Royalty Report: Drugs, Disease, Pharmaceuticals – Collection: 7592

License Grant

Licensor grants to Licensee the exclusive license to make, have made, use and develop collaboration products, commercialize, sell, offer for sale and import collaboration products and manufacture, to make and have made API compound or formulated collaboration product in the territory.

License Property

The collaboration product means any of the long-acting ß2 adrenoceptor agonists.
Long-acting ß2 adrenoceptor agonist or LABA means a chemical entity that selectively binds to human ß2 adrenoceptors and activates certain human ß2 adrenoceptors.

API compound means bulk quantities of active pharmaceutical ingredient compound prior to the commencement of secondary manufacturing resulting in a collaboration product.

Field of Use

The field of use is the human pharmaceutical use of long-acting ß2 adrenoceptor agonists for the treatment and/or prophylaxis of respiratory diseases.

License Grant

The Company entered into its collaboration agreement to develop and commercialize a long-acting beta2 agonist (LABA) product candidate both as a single agent new medicine for the treatment of chronic obstructive pulmonary disease (COPD) and as part of a new combination medicine with an inhaled corticosteroid (ICS) for the treatment of asthma and/or a long-acting muscarinic antagonist (LAMA) for COPD.

License Property

The collaboration's resources are focused on the development of the lead LABA, GW642444, together with fluticasone furoate.

Field of Use

The rights granted apply to the healthcare industry.

License Grant

Licensor grants:
– a worldwide, nonexclusive, non-transferable license under the Licensors IP and interest in the Collaboration IP, to research such Specified Compound(s) and such Product(s) for applications in the Field;
– a worldwide, exclusive, royalty-bearing, non-transferable license, with the right to sublicense, under the Licensors IP and interest in the Collaboration IP, to develop, make, have made, and use such Specified Compound(s) and Product(s) in the Field; and
– a worldwide, exclusive, royalty-bearing, non-transferable license, with the right to sublicense, under the Licensors IP and interest in the Collaboration IP, to promote, market, distribute, sell, offer to sell, import, and otherwise commercialize Product(s) in the Field.

License Property

Licensor has expertise in the discovery and optimization of pharmaceutical compounds.   A0001 shall mean the Compound known as EPI-AOOO1 (alpha-Tocopherol Quinone).

EPI-A0001 has received orphan drug status in the treatment of inherited mitochondrial respiratory chain diseases.

The mitochondrial respiratory chain has the crucial function of supplying the cell with energy in the form of ATP. Mutations affecting this chain can arise in mitochondrial or nuclear DNA and cause diseases known as mitochondrial encephalomyopathies. Because the rules of inheritance of mitochondrial and nuclear DNA differ considerably, these brain–muscle syndromes often have unpredictable clinical and genetic features.

Field of Use

Penwest is in the business of developing and commercializing pharmaceutical products;

The Field shall mean the treatment or prophylaxis of all diseases and conditions in humans including all indications in the Non-Orphan Field and the Target Field.  The Target Field shall mean the treatment of inherited mitochondrial diseases of the cellular respiratory chain that satisfy the FDA’s requirements for orphan product designation.