Posted by: ctraderd | July 10, 2012

Horizon Pharmaceuticals News Coming Soon

Horizon Pharmaceuticals (HZNP) has a rheumatoid arthritis drug called NP01, frequently known as Lodotra that has cleared the NDA and has it’s PDUFA date scheduled on July 26. Lodotra has been approved in Europe but not in the United States yet. If the drug is approved, the stock price might soar, but if the drug is rejected, the stock price could very well do the opposite.

The proprietary formulation technology of NP01 enables a programmed release of prednisone approximately four hours after administration. As reflected in the chart below, NP01 synchronizes the prednisone delivery time with the patient’s elevated cytokine levels, thereby taking effect at a physiologically optimal point to inhibit cytokine production. (Buttgereit et al, Lancet, 2008).

NP01 was developed utilizing SkyePharma’s proprietary GeoClock™ and GeoMatrix™ technologies, for which we hold an exclusive worldwide license for the delivery of corticosteroids. NP01 is comprised of an active core containing prednisone, which is encapsulated by an inactive porous shell. The inactive shell acts as a barrier between the product’s active core and a patient’s GI fluids. NP01 is intended to be administered at bedtime. At approximately four hours following bedtime administration of NP01, water in the digestive tract diffuses through the shell, causing the active core to expand, which leads to a weakening and breakage of the shell and allows the release of prednisone from the active core.




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