Eisai of Japan has celebrated a vital patent victory for its antiulcerant Aciphex by posting a strong set of financials for the year ended March 2007.
Total revenues increased 12.1% to 674.1 billion yen (about $5.61 billion), while operating profit was up 10% to 105.3 billion yen and net income came in at 70.6 billion yen, a jump of 11.4%. The rises were driven once again by Aricept (donepezil) for Alzheimer’s disease which had sales of 252.9 billion yen, a leap of 28.7%. The USA was a particularly fertile ground for the product, as revenues from there climbed 31% to $1.39 billion, despite competition from Novartis’ Exelon (rivastigmine).
Aciphex (rabeprazole), a proton pump inhibitor sold as Pariet in Japan, managed a 12.8% increase in sales to 174.3 billion yen worldwide, while US turnover of the drug grew 7.4%, to $1.08 billion. However sales of the anti-epileptic Zonegran (zonisamide) slumped 62.6% to 4.9 billion yen, cannibalised by generics.
In terms of pipeline, Eisai noted that the epilepsy drug Inovelon (rufinamide), which has been given the green light in Europe, is awaiting approval from the US Food and Drug Administration as an adjunctive treatment of partial-onset seizures in adults and adolescent patients, and seizures associated with Lennox-Gastaut Syndrome in children.
The Japanese firm also noted that E5564 (eritoran), an endotoxin antagonist for severe sepsis, is in Phase III trials, as is E2007 (perampanel) for Parkinson’s disease. The latter compound, one of a new class of selective AMPA receptor blockers, is also being studied for epilepsy, multiple sclerosis and migraine prophylaxis. Oncology has also become a priority for the firm following its recent $325 million acquisition of the USA’s Morphotek and it also bought four cancer-related treatments from Ligand for $205 million last September.
Stock soars on Aciphex patent win
The results came out just after Eisai’s stock had enjoyed its biggest gain for six years (around 12%) based on a ruling by a US court that has upheld its patents on Aciphex. A district judge in New York ruled that India’s Dr Reddy’s and Teva Pharmaceutical Industries of Israel had infringed a valid patent in preparing generic versions of the stomach ulcer drug and confirmed that Aciphex is covered in the USA, where it is co-marketed by Johnson & Johnson, until 2013. Teva plans to appeal the decision.
The ruling is great news for Eisai as many analysts expected the Japanese drugmaker to lose the case. Copycat versions would have clearly eroded Aciphex sales and the importance of the drug to Eisai’s earnings is clear. However the pressure is still firmly on the company to find products to reduce its reliance on Aciphex and Aricept.
Marketing deal for Neurobloc signed with Solstice
Completing a good start to the week, Eisai has entered into a commercialisation agreement with USA-based Solstice Neurosciences for the latter’s treatment for cervical dystonia, NeuroBloc (botulinum toxin type B). This deal includes the 27 European Union countries, as well as Norway, Iceland, Liechtenstein, Monaco, Switzerland, Croatia, Turkey, and Russia and Solstice will receive up to 41 million euros from Eisai which includes an upfront payment and cash on reaching development milestones. The firms will jointly develop the product for additional therapeutic indications in Europe.
In January 2001, the European Commission granted marketing authorisation for NeuroBloc, known as Myobloc in the USA. Eisai secured the Japanese rights to the treatment in September 2000 and last December it filed a new drug application for the product there.
