Royalty Report: Drugs, Ophthalmological, Pharmaceuticals – Collection: 1449

License Grant

The Company has license agreements with an undisclosed former director wherein the Company has acquired rights to develop and commercialize certain research technologies.

The sale and assignment of Lotemax and Alrex.

License Property

Lotemax and Alrex are the trade names of drug products in the form of eye drop suspensions in which the active compound is loteprednol etabonate ('LE').

Lotemax is a topical, site-specific steroid that is used to treat steroid responsive inflammatory eye conditions. The prescription eye drop is also used for post-operative eye inflammations such as experienced following cataract surgery. The novel chemical structure of Lotemax allows it to be predictably transformed by enzymes in the eye to an inactive metabolite, thereby increasing its safety profile.

Alrex is a specially developed formula of loteprednol etabonate that is used in the treatment of ophthalmic allergies. Alrex is indicated for the treatment of seasonal allergic conjunctivitis, an inflammation of the eye usually caused by pollens. Seasonal allergic conjunctivitis produces itching, tearing, redness and swelling in the conjunctiva, the membrane that covers the inside of the eyelid and the white part of the eye.

License Grant

The Licensor amended the research and License Agreement with the Licensee to enhance the Licensor's economic interest in Prednisporin and the other product candidates Licensed to the Licensee for further ophthalmic development.

License Property

Prednisporin(TM) is the first combination therapy developed for the treatment of persistent allergic conjunctivitis. It is a proprietary topical formulation of lower than the usual therapeutic doses prednisolone acetate and cyclosporine A, to retain the efficacy of a very potent steroid with an improved safety profile. Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances such as pollen and dander.

Field of Use

The rights granted apply to healthcare industry relating to allergy of the eyes.

License Grant

Licensor hereby grants to Licensee a royalty-bearing, exclusive (even as to CombinatoRx) worldwide right and license, with the right to grant sublicenses, under the CombinatoRx Licensed Combination IP and CombinatoRx’s interest in the Licensee Licensed Combination IP to use Licensed Combinations in the Licensed Combination Field to Exploit Licensed Products.

License Property

Licensor derived combination drug candidate, Prednisporin TM (FOV1101), was recognized as a key asset by Sanofi-Aventis in its pending acquisition of our collaborator, Licensee Pharmaceuticals, also the Licensee. This acquisition validates our business strategy of leveraging the Licensor's discovery technology platform and products through strategic alliances. Positive clinical results with Prednisporin in subjects with persistent allergic conjunctivitis were recently announced and based on this data; further advanced clinical trials for Prednisporin both in the United States and in Europe are planned by Licensee, the Licensee.

The Licensor also recently enhanced its economic interest in Prednisporin and the other product candidates Licensed to Licensee for ophthalmic development.  

Allergic conjunctivitis is inflammation of the conjunctiva (the membrane covering the white part of the eye) due to allergy.[1] Although allergens differ between patients, the most common cause is hay fever. Symptoms consist of redness (mainly due to vasodilation of the peripheral small blood vessels), oedema of the conjunctiva, itching and increased lacrimation (production of tears). If this is combined with rhinitis, the condition is termed allergic rhinoconjunctivitis.

Prednisporin(TM) is the first combination therapy developed for the treatment of persistent allergic conjunctivitis. Allergic conjunctivitis is inflammation of the conjunctiva (the membrane covering the white part of the eye) due to allergy.[1] Although allergens differ between patients, the most common cause is hay fever. Symptoms consist of redness (mainly due to vasodilation of the peripheral small blood vessels), oedema of the conjunctiva, itching and increased lacrimation (production of tears). If this is combined with rhinitis, the condition is termed allergic rhinoconjunctivitis.

Field of Use

The rights granted apply to the healthcare industry relating to the use of Licensed Combinations for treating FOE Diseases by Local Administration. A  pharmaceutical preparation suitable for administration to a human, containing a Licensed Combination as an Active Ingredient.

License Grant

Licensor hereby grants to Licensee an exclusive right and license (with the right to grant sublicenses to Affiliates, contractors (including manufacturers), consultants and representatives; provided, however, sublicenses to other Third Parties require the prior written consent of Licensor) under the Licensor IP Rights (a) to research, develop, make, have made, use, offer for sale, sell, import, or otherwise exploit, commercialize or dispose of Products in the Territory, and (b) to make or have made Products worldwide for use, offering for sale, sale, importation or other exploitation, commercialization or disposition of Products in the Territory. Subject to the satisfaction of Licensor’s obligations hereunder and obtaining applicable Registration(s) for Product, Licensee shall use commercially reasonable efforts to commercialize such Product in the Territory.

License Property

Product shall mean any product, in any form or formulation, including (without limitation) unit dose vials or multi-dose containers, for ophthalmic administration.

Technology shall mean, collectively, all forms and formulations, all methods of manufacture or use thereof, and all data, information, compositions, formulae, procedures, protocols, techniques and results of experimentation and testing and other technology relating to or reasonably necessary or useful to make, use, sell, offer for sale, import, develop, seek regulatory approval, market, commercialize or otherwise exploit the foregoing.

EM-100 is an ophthalmic product indicated for the treatment of allergic conjunctivitis. EM-100 is a unique formulation of an already FDA-approved molecule that is widely used for allergic conjunctivitis.

Allergic conjunctivitis is an eye inflammation caused by an allergic reaction to substances like pollen or mold spores. The inside of your eyelids and the covering of your eyeball have a membrane called the conjunctiva. The conjunctiva is susceptible to irritation from allergens, especially during hay fever season.

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor hereby grants by way of a license to Licensee, and Licensee hereby accepts, a sole and exclusive, running royalty-bearing license under the Patent Rights and using the Technical Information & Know-How to make or have the Product made, develop, manufacture, use, market, off er to sell, and sell the Product, in the Territory. This license shall not include the right for Licensee to sell the Product from the Territory to any party outside of the Territory.

The license granted to Licensee herein shall not include the right to grant further licenses or sub-licenses to any third party without the prior written consent of Licensor, such consent not to be unreasonably withheld. Nothing in this Agreement shall affect, and Licensor shall retain the right to grant, other sub-licenses to the Product outside of the Territory.

License Property

Patent Rights shall mean that granted under U.S. Patents No. 5,556,848, issued September 17, 1996; and No. 6,114,319, issued September 5, 2000; as well as any and all reissues, re-examinations, and patent term extensions thereof.

5,556,848 – Ophthalmic suspension containing diflupredonate
6,114,319 – Compositions containing difluprednate

Product shall mean the topical corticosteroid ophthalmic emulsion and/or suspension containing the Compound as an active ingredient for the treatment of ophthalmic diseases in humans only. Combination products containing the Compound and other active ingredients, whether patented or not, are initially excluded from this definition, but may be included only with the express prior written consent of Licensor, such consent not to be unreasonably withheld. Furthermore, Licensor has the right to amend this Agreement in exchange for the grant of permission to allow a patented combination product into this definition, provided however, that for the term of this Agreement,  there shall be a royalty on sales of combination products identical to those on the Product. After the term of this Agreement ends, the Parties shall negotiate in good faith for the future terms of such a grant.

Compound shall mean a certain chemical substance having the chemical structure of 6á, 9-Difluoro- 11 â, 17, 2 1-trihydroxy-1, 4-pregnadiene-3, 20-dione 21-acetate 17-butyrate. The Compound as also referred to as “Difluprednate.”

Field of Use

ST-601 is a potent ophthalmic steroid emulsion with indications for steroid responsive inflammatory ophthalmic diseases. Ophthalmic steroids are widely used to treat many ophthalmic diseases and to prevent inflammation following most ophthalmic surgeries.