Royalty Report: Drugs, Cancer, Drug Discovery – Collection: 344493

Licensor grants a right of first negotiation to Licensee in case Licensee intends to license from Licensor any additional analogs which all under a valid claim of the LHRH Patents in the United States.

The active ingredient is referred to as ozarelix.  Ozarelix is a Luteinizing Hormone Releasing Hormone, or LHRH, antagonist (a substance that blocks the effects of a natural hormone found in the body). Mechanistically, LHRH antagonists exert rapid inhibition of luteinizing hormone and follicle stimulating hormone with an accompanying rapid decrease in sex hormones and would therefore be expected to be effective in a variety of hormonally dependent disease states including ovarian cancer, prostate cancer, BPH, infertility, uterine myoma and endometriosis.

LHRH Patents shall mean the composition in matter patents regarding a novel LHRH antagonist having improved solubility properties· with the internal No. 98/20 PH, the LHRH.

The patents are titled
— LHRH antagonists having improved solubility properties,
— Administration form for pharmaceutically active peptides with sustained release of active ingredient, and method for the production thereof,
— Application of initial Doses of LHRH Analogues and Maintenance Doses of LHRH Antagonists for the Treatment of Hormone-dependent Cancers and Corresponding Pharmaceutical Kits, and,
— Use of LHRH Antagonists for intermittent Treatments.

Licensor grants an exclusive license, with a right to sublicense, under the Collaboration Technology, to make, have made, use, sell, offer to sell, export and import Licensed Products in the Field of Use in the Licensed Territory.

This agreement includes a non-exclusive grant back to Licensor from Licensee.

LHRH Antagonist Compounds means compounds, including salts and prodrugs, which exhibit Lutenizing Hormone Releasing Hormone (LHRH) antagonist activity, including but not limited to the decapeptide known as Abarelix or PPI-149 and, all compounds included in the IUF License Agreement and any other technology owned or controlled by Licensor which Licensor is entitled to license or sublicense and which is necessary or useful to make, have made, use, sell, or offer to sell any compounds that exhibit LHRH antagonist activity.

The collaboration relates to the development and commercialization of abarelix-depot for all indications, including prostate cancer and endometriosis.

Licensed Product means a sealed, hollow cartridge containing the luteinizing hormone releasing hormone (LHRH), histrelin, a synthetic nonapeptide agonist of naturally occurring luteinizing hormone releasing hormone, which cartridge is constructed from biocompatible hydro gel copolymers, consisting of hydrophilic monomers such as 2-hydroxyethylmethacrylate (HEMA) and hydroxy propyl methacrylate (HPMA).   Carcinoma  An invasive malignant tumor derived from epithelial tissue that tends to metastasize to other areas of the body.

Hydro Med Patents and Patent Applications
U.S. 5,266,325         11/30/93     Preparation of Homogeneous Hydrogel Copolymers ('Preparation')

U.S. 5,292,515         03/08/94     Manufacture of Water Soluble Hydrophilic Articles and Drug Delivery Devices ('Manufacture')

Patent
U.S. Patent No. 5,506,207, issued April 9, 1996, entitled, 'GnRH Antagonists XIII'

GnRH antagonists prevents ovulation of female mammalian eggs and/or the release of steroids by the gonads and may be used to treat steroid-dependent tumors.

The term Patent Rights shall mean the inventions claimed in the patents and patent applications described below
(a) Patent applications listed in agreement and patents issuing therefrom.
(b) Patents listed U.S. Patent No. 5,506,207, issued April 9, 1996, entitled, 'GnRH Antagonists XIII'.
(c) Divisional applications, provisional applications, and continuation applications that claim the benefit of priority to any of the patents described in (a) or (b) or patent applications described in (a) or (b) and patents issuing therefrom.
(d) Continuation-in-part applications only to the extent the claimed inventions are supported by the patents described in (a) or (b) or patent applications described in (a) or (b) and patents issuing therefrom.
(e) Reissue patents, extensions (including extensions under the United States Patent Term Restoration Act), renewals, substitutions and additions thereof, and reexamination patents related to patents described in (a), (b), (c) and (d).
(f) Any and all foreign counterparts of the patent applications and patents described in (a), (b), (c), (d) and (e).

Licensor is the owner of certain Patent Rights (as hereinafter defined), an Institution that explores to understand neuroscience, genetics, immunology, plant biology and more.

MER 104 is under development for the treatment of hormone-sensitive prostate cancer. MER 104 is a gonadotropin-releasing hormone, or GnRH, antagonist formulated using GIPET technology designed to provide an oral dosage alternative to current therapies, all of which are injectable. An oral product would eliminate the inconvenience of injection therapy. It may also avoid severe allergic reactions that have been encountered with some injectable GnRH antagonists and allow tailored dosing regimens.

Licensee is a specialty pharmaceutical company engaged in the development of improved oral dosage forms of drugs that are poorly absorbed.