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Lutrepatch

Vyteris, Inc.

Drug Names(s): Fertility Enhancement Peptide, Ferring/Vyteris Fertility Peptide Patch, transdermal fertility patch

Description: This product consists of a FDA-approved hormone to induce ovulation in women having ovulation disorders administered via Vyteris' Smart Patch (previously known as Actyve) transdermal technology. This technology uses an integrated circuit to control a small amount of current that delivers drugs through the skin (iontophoresis). The two-component system employs a transdermal patch containing the drug and a small battery-powered controller that precisely controls the rate and amount of drug released from the patch. The level of control is intended to mimic IV or infusion pump delivery without needles.

The product would make it possible to administer a fertility peptide without needles, and is being designed to deliver multiple transdermal pulses automatically, around the clock, in a painless, convenient and cost-effective manner, possibly with as little as two 12-hour patches per day. In addition to this less painful therapy, there are also potential benefits that would possibly reduce the likelihood of multiple births.

Deal Structure: In September 2004, Vyteris entered into a license and development agreement and a supply agreement with Ferring for this infertility product. The principal terms of the agreement call for, among other things, Ferring and Vyteris to share the development costs, for Ferring to pay for the costs of the clinical trials and regulatory filings, for Ferring to make milestone payments to Vyteris, for Ferring to pay Vyteris a royalty based on sales and for Ferring to pay Vyteris a transfer price for manufacturing the product.

In December 2009, Vyteris received notice from Ferring Pharmaceuticals of its termination of the License and Development Agreement, dated September 30, 2004.


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