Schwarz Pharma of Germany has unveiled complete Phase III data which show that its epilepsy drug candidate, lacosamide, reduces seizures.
Full results from the 485-patient study, for which preliminary data were announced in March, were presented at the North American Regional Epilepsy Congress in San Diego, showed that both lacosamide 200 and 400mg/day demonstrated statistically significant and clinically relevant improvements over placebo and were generally well tolerated when administered concomitantly to patients previously uncontrolled on one-three antiepileptic drugs.
During the trial, lacosamide was generally well tolerated, with dizziness,
headache and double vision being the most commonly reported adverse events. Schwarz noted that other adverse events often associated with antiepileptic treatments, such as somnolence and cognitive disorder, were notably low and similar to placebo.
Iris Loew-Friedrich, member of the executive board at Schwarz said that the data will be submitted to the regulatory agencies in both the European Union and the USA as part of the marketing authorisation application for lacosamide as adjunctive therapy in adults with partial seizures during the first half of next year.
The drug is expected to be a big seller for Schwarz, with sales potential of 300 million euros, helped by a favourable side effect profile which could help it compete against Pfizer’s rival drug Lyrica (pregabalin). The company is also looking at expanding lacosamide into a secondary indication, neuropathic pain, which could prove to be worth some 600 million euros more.
Schwarz family accept UCB bid
Meantime, the company also announced that the Schwarz family, which holds a 59.2% stake in the firm, has accepted UCB of Belgium’s friendly acquisition bid and tendered all their 28.4 million shares. UCB is offering 50 euros in cash and new stock for every Schwarz share and the acquisition is valued at around 4.4 billion euros.