Royalty Report: Drugs, Vaccine, Therapeutic – Collection: 248394

Anthrax Vaccine Dose shall mean the quantity of a formulation containing Anthrax Vaccine given to an individual in a single immunization.

Licensed Product shall mean an Anthrax Vaccine Dose the manufacture, use, sale, keeping, importing or exporting of which would, in the absence of the license granted under this Agreement, constitute an infringement of the Patents or that uses other Intellectual Property.

The patent is for Expression System (Anthrax Immuuogenic Polypeptide), a UK Priority Patent Application.

Recombinant Bacillus Anthracis (Anthrax) Protective Antigen Vaccine containing Alum

The patent covers MOD Case P1454 Expression System.

PharmAthene is a biodefense company engaged in the development and commercialization of medical countermeasures against biological and chemical weapons.

Recombinant Bacillus Anthracis (Anthrax) Protective Antigen Vaccine containing Alum

The patent covers MOD Case P1454 Expression System.

Licensed Product shall mean a Plague Antigen, and/or a Vaccine including but not limited to a Plague Vaccine Dose, the manufacture, use, sale, keeping, importing or exporting of which would, in the absence of the license granted under this Agreement, constitute an infringement of the Patents or that uses other Intellectual Property.

Plague Antigen shall mean individually each of the F1 antigen and V antigen of Yesinnia Pestis.

Plague Vaccine Dose shall mean the quantity of Vaccine given to an individual in a single dose.

Patents are for Plague Vaccines and Vaccine Compositions.

Plague Vaccine Dose shall mean a dose of recombinant protective antigen plague vaccine the manufacture, use, sale, keeping1 importing or exporting of which would, lo the absence of the license granted under this Agreement, constitute an infringement or actionable misuse of the Vaccine IP.

Patents are for Plague vacclnes and Vaccine Compositions.

The use beyond the United States is for inter alia the development of a prototype recombinant protective antigen plague vaccine and the production of trials doses thereof.

ThermoVax® is a novel method of rendering aluminum salt, (known colloquially as Alum), adjuvanted vaccines stable at elevated temperatures. Alum is the most widely employed adjuvant technology in the vaccine industry. The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and storage for Alum adjuvanted vaccines. This would relieve the high costs of producing and maintaining vaccines under refrigerated conditions. Based on historical reports from the World Health Organization and other scientific reports, we believe that a meaningful proportion of vaccine doses globally are wasted due to excursions from required cold chain temperature ranges. This is due to the fact that most Alum adjuvanted vaccines need to be maintained at between 2 and 8 degrees Celsius (“C”) and even brief excursions from this temperature range (especially below freezing) usually necessitates the destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question. ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in emergency settings.

The development of the vaccine programs currently is supported by our heat stabilization technology.  The focus is on developing and commercializing products to treat rare diseases where there is an unmet medical need.

Proof-of-concept preclinical studies with ThermoVax® indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with our aluminum-adjuvanted ricin toxin vaccine, RiVax® and our aluminum-adjuvanted anthrax vaccine, VeloThrax®.

The company is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.  The Company maintains two active business segments: BioTherapeutics and Vaccines/BioDefense.

The Company’s BioTherapeutics business segment is developing a first-in-class photodynamic therapy (SGX301) utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”), proprietary formulations of oral beclomethasone 17, 21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201), and it’s novel innate defense regulator (“IDR”) technology dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer.

The Company’s Vaccines/BioDefense business segment includes active development programs for RiVax™, its ricin toxin vaccine candidate, VeloThrax™, an anthrax vaccine candidate, OrbeShield®, a GI acute radiation syndrome (“GI ARS”) therapeutic candidate and SGX943, a melioidosis therapeutic candidate. The development of the vaccine programs currently supported by the heat stabilization technology, known as ThermoVax®, under existing and on-going government contract funding. With the government contract from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Company will attempt to advance the development of RiVax™ to protect against exposure to ricin toxin. The Company plans to use the funds received under the government contracts with the Biomedical Advanced Research and Development Authority (“BARDA”) and NIAID to advance the development of OrbeShield® for the treatment of GI ARS.

Food Safety Product means a Product to eliminate or reduce organisms associated with food borne disease in livestock.

The licensed property include patents for Immunogenic compositions comprising avirulent derivatives of Salmonella typhi with mutations in cya, crp and cdt, Method of maintaining a desired recombinant gene in a genetic population of cells, Avirulent Salmonella containing genes encoding gamete specific antigen useful as vaccine for diminishing or preventing fertility, Method of vaccination of newly hatched poultry, Recombinant vaccines comprising immunogenic attenuated bacteria having RpoS  phenotype, Methods of producing and using virulence attenuated poxRmutant bacteria, Recombinant bacterial system with environmentally limited viability, Live attenuated Salmonella vaccines to control avian pathogens, Regulated Antigen Delivery Systems, and, various patents for Avirulent microbes.