AzureBio is developing an alternative drug delivery format for the subcutaneous administration of vaccines and high activity drugs based on its proprietary solid "Injectable Needles". The simultaneous development of a simple disposable delivery device facilitates administration of the injectable needles while avoiding the need for trained personnel, cold storage, reconstitution and use of hypodermic needles.

Over 16 Billion injections (480 Million in immunizations) are administered every year. However, injecting current freeze-dried drugs and vaccines is a demanding protocol that currently involves:

1.  Trained personnel
2.  Sterile vials that require cold storage
3.  Manipulation of sterile hypodermic needles
4.  Resuspension with correct volume of sterile water for injection
5.  Safe disposal of used hypodermic needles

These requirements represent a significant problem, specially in the Developing World:

• Worldwide, 40% (70% in some countries) of injections are given with reused unsterilized needles,
• Unsafe injections transmit hepatitis B and C, and HIV causing estimated 1.3 M early deaths and an annual burden of $ 535 M in direct medical costs,
• Vaccination programs cannot afford the $200 M /year cost of the “cold-chain”,
• It is estimated that over 50% of vaccines go to waste,
• Deficient immunity resulting from non-compliance for booster doses.

In the First World improved drug and vaccine delivery can also have a direct application for established and upcoming vaccines against cervical cancer, seasonal flu, epidemic flu, etc. and administration of high activity drugs for chronic diseases.

AzureBio "Injectable Needle" proposal meets the requirements for XXI century subcutaneous delivery of vaccines and high activity drugs as it:

• Avoids need for cold-chain and potential product degradation during trasnport and storage,
• Avoids manipulation of hypodermic needles, potential needle-stick injuries and reuse of contaminated needles,
• Avoids potential errors and contamination upon reconstitution with water for injection,
• Permits preloaded devices that avoid the need for trained personnel and facilitate self administration.

AzureBio is looking to establish colaborations with vaccine and high activity drugs manuffacturing companies for the co-development of its "Injectable Needles" for diferent indications.