Neurim Pharmaceuticals Ltd. has granted Danish pharmaceutical company H. Lundbeck A/S (KFX:LUN) a license for exclusive rights to market its Circadin treatment of primary insomnia in the majority of European markets, including the UK, Germany, France, Spain, and Poland. Lundbeck was also granted an exclusive option to evaluate commercialization in markets outside of Europe. Lundbeck said that it expected to launch Circadin in the first markets during 2008.
Neurim declined to disclose the size of the deal, but said that it “receives an upfront payment and a share of revenue. Neurim is responsible for manufacturing.”
A rough estimate on the basis of the product’s stage of development, competition, and target market, indicates that the upfront payment is worth tens of millions of dollars and the royalties could total hundreds of millions of dollars.
Neurim previously granted marketing rights in some European markets to Nycomed. The drug marketing company has marketing rights in Scandinavia, the Baltic states, and some other countries.
Neurim CSO Prof. Nava Zisapel founded the company. She is the wife of high-tech entrepreneur Yehuda Zisapel, who serves as company president. The company is partly based on research at Tel Aviv University and is a wholly owned subsidiary of RAD Group, which has invested tens of millions of dollars in the company.
The European Commission approved Circadin three months ago, and Neurim has applied to the US Food and Drug Administration (FDA) for marketing approval. However, Neurim SA CEO Francesca Stingele said that this would take at least two years.
Circadin is a monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients aged over 55. It is the first and only IP-protected prolonged-release, melatonin containing ethical drug approved in the EU. Melatonin is a naturally occurring hormone produced by the pineal gland; it has a pivotal role in the regulation of circadian rhythms and sleep. Endogenous melatonin levels decrease with age and may contribute to the common complaint of poor sleep quality seen amongst those in middle age and in the elderly.
Melatonin can be purchased as a nutritional supplement. However, Nava Zisapel explained to “Globes” a few months ago the difference between it and Circadin. “It is currently illegal to sell pure Melatonin in Israel and Europe. In the US, Melatonin is approved for use as a nutritional supplement, which means that marketers may not claim that it treats insomnia. The Melatonin currently on sale as a nutritional supplement quickly reaches peak concentration and dissipates within 30 minutes. Circadin, a prescription drug, releases Melatonin after a delay and in controlled dosages throughout the night, similar to the natural release of the hormone. The product is authorized for use in people over the age of 55 because studies have shown decreased Melatonin production with age resulting in frequent sleep disruption.”
Lundbeck specializes in developing treatments for diseases of the central nervous system. The company has partnered with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) in the development of Azilect, for the treatment of Parkinson’s disease.
Published by Globes [online], Israel business news - www.globes.co.il - on September 25, 2007
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