With it being a fairly slow news day, we thought we'd write a profile on Supernus Pharma (SUPN), which has been a nice mover and it's a name that is not well known but it has been making a strong move of late and making new 52-week highs.
SUPN is a commercial stage biopharma with a focus on treating central nervous system diseases. It has two marketed products for the treatment of epilepsy: Oxtellar XR (extended-release oxcarbazepine) and Trokendi XR (extended-release topiramate). In addition to epilepsy, in April 2017, the FDA approved another indication for Trokendi XR: as a treatment for migraine headaches (launched in April 2017). SUPN is also developing several product candidates in psychiatry, including SPN-810 for Impulsive Aggression in ADHD patients and SPN-812 for the treatment of ADHD.
Epilepsy is a complex neurological disorder characterized by spontaneous recurrence of unprovoked seizures, which are sudden surges of electrical activity in the brain that impair a person's mental and/or physical abilities. Compliance with drug treatment regimens is critically important. Patient non-compliance with anti-epileptic drug (AED) therapy is a serious issue and remains the most common cause of breakthrough seizures. Not only is taking all prescribed doses critical for epileptic patients, but the timing of when patients take their prescribed doses can also be crucial.
SUPN's drugs are extended release formulations so they are the only pill on the market that can be taken just once-daily. This is a huge advantage over competitive drugs which must be taken several times a day and at specific times. This results in a significantly lower rate of hospitalization stays, lower rate of ER visits, and a higher rate of patient compliance.
In addition to epilepsy, SUPN has been seeking a label expansion for Trokendi XR to include prophylaxis of migraine headache. In early April 2017, the FDA granted final approval to SUPN's sNDAs requesting the label expansion. Topiramate is the most prescribed drug to treat migraines so there is good potential here for SUPN.
In April 2017, SUPN launched Trokendi XR as a new treatment for prophylaxis of migraine headache in adults and adolescents 12 years and older. While it is still early in the launch, IMS prescription data for Trokendi XR show a strong upward trend in total and new prescriptions. During the first three week period post launch, total prescriptions were 26,472 compared to 24,109 in the three weeks prior to launch, representing a 10% increase.
Similarly, for the same three week period post launch, new prescriptions were 12,978 compared to 10,898 in the three weeks prior to launch, representing a 19% increase. SUPN has said it's very encouraged by the early IMS prescription data. Consistent with these early data, feedback from SUPN's sales force indicates that physicians are very receptive to the new indication and appreciate the unique benefits that Trokendi XR brings to migraine patients.
Specifically, Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to immediate-release topiramate products, making it an important new prophylactic treatment option for adult and adolescent patients suffering from migraine headache.
In terms of its other development stage products, SPN-810 could be useful in a number of areas in the psychiatric market, with potential of $400-700 mln in ADHD. SPN-812 is further behind as it's in Phase 2b testing, but it has the potential to address a lack of non-stimulant options in its market.