PF0713 Intravenous (IV) Sedative-Hypnotic

Market

IV sedative-hypnotic agents are widely used for induction of general anesthesia, maintenance of general anesthesia, conscious sedation for diagnostic and therapeutic procedures, and sedation of critically ill ICU patients. Worldwide, IV anesthetic sales are estimated to exceed $1.5B in 2009.

Unmet Needs

Currently, propofol and midazolam are among the market leading IV sedative-hypnotics. While effective, these drugs have a number of weaknesses:

• Propofol
  • Hemodynamic instability
  • High incidence of mild-to-severe pain on injection (often managed by procedural intervention)
  • High lipid content
  • Restricted administration by anesthesiologists or those trained in administration of general anesthesia
• Midazolam
  • Limited clinical application
  • Sluggish onset and offset of sedation

PharmacoFore's Solution

We have discovered a novel drug, PF0713, which maintains desirable features of current sedative-hypnotics while addressing their key weaknesses. We have achieved human proof-of-concept for PF0713 in a phase1 clinical study. This study demonstrated not only PF0713’s safety and efficacy, but also key competitive advantages over other drugs it will compete with:

• Safer hemodynamic profile (less drop in blood pressure)
  • Hemodynamics in normal clinical range even at twice the effective dose for induction of anesthesia
• Attractive pharmacokinetics Study of the mechanisms of absorption and distribution of an administered drug, the rate at which a drug action begins, the duration of the effect, the chemical changes of the substance in the body, and the routes of excretion of the drug’s metabolites. and pharmacodynamics
  • Rapid onset and offset, smooth induction, and pleasant emergence profile
• No pain on injection
  • In contrast to mild to severe pain experienced by approximately 70% of patients administered propofol, the leading IV sedative-hypnotic agent at present
• Small lipid load (less “fatty” material introduced into the blood)
  • Potential safety benefits compared to other agents

Consistent with our strategy, PF0713 has the potential to yield multiple products, including, general anesthetic, procedural sedative, ICU sedative, and antiemetic.

Posters and Abstract

Posters

• Initial Studies of the Mechanism of Action of PF0713, an Investigational Anesthetic Agent (ASA 2008)

• Dose Response of PF0713, a Novel Investigational Intravenous Anesthetic Agent (ASA 2008)

• PF0713 Produced Rapid Induction of General Anesthesia Without Hypotension or Injection Pain in a Phase 1 Study

Abstract

• PF0713 Produced Rapid Induction of General Anesthesia without Injection Pain in a Phase 1 Study (ASA 2009)

Partnering

We are currently seeking a worldwide partner for full development and commercialization of PF0713.