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Zoraxel

Rexahn Pharmaceuticals, Inc.

Drug Names(s): immediate-release clavulanic acid/RX-10100

Description: Zoraxel is being developed as an orally administered, on-demand tablet. Zoraxel is a dual serotonin (5HT) and dopamine (DA) enhancer in the brain, where neurotransmitters play a key role in sexual functions of sexual motivation and arousal, erection and release.

One of the ingredients is clavulanic acid, a beta lactam inhibitor used to prevent inactivation of penicillins. Clavulonic acid has also been found to block N-acetylated-a-linked acidic dipeptidases (NAALADases), which cleaves N-acetyl-aspartyl-glutamate to produce glutamate. Blockade of this enzyme may reduce the high levels of glutamate that follow, for example, ischemic stroke. The company believes this mechanism is also involved in behavioral disturbances and can impact other neurotransmitters (presumably the mechanism for the impact on serotonin and dopamine, though the company has not stated this).

The company has stated there is another ingredient in the drug that is an NME. While they have not disclosed what it is, a number of their patents in this area refer to beta-lactam compounds or their derivatives (ie drugs analogous to the penicillins/cephalosporins), which the company claims can also inhibit NAALADase.

Deal Structure: On February 10, 2005, Rexahn licensed on an exclusive basis, with the right to sublicense, all of the intellectual property of Revaax, which includes five patents and 14 patent applications, with respect to certain chemical structures that have demonstrated in pre-clinical research the potential to treat certain behavioral disorders, such as anxiety, depression and cognitive disorders. This agreement expires upon the expiration of the royalty term for all licensed products in all countries, which is no earlier than August 2020 and could extend to August 2024.

This agreement provides for an initial license fee of $375,000 to be paid to Revaax in eight quarterly installments. In addition, Rexahn will make the following milestone payments to Revaax for each licensed product under the agreement: $500,000 upon initiation of a pivotal trial for the first disease treatment indication for the licensed product; $250,000 upon initiation of pivotal trials for the next four distinct disease...See full deal structure in Biomedtracker


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