Medigene had contracted Mitsui Norin since 2005 for manufacturing and supplying the active pharmaceutical ingredient (API) of Veregen®.
Based on new supporting data regarding a longer shelf life of the API, Medigene now estimates that there is a sufficiently high stockpile to market the drug for several years – well beyond the maximum patent term covering the product. For this reason, the current manufacturing and supply agreement has been mutually terminated as of 31 March 2017.
The previous agreement has been replaced by a new license agreement covering the drug master file (DMF) for Veregen®. The DMF, for which Medigene has now acquired an exclusive license from Mitsui Norin, is vital for admission to existing and new potential markets for Veregen®, as well as for future product sales by distribution partners. The term of the license is not limited by the expiration of the patents. In addition, appropriate steps to resume production of the API can be initiated at any time, as needed.
As a part of the arrangement to terminate the existing manufacturing and supply agreement, Medigene has agreed to a one-time payment of USD 1.75 million to Mitsui Norin. This amount is offset by Medigene’s annual savings resulting from the elimination of an existing annual minimum purchase requirement. An additional payment to Mitsui Norin for up to USD 0.5 million to reimburse the costs of ending production is also expected in the course of 2017. No further financial details regarding the new license agreement were disclosed.
Commenting, Dave Lemus, COO of Medigene, said, “We are pleased with today’s announcement as it relates to the new direction of our relationship with Mitsui Norin. Moreover, the new agreement allows us maximum flexibility to manage Medigene’s supply chain supporting Veregen®, especially as we consider our strategic alternatives for this product going forward.”
With the realignment of Medigene’s strategic focus towards immunotherapies in 2014, Veregen® is not considered to be part of the core business of the company and is currently marketed by various distribution partners around the world.
More on Veregen®: The drug, which is used to treat genital warts by patients exposed to human papillomavirus types 6 and 11, is approved in 21 countries and marketed worldwide by a range of distribution partners. In 2015 Medigene generated revenue of approximately Eur3 m with sales of Veregen®. More information on Veregen® can be found at www.medigene.com/pipeline/other-products/
Medigene AG is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in clinical and pre-clinical development.For more information, please visit www.medigene.com