XTL Biopharmaceuticals Ltd. has received a Staff Deficiency Letter from Nasdaq Global Market stating Nasdaq's concern that XTL does not have the minimum $10 million shareholders' equity requirement needed in order for it to remain listed on Nasdaq. XTL has a reported $9 million in shareholders' equity and has the option to transfer its ADR listing to Nasdaq Capital Market.

Shmulik Shelah 29 Aug 07   10:04

Nasdaq has sent drug development company XTL Biopharmaceuticals Ltd. a Staff Deficiency Letter which states that the company’s financial statements for the first half of 2007 indicate that it no longer complies with the minimum $10 million shareholders' equity requirement for continued listing on the Nasdaq Global Market.

XTL stated in its latest financial report that it has $9 million in shareholders’ equity.

XTL intends to respond to Nasdaq with information that may enable it to maintain its listing on the Nasdaq Global Market, but added that if its plan for compliance is not satisfactory it has the option to transfer its ADR listing to the Nasdaq Capital Market (previously the NASDAQ SmallCap Market).

Last week, XTL CEO Ron Bentsur told “Globes” that the company was considering delisting from the London Stock Exchange in an effort to cut costs, while continuing its listing on Nasdaq and the Tel Aviv Stock Exchange (TASE).

Published by Globes [online], Israel business news - www.globes.co.il - on August 29, 2007

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

Teva Pharmaceutical Industries Ltd. has obtained approval from the US Food and Drug Administration to market a generic version of famvir (Famciclovir) Tablets. Famvir is currently being used to treat recurrent genital herpes. Teva has received a 180-day exclusivity period for generic Famvir.

Globes’ correspondent 26 Aug 07   10:23

Teva Pharmaceutical Industries Ltd. has obtained final US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) to market its generic version of Famvir (Famciclovir) Tablets, 125 mg, 250 mg and 500 mg. made by Novartis AG. Famvir is used to treat or shorten the duration of recurrent genital herpes. Teva has a 180-day exclusivity period for generic Famvir.

The brand product had annual sales of $200 million in the US in the twelve months through June 2007, based on IMS sales data.

Novartis filed a patent infringement suit against Teva in April 2005 over Famciclovir products. The US District Court for the District of New Jersey hearing is due to hear Novartis' motion for a preliminary injunction in this case on September 5, 2007. Both parties have agreed not to launch a generic Famciclovir product until the conclusion of the hearing.

Published by Globes [online], Israel business news - www.globes.co.il - on August 26, 2007

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

Brainsway Ltd. will conduct human clinical trials of its Deep TMS transcranial magnetic stimulation device in the UK for the treatment of Blepharospasm (BSP) and Tourette's syndrome. The trials will be carries out together with the National Institute of Neurological Disorders and Stroke (NINDS), a branch of Britain's National Institutes of Health (NIH).

Batya Feldman 28 Aug 07   09:51

Brainsway Ltd. will conduct human clinical trials of its Deep TMS transcranial magnetic stimulation device in the UK in partnership with the National Institute of Neurological Disorders and Stroke (NINDS), a branch of Britain’s National Institutes of Health (NIH), for the treatment of Blepharospasm (BSP) and Tourette’s syndrome.

In the case of BSP, the research will seek to achieve a better understanding of the internal mechanism of the disease and test the effectiveness of Brainsway’s methodology of external brain stimulation using TMS to treat it. 23 patients will participate in the trial.

In the case of Tourette’s syndrome, the trial will attempt discover whether the source of the sensory experience is in the peripheral nervous system, rather than the central nervous system, and whether the sensory and physiological experience are necessary conditions for the motor reflex. 35 volunteers suffering from Tourette’s syndrome will participate in the trial.

Brainsway has a market cap of NIS 192 million. The company was founded in 2003. Transcranial magnetic stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed upon the patient's scalp. Deep TMS System enables direct non-invasive activation of deep brain structures.

The company is conducting a number of clinical trials with the NIH for involuntary blinking, manic depression for patients who do not respond to pharmaceutical treatments, depression for patients who are resistant to drug therapies, cannabis rehab and reducing drug dependence, and for Parkinson’s disease.

Published by Globes [online], Israel business news - www.globes.co.il - on August 28, 2007

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

Teva Pharmaceutical Industries Ltd. is set to go ahead with two at-risk launches by the end of September. Teva Pharmaceutical Industries Ltd. has received final approval from the US Food and Drug Administration for a generic version of Novartis AG's Famvir (Famciclovir) tablets and is awaiting final approval for a generic version of Wyeth's Protonix drug.

Gitit Pincas 27 Aug 07   11:26

In the quarter just ended, it was the at-risk launch of the generic version of Novartis AG 's (NYSE: NVS) drug Lotrel which was the joker in the pack that helped Teva Pharmaceutical Industries Ltd. deliver good figures. By the end of the third quarter on September 30 Teva, will have made two more such launches: the generic version of Wyeth's Protonix for the treatment of GERD, and a generic version of Novartis's Famvir, announced at the end of last week.

Teva said that the US Food and Drug Administration (FDA) had granted final approval for its Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' Famvir (Famciclovir) tablets, 125 mg, 250 mg and 500 mg doses. The brand product had annual sales of approximately $200 million in the US for the twelve months ended June 30, 2007.

Teva is the first company to file a product approval application containing a paragraph IV certification for this product, which will give it a 180-day period of marketing exclusivity. However, the company faces a patent infringement lawsuit filed in April 2005 when it first submitted its application. A hearing is scheduled for September 5, in the US District Court for the District of New Jersey on Novartis' motion for a preliminary injunction in that action. The parties have agreed not to launch a generic Famciclovir product until the conclusion of the hearing on September 5, 2007. This would appear to imply that Teva is set to go ahead with an at-risk launch if necessary.

Teva will find itself back in the same court two days, later on September 7, this time in connection with Wyeth's $2.5 billion drug Protonix for the treatment of gastroesophageal reflux disease (GERD), more commonly known as chronic indigestion. Having learned from Novartis's bad experience with Lotrel, Wyeth has launched an all-out battle to protect its patent on Protonix, before the FDA grants final approval to Teva to go ahead with its generic version. As with Famvir, Teva has undertaken not to launch its version until the court ruling is handed down, or until September 7, whichever comes first. September 7 is the final date for a court ruling on Protonix and, theoretically, Teva can make an at-risk launch of a generic version on September 5, and on September 7 or earlier launch a second version.

Speaking at Teva's press conference to discuss up the second quarter, chairman Eli Hurvitz said, "The risk has not increased, but rather it has actually fallen. As we see it, the risk level is now lower. We've learned more, and we now sleep much better at night than we did a few years back."

When it launched Lotrel, Teva managed in one day to distribute a quantity that would last for two to three months, thereby taking the sting out of the temporary injunction that Novartis had filed against it. The same will almost certainly apply to the other two drugs, of which Teva can also dispatch large quantities, thanks to its well-oiled distribution network.

Published by Globes [online], Israel business news - www.globes.co.il - on August 27, 2007

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

Teva Pharmaceutical Industries Ltd. has been granted final approval by the US Food and Drug Administration to market its generic version of Pfizer's hypertension treatment Accupril (Quinapril Hydrochloride) tablets.

Globes' correspondent 28 Aug 07   09:22

Teva Pharmaceutical Industries Ltd. announced today that the FDA has granted final approval for the company's abbreviated new drug application (ANDA) to market its generic version of Pfizer's hypertension treatment Accupril (Quinapril Hydrochloride) tablets. The tablets are produced in strengths varying from 5 mg to 40 mg.

The FDA decision follows the expiration of pediatric exclusivity for U.S. Patent No. 4,743,450.

Total annual sales of Quinapril HCl Tablets in the U.S., including brand and generic sales, were approximately $150 million for the twelve months ended June 30, 2007, based on IMS sales data.

Teva Pharmaceutical Industries Ltd. develops, manufactures, and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

Published by Globes [online], Israel business news - www.globes.co.il - on August 28, 2007

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

LifeWave Hi-Tech Medical Devices Ltd. has posted NIS 651,000 in sales for its Bed Sore Treatment device for the second quarter of 2007. LifeWave also posted its first-ever gross profit, totaling NIS 268,000 for the second quarter. Nonetheless, the company's net loss rose to NIS 3.4 million for the second quarter as R&D expenses more than doubled and total expenses more than tripled.

Michal Yoshai 30 Aug 07   15:20

LifeWave Hi-Tech Medical Devices Ltd. today published its financial report for the second quarter of 2007. The company posted NIS 651,000 in sales of peripherals for its Bed Sore Treatment device for the second quarter, compared with zero for the corresponding quarter.

Lifewave also posted its first-ever gross profit, which totaled NIS 268,000 for the second quarter. Financing revenue totaled NIS 102,000 for the second quarter, compared with NIS 17,000 for the corresponding quarter. Most of the increase came from cash reserves and short-term deposits using proceeds from its IPO in late 2006.

The company’s operating loss widened to NIS 3.5 million for the second quarter from NIS 817,000 for the corresponding quarter. Net loss rose to NIS 3.4 million (NIS 0.30 per share) for the second quarter from NIS 800,000 for the corresponding quarter.

R&D expenses more than doubled to NIS 630,000 for the second quarter from NIS 230,000 for the corresponding quarter, and total expenses more than tripled to NIS 1.8 million from NIS 587,000.

Lifewave has developed a non-invasive bed sore treatment device for chronic wounds. In July, the company announced that the device had successfully passed a pilot program with Meuhedet Sick Fund, and that the HMO is preparing to order the devices for routine usage.

Published by Globes [online], Israel business news - www.globes.co.il - on August 30, 2007

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

Aviv Bushinsky has resigned from his position as chairman of LifeWave Hi-Tech Medical Devices Ltd. RLB Investments Ltd., the controlling shareholder of LifeWave, has said that the company has reached the stage that requires strategic management ability in the international market. LifeWave's shares rose by over 17.5% in TASE trading today.

Erez Wollberg 26 Aug 07   20:22

The saga of LifeWave continues. Moments before a scheduled general meeting, which had been called to fire him, Aviv Bushinsky resigned as chairman at LifeWave Hi-Tech Medical Devices Ltd. His resignation was effective immediately. As a result, the general meeting that was to take place this evening was cancelled.

The price of LifeWave's shares rose by over 17.5% today in TASE trading.

Several weeks ago, LifeWave's controlling shareholder RLB Investments Ltd., controlled by Yitzhak Kaufman and Reuven Shulman, reported that it would begin the process to oust the LifeWave chairman. At the time, Kaufman and Shulman said, “The company has reached the stage that requires strategic management ability in the international market in order to accelerate the company’s overseas development and exploit its current momentum. The company’s distribution agreements are excellent entry tickets to foreign markets, but more intensive efforts will be requires to further expand the distribution network to more markets."

Published by Globes [online], Israel business news - www.globes.co.il - on August 26, 2007

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

Kamada Ltd. has raised NIS 40 million from the exercise of Series 1 warrants. Kamada Ltd.'s net loss for the second quarter widened to NIS 15 million. The company is currently carrying out Phase III clinical trials for its injectible Alpha-1 Antitrypsin (AAT) drug for the treatment of cystic fibrosis.

Yaniv Magal 29 Aug 07   15:38

Biopharmaceutical development company Kamada Ltd. has raised NIS 40 million from the exercise of Series 1 warrants, which will expire in another year. The company also published its financial report for the second quarter of 2007 today.

NIS 15 million of the amount raised came from parties at interest. GlenRock Israel, controlled by Leon Recanati, exercised warrants for NIS 8.3 million; Kamada chairman Ralph Hahn, the company’s largest shareholder, exercised warrants for NIS 4.3 million; and Excellence Investments Ltd. exercised warrants for NIS 2.9 million.

As for the quarterly results, Kamada’s net loss widened to NIS 15 million for the second quarter from NIS 2 million for the corresponding quarter of 2006. Kamada CEO David Tsur attributed the increased loss to R&D expenses, which rose to NIS 7.7 million for the second quarter from NIS 3.2 million for the corresponding quarter, and to the cost of upgrading the company’s plant in Beit Kama. The higher R&D expenses were incurred because of the expansion of the company’s line of products under development and the financing of initial clinical trials.

Kamada develops and sells plasma therapeutics. The company is currently developing drugs primarily for critical care situations that arise in emergency rooms, operating theaters and intensive care units. The company has sales in 15 countries. The company is currently carrying out Phase III clinical trials for its injectable Alpha-1 Antitrypsin (AAT) drug Alpha-1 Proteinase Inhibitor (API) for the treatment of cystic fibrosis and Phase I trials for an inhalable version of the drug.

Published by Globes [online], Israel business news - www.globes.co.il - on August 29, 2007

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

Compugen Ltd. and Teva Pharmaceutical Industries Ltd. will work together to jointly develop CGEN-54, a Compugen-discovered novel splice variant of Monocyte Chemoattractant Protein 1 (MCP1) that is a candidate for chronic inflammatory diseases. Compugen Ltd. will provide Teva with research quantities of CGEN-54 and Teva will have its worldwide exclusive development and commercialization license.

Yaniv Magal 28 Aug 07   19:06

Compugen Ltd. and Teva Pharmaceutical Industries Ltd. will collaborate to jointly develop CGEN-54, a Compugen-discovered novel splice variant of Monocyte Chemoattractant Protein 1 (MCP1). Teva will have worldwide exclusive development and commercialization license