September 06, 2006

It was recently announced that Ardana plc obtained a U.S. patent on Teverelix LA, a specific GnRH antagonist. U.S. Patent No. 7,098,305, entitled "Sustained release of microcrystalline peptide suspensions," issued on August 29, 2006, and includes 14 claims on suspensions and methods for preparing suspensions of hydrophobic peptides. The first claim is for a suspension of Ac-D-Nal-D-Cpa-D-Pal-Ser-Tyr-D-Hci-Leu-Ilys-Pro-D-Ala-NH2 trifluoroacetate and an isotonic agent, which may be prepared by the method of claim 9 which associates the aforementioned peptide with trifluoroacetate counter-ion "in an amount and at a molar ratio that are sufficient to provide a fluid, milky microcrystalline aqueous suspension without formation of a gel." According to the patent, traditional peptide formulations have specific drawbacks and limitations, such as "the large volume of suspending fluids or the need to remove the non-degradable device," and specifically regarding gel forming peptides, "there is frequently a problem of bioavailability, which interferes with the desired sustained action of the active principle." According to Ardana's website, Teverelix LA is currently in Phase IIa clinical trials for prostate cancer and benign prostatic hyperplasia (BPH), and is in Phase I to treat endometriosis and fibroids.

U.S. Patent No. 7,098,305: LINK
ag-IP-news Article: LINK
Ardana plc Press Release: LINK


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