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| Main | | |
| Brand Name | TPOXX, fka Arestvyr, fka ST-246 |
| Generic Name | tecovirimat |
| Purchases | $705m "over the last decade" (Q122 PR). First courses delivered to BARDA 3/12/13 (investigational drug not yet approved). |
| Indication | Treatment of smallpox |
| IP / Expiry | 8802714 / Jul 2028 - Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
| | 8530509 / Jul 2031 - Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
| | 8124643 / December 2029 - Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
| | 8039504 / April 2027 - Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
| | 7956197 / April 2030 - Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
| | 7737168 / December 2024 - Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
| | 7687641 / April 2027 - Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |
| | 7067248 / September 2023 - Screening method for orthopoxvirus antivirals |
| Mechanism | Orthopoxvirus replication inhibitor |
| Economics | Judge ruled 50% with PharmAthene after first $40M of net profits (for 10 years) - Siga appealing |
| Administration | Oral (capsule), IV |
| Competition | Smallpox vaccines, cidofovir, manufacturers (Bavarian Nordic, Chimerix, Emergent BioSolutions) - there is enough vaccine stockpiled in the US for every citizen |
| Clinical Trials | |
| | Phase II, n=107 |
| | n=107, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Assess Safety, Tolerability, and PK |
| | met primary endpoint of safety and secondary endpoint of of pharmacokinetic parameters to assess interventions (Days 1 to 14; 24,48,72,96 and 120 hours and 4 weeks after final dose) |
| | |
| | Phase I, n=30 |
| | n=30, Double-blind, Randomized, Placebo-controlled, Escalating, Multiple-dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetics |
| | met primary endpoint of safety and secondary endpoint of of pharmacokinetic parameters to assess interventions (Days 1, 6, 14-16, 21-24, 28-31, and 51-53) |
| | safety parameters included physical examination/vital signs, electrocardiograms, laboratory safety tests and adverse events |
| | |
| | Phase I, n=12 |
| | n=12, Randomized, Double-Blind, Crossover, Exploratory Study of the Pharmacokinetics of a Single Oral Dose of Form I Versus Form V Capsules |
| | met primary endpoint of pharmacokinetic parameters to assess interventions |
| | |
| Papers | An Orally Bioavailable Antipoxvirus Compound (ST-246) Inhibits Extracellular Virus Formation and Protects Mice from Lethal Orthopoxvirus Challenge. Yang et al. J Virology 2005. |
| Customers | Product does not need to be approved to begin stockpiling. |
| | BARDA awarded $433M contract to deliver 1.7 million courses of ST-246 |
| | In addition to $33M HHS contract to supply ST-246 |
| | Cumulatively, as of the end of July 2014, Siga has delivered 1.3M courses of Tecovirimat since the beginning of 2013 |