Sosei Announces Agreement With Mundipharma For Ad 923
Sosei Co. Ltd announced that it has entered into an agreement with Mundipharma International Corporation Limited for the development and commercialisation of AD 923, Sosei's novel sublingual fentanyl spray for cancer breakthrough pain, in Europe and other international markets, excluding North America and Japan.
AD 923 is an optimised, sublingual formulation of the strong opioid analgesic fentanyl. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver. An additional benefit is the lockout system that prevents inadvertent overdosage. Sosei has concluded a range of studies that confirm the potential of this novel product for which the next development milestone will be the start of Phase III.
Under the terms of the agreement Sosei will be responsible for developing and registering AD 923 and Mundipharma will be responsible for manufacture, marketing and sales within the licensed territories. Sosei has, however, retained the option to co-promote AD 923 in the UK and Germany. A joint committee will be established to oversee all activities covered under the agreement. Under the terms of the agreement, Sosei will receive up to GBP17.5 million including upfront and milestone payments and significant double digit royalties on product sales.
Sosei will evaluate its options for commercialisation of AD 923 in North America and Japan. This will include the possibility for own sales or co-promotion in these territories.
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