About five years ago, former Teva Pharmaceutical CEO Jeremy Levin launched Ovid Therapeutics with a plan to develop treatments for rare brain diseases.
Now, with the completion of a clinical trial on the horizon anticipated to provide enough data to file for FDA approval, the 55-person biotech has recruited a Novartis (NYSE: [[ticker:NVS]]) executive to map out its commercialization strategy.
Jason Tardio (pictured above), who most recently ran the multiple sclerosis unit at Novartis, joins Ovid (NASDAQ: [[ticker:OVID]]) today as its chief commercial officer. Previously he spent nearly 10 years at Biogen (NASDAQ: [[ticker:BIIB]]), including overseeing its business in Argentina, Chile, and Uruguay.
His decision to leave the pharma giant for a small biotech was prompted, in part, by its focus. “My heart’s in rare disease,” he says.
Mid next year New York-based Ovid is slated to get data from a Phase 3 trial of its lead drug candidate, gaboxadol (OV101), in children with Angelman syndrome. The disease, estimated to affect 1 in every 12,000 to 20,000 people, can cause epileptic seizures and attention, walking, and speaking problems. Treatments exist to manage the symptoms, but there are no approved drugs.
If the trial meets its goal, the company plans to combine those data with results reported last year in a trial of the same experimental drug in adolescents and adults with the disorder to present to the FDA for review. Ovid’s drug is meant to boost levels of an inhibitory neurotransmitter called GABA, which the company believes leads to many of the symptoms that the disorder causes.
In September, RBC Capital Markets analyst Brian Abrahams estimated the drug, were it approved, would bring in annual revenue of $280 million.
The company also believes that low levels of GABA contribute to Fragile X syndrome, which causes intellectual disabilities and behavioral and learning challenges, and is testing the drug as a potential treatment for that disorder, too. Fragile X is estimated to affect about 1 in 4,000 males and 1 in 6,000 to 8,000 females in the US.
Ovid also anticipates data from that trial, a Phase 2 study, next year.
In addition, Ovid expects results in 2020 from two other mid-stage studies testing a drug called soticlestat (OV935) as a treatment for rare forms of epilepsy. The ARCADE study is in children with CDKL5 deficiency disorder and Dup15q syndrome: ELEKTRA, with Dravet syndrome and Lennox-Gastaut syndrome, all types of epilepsy that are typically detected in childhood and associated with severe cognitive and developmental impairment.
Ovid shares the rights to soticlestat—which blocks cholesterol 24-hydroxylase, an enzyme primarily expressed in the brain that is thought to play a role in some neurological diseases—with Japanese pharma giant Takeda (NYSE: [[ticker:TAK]]), but if it’s approved the biotech is slated to lead commercialization in the US and Europe.
Data from ELEKTRA weren’t anticipated until 2021, but enrollment occurred more rapidly than expected, prompting the company to accelerate its timeline for bringing in a CCO, Levin says.
One activity the company doesn’t plan to focus on next year is financing. Ovid is set until “well into 2021” when it comes to capital, Levin says.
The biotech raised $75 million in its initial public offering in 2017, its shares pricing at $15. Shares of Ovid closed at $2.59 Friday. Before its IPO, outside investors contributed about $76 million.
