- Takeda, the world's largest developer of rare disease drugs, said Tuesday that it has reclaimed full rights to an experimental medicine being tested against uncommon forms of epilepsy. The deal inked with New York-based Ovid Therapeutics carries an almost $200 million upfront payment and could be worth as much as $856 million provided the medicine, known as soticlestat, hits certain milestones.
- Soticlestat was discovered at Takeda's research center in Shonan, Japan, and is supposed to block an enzyme expressed in parts of the brain responsible for learning and memory. In 2017, Takeda teamed up with Ovid, a neuroscience-focused biotech, to develop and commercialize the drug for rare epilepsies. The companies then expanded their collaboration the following year.
- Now, Takeda is working to secure all rights to its drug. Terms of the new deal, which is expected to close this month, have Takeda taking sole responsibility of the drug, while Ovid is absolved of any financial obligations under the original agreement. Soticlestat is currently in mid-stage testing, where researchers are evaluating it across several developmental and epileptic brain diseases, including Dravet syndrome and Lennox-Gastaut syndrome.
Takeda clearly sees value in taking full control of soticlestat. Last summer, a medium-sized study found the drug significantly reduced seizures in patients with Dravet syndrome, which then encouraged Takeda and Ovid to move forward into a registrational program. Pivotal testing in both Dravet syndrome and Lennox-Gastaut syndrome is expected to begin in the second quarter.
Should that testing also read out positive, soticlestat may be able to join a growing crop of new treatments for the two rare epilepsies. Just this year, the Food and Drug Administration approved Fintepla, a Dravet medicine developed by the Californian biotech Zogenix. And in 2018, the agency gave a thumbs up to Diacomit, from the French drugmaker Biocodex.
Before Diacomit and Fintepla, though, there was Epidiolex. Not only did Epidiolex become the first FDA-approved drug specifically for Dravet syndrome in mid-2017, but it's also the first cannabidiol-based therapy cleared for the U.S. market.
Epidiolex, which is also indicated for Lennox-Gastaut and seizures associated with a rare genetic disorder, fetched north of $500 million for its developer GW Pharmaceuticals last year. Additionally, the drug is a catalyst for the recent $7 billion bid from Jazz Pharmaceuticals to take over GW.
If soticlestat achieves similar success, it could help lift Takeda's rare disease drug business, which was largely built through the $62 billion acquisition of Shire in 2018.
Between March and December 2020, revenue from the company's portfolio of rare disease drugs totaled $4.3 billion, an 8% decrease year over year that the company pinned on greater market competition from rival products and generics. Revenue from Takeda's overall business reached $23.5 billion for that nine-month period, a decline of 3.6%.
Last year, Takeda licensed seven experimental drugs for psychiatric disorders to Neurocrine Biosciences, the most advanced of which just fell short in a Phase 2 study.
As for Ovid, the new collaboration with Takeda is somewhat of a double-edged sword.
On the positive side, it provides a near-term source of cash that may be especially useful for the company, given the recent setback to one of its most closely watched drugs. In December, Ovid revealed that the drug had failed in a late-stage study of patients with Angelman syndrome, a rare genetic disorder — results which cut the company's share price in half.
"Importantly, with the resources this agreement delivers, Ovid is strategically and financially positioned well into the future," CEO Jeremy Levin said in a March 3 statement.
On the other hand, Ovid has parted ways with its most high-profile partner and traded away one of the most advanced programs in its pipeline. Beyond its drug for Angelman, which is also being tested for Fragile X syndrome, the rest of Ovid's medicines in development are in preclinical stages.