The deal is particularly significant as a validation of LifeCycle's technology as it is the first that has not come from Lundbeck, the Danish pharmaceutical company from which LifeCycle was spun out in June 2002. It is also the first agreement for a drug already on the market.
The company specialises in improving the solubility of poorly soluble drugs by applying a technology called MeltDose that is based on the creation of ultrafine drug particles, much smaller than can be achieved using standard micronising approaches. The smaller the particles, the better the drug can be absorbed by the body.
Typically, drug particles are usually less than 10 microns in diameter, and with standard micronising this can be reduced to 1-5 microns. Other processing techniques have been developed that can reduce the particle size to the 0.5-1 micron range, but LifeCycle has taken this as far as it can go: its technology produces particles consisting of a single drug molecule in a water-soluble polymer that can still be processed into tablets.
"By formulating individual molecules the main limiting parameter for oral absorption of drugs with low water solubility is avoided, and the most favourable bioavailability can be attained," said LifeCycle.
The company will use its MeltDose technology to enhance uptake of lercanidipine by the body, with the double aim of not only improving its therapeutic profile but also extending the patent life of the product.
Recordati will pay a licence fee for the use of the MeltDose technology and fund the preclinical development of the drug. Meanwhile, LifeCycle will receive milestone payments and royalties from sales of the new drug, and will also develop the manufacturing process for this formulation.
Zanidip is one of Recordati's top products, brining in sales of €91 million out of the company's total turnover of €488 million in 2003.