Angelini lands EU rights to Ovid's phase 3 rare disease drug

Jeremy Levin - Credit: Kelly Boothe, agent of Ovid Therapeutics - Own work - CC BY-SA 4.0
Ovid CEO Jeremy Levin (Kelly Boothe, agent of Ovid Therapeutics - Own work - CC BY-SA 4.0)

Ovid Therapeutics has offloaded the European rights to OV101 in a genetic nervous system disorder to Angelini Pharma. Italy’s Angelini Pharma is paying $20 million upfront to secure a license to a drug that is due to come through a phase 3 trial in Angelman syndrome by the end of the year. 

OV101, also known as gaboxadol, is a delta-selective GABAA receptor agonist designed to target a physiological process thought to play a role in neurodevelopmental disorders such as Angelman and Fragile X syndromes. That thinking led Ovid to buy the rights to gaboxadol from Lundbeck, which tried without success to develop it as an insomnia drug in partnership with Merck.

Led by ex-Teva CEO Jeremy Levin, Ovid has advanced OV101 into a pivotal study that is due to read out by the end of the year while evaluating ex-U.S. licensing opportunities. Now, Ovid has landed a European partner for OV101.

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Angelini, which sells a range of mental health and pain drugs, has agreed to pay $20 million upfront and committed to up to $212.5 million in milestones to secure the exclusive rights to market OV101 as a treatment for Angelman in the EU and neighboring countries including the U.K. Ovid has retained the rights to OV101 in the U.S. and the rest of the world.

The licensing deal moves Angelini into rare diseases. Angelini is setting up a new rare disease unit to handle the asset, but, despite its limited experience in the orphan drug sector, Ovid thinks the Italian company is equipped to make a success of OV101 in the EU.

“Angelini Pharma is an ideal partner for Europe as they have deep regional knowledge, an established infrastructure with a history of successful product launches and a commitment to improving the quality of life of the patient communities they serve,” Levin said in a statement.

Whether Angelini gets a shot at applying those capabilities to the commercialization of OV101 will depend on data from an ongoing phase 3 trial in 95 children with Angelman. Ovid expects to release top-line results from the placebo-controlled trial in the fourth quarter. The primary endpoint of the trial is looking at change on an Angelman disease scale over 12 weeks of daily dosing. 

Ovid moved OV101 into phase 3 on the back of a midstage study that sent the biotech’s stock down 30% when it read out in 2018. The stock has rallied in the weeks since Ovid released results from a phase 2 trial in Fragile X but remains well down from the highs it hit in 2017 and 2018 in the run-up to the publication of the midstage Angelman data. 

Success in phase 3 would position Ovid and Angelini to become the first companies to win approval for an Angelman drug in their respective markets. Other companies are giving chase, though. Roche has filed to study RO7248824 in 66 Angelman patients, while GeneTX Biotherapeutics is already enrolling in a phase 1/2 trial of its Ultragenyx Pharmaceutical-partnered antisense oligonucleotide GTX-102.

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