Adamas settles Gocovri clash with Sandoz
California-based Adamas Pharmaceuticals has entered into a settlement agreement with Novartis’ generics unit Sandoz over a treatment for dyskinesia, the involuntary movements in Parkinson’s disease patients.
In the announcement, published yesterday, January 2, Adamas said that the settlement will resolve its litigation concerning Sandoz’s Abbreviated New Drug Application (ANDA) seeking approval by the US Food and Drug Administration to market a generic version of Gocovri (amantadine) extended-release capsules.
Neil McFarlane, CEO of Adamas Pharmaceuticals, said: “I am pleased to announce this settlement agreement with Sandoz, which demonstrates the strength of Adamas’ IP and provides both parties with certainty.”
Under the agreement, Adamas has granted Sandoz a non-exclusive licence to make and sell a generic version on March 4, 2030, which is less than nine months prior to the December 2, 2030, expiration of the last-to-expire patent.
There’s also the potential for an accelerated licence date if the unit sales of Gocovri in the 12-month period ending July 31, 2025, or any subsequent 12-month period decline by a specified percentage below the unit sales of the dyskinesia treatment in the year ended December 31, 2019.
McFarlane added: “With the launch of Gocovri still in its early stages, this agreement facilitates our ability to maximise the number of patients who may benefit from Gocovri.”
The parties will submit a joint stipulation and order to the US District Court for the District of New Jersey, and the settlement agreement to the US Federal Trade Commission and the US Department of Justice.
In June 2019, Sandoz and Momenta Pharmaceuticals agreed to pay nearly $60 million to US pharmaceutical company Amphastar Pharmaceuticals as part of a settlement related to Amphastar’s enoxaparin sodium injection, a blood thinner which is used to prevent blood clots.
The year before, Sandoz resolved its dispute with AbbVie over Humira (adalimumab), a drug used to treat multiple types of arthritis as well as psoriasis.
AbbVie granted the generics maker a non-exclusive licence to IP relating to Humira, beginning on October 16, 2018, in most EU countries and on September 30, 2023, in the US.
The settlement was the latest in a long line of licences that AbbVie has secured in relation to Humira.
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