Royalty Report: Drugs, Delivery, Diabetes Treatment – Collection: 372487

License Grant

For the Licensors Technology, Licensor grants an exclusive, even as against Licensor except for use pursuant to the Supply Agreement, sublicensable, worldwide license under the Licensor Technology to Exploit the Products and the exclusive right to negotiate additional licenses.

License Property

Patents include, but are not limited to
— Method of increasing nasal peptide drug delivery,
— Absorption Enhancers for Drug Administration, and
— Anti-bacterial compositions for drug administration.

Licensor has rights in certain proprietary technology regarding the chemically synthesizable delivery enhancement and stability agents that, among other things, allow noninvasive systemic delivery of potent peptide, protein, and large molecule drugs.

Compound shall mean glucagon or any glucagon analog, including any isomer, hydrates, anhydrides, solvates, esters, salt forms, free acids or bases, prodrugs, complexes or polymorphs.

Material shall mean the Licensor product known as Intravail® and/or ProTek® stabilization agents.

Product shall mean any product for use in the Field, comprising the Compound and formulated using the Enhancement Agents.

Enhancement Agents shall mean Licensors proprietary chemically synthesizable delivery enhancement agents (including without limitation the lntravail® absorption enhancement and ProTck® stabilization agents), that, among other things, allow non-invasive systemic delivery of potent peptide, protein, and small and large molecule drugs.

ProTek® protein stabilization technology comprises the use of proprietary GRAS excipients that prevent aggregation of proteins and peptides thereby improving the stability of drug product formulated with these excipients. Intravail® comprises a broad class of transmucosal absorption enhancement agents that allow non-invasive systemic delivery of potent peptide, protein, nucleotide-related, and other small and large molecule drugs.

Field of Use

The agreement will enable the development and commercialization of a wide variety of glucagon presentations, including Licensee's lead glucagon product candidate, a liquid formulation in an auto injector intended for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia. Other presentations and indications contemplated by the agreement include the use of glucagon in the treatment of hyperinsulinemia with continuous subcutaneous infusion and the treatment of hypoglycemia via intranasal administration and administration via a bi-hormonal pump.

License Grant

Licensor grants Licensee of Denmark a worldwide, exclusive license, with the right for Licensee to sublicense under the Licensed Patents and Licensed Know-How, to research, develop, make, have made, use, import, export, sell, offer for sale, and otherwise transfer the Licensed Products in the Territory during the Term.

License Property

Licensor's broad-based drug delivery technology platform, known as the eligen(R) technology, uses proprietary, synthetic chemical compounds, known as Emisphere delivery agents, sometimes called carriers. Licensor's eligen(R) technology makes it possible to deliver a therapeutic molecule without altering its chemical form or biological integrity.

Licensed Products means any pharmaceutical formulation suitable for administration to humans where such formulation contains at least one Product in combination with a Program Carrier.

GLP-1 Receptor Agonist means a compound that has the ability to bind the GLP-1 receptor in vitro and initiate an increase in cAMP where such compounds include but are not limited to GLP-1 and GLP-1 analogs and derivatives and Exendin-4 and Exendin-4 analogs and derivatives but excluding Native GLP-1.

Native GLP-1 means GLP-1(7-36) amide and GLP-1 (7-37).

Products means any GLP-1 Receptor Agonists.

Program Carriers means up to 6 Carriers that are selected by Licensee, at its sole discretion, in writing during or before the Term of this Agreement from the Carriers made available by Licensee. Program Carriers may be either Exclusive Program Carriers or Non-Exclusive Program Carriers. Carrier 1082 and SNAC have been selected by License as an Exclusive Program Carrier and a Non-Exclusive Program Carrier respectively as of the Effective Date.  Carrier 1082 and SNAC are sodium salts.

Field of Use

The Development and License Agreement is to develop and commercialize oral formulations of Licensee's proprietary GLP-1 receptor agonists, which have the potential of treating Type 2 diabetes, using Emisphere's eligen(R) technology.

License Grant

For the Licensed Patents,  Licensor grants an exclusive, nontransferable license during the Term under the Licensed Patents, solely to develop, make, have made, use, market, distribute, import, offer to sell and sell the Licensed Product in the Territory.

For the CAPTISOL Data Package, Licensor grants a non-exclusive, nontransferable license during the Term under Licensors right in and to the CAPTISOL Data Package, solely to develop, make, have made, use, market, distribute, import, offer to sell and sell the Licensed Product in the Territory.

License Property

Licensor is engaged in the business of developing and commercializing novel drug delivery technologies designed to enhance the solubility and effectiveness of existing and development-stage drugs.

Licensor is the exclusive worldwide licensee of CAPTISOL®, a patented drug formulation system.

CAPTISOL means the drug formulation technology marketed by Licensor as CAPTISOL®, also known scientifically as sulfobutylether ~(beta) cyclodextrin, sodium salt.

The CAPTISOL Data Package means all toxicology/safety and other relevant scientific safety data owned, licensed or developed by Licensor and its Affiliates; all toxicology/safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of Licensor or its Affiliates or other third parties on CAPTISOL alone, and not in conjunction with a product formulation; and all CMC and manufacturing process data relating to the preparation of CAPTISOL, in each case to the extent necessary or useful for the formulation of the Licensed Product.

Licensed Product means the Compound combined with or formulated using CAPTISOL in an injectable dosage form/formulation for ultimate use in humans.

Captisol® is a modified cyclodextrin that can form ionic and inclusion complexes with many types of drugs. Complexation can significantly increase the solubility and often times, the physico chemical stability of the drug. Complexation has also been used to improve dissolution and bioavailability, reduce volatility, allow incorporation of liquids into solid formulations, and reduce unpleasant side effects such as taste and irritation caused by drug contact with tissues, e.g. extravasation at injection sites and GI irritation.

Field of Use

The technology is designed to enhance the solubility and stability of drugs.  patented Captisol technology improves water solubility, bioavailability and complexation characteristics of insoluble and/or unstable drugs.

Captisol® enabling technology is for the development of an injectable formulation of zileuton (ZYFLO®).
ZYFLO CR and ZYFLO are indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. The injectable formulation of zileuton is being developed for use in emergency room or urgent care settings for patients experiencing acute exacerbations of asthma.

License Grant

Japanese Licensor hereby grants to Licensee an exclusive, royalty-bearing license (with the right to sublicense in accordance with this agreement, under the Licensed Technology to (i) develop, use, sell, offer for sale, import or otherwise commercialize the Product, and (ii), make or have made the Product (using the Device supplied by Licensor or a Third Party permitted under this Agreement); in each case of (i) and (ii) solely for the Field within the Territory.

Licensee has the right to grant sublicenses under the license granted to any Affiliate or Third Party, other than a Licensor Competitor, to commercialize the Product in EU, Japan, Australia, New Zealand, Canada, the United States and/or the Territory in its entirety without Licensor’s prior written approval.

License Property

Licensed Patents
8,337,817 – Preparation for transnasal application

Product means the product consisting of (i) a pharmaceutical product containing the Compound, as the only active pharmaceutical ingredient, formulated using the Formulation Technology and (ii) the Device that contains such pharmaceutical product.

Device means the single-use version of Licensor’s proprietary nasal delivery device (Fit-lizer™).

Compound means the compound known as Dihydroergotamine or DHE, and any complex, chelate, salt, hydrate, polymorph, isomer, diastereomer, prodrug, congener, metabolite or ion pair thereof.

Formulation Technology means Licensor’s proprietary nasal drug delivery formulation technology as further described below, including its powdery drug carrier (µco™ System carrier).
– Licensors proprietary inhalable dry powder pharmaceutical formulations designed to enhance drug absorption, comprising of one or more physiologically active substance and muco-adhesive powder drug carrier (µcoâ„¢ Carrier) including Microcrystalline cellulose Ceolus® PH-F20JP (Manufacturer Asahi Kasei Corporation), microcrystalline cellulose Ceolus® PH-301; (Manufacturer Asahi Kasei Corporation) and tribasic calcium phosphate.

Field of Use

The licensing agreement is for a novel, rapidly absorbed treatment for acute migraine incorporating dihydroergotamine (DHE) as the active drug.

TO-2070 is expected to offer a new and potentially improved approach to the treatment of acute migraine.  Preclinical data suggest that TO-2070 may offer significant migraine treatment benefits beyond those provided by less convenient and more invasive DHE drug delivery methods, such as injection, liquid nasal sprays or pulmonary inhalation.  TO-2070 is designed to provide these benefits at a relatively low cost via a unique and proprietary nasal powder drug delivery system that can be easily self-administered by patients.

TO-2070 is based on a novel nasal powder drug delivery technology created by SNBL that combines a muco-adhesive drug carrier with a proprietary nasal powder drug delivery device.  This system is the product of a decade-long SNBL internal development program with the objective of unlocking the significant market potential for nasal drug delivery by overcoming many of the obstacles that have limited its application to date.  Unlike previous nasal drug delivery technologies, the SNBL system is able to consistently deliver drug into the nasal cavity with each administration and hold it in place on the nasal mucosa to enable enhanced absorption into the bloodstream. Delivery of the dry powder drug formulation to the nasal mucosa via the specially designed device nozzle is achieved by simply squeezing the device.

License Grant

The French Licensor grants to the Licensee in Puerto Rico, an exclusive license, even as to Licensor, with the right to grant sublicenses, under Licensed Technology, to make, have made, use, sell, offer for sale The Parties  have undertaken a feasibility study to develop a Formulation by applying the Licensors Micropump Technology to Carvedilol.

License Property

Licensor has developed certain proprietary technology related to Licensor Micropump Technology.

Carvedilol11 means (l-(9H-carbazol-4-yloxy)-[[2-2(2-methoxyphenoxy)ethyl] amino ]-2-propanol), the compound that is known by the generic name of Carvedilol and including all racemates, chelates, complexes, enantiomers, diastereoisomers, salts, bases, esters, hydrates, solvates, polymorphs, crystal forms, crystal habits, prodrugs, isotopic or radiolabeled equivalents, metabolites, or the like, thereof and all mixtures and any of the foregoing, and compositions comprising Carvedilol.

Licensor Micropump Technology means a multiple-dose system containing a large number of microparticles that may be contained in capsule, tablet, orally dispersible, sachet or suspension formulations. It is expected that the microparticles are released in the stomach and pass into the small intestine, where each microparticle operates as a miniature delivery system, releasing the drug at a controlled rate and over an extended period of time.

Licensor Patent Rights means all patents and patent applications in existence as of the Effective Date or during the Term of this Agreement claiming generically or specifically a product or process using the Licensors Micropump Technology.

Product means any presentation or presentations of Carvedilol that incorporate the Licensed Technology, alone or in combination with other therapeutically active compounds, for the therapeutic or prophylactic treatment of diseases and conditions in humans in any dosage or strength.

Field of Use

The Micropump® technology is a controlled release and taste-masking technology for the oral administration of small molecule drugs.

License Grant

Israeli Licensor hereby grants to the Licensee an exclusive worldwide through multiple tier license, in the Territory, to 1) the Intellectual Property Rights resulting from and/or arising under the Development Plan and/or Development Results including Resulting Patents, and/or the Drug Formulation and/or Product ; and 2) to make, have made, use, have used and/or license the Drug Formulation and/or the Development Results, and 3) to make, have made, sell, have sold, use, have used, license, and/or import Product; and 4) an exclusive license in the Territory to any Patents covering the Drug Formulation and Product to enable the Licensee to make, have made, sell, have sold, and/or use Products. The Licensee shall not use the Drug Formulation and/or the Development Results for any purpose other than exercise of the License. Licensor hereby grants to the Licensee a non-exclusive license, in the Territory under the Licensor Patents, to use the Licensor Formulation Technology to 1) develop, make, have made, and use, the Drug Formulation, and 2) develop, make, have made, sell, have sold, and use, Product.

License Property

Licensor Patents shall mean the patents and/or patent applications covering or disclosing Licensor Formulation Technology; and including but not limited to,  U.S. Patent No. 5,540,934, U.S. Patent No. 5,716,638 and PCT International Application No. PCT/EP95/02397 and any continuations, continuations-in-part, extensions, divisions, substitutions or additions to such applications and all patents which are reissues thereof, re-validations and registrations based thereon, and any and all foreign patents and patent applications corresponding thereto.

5,540,934 – Compositions for applying active substances to or through the skin
5,716,638 – Composition for applying active substances to or through the skin

Product means a pharmaceutical preparation or composition containing the Drug Formulation which is covered by a Valid Patent Claim.

Drug means the Licensees organoselenium drug or materials, as specified in this Agreement, and its racemate, metabolite, derivatives, isomers, polymorphs, crystals.

Drug Formulation means the formulation of the Drug utilizing Licensors Formulation Technology.

Field of Use

Field of use is for Ethosome, a non-invasive, transdermal drug delivery technology.

Ethosomes are phospholipid nanovesicles used for dermal and transdermal delivery of molecules.