It is clear that there are numerous drugs which, at least in principle, would benefit from a nasal spray formulation. In particular drugs where a rapid onset of action would be preferable (e.g. pain relievers), drugs with significant GI side effects (e.g. certain antiinflammatories), drugs which are not absorbed through the GI tract or are unable to tolerate GI pH, enzymes etc. (e.g. proteins and peptides) and patients who are either unable to or prefer not to swallow (the elderly, children) all are potential targets for nasal spray formulations. However a combination of formulation challenges, market size and delivery device design has precluded the development of nearly all of the potential products that could take advantage of this delivery route.

Nasally-delivered drugs have numerous advantages:

nEnter the bloodstream rapidly (tiny blood vessels lining nasal passages quickly absorb).

nDo not enter the stomach – avoiding GI degradation, side effects and first-pass metabolism by the liver.

nPotential for injection-type performance (rapid absorption and quick onset) without the use of a needle.

nOpportunity to deliver drugs which do not absorb well in the G.I. tract following oral administration (e.g. most proteins and peptides).

nPatient convenience, especially for those on long term therapy, the young, the elderly, those who cannot swallow and those who are needle-phobic.

However significant challenges still exist:

nThe nasal cavity provides a smaller absorption surface area when compared to the gastrointestinal tract so absorption enhancers are typically used. The compounds used to enhance nasal absorption may be toxic or cause unwanted side-effects.

nNasally-delivered formulations can irritate the nose particularly in sensitive patients.

nNasal formulations are “all or nothing” – no formulation has provided an opportunity effectively to control drug pharmacokinetics.

The unique characteristics of LiPoint formulations address these challenges.

As a result we will be able to improve the quality, convenience and efficiency of the delivery of current drugs, and deliver drugs which have so far not been amenable to nasal delivery, such as most NSAIDs. We have confirmed these benefits through human data from similar formulations developed for delivery of compounds across the skin, as well as animal studies involving nasal delivery of testosterone.

LiPoint technology is the subject of filed US and PCT patent applications.

Our formulations differ from other mucosal (nasal) delivery because they contain a unique composition of a mixture of particles and vesicles, including both lipid and aqueous environments in which active drugs can reside.

LiPoint formulations have specific patient benefits because:

nthe mixture of particles and vesicles and the lipid content of the formulation enable the delivery of a broader range of drugs across mucosal membranes than is currently possible using existing nasal delivery technologies.

nno surfactants or toxic absorption enhancers means the formulations can be used chronically without causing irritation or damage to the nasal mucosal barrier which is vital for the body’s protection against pathogens.

nby altering the size, composition and relative amounts of the particles and vesicles in the formulation, the delivery of active drugs can be controlled thereby optimizing time of onset and relief of symptoms.

LiPoint is organized with minimal overhead to efficiently deliver new products rapidly and with limited investment prior to proof-of-concept. LiPoint formulations will initially be manufactured on a scale for animal and early stage human studies in laboratories specifically designed for the purpose in Stockholm, Sweden. However manufacturing methods (while proprietary) will be scalable to independent manufacturers, enabling the company to take advantage of low-cost contract manufacturers worldwide.

LiPoint intends to commercialize its formulations in the United States through pharmaceutical companies with specific distribution and sales skills and focus in the same clinical markets as LiPoint’s drug products. Outside the US LiPoint will seek local development and marketing partners with the clinical, regulatory and sales capabilities to maximize value in those markets.

All LiPoint products will address large markets. The market for our lead product, LiPoint NSAID, is predicted to be in excess of $8B by 2015. Future product development may include larger proteins and peptides and particulate vaccines.  In addition to developing proprietary drugs, the Company will seek partnerships with other drug development and pharmaceutical companies seeking the means to deliver their drugs more efficaciously by avoiding first-pass liver metabolism and GI tract absorption.