industry sources told us that the Phase II data would be the exact opposite of the impression given by former partner Ferring Pharmaceuticals' withdrawal in 2009 from a License and Development Agreement, dated September 30, 2004. 

Other industry sources told us that the company is very close to signing a new deal for $20 million upfront loaded with not only milestones, but also hefty royalties. We feel the rumored licensing deal is not far behind and now very close to happening. Given that, we are issuing a trade alert for the stock. Please read my original report about the stock for more details and analysis.

According to Family Planning International, approximately 10 percent of all couples worldwide have or have had fertility problems. The World Health Organization estimates that there are approximately 60-80 million cases of infertility around the world. Infertility affects about 7.3 million women and their partners in the U.S. -- about 12% of the reproductive-age population.

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