Royalty Report: Drugs, Pharmaceuticals, Therapeutic – Collection: 7238

License Grant

The Australian Licensor Licensed zanamivir on an exclusive, worldwide basis to the Belgium Licensee, which markets the product as Relenzaâ„¢.

License Property

Zanamivir is a neuraminidase inhibitor used in the treatment and prophylaxis of influenza caused by influenza A and B viruses.

Neuraminidase inhibitors work against influenza by preventing viruses from being released from infected cells and subsequently infecting further cells. Neuraminidase inhibitors are usually prescribed to patients presenting with flu-like symptoms during epidemic periods to reduce symptoms or prevent spread of the virus.

Field of Use

The Licensor's zanamivir, was developed as the first-in-class NI to treat influenza.

License Grant

The Licensor receives royalty revenue from the sale of Inavir in Japan. Under the agreement, the parties cross-licensed the world-wide rights to develop and commercialize the related intellectual property.

License Property

In September 2010, laninamivir octanoate (Inavir) was approved for sale by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children. Patents on laninamivir octanoate in Japan generally expire in 2024.

Inavir® is a brand of laninamivir octanoate and also previously known as CS-8958. The approved indication is for the treatment of influenza in adults and children.

Inavir® (laninamivir octanoate), is the first drug of a new class of long acting neuraminidase inhibitors (LANIs) to address the limitation of the current products, which require daily or more frequent dosing. Neuraminidase inhibitors (NIs) are antiviral agents effective against influenza, providing both for the treatment of an established influenza infection or for the prevention of influenza prior to exposure.

License Grant

The Australian Licensor's Products and Product Candidates, Laninamivir, are marketed in Japan by the Japanese Licensee as Inavir® under a commercialization Agreement.

License Property

The Licensor is an anti-infective drug development company based in Melbourne, Australia.

Drugs that limit the multiplication of the influenza virus are generally only available by prescription from a doctor. This group comprises the drugs known as NIs, zanamivir (Relenza™), laninamivir (Inavir®) and oseltamivir (Tamiflu®) which act on both influenza A and B.

Field of Use

Inavir® was approved by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children.

License Grant

Licensor  hereby grants to Licensee and its Affiliates a sole and exclusive, worldwide license to a Swiss drug firm for the manufacture, importation, use, sale and offer for sale of Products for any and all uses. The companies desire to enter into a development and license agreement for the worldwide development and marketing of influenza neuraminidase inhibitors for the prevention and treatment of influenza.  Amiflu is now approved widely throughout the world for both treatment and prevention of all strains of influenza A and B.  It is still the only oral antiviral for the treatment of all strains of influenza A and B.  Licensee sells the drug worldwide.  Most of the activity to date has been in the U.S. and Japan.

Field of Use

Field of Use means for any and all uses.

License Grant

The Company hereby grants the exclusive right and license in, to, and under the Novavax IP in the Field within the Territory.  The exclusive license shall be for the period in which any Novavax IP or patents covering the Joint Improvement(s) shall remain valid and enforceable, unless earlier terminated as provided.

License Property

The Licensor has certain proprietary know-how in the field of encapsulated drug delivery systems and has developed certain proprietary adjuvants, such as a Novasome® delivery system; and the Licensee has certain proprietary know-how in the field of vaccines and has developed and continues to develop proprietary vaccines, especially a vaccine comprising antigenic determinants of an influenza virus.

The parties desire for Licensee to develop, manufacture, market, distribute and sell a product for treating or preventing influenza virus and/or infection, such as a vaccine comprising antigenic determinants of an influenza virus, like Fluogen®, which includes a proprietary adjuvant developed by Licensor.

Field of Use

Field shall mean (a) the use of Novavax IP in any manner whatsoever to develop, create, invent, manufacture, promote, market, offer-for-sale, sell, import and/or export an Influenza Product involved in or concerned with the treatment or prevention of influenza virus or any other purpose for which an Influenza Product may be indicated, and (b) the subsequent exploitation of an Influenza Product in the territory.

License Grant

The Company licensed rights to the use of MTCH-24(tm) against three viruses, the aids virus (hiv), Epstein-Barr virus and cytomegalovirus to a party for an ownership share.

License Property

MTCH-24 is an anti-microbial agent effective against a wide range of other enveloped viruses such as influenza, Epstein-Barr virus (EBV), respiratory syncytial virus (RSV, a virus which affects the respiratory system), pseudorabies (a specific virus in the rabies family), rhino tracheitis (an infection of the lungs and throat), and cytomegalovirus (CMV).  It is also believed to be effective against rotavirus, a non-enveloped virus that is a major cause of diarrhea and inflammation of the intestinal tract in infants and in certain animals.  MTCH-24 (TM) has been shown to be effective in inhibiting and preventing the growth of Aspergillus on wheat and corn.

License Grant

University hereby grants  a) a non-exclusive License to use the Know-How in the territory and within the Fields of Use; and b) an exclusive License to University's Patent Rights in the territory to make, use, sell, lease, offer to sell, and import any Licensed Products and to practice any Licensed Processes.

License Property

Patent Rights
· U.S. Patent No. 6,846,605 Inhibitors of serine protease activity, methods and compositions for the treatment of viral infections (related to Case # CU9014H).

· U.S. Patent Application No. 11/044,224 Inhibitors of serine protease activity, methods and compositions for the treatment of viral infections (Continuation application of Patent No. 6,846,605).

· Provisional Patent Application No. 60/742,191 Alpha-1-antitrypsin inhibition of disease and conditions mediated by binding to cell-associate actin (related to Case # CU1428H).

· Provisional Application No. 60/913,174 Title Compositions and Methods of Use for Alpha­Anti Trypsin Having No Significant Serine Protease Inhibitor Activity (CU1697H US).

· PCT Application No, PCT/US2006/061577 Title Compositions and Methods For Treating Actin-Mediated Conditions (CU1428H).

· U.S. Patent Application No.11/719,200 Compositions and Methods For Treating Actin- Mediated Conditions (CU1428H US1).

Field of Use

Fields of Use use of alpha-1 antitrypsin, and any analogs thereof, including but not limited to synthetic analogs, alpha-1 antitrypsin derivatives, alpha-1 antitrypsin fragments, combinations with alpha-1 antitrypsin and modifications of alpha-1 antitrypsin, for the prevention and/or treatment including prophylaxis of, reduction of and/or reduction of symptoms related to any and all viral infections.

Treatment of all viral infections including, without limitation, any and all mutations, strains, and subtypes, including future mutations, strains, and subtypes of Human Immunodeficiency Virus (HIV) (including any viral infections reasonably and/or previously withheld by the University, when they become available); Human Papilloma Virus (HPV); Herpes Simplex Virus (HSV); Hepacivirus; Pestivirus; Avian influenza virus; Human influenza virus; Murray Valley encephalitis; St. Louis encephalitis.