Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products and Ipsen, a global specialty-driven pharmaceutical company, have renegotiated their fipamezole licensing agreement. Santhera regains the worldwide rights to the development and commercialization of fipamezole, its first-in-class selective adrenergic alpha-2 receptor antagonist for the management of levodopa-induced Dyskinesia in Parkinson's disease.
Under the renegotiated terms, Ipsen returns its rights for territories outside of North America and Japan in exchange for milestone payments and royalties based on future partnering and commercial success of fipamezole. Ipsen retains a call option for worldwide license to the programme under certain conditions.
Fipamezole is widely perceived by clinicians as one of the most promising drug candidates to treat Dyskinesia in Parkinson's disease, the second most common and a severely debilitating neurodegenerative disorder. As a highly selective adrenergic alpha-2 receptor antagonist, fipamezole is an innovative, first-in-class drug in clinical development for the treatment of levodopa-induced Dyskinesia in Parkinson's Disease. Santhera successfully completed two Phase II clinical studies which demonstrated efficacy and safety of fipamezole in the treatment of dyskinesia in Parkinson's Disease. Fipamezole also showed attractive potential for the reduction of levodopa "wearing-off", and demonstrated improvement in cognition and activities of daily living.
Thomas Meier, chief executive officer of Santhera, commented: “Under the agreement reached with Ipsen, Santhera has regained global marketing rights for fipamezole, which we can further develop in line with the company's strategy. In the short term, the focus of our investments remains on our lead product Catena and its multiple product opportunities in neuromuscular and mitochondrial orphan indications. However, fipamezole continues to be a valuable asset in Santhera's late-stage clinical pipeline.”
Pierre Boulud, Ipsen's executive vice-president, Corporate Strategy stated: “We are pleased that Santhera regains the worldwide rights to an agent like fipamezole. This new agreement will help to leverage the drug's value on a global basis while allowing Ipsen to focus on its rich late stage development pipeline. With its important commercial overlap with movement disorders, Parkinson Disease remains an important area of commercial focus for Ipsen. Santhera's commitment to this first-in-class drug has the potential to benefit levodopa-induced dyskinesia in Parkinson's Disease patients in crucial need of better therapies.”
According to a licensing agreement signed in September 2010, Ipsen had acquired the rights to fipamezole outside the United States, Canada and Japan for an upfront payment of 13 million euros. Under the new agreement, Santhera regains full control over the development and commercialization of fipamezole, whilst Ipsen is entitled to receive milestone and royalty payments contingent upon the occurrence of certain events. Santhera is free to license the program to a third party whereby Ipsen is entitled to receive a percentage of any license income. In addition, the agreement includes a call option allowing Ipsen under certain circumstances to obtain an exclusive worldwide license. Should Ipsen exercise this call option, Santhera will receive milestone and royalty payments from Ipsen.