Ampio has also submitted the application to the Therapeutic Goods Administration (TGA) for approval of Zertane in Australia. The Company expects to receive marketing authorization (approval) in the first half of 2014. An approval in Australia will open up numerous markets worldwide including South Korea and Brazil where Ampio has licensing agreements. This could also be important for additional business negotiations and revenue for Ampio.
Luoxis Diagnostics, Inc.
Luoxis Diagnostics recently completed a private placement financing to initially fund the carve-out of Ampio Pharmaceuticals. Under terms of the private placement, which raised $4.7 million in gross proceeds, Ampio will retain approximately 80% ownership of the newly formed in-vitro diagnostics company focused on the commercialization of the Oxidation Reduction Potential ("ORP") technology platform. Luoxis, under a newly appointed management team, is now fully funded to pursue FDA and CE Mark clearance for its proprietary point-of-care diagnostic system. In support of these regulatory submissions, and subsequent commercialization of the ORP product, will be data demonstrating the diagnostic capability of the product to detect serious medical conditions within more than 5,000 patients. This data will be available in 3 rd quarter 2013.
About Ampion TMAmpion is a non-steroidal anti-inflammatory biologic that has the potential to be used in a broad array of inflammatory conditions and autoimmune diseases. The active ingredient is aspartyl-alanyl diketopiperazine, referred to as DA-DKP, which is derived from two amino acids from human albumin and appears to have a significant role in the homeostasis of inflammation. Ampion is protected by composition of matter, use, and synthetic form patents. Ampio has published a number of studies and articles on the anti-inflammatory activity of DA-DKP. About Optina TM Optina is a drug based on a low dose of the weak androgen, low-molecular-weight, very lipophilic steroid danazol. Oral administration of low dose danazol to patients with DME is safe with no evidence of serious adverse events. Ampio's in vitro data suggest that danazol has a biphasic effect on endothelial cells: At low doses, danazol decreases vascular leakage, while at higher concentrations an increase in vascular permeability is observed. This biphasic effect was supported by the efficacy of danazol in vivo at various BMIs. From Ampio's previously announced results, Optina appears to reduce DME in a BMI dosage-adjusted manner and appears to trend toward improved visual acuity and seems to be safe with few, if any, side effects. 1, 2 About The Sexual Dysfunction Portfolio Zertane is a repurposed, on-demand, orally dissolving tablet to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient, tramadol, has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use for other medical indications. Zertane-ED, a patented combination of Zertane and any PDE-5 inhibitor, can be used to treat premature ejaculation and erectile dysfunction. It is estimated that 41% of men with erectile dysfunction are comorbid for premature ejaculation.