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DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology
Date:7/8/2009

degradation.

DOR anticipates proceeding towards clinical development of an oral form of the peptide hormone drug leuprolide using the LPM(TM) technology. Leuprolide is a synthetic peptide agonist of gonadotropin releasing hormone (GnRh) that is used in treatment of endometriosis in women and prostate cancer in men. In preclinical studies in rats and dogs, DOR has demonstrated that the LPM(TM) technology results in high systemic bioavailability of intestinally absorbed leuprolide. In both animal models, the bioavailability of leuprolide ranged from 20 to 40 percent, compared to 2.2 percent for the control oral solution. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Injectable forms of leuprolide marketed under tradenames such as Lupron(R) and Eligard(R) had worldwide sales of approximately $1.8 billion in 2006. Injectable leuprolide is also widely used in non-cancer indications, such as endometriosis in women (a common condition in which cells normally found in the uterus become implanted in other areas of the body), uterine fibroids in women (noncancerous growths in the uterus) and central precocious puberty in children (a condition causing children to enter puberty too soon). Leuprolide is currently available only in injectable, injectable depot and subcutaneous implant routes of delivery.

LPM(TM) is thought to promote intestinal absorption through the action of the micelles to open up small channels that allow only molecules of a certain dimension to pass through, excluding extremely large molecules, bacteria and viruses. The reverse micelles also structurally prevent the rapid inactivation of peptides by enzymes in the upper gastrointestinal tract. Other sensitive drugs that can be delivered orally with the LPM(TM) system include various classes of drugs such as peptides, nucleic acids and proteins which are degraded in the stomach and small intestine. Corresponding patents in
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SOURCE DOR BioPharma, Inc.
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