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Ampio Patent Protection For Optina™ Expands To Include Europe

GREENWOOD VILLAGE, Colo., May 31, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion™, Optina™ and Zertane™), licensing distribution of these drugs and developing additional new drugs, today announced that The European Patent Office (EPO) has notified the company that it will grant a patent covering Ampio's Optina product. The patent will protect vascular-hyperpermeability-inhibiting amounts of danazol, the active ingredient in Optina , for use in treating macular edema as well as pharmaceutical compositions that include danazol in amounts effective for such uses. Ampio previously received a notice of allowance of a similar patent from the Canadian Intellectual Property Office and from the US patent and trademark office (PTO). These allowed patents now cover the North American territories (including the US and Canada), Europe and many other countries.

(Logo:  http://photos.prnewswire.com/prnh/20120516/MM09116LOGO)

According to Michael Macaluso, Ampio's CEO, "Optina™ is an ultra-low oral dose of danazol for the treatment of DME. This low dose in commercially unavailable for any approved indication of the drug.  To our knowledge, no other oral drug to treat this condition exists and there is currently no drug approved by the FDA for this condition. In certain countries in Europe, Lucentis™, an anti-vascular endothelial growth factor (VEGF) antibody is approved for use in DME in the form of periodic injections into the eyeball (about every 6 weeks).

Mr. Macaluso continued,  "Optina™ is an oral drug with an excellent safety profile, especially at the ultra-low doses. The allowance of these patents in North America and Europe complete the portfolio of patents protecting the use and manufacture of this clinically effective dose of Danazol. These patents include multiple claims for formulation, dosage, composition, method of use and indications for use of the ultra-low dose Optina™ on vascular hyperpermeability encountered in DME and other vascular leakage syndromes. These patents have an unusually long patent life that expires in 2030. In contrast, most drugs at this stage of development (just before a pivotal trial) have exhausted a large portion of their patent life. These patent claims provide especially strong protection because of the unexpected finding of efficacy only at the very low doses. Ampio is currently in discussions with potential partners to co-develop Optina™ for DME."

Dr. David Bar-Or, Chief Scientific Officer for Ampio, explained, "The mode of action of Optina™ involves the remodeling of the actin cytoskeleton (F-actin) of endothelial cells (cells that line the inside of blood vessels, including the retinal blood vessels) so that the adhesion molecules between these cells are tightly bound to the peripheral actin (cortical) resulting in tighter junctions among these cells, hence preventing vascular leakage from the blood compartment into tissue. The basic mechanism of action of Optina™ is described in a recently published manuscript by Dr. Bar-Or's research team entitled: "Biphasic effect of danazol on human vascular endothelial cell permeability and f-actin cytoskeleton dynamics" in Biochemical Biophysical Research Communications (BBRC 21 April 2012, http://www.sciencedirect.com/science/article/pii/S0006291X12007334 .)  This is the first in a series of publications describing the biphasic effect of danazol on vascular permeability which is beneficial in reducing permeability at nano molar concentrations and increasing permeability at the higher, micromolar concentrations used in other approved higher dosages and indications.

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted, "A clinical study of Optina™ for DME conducted in a double masked, placebo controlled manner at Saint Michael Hospital in Toronto, Canada, confirmed the in vitro findings that the ultra-low dose of danazol is beneficial while the high dose is detrimental. Complete analysis of the Optina™ trial is underway by our CRO and results will be published in the proper venues following a planned pre-IND meeting with the FDA. Ampio is preparing for a pre-IND meeting with the FDA to discuss plans for a trial(s) in the US under the 505(b)2 registration." About Diabetic Retinopathy, Diabetic Macular Edema and current treatmentsDiabetic retinopathy is damage to the retina of the eyes caused by complications of diabetes mellitus and often resulting in loss of visual acuity and blindness. Macular edema of the eyes is often an early form of diabetic retinopathy that causes significant vision loss. Almost all Type 1 diabetics and more than 60% of Type 2 diabetics will develop retinopathy. There is no effective daily drug treatment for diabetic retinopathy other than general measures, such as controlling blood sugar, hypertension, blood lipids, etc. Due to the global diabetes epidemic, diabetic retinopathy is recognized as a high, unmet medical need that would benefit from having oral therapeutic options available. The only treatments available for macular edema now are laser therapy, injection or implantation of drugs into or around the eyeball (not approved in the US or Canada). To our knowledge, Optina™ is the only proposed oral treatment for this condition. About Optina™Optina™ is an orally administered ultra-low dose of danazol, for the treatment of diabetic macular edema (DME). Ampio's Chief Scientific Officer discovered an unexpected activity in his investigation of the mechanism of action of danazol: very low doses reversed inflammation-induced increases in the permeability of blood vessels, thus reducing vascular leakage. Dr. Bar-Or subsequently managed in-vitro studies that suggested this effect may reduce the vasogenic edema produced by various vascular leak syndromes, including diabetic macular edema (DME) which can impair vision and cause blindness. The specific Optina dosages used in the trial are proprietary and subject to multiple issued patents worldwide.

Danazol, a derivative of the synthetic steroid ethisterone, was approved by the FDA in the 1970s for endometriosis and, more recently, for other chronic indications, including hereditary angioedema, ITP and fibrocystic disease of the breast at doses ranging from 100 to 800mg per day. In some conditions it is used chronically.

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