Yediot

September 30, 2007


Lundbeck to market Neurim insomnia treatment

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.

Gali Weinreb 25 Sep 07 13:13

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 Pharmaceuticals Industries Ltd. 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

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007


Ilex Medical wins Magen David Adom tender

Ilex Medical Ltd. Subsidiary Ilex Biotech Ltd. has won an Israel Blood Bank - Magen David Adom tender to supply 300,000 automated blood donation test kits a year for three years. The contract is worth NIS 50 million. The company has an option to extend the contract by two years.

The kits use a Nucleic Acid Testing (NAT) system developed by Novartis AG subsidiary Chiron Corporation to test for the presence of HIV in donated blood. Ilex is a distributor for Chiron blood test kits. Ilex Medical already has franchises from Chiron to distribute the blood test kits in several countries in Europe and Africa.


Can-Fite tests raises clinical trial success rate

Can-Fite BioPharma Ltd. reports that it has developed a test that “substantially increases the chances of success of clinical trials of the company’s pharmaceuticals.”

Can-Fite has completed development of a blood test to determine the target receptor level in candidate patients for the company’s drug therapies. The company has applied for a patent for the test.

Michal Yoshai 24 Sep 07 12:04

Can-Fite BioPharma Ltd. reports that it has developed a test that “substantially increases the chances of success of clinical trials of the company’s pharmaceuticals.”

Can-Fite has completed development of a blood test to determine the target receptor level in candidate patients for the company’s drug therapies. The company has applied for a patent for the test.

The technology platform is based on pharmaceuticals related to the Adenosine A3 receptor, which is the target of the company’s drugs, and which is found in large quantities in inflamed and cancerous cells, in contrast to the low level in healthy cells. The blood test uses a miniscule quantity of blood, which can be taken at any hospital in the world, and measures the quantity of the Adenosine A3 receptor in the sample. Can-Fite’s scientists found that level of the receptor in the blood reflects its level in the patient’s inflamed or cancerous cells.

Earlier clinical trials for the drug CF-101 for the treatment of rheumatoid arthritis found that patients with high levels of the Adenosine A3 receptor responded well to treatment. The results indicate that the blood test enables Can-Fite to predict a patient’s response to treatment in advance. The company therefore believes that the test greatly increases the chances of success of clinical trials of the company’s drugs.

Can-Fite adds that the blood test can enable the company to check the target findings during advanced international clinical trials, thereby ratifying the test as a predictor of a patient’s response to treatment. If the trials are successful, the company will consider licensing the blood test, which will serve doctors before they administer drugs in line with the personalized medicine approach in which a patient’s response to a drug is tested before it is administered.

Published by Globes [online], Israel business news - www.globes.co.il - on September 24, 2007


Biocancell cancer drug trial shows good results

Biocancell Therapeutics Ltd. has obtained the final results of its Phase I/IIa clinical trial for its bladder cancer treatment, BC-819.

Bioccancell CEO Avi Barak said that the results of the trial were good and that the company would begin a Phase IIb trial with 33 patients. The trial would probably begin during the fourth quarter of the year, after the company obtains approval from the US Food and Drug Administration (FDA).


Nine new incubator companies are approved

The Technical Incubators Program has approved the establishment of nine new incubator companies with a total investment of NIS 16 million. Five of the projects are in communications and software, three are in the life sciences, and one is in water technology. The Technical Incubators Program is part of the Office of the Chief Scientist of the Ministry of Industry, Trade and Labor.

The three projects in the life sciences are:

A project at Meytav Technological Enterprises Innovation Center Ltd. in Kiryat Shmona to develop a screwless device for knee implants.
A project at Maayan Ventures Ltd. for a non-invasive method for continuous monitoring of cardiovascular pressure and the functioning of heart muscle.
A project at Rad BioMed Incubator to develop a drug delivery device for the eye.


BSP wins FDA approval for upgraded system

BSP – Biological Signal Processing Ltd. has won US Food and Drug Administration (FDA) approval to market a new 2.0 version of its HyperQ stress system for diagnosis and monitoring of ischemic heart diseases. This latest version includes improved diagnostic capabilities and a more advanced user interface. BSP said the FDA clearance also covers the new system's advanced analysis of standard ECGs.