electroCore has appointed Piper Jaffray to assist in discussions with pharma companies who are interested in partnering with it on the commercialisation of its breakthrough non-invasive vagus nerve (nVNS) stimulation therapy.
“The interest from pharma, medical devices and even technology companies has grown considerably over the last six months,” comments chief executive officer and founder JP Errico. “We wanted to explore all the opportunities for our future, from partnership to remaining independent. We therefore had discussions with several banks to help us with this process and chose Piper Jaffray. We are under no pressure to do a deal as we are fully funded until 2016. However, as we move from proving that nVNS is a promising treatment for primary headache, to rolling out a sales organisation we wanted to be mindful of all our options.”
electroCore, a US based company, has developed non-invasive Vagus Nerve Stimulation (nVNS) self-administered therapies, which are self-administered by patients for the treatment of multiple conditions in neurology, psychiatry, respiratory and other fields. Initial focus is on primary headache (migraine and cluster headache), with trials continuing in respiratory and gastric motility disorders, depression and anxiety.
In Europe, electroCore’s nVNS technology has a CE mark for primary headache, bronchoconstriction, epilepsy, gastric motility disorders, and depression and anxiety. It also has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in South Africa, India, New Zealand, Australia, Colombia, Brazil and Malaysia, and in Canada for cluster headache. US approval is expected in 2015.
electroCore recently reported that its successful funding initiative of US$40 million, announced in April last year, has been oversubscribed by US$10 million by all parties including Merck’s Global Health Innovation Fund and private equity groups Easton Capital and Core Ventures. The final tranche of US$15 million of the US$40 million was optional but following discussions between the investors this was not only made compulsory but increased by US$10 million to a total of US$50 million. The company reports having more than US$25 million still at its disposal.
electroCore has also recently reported on findings of two of four clinical studies (three against a sham device and one against standard of care), full details of which will be presented at the European headache (EHMTIC) meeting in Copenhagen in mid-September this year on the prevention and treatment of migraine and cluster headache.
At the American Headache Society (AHS) in June preliminary results of the US sham controlled pilot study that examined the use of electroCore’s non-invasive vagus nerve stimulation therapy (nVNS) in the prevention of chronic migraine were presented showing that the study met its endpoint of safety, and demonstrated a reduction in the number of headache days per month for patients using the active device. The study further suggests that patients who remained on therapy for longer periods of time, may enjoy progressively larger decreases in headache days over the period they are on therapy.
Earlier in June electroCore reported preliminary results of a multicentre, randomised, trial across Europe. The trial was found to have met its primary endpoint of statistical significance in reducing the number of cluster headache attacks when compared with the standard of care. During weeks three and four following the beginning of therapy, the number of cluster headache attacks per week was reduced by 46.3% in patients treated with nVNS compared with 12.5% (p=0.002) in patients treated with the best available standard of care.
Charly Gaul, director of the Migraine and Headache Clinic Königstein, Germany and the principal investigator of this study comments; “This study is one of the few well controlled, randomised studies of any preventative treatment for cluster headache. The ability of electroCore’s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.”