The companies enter into a license agreement for the European rights to leriglitazone, currently under EMA review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD)

Mataró, Barcelona (Spain) and Düsseldorf (Germany), November 10, 2022 - Minoryx Therapeutics, a late-stage biotech company focused on the development of treatments for orphan central nervous system (CNS) disorders and the Neuraxpharm Group (“Neuraxpharm”), a leading European specialty pharmaceutical company focused on CNS therapies, today announce the completion of a strategic license agreement.

Under the agreement, Minoryx grants Neuraxpharm exclusive European rights to its lead candidate leriglitazone, a novel, brain penetrant and selective PPAR gamma agonist. Neuraxpharm obtains exclusive rights to commercialize leriglitazone in Europe and will join with Minoryx to continue the further development of leriglitazone. Minoryx retains full rights to leriglitazone in the US and the rest of world, excluding already partnered China.

As part of the agreement, Neuraxpharm has agreed to pay Minoryx a significant double-digit upfront payment in addition to milestone payments and development funding totalling up to EUR 258 million in the aggregate. Also, Minoryx will further receive material tiered double-digit royalties.

Minoryx and Neuraxpharm will collaborate on concluding the ongoing European regulatory process to obtain approval for leriglitazone for the treatment of adult male patients with X-ALD. Leriglitazone will be the first approved treatment for this population if it is approved by the European Medicines Agency (EMA). Minoryx and Neuraxpharm are further committed to jointly continue the development of leriglitazone for additional X-ALD patient populations and other orphan indications.

Tapping into the business segment of orphan drugs to treat rare diseases via this license agreement is a new approach for Neuraxpharm. In this strategically relevant step, the company builds on its extensive CNS expertise stemming from 35 years in the field of CNS disorders. Neuraxpharm will create a centre of excellence dedicated to leriglitazone. With this, Neuraxpharm plans to accelerate diagnosis and allow for early treatments through better population screening and shorter referral ways. Another important part of the work will consist of closely collaborating with patient advocacy groups and associations.

“This agreement is not only an important strategic step for Neuraxpharm, it will also be to the benefit of patients who may not be too numerous but whose medical needs are as urgent as they can get. Helping them and at the same time entering a highly attractive business area with a great partner like Minoryx is something I am very proud of,” said Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm.

“Minoryx remains fully committed to ensure that leriglitazone reaches X-ALD patients as quickly as possible. With the Neuraxpharm partnership Minoryx has secured a strong partner that will enable an optimal launch of leriglitazone throughout Europe. Minoryx selected Neuraxpharm specifically for its expertise in the European central nervous system marketplace and its substantial experience and capabilities in successfully commercializing CNS drugs in Europe,” said Marc Martinell, CEO, Minoryx. “Minoryx will continue the development and regulatory preparations for the US and is currently in discussions with the FDA to define the next steps for the US approval path.”