BioSante's CaP nanoparticles have successfully passed the first stage of toxicity studies for administration orally, into muscles, under the skin and into the lungs by inhalation. The latest deal represents the first time that BioSante has partneree the technology for small molecule drug delivery applications, although its use as a vaccine adjuvant is being tested by the US Army and Navy.
The European partner company has acquired an exclusive, worldwide license to use CaP in the development of a series of allergy products. It will fund the development of potential products for the treatment of conditions including rhinitis, asthma, conjunctivitis, dermatitis, and allergic gastrointestinal diseases.
"The US anti-allergy medication market is expected to exceed $10 billion by 2010, and it is estimated that up to 25 per cent of the US population suffers from at least one allergy," said Stephen Simes, president and chief executive of BioSante. "This agreement … acknowledges a new potential use for CaP within this growing market."
During the evaluation period, the European company will evaluate CaP's ability to improve current allergy products. The European company may exercise its option to enter into an exclusive license for the use of CaP in allergy products at any time but must exercise no later than within 60 days of the end of the 22-month evaluation period.
BioSante could receive up to $10 million or more under the terms of the deal, assuming at least three products are developed through to the market, plus royalties on sales. The license includes a $250,000 upfront option payment.
BioSante now is developing CaP for a growing range of applications, including its use as a superior alternative to aluminum salts (alum) as an adjuvant to enhance the immunogenicity and corresponding effectiveness of vaccines. Alum is currently the only vaccine adjuvant approved for human use; however it has several drawbacks that may be overcome with CaP, including irritation and inflammation at the injection site and limited utility against intracellular pathogens such as viruses. CaP also may serve as a vaccine delivery system for non-injected vaccines.
Meanwhile, BioSante has successfully completed preclinical trials of CaP formulations for long-acting insulin injections, inhaled insulin and oral insulin, among other proteins. CaP also has been shown to be safe and non-toxic after subcutaneous administration in a Phase I human clinical trial.