Hikma/GP Pharm Enter Agreement For Lutrate In Germany/Portugal


Hikma Pharmaceuticals has signed a licence and supply agreement with GP Pharm for Lutrate (leuprolide acetate 3.75mg), GP Pharm’s 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 Pharm’s 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 Hikma’s existing agreement to license and supply GP Pharm’s 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 Information:
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
Indication: Cancer (prostate)
Techonology/Field: N/A
This article is tagged to:
Sector: Pharmaceuticals & Healthcare, Medical Devices
Geography: Germany, Portugal

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