Hikma Pharmaceuticals has signed a licence and supply agreement with GP Pharm for Lutrate (leuprolide acetate 3.75mg), GP Pharmâs anticancer compound, in Germany and Portugal. Lutrate is a hormonal androgen deprivation therapy to prevent tumour growth in patients with advanced prostate cancer.
Lutrate depot formulation is a novel pharmaceutical product that incorporates GP Pharmâs patented microsphere technology for sustained-release encapsulation. The same efficacy is observed, however, with less potential side effects for the patients due to a more controlled, sustained release of the active pharmaceutical ingredient over time.
This agreement covers Lutrate one-month formulation, which has achieved regulatory approval in 23 countries in the EU, and the three-month depot formulation, which is still under development. In addition, the agreement includes an option for the six month depot formulation. This agreement for Germany and Portugal complements Hikmaâs existing agreement to license and supply GP Pharmâs Lutrate one-month formulation in the Middle East and North Africa region. Lutrate one-month formulation is already being marketed in several European countries.
Lutrate one-month formulation is expected to be filed in the US shortly and in a number of other countries worldwide. Other presentations of Lutrate are currently under development by GP Pharm in three- and six-month depots.
|Agreement Status:||New||Date Announced:||20 Sep 2013|
|Date Last Reported:||Duration:|
|Est Total Value:||Investment To Date:|
|Agreement Type:||Commercialisation Distribution Supply|
|Generic / Brand Name:||Lutrate leuprolide|
|Therapeutic Area:||Antineoplastic and Immunomodulating Agents|