Royalty Report: Drugs, Diagnostic, cardiac – Collection: 369377

License Grant

The University grants an exclusive, worldwide license in the Field under the Licensed Know-how and the Licensed Patents to make, have made, use, import, offer for sale, develop, have developed, promote, have promoted and sell Licensed Products throughout term hereof.

License Property

Licensor owns certain proprietary know-how, patent applications and patents pertaining to human therapeutic uses of adenosine and adenosine derivatives, receptor-selective adenosine derivatives, and compounds that interact with adenosine receptors or their signaling pathways.

Patents relate to Method For Improving Insulin Sensitivity Using An Adenosine Receptor Antagonist, and, Methods And Compositions For Treating Inflammatory Response.

Field of Use

The Agreement includes certain intellectual property relating to the Licensee’s late-stage drug candidate, apadenoson, trademarked Stedivaze, a selective adenosine receptor 2A agonist and potential best-in-class coronary vasodilator for use in nuclear-SPECT myocardial perfusion imaging, which currently is in Phase III of clinical development.

Stedivaze is a potential best-in-class vasodilator for use in cardiac stress testing. The study will evaluate the safety and efficacy of Stedivaze (apadenoson) for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a method for detecting defects in the blood supply to the heart. The Phase III trial will also compare the tolerability of Stedivaze to adenosine, a standard pharmacologic stress agent used in MPI scans.

License Grant

The Parties agree on the following license rights to Licensee to use the Licensor Development Technology, including, without limitation, the Collaborative Clinical Data in the Licensor Field, the Licensor Clinical Data in the Development Field and the Licensor Manufacturing Technology
—  Licensor grants an exclusive, except as to Licensor and Licensor Affiliates, license, with the right to sublicense, to use the Collaborative Clinical Data in the Licensor Field and the Licensor Clinical Data in the Development Field outside of the Territory to develop, make, have made, use, market, export and import any pharmaceutical products.

Licensor grants an exclusive, except as to Licensor and Licensor Affiliates, license, with the right to sublicense, to use Licensor Manufacturing Technology and Improvements thereto that are Controlled by Licensor in the Development Field to develop, make, have made, use, market, export and import any pharmaceutical products, including any Licensed Products, outside of the Territory.

In addition, Licensor grants a non-exclusive license to use Licensor Manufacturing Technology and Improvements thereto that are Controlled by Licensor in the Development Field to develop, make, have made, use, other than for marketing or sale, and export any pharmaceutical products, including any Licensed Products, inside the Territory, but only to in connection with and in support of Licensors exclusive license.

Licensor grants to an exclusive, except as to Licensor and Licensor Affiliates, license, with the right to sublicense, to use and practice all other Licensor Development Technology Controlled by Licensor, other than the Collaborative Clinical Data, the Licensor Clinical Data, the Licensor Manufacturing Technology, and Improvements to any of the foregoing, outside of the Territory to develop, make, have made, use, market, sell, export and import any pharmaceutical products, including any Licensed Products.

License Property

Licensed Compounds means the compounds known as x-3146, or regadenoson, and x–3033.

The patents include
N-Pyrazole A2A Receptor Agonists;
C-Pyrazole A2A Receptor Agonists;
Partial A2A Adenosine Receptor Agonists;
Myocardial Perfusion Imaging Method;
Use of A2A Adenosine Receptor Agonists;
Selective A2A Agonist attenuates coronary vasoconstriction induced by lowering perfusion pressure in mouse isolated hearts; and,
Method of Preventing Reperfusion Injury.

Field of Use

Regadenoson injection is used as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

License Grant

The original agreement between the Licensor of Sweden and Licensee is for selective inhibition ADP compound known as Cangrelor.

This amendment addresses performing the CHAMPION-PHOENIX Study, and financial considerations.

License Property

Cangrelor, a potent intravenous adenosine diphosphate-receptor antagonist, significantly reduced the rate of ischemic events, including stent thrombosis, during PCI without increasing severe bleeding when compared with clopidogrel, according to a late-breaking trial presented here.

CHAMPION-PHOENIX Study shall mean a repeat phase III prospective, randomized, double blind, standard clopidogrel care controlled, parallel group, superiority study in which the primary objective is to demonstrate that the efficacy of Cangrelor ( combined with 600mg of clopidogrel) is superior to that of usual care, in patients requiring percutaneous coronary intervention (PCI) as measured by a composite of all cause mortality, myocardial infarction (Ml), IDR and stent thrombosis which will be performed under US IND 56,812.

Ticagrelor Product shall mean Licensor s pharmaceutical product containing the pharmaceutical compound known as ticagrelor, a reversibly binding oral P2Y12 adenosine di phosphate (ADP) receptor antagonist.

Field of Use

The field of use is in patients undergoing percutaneous coronary intervention or PCI.  Cangrelor is used during percutaneous coronary intervention (PCI) for reducing the risk of heart attacks.  Percutaneous coronary intervention (PCI) refers to a family of minimally invasive procedures used to open clogged coronary arteries (those that deliver blood to the heart). By restoring blood flow, the treatment can improve symptoms of blocked arteries, such as chest pain or shortness of breath.