Thursday, June 13, 2013

Actavis partner with Medicine360 to gain US rights for Intrauterine Device - LNG20


Medicines360, a non-profit pharmaceutical company, and Actavis, Inc., a leading global specialty pharmaceutical company, today announced a historic partnership to support Medicines360's mission to reduce cost as a barrier to accessing women's birth control.  The Medicines360 and Actavis partnership will make the IUD available in the U.S. commercially and at a very low price in U.S. public sector clinics.  As part of this agreement, Actavis has licensed the U.S. commercial rights for the Medicines360 LNG20 Intrauterine Device (IUD). 



LNG20, originally developed by Uteron Pharma S.P.R.L. in Belgium, is designed to initially deliver 20 mcg of levonorgestrel per day for the indication of long term contraception, and is currently in Phase III clinical trials in the United States.  Pending U.S. Food and Drug Administration (FDA) approval, the LNG20 IUD could be launched in the U.S. as early as 2014.  

 

Terms of the Agreement

Under terms of this exclusive agreement, Actavis acquires the rights to market, sell and distribute LNG20 in the private sector commercial markets in the U.S and Canada for a payment of approximately $50 million.  Actavis will pay Medicines360 additional milestone payments totaling up to $125 million plus royalties on annual net sales.  All monies received by Medicines360 from this partnership will go toward driving down the product's cost in the public sector and future product development

 

Actavis already owns Western EU rights for LNG20, by virtue of acquisition of Belgium based Uteron Pharma S.P.R.L  earlier this year

In January 2013, Actavis, Inc. acquired Uteron Pharma S.P.R.L., based in Liege, Belgium, which developed the levonorgestrel IUD product.  The product is currently pending approval in several EU countries, with potential launch in 2013, and is in late Phase III development for the U.S. market.  A patent portfolio covers this product until 2031.  Actavis has marketing rights in Western Europe and other regions and is partnered with Gedeon Richter in certain European countries.  Medicines360 had previously acquired the commercial rights from Uteron for the IUD in the U.S. and certain other countries