Imaginot is an emerging drug delivery technology company with strong in vitro and Phase I validation for our  technology.

Imaginot Pty Ltd is privately owned company and was formed as a spin out from an Australian pharmaceutical company, Herron Pharmaceuticals which held major market share positions in a range of analgesics including paracetamol and ibuprofen.

The company focused on developing an oral technology which could improve the rate of absorption of oral analgesics to match that of an injection or an oral solution.

Research soon showed that in vivo dissolution and gastric emptying were rate limiting steps for the absorption of paracetamol, factors which will affect the absorption of any drug absorbed by passive diffusion.

Further research showed that variability in gastric motility and gastric pH were key impediments to in vivo dissolution. Even standard tablets will dissolve quickly if motility is high and the pH suits the solubility of the drug BUT gastric quiescence and an adverse pH to solubility will slow dissolution substantially – leading to slow gastric emptying and slow absorption.

It became clear that once the drug dissolved in the co-administered water it reached the small intestine quickly as liquids empty independently of the gastric emptying cycle in both fed and fasted states.

Once the drug in solution reaches the small intestine, rapid absorption ensues as the concentration gradient across the small intestinal wall, into the plasma is high.

Imaginot believes that its SurgeDose® technology solves an important and unrecognised problem, variability in oral absorption kinetics which leads to variability in the timing and extent of peak plasma concentrations. This variability reduces efficacy and delays the mean time to peak effect.

Imaginot….history

• 1999 Incorporated
  • privately owned spin out from Herron Pharmaceuticals
• Developed ultra-rapid in vivo dissolution technology
  • pH modulation to increase solubility PLUS activated dissolution
• 2004 First provisional patent applications filed
• 2007 Licensing agreement development with multinational in (confidential)
• 2008 Licensing Areement with Ethypharm in 
• 2009 Licensing Agreement with Abbott India (novated from Piramal) in
  • Development of SurgeDose® range of 5+ drugs
  • First product lornoxicam launched Sep 2011 with superior PK
  • Second product SurgeDose® diclofenac showed outstanding results against the dispersible tablet market leader
• 2010 Piramal Healthcare (Pharma Solutions Division) 
  • Co-marketing agreement; Currently working with eight of top ten Pharma Cos
  • Focus on emerging drugs (NCE’s), recently approved drugs (LCE’s) & drugs reformulated for new indications (NI’s)

SurgeDose®… manufacturing & regulatory

• Very low incremental cost of goods
• Straight- forward and “do-able”manufacturing
  • Standard tablett & packaging equipment & processes
  • Need controlled, low humidity manufacturing and packaging conditions
  • High integrity impermeable unit dose packaging
  • Can be film coated
• Regulatory
  • Generally Recognised As Safe (GRAS) excipients
  • Opportunity for to design clinical trials to demonstrate PK and PD superiority
  • 505 (b) (2) NDA or sNDA regulatory pathways

SurgeDose®… clinical and patient benefits

• Improved efficacy driving preference by clinicians & patients
• Reduced time to effect preferred by both patient & clinician
• An oral dosage form with kinetics approaching an injection
• A convenient and easy to swallow oral dosage that is strongly preferred by patients compared with alternative routes of administration which deliver rapid onset of action – injection, intranasal, inhaled etc.
• Potential for reduced adverse events through shorter gastric residence time or reduced dose without compromising efficacy

SurgeDose®… the commercial benefits

• Clinical improvements may make the difference between approvable and non-approvable NCEs and between fully reimbursed or reimbursed only for gold standard non-responders
• Reimbursement price point
• Brand loyalty & market share
• Extended lifecycle with additional patent protection
• Piramal offers cost effective contract alternative to in-house evaluation with a well-trained development team in Ahmedabad, India with SurgeDose® experience & expertise
• No capital outlay or major changes required to manufacturing plant or equipment
• In-house manufacture is practical and if necessary there are many contract manufacturers with suitable facilities including Piramal