Royalty Report: Drugs, Disease, Pharmaceuticals – Collection: 280835

License Grant

Licensor grants Licensee an exclusive, sublicense under the Patents and license under the Know-How and Licensor Improvements to offer, make, have made, use, lease, export, import, sell and resell Products, use the Process or both in the Territory.

License Property

Licensor has developed certain additional technology and know-how related to the patents, patent applications and the medical use of dextromethorphan or a combination of dextromethorphan with quinidine or other enzyme inhibitors.

United States Patent Number 5,166,207, 'Method for Enhancing the Systemic Delivery of Dextromethorphan for the Treatment of Neurological Disorders'

United States Patent Number 5,166,207, 'Method for Enhancing the Systemic Delivery of Dextromethorphan for the Treatment of Neurological Disorders'

United States Patent Number 5,350,756, 'Use of a Cytochrome Oxidase Inhibitor to Increase the Cough-Suppressing Activity of Dextromethorphan'

United States Patent Number 5,366,980, 'Use of extromethorphan and an Oxidase Inhibitor to Treat Dermatitis'

United States Patent Number 5,863,927, 'Dextromethorphan and an Oxidase Inhibitor for Treating Intractable Conditions'

PCT Application PCT/US94/10771, 'Compositions Useful for the
Preparation of Medicines for Treating a Variety of Intractable Disorders'

United States Patent Application Number 09/471,060, filed December 22, 1999, entitled 'Dextromethorphan and Oxidase Inhibitor for Weaning Patients from Narcotics and Anti-Depressants'

Field of Use

Dextromethorphan or DM, is a well-known NMDA receptor antagonist. It has been reported in medical literature that DM is effective in reducing pain associated with diabetic neuropathy.

(i) EMOTIONAL LABILITY INDICATION.
(ii) CHRONIC PAIN INDICATION.
(iii) CHRONIC COUGH INDICATION.
(iv) DERMATITIS INDICATION.
(v) PRODUCTS FOR WEANING PATIENTS FROM NARCOTICS AND ANTI-DEPRESSANTS.

Emotional lability refers to rapid, often exaggerated changes in mood, where strong emotions or feelings (uncontrollable laughing or crying, or heightened irritability or temper) occur.

Dermatitis, also known as eczema, is a group of diseases that result in inflammation of the skin.

License Grant

Licensor hereby grants to Licensee an exclusive (even as to Licensor) license (with the right to sublicense to others) to offer, make, use and sell technology, products or processes with respect to, and covered by, the Licensed Patents in the United States.

License Property

Licensed Patents
1. 5,166,207, Method for Enhancing the Systemic Delivery of Dextromethorphan for the Treatment of Neurological Disorders, issued November 24, 1992.
2. 5,206,248, Method for Reducing Emotional Lability in Neurologically Impaired Patients, issued April 27, 1993.
3. 5,350,756, Use of a Cytochrome Oxidase Inhibitor to Increase the Cough-Suppressing Activity of Dextromethorphan, issued September 27, 1994.
4. 5,366,980, Use of Dextromethorphan and an Oxidase Inhibitor to Treat Dermatitis, issued November 22, 1994.
5. PCT Application PCT/US94110771, Compositions Useful for the Preparation of Medicines for Treating a Variety of Intractable Disorders.  Neurodex treats multiple central nervous system disorders.

Field of Use

The rights granted apply in the Neurological field.

License Grant

For the Research License, Licensor grants an exclusive license under the Licensor Intellectual Property Rights and the Formulation, in the Territory to use the CTM, or clinical trial material, manufactured by Licensor to conduct the Clinical Studies required to file and maintain the Regulatory Filings.

For the Commercial License, Licensor grants an exclusive license under the Licensor Intellectual Property Rights in the Territory to use, offer for sale, import and sell the Product. Licensor grants a license under the  Intellectual Property Rights, in the Territory to make, and have made, the Product to the extent permitted under the Commercial Supply Agreement.

Licensor grants a non-exclusive license to use, and sublicense the right to use, the Licensor Trademarks in the sale and marketing of the Product provided the Product has been manufactured by, on behalf of, or under a license from Licensor.

License Property

Licensor is the owner or licensee of certain technology including processes, patents, trade secrets, trademarks and know-how for the development and manufacture of orally administered pharmaceutical formulations, including controlled release technologies.

DIFFUCAPS® Trademarks

This agreement is for the development of a once-a-day controlled release (CR) capsule dosage form containing a combination of dextromethorphan hydrobromide (DM) and quinidine sulfate (Q). The new product, Neurodex CR, is projected to have 60 mg of DM and up to 60 mg of Q and will be based on Licensors proprietary multi-particulate Diffucaps® technology. Diffucaps beads will allow separate adjustment of the DM and Q doses based on the fill volume of beads in the capsules.

The API or active pharmaceutical ingredients are dextromethorphan hydrobromide or quinidine sulfate separately, or dextromethorphan hydrobromide and quinidine sulfate together.

Product means the pharmaceutical dosage form resulting from the Formulation developed by Licensor pursuant to this agreement.

Formulation means both the identification and selection of ingredients, including the Drug Combination, and the Licensor Patent Rights and Know-How solely related to the Product and improvements thereto.

Field of Use

The field of use is orally administered pharmaceutical formulations, including controlled release technologies.  Diffucaps® incorporate release-controlling polymers or protective coatings onto drug-layered cores, granules, or crystals with one or more drugs.

License Grant

The Licensee holds the exclusive worldwide marketing rights to Nuedexta for certain indications pursuant to an exclusive license agreement with the Licensor.

License Property

Under certain circumstances, the Licensee may have the obligation to pay the Licensor a portion of net revenues received if it sublicenses Nuedexta to a third party.

Under the agreement, the Licensee is required to make payments on achievements of up to a maximum of ten milestones, based upon five specific medical indications.

The Licensee does not have the obligation to develop additional indications under the license agreement.

In October 2010, the U.S. Food and Drug Administration approved Nuedexta® (formally referred to as AVP-923 during clinical development), a unique proprietary combination of dextromethorphan/quinidine, for the treatment of pseudobulbar affect.

Pseudobulbar affect  is an emotional liability, labile affect or emotional incontinence refers to a neurologic disorder characterized by involuntary crying or uncontrollable episodes of crying and/or laughing, or other emotional displays.

Field of Use

The rights granted apply to the healthcare industry.

The Licensee commenced promotion of Nuedexta in the United States in February 2011 and is currently pursuing approval of Nudexta in Europe.

License Grant

The Licensee holds the exclusive worldwide marketing rights to Zenvia for certain indications pursuant to an exclusive license agreement with the Licensor, a non profit corporation.

License Property

Zenvia is a combination of two well-characterized compounds the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of PBA and diabetic peripheral neuropathic (DPN) pain.

Field of Use

The Licensee will be obligated to pay the Licensor up to $400,000 in the aggregate in milestones to continue to develop Zenvia for both IEED/PBA and diabetic peripheral neuropathic pain (DPN pain), assuming they are both approved for marketing by the FDA.  The Licensee is not currently developing, nor do they have an obligation to develop, any other indications under the license agreement.