Royalty Report: Drugs, Delivery, Pharmaceuticals – Collection: 7195

License Grant

Pursuant to the terms of this agreement, upon approval by the Licensor of one or both products to be combined with NexACT® drug delivery technology, the individual product Licenses will be granted to the Licensee.  Licensee has ownership interest in Licensor.

License Property

Upon grant of such product License, the Licensee will make Milestone and Royalty Payments on sales of the Licensed Product directly or as a co-marketer.

Royalties in will be payable on a country-by-country basis for the longer of the time during which manufacture, use or sale of Licensed Product would infringe any patent rights within the Patents and 15 years from the first commercial sale of Licensed Product in such country.

NexACT, a clinically validated multi-route drug delivery technology, utilizes patented highly effective, novel excipients or penetration enhancers to dramatically improve absorption and bioavailability of drugs. Varying the concentration of the enhancer allows for local or systemic delivery of drug, as desired.

Field of Use

The NexACT® technology allows
1.Topical/transdermal delivery of drugs (even proteins),
2.Subcutaneous delivery of drugs in a depot-like fashion with improved bioavailability, and
3.Oral delivery of poorly permeable/soluble compounds including compounds belonging to BCS 2 to 4 categories.

License Grant

This Agreement provides for a feasibility and phase I study to be conducted to study the feasibility of oral delivery of the product cyclobenzoprine using Licensors delivery technology.

Licensor grants the exclusive option to obtain an exclusive, worldwide license under the Licensor Intellectual Property for the further development and commercialization of the Product.

License Property

Licensors property is LipralTM technology.   Lipralâ„¢ is for improved oral absorption of poorly water soluble drugs and elimination of food effects on absorption.

The Licensees property relates to very low dose cyclobenzoprine (VLD-cyclo).

Field of Use

The field is for improving absorption of poorly water-soluble compounds.

License Grant

The Company has previously agreed to pay royalties to CONSULTANT, a member of the Company's Board of Directors, in recognition of the patents developed by CONSULTANT for TIMERx.

License Property

The Company has developed the TIMERx delivery system, a novel drug delivery technology, to address the limitations of currently available oral controlled release delivery systems. The Company believes that the TIMERx system is a major advancement in oral drug delivery that represents the first easily-manufactured oral controlled release drug delivery system that is applicable to a wide variety of drug classes, including soluble drugs, insoluble drugs and drugs with a narrow therapeutic index. The Company is utilizing the TIMERx system to formulate generic versions of branded controlled release drugs, controlled release formulations of currently-marketed.

The TIMERx drug delivery system is a hydrophilic matrix combining primarily a heterodispersed mixture, usually polysaccharides xanthan and locust bean gums, in the presence of dextrose. The physical interaction between these components works to form a strong, binding gel in the presence of water. Drug release is controlled by the rate of water penetration from the gastrointestinal tract into the TIMERx gum matrix, which expands to form a gel and subsequently releases the active drug substance. The TIMERx system can precisely control the release of the active drug substance in a tablet by varying the proportion of the gums, together with the third component, the tablet coating and the tablet manufacturing process. Drugs using TIMERx technology are formulated by combining the active drug substance, the TIMERx drug delivery system and additional excipients and compressing such materials into a tablet.

1)  Directly compressible sustained release excipient.

2)  Sustained release excipient and tablet formulation.

3)  Compressible sustained release solid dosage forms.

4)  EPO Application No. 89309518.2; filed September 19, 1989.

5)  Australian Patent Application No. 43057/89

6)  Japanese Patent Application No. 1-510135

7)  Irish Patent Application No. 2968/89

8)  Canadian Patent Application No. 611,700

9)  Verapamil Tablet Application, Serial No. 736,031 & EPO PCT Applications.

10)  2 U.S. Applications on Bi-modal release.

License Grant

The Irish Licensee entered into a purchase and license agreement with the Irish Licensor, to license several oral drug delivery technologies, including a large intellectual property portfolio, which included the GIPET and GIRES delivery technologies, as well as a pipeline of future products and technologies relating to oral vaccine delivery and targeting ligands.

Field of Use

The rights granted apply to the healthcare industry relating in the development of improved oral dosage forms of drugs with poor bioavailability.