Royalty Report: Drugs, Cancer, Therapeutic – Collection: 26485

License Grant

The Company entered into a licensing agreement with South Africa Licensee with respect to co-development of various RNA drugs, including Ampligen® . The licensing agreement provides Licensee with an exclusive manufacturing and marketing license for certain southern hemisphere countries (including certain countries in South America, Africa and Australia as well as the United Kingdom and Ireland (the licensed territory) .

License Property

Ampligen® is a our proprietary drug to treat diseases for which adequate treatment is not available. We seek the required regulatory approvals which will allow the progressive introduction of Ampligen® for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”), HIV, Hepatitis C (“HCV”) and Hepatitis B (“HBV”) in the U.S., Canada, Europe and Japan. Ampligen® is currently in phase III clinical trials in the U.S. for use in treatment of ME/CFS and is in Phase IIb clinical trials in the U.S. for the treatment of newly emerged multi-drug resistant HIV, and for the induction of cell mediated immunity in HIV patients that are under control using potentially toxic drug cocktails.

Our proprietary drug technology Ampligen® utilizes specially configured ribonucleic acid (“RNA”) and is protected by more than 350 patents worldwide with over 80 additional patent applications  pending to provide further proprietary protection in various international markets. Certain patents apply to the use of Ampligen® alone and certain patents apply to the use of Ampligen® in combination with certain other drugs. Some composition of matter patents pertain to other new medications which have a similar mechanism of action. The main U.S. ME/CFS treatment patent (#6130206) expires January 23, 2015. Our main patents covering HIV treatment (#4795744,#4820696, #5063209, and #5091374) expire on August 26, 2006, September 30, 2008, August 10, 2010, respectively; Hepatitis treatment coverage is conveyed by U.S. patent #5593973 which expires on October 15, 2014. The U.S. Ampligen® Trademark (#1,515,099) expires on December 6, 2008 and can be renewed thereafter for an additional 10 years. The U.S. FDA has granted us “orphan drug status” for our nucleic acid-derived therapeutics for ME/CFS, HIV, and renal cell carcinoma and malignant melanoma. Orphan drug status grants the Company protection against competition for a period of seven years following FDA approval, as well as certain federal tax incentives, and other regulatory benefits.

License Grant

The Transaction relates to the development of certain compounds, including Ampligen(R), and allows licensee to obtain from university exclusive information and regulatory rights relating to these compounds.

License Property

Ampligen utilizes specially configured ribonucleic acid.  FDA has granted 'orphan drug status' for these nucleic acid-derived therapeutics for ME/CFS, HIV, and renal cell carcinoma and malignant melanoma.  Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a debilitating disease that is difficult to diagnose and for which, at present, there is no cure.  People suffering from this illness experience,  among other symptoms, a constant tiredness, recurring dull headaches, joint and muscle aches, a feeling of feverishness and chills low grade fever, depression, difficulty in concentrating on tasks, and tender lymph glands.

License Grant

The Company announced that it had begun to develop its lung cancer-specific drug compound L-DOS47.

For this purpose, the Company entered into a worldwide exclusive license with the Licensor, through which it obtained the right to combine an antibody that specifically binds to lung adenocarcinoma cells with minimal cross reactivity to other tissues with Company's DOS47â„¢ technology.

License Property

A patent application in respect of the antibody has been filed in Canada, the United States, and as a PCT filing. L-DOS47 is still in the pre-clinical stage though the Company intends to seek approval from the FDA for a Phase I clinical study in lung adenocarcinoma patients.

Field of Use

The rights granted relate to biopharmaceutical company specializing in the field of cancer therapy. The Company is actively developing innovative products for the treatment and prevention of cancer based on its proprietary technologies.

License Grant

The Licensee has the exclusive right to develop, manufacture and commercialize Opdivo in all territories worldwide except Japan, South Korea and Taiwan (where the Licensor was responsible for all development and commercialization prior to the amendment). The alliance agreement was amended to provide for additional collaboration activities in Japan, South Korea and Taiwan pertaining to Opdivo and several other Licensee compounds including ipilimumab, lirilumab, urelumab and BMS-986016 (anti-LAG3). Both parties have the right and obligation to jointly develop and commercialize the compounds. The Licensee is responsible for supply of the product.

License Property

The agreement is to develop and commercialize Opdivo, an anti-PD-1 human monoclonal antibody being investigated as an anti-cancer treatment. Opdivo (nivolumab) is a fully human monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T and NKT cells. It is being investigated as an anticancer treatment. It is in Phase III trials (which commenced in 2012) in non-small cell lung cancer, renal cell cancer and melanoma.

Field of Use

The parties jointly own a patent covering Opdivo as a composition of matter that expires in 2027 in the U.S. (excluding potential patent term extension). In December 2014, the FDA approved Opdivo for unresectable (inoperable) or metastatic melanoma, and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo was also approved in Japan in July 2014 for the same indication. The FDA has granted Fast Track designation for Opdivo in three tumor types non-small cell lung cancer, renal cell carcinoma and metastatic melanoma, and it is in the registrational process for melanoma and non-small cell lung cancer in the U.S. and Europe. The FDA granted Breakthrough Therapy designation for Hodgkin Lymphoma in 2014.

License Grant

The Company acquired the rights to the HIV viral-entry inhibitor drug candidate PRO 140, a humanized anti-CCR5 monoclonal antibody, as well as certain other related assets, including the existing inventory of bulk PRO 140 drug product, intellectual property, certain related licenses and sublicenses, and U.S. Food and Drug administration regulatory filings.

License Property

PRO 140 belongs to a class of HIV therapies known as entry inhibitors. These therapies block HIV from entering into and infecting certain cells. We believe that monoclonal antibodies are a new emerging class of therapeutics for the treatment of HIV. Seven clinical trials demonstrating safety and efficacy for PRO 140 have been completed.

Field of Use

The rights granted apply to the drug industry.