| October 14, 2007 |
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| Aesthetic medical device company Syneron Medical Ltd. is to invest $1.05 million in Shaldot Metal Works subsidiary QRay Ltd. The company is making the investment at a value of $11.6 million, and will invest a further $540,000 within three years and half, at one of the following milestones: additional investment in the company, a public offering, or achievement of agreed sales targets.
Like Syneron, QRay has also developed methods for treating cell tissue using light at differing ranges. It specializes in the prevention of mouth sores in bone marrow transplant patients, and the treatment of chronic sores caused by, among other things, diabetes.
| | | Gali Weinreb 11 Oct 07 11:15
Aesthetic medical device company Syneron Medical Ltd. is to invest $1.05 million in Shaldot Metal Works subsidiary QRay Ltd. The company is making the investment at a value of $11.6 million, and will invest a further $540,000 within three years and half, at one of the following milestones: additional investment in the company, a public offering, or achievement of agreed sales targets.
In addition, the two sides agreed that Syneron will pay Shaldot a one-time license fee of $100,000 for a limited, non-exclusive, worldwide license to use QRay's patents. The agreement was reached following a lawsuit originally filed by Shaldot three years ago in which it sought damages and injunctive relief for infringement of Shaldot's Israeli patent. Syneron also filed a countersuit against Shaldot for damage it caused to Syneron's IPO on Nasdaq. Aesthetic phototherapy is a field that has seen countless patent infringement suits and countersuits in recent years, and these usually end with out-of-court settlements that allow all sides to continue using the technology.
Like Syneron, QRay has also developed methods for treating cell tissue using light at differing ranges. It specializes in the prevention of mouth sores in bone marrow transplant patients, and the treatment of chronic sores caused by, among other things, diabetes. Syneron has plenty of cash, and for that and strategic reasons, it occasionally invests in various start-ups whose activity corresponds to its own.
Syneron's investment reflects a value of $11.6 million for QRay, which implies a $10 million value for the stake of Shaldot, which will continue to own 88% of its subsidiary. Shaldot, which produces and markets vehicle towing accessories, posted a profit of NIS 1.6 million on sales of NIS 20.8 million for 2006.
Published by Globes [online], Israel business news - www.globes.co.il - on October 11, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
| | | | | Citi Investment Research has published a review of Teva in the light of a study by Merck KGaA which pitted Teva's multiple sclerosis drug Copaxone against its Rebif. "Results from Merck KGaA's REGARD study missed the primary endpoint, failing to prove the company's multiple sclerosis drug Rebif superior to Teva's Copaxone," Citi analysts Andrew Swanson, Andrew Finkelstein, and Sara Moreno report.. The data will be presented at European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). | | | Globes correspondent 10 Oct 07 17:41
Citi Investment Research has published a review of Teva in the light of a study by Merck KGaA which pitted Teva's multiple sclerosis drug Copaxone against its Rebif. "Results from Merck KGaA's REGARD study missed the primary endpoint, failing to prove the company's multiple sclerosis drug Rebif superior to Teva's Copaxone," Citi analysts Andrew Swanson, Andrew Finkelstein, and Sara Moreno report.. The data will be presented at European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
"Although the data favored Rebif and a secondary endpoint was met, we believe there is no damage to Copaxone because it is already viewed as less effective than interferons like Rebif. Copaxone's position as a drug that can be used in interferon failures, that has a relatively benign tolerability profile, and that is somewhat less expensive is undisturbed, in our view," the report continues.
"The re-entry of Tysabri at a premium price allowed Teva to take a hefty Copaxone price increase but remain the low-cost option. After a price benefit in 2007, Teva benefits from improving economics in 2008 and 2010 as the Sanofi co-promotion ends. Thus, we expect Copaxone to contribute to Teva's growth even with modest volume gains," the analysts write.
Citi gives Teva a "Buy" recommendation, with a $52 target price. This compares with a current price on Nasdaq of $43.89. "We believe Teva's current valuation is insufficient reward for the advantages of its scale," the Citi report says.
Published by Globes [online], Israel business news - www.globes.co.il - on October 10, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
| | | | | Israeli medical device start-up DeepBreeze Ltd. and GE Healthcare have unveiled a version of the Vibration Response Imaging (VRI) system for intensive care units and preoperative care areas, known as the VRIICU, at the European Society of Intensive Care Medicine convention in Berlin. The companies plan to launch the device in Asia soon. The device is a non-invasive, radiation-free, pulmonary imaging system.
DeepBreeze has a second VRI device for pulmonary imaging at clinics, which it plans to market independently.
| | | Gali Weinreb 8 Oct 07 18:39
Israeli medical device start-up DeepBreeze Ltd. and GE Healthcare have unveiled a version of the Vibration Response Imaging (VRI) system for intensive care units and preoperative care areas, known as the VRIICU, at the European Society of Intensive Care Medicine convention in Berlin. The companies plan to launch the device in Asia soon. The device is a non-invasive, radiation-free, pulmonary imaging system.
GE Healthcare has received exclusive global rights to market the VRIICU for use in emergency and operating rooms. DeepBreeze’s Vibration Response Imaging (VRI) monitors the breathing of patients on artificial respirators. The US Food and Drug Administration (FDA) recently approved the basic technology. However, more regulatory permits will be needed for the VRIICU before it can be sold in the US, and the companies expect a US launch in January.
DeepBreeze has a second VRI device for pulmonary imaging at clinics, which it plans to market independently.
DeepBreeze president and CEO Dr. Igal Kushnir says that GE Healthcare controls about 80% of the market for artificial respirators for operating theaters and 15-20% of the market for respirators for ICUs. The company’s VRI device is suitable for all type of artificial respirators.
Published by Globes [online], Israel business news - www.globes.co.il - on October 8, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
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Sources inform Globes that ETView is currently considering a TASE IPO, with the aim of raising $15 million. The offering would value the firm at $30 million. While the firm has not finalized its planned offering process, it has already started to put together the prospectus.
ETView, a graduate of the Misgav Technology Center, has developed an intubation tube with a miniature video camera at the tip, which greatly enhances the success of the complicated procedure. Additionally, the device can keep the camera in place for an extended period after the procedure, potentially reducing the need for x-rays.
Several months ago, the firm received FDA approval to market its product, and has already signed distribution deals in Turkey, Italy, and Spain. Each of the deals can be worth up to several hundred thousand Euros in annual sales.
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Gali Weinreb 8 Oct 07 15:48
Sources inform Globes that ETView is currently considering a TASE IPO, with the aim of raising $15 million. The offering would value the firm at $30 million. While the firm has not finalized its planned offering process, it has already started to put together the prospectus.
ETView, a graduate of the Misgav Technology Center, has developed an intubation tube with a miniature video camera at the tip, which greatly enhances the success of the complicated procedure. Additionally, the device can keep the camera in place for an extended period after the procedure, potentially reducing the need for x-rays.
Several months ago, the firm received FDA approval to market its product, and has already signed distribution deals in Turkey, Italy, and Spain. Each of the deals can be worth up to several hundred thousand Euros in annual sales.
In Europe and the US, over one hundred thousand intubations are performed daily. Over half of the procedures are conducted in operating rooms. According to ETView, between 3% and 5% of these operating room intubations are considered “difficult”” and in these cases, a camera would ease the process. The rate of successful procedures is considerably lower in procedures performed outside of operating rooms, and about one-quarter fail in the first attempt. Using ETViews’s product in these cases is expected to allow medical staff to precisely identify the location of breathing tubes and foster first-time success.
Published by Globes [online], Israel business news - www.globes.co.il - on October 8, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
| | | | | Teva Pharmaceuticals Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the firm to market its generic version of GlaxoSmithKline's antiviral product Valtrex (Valacyclovir Hydrochloride) Tablets.
Final approval of Teva's application is anticipated in December 2009.
| | | Globes' correspondent 7 Oct 07 09:23
Teva Pharmaceuticals Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the firm to market its generic version of GlaxoSmithKline's antiviral product Valtrex (Valacyclovir Hydrochloride) Tablets.
Final approval of Teva's application is anticipated in December 2009.
The brand product had annual sales of approximately $1.5 billion in the United States for the twelve months ended June 30, 2007, based on IMS sales data.
Antiviral drug Valtrex is used to treat genital herpes, shingles, and cold sores.
Shares in Teva were unchanged on Friday in Nasdaq trading, closing at $43.84. The price gives the generic pharmaceuticals firm a market cap of $33.4 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on October 7, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
| | | | | Teva Pharmaceuticals Industries Ltd. has obtained final US Food and Drug Administration (FDA) approval for its generic version of Actonel, made by Proctor & Gamble Inc. for the treatment of osteoporosis.
Teva's AB-rated Risedronate Sodium tablets treat and prevent postmenopausal and glucocorticoid-induced osteoporosis, and treat Paget's disease. According to IMS sales data, brand Actonel had $1 billion in US sales in the twelve months through June.
| | | Globes’ correspondent 8 Oct 07 18:54
Teva Pharmaceuticals Industries Ltd. has obtained final US Food and Drug Administration (FDA) approval for its generic version of Actonel, made by Proctor & Gamble Inc. for the treatment of osteoporosis.
Teva is in litigation with Proctor & Gamble over the drug. The US District Court for the District of Delaware heard the case in November 2006, but no judgement has been handed down yet. In connection with the pending patent litigation, Teva agreed to provide 30 days advance notice to Procter & Gamble of any launch activities, and it has not yet done so.
Teva's AB-rated Risedronate Sodium tablets treat and prevent postmenopausal and glucocorticoid-induced osteoporosis, and treat Paget's disease. According to IMS sales data, brand Actonel had $1 billion in US sales in the twelve months through June.
As the first company to file an Abbreviated New Drug Application (ANDA) with a Paragraph IV patent certification for generic Actonel, Teva has 180 days marketing exclusivity for this product.
Teva rose 0.5% to $44 by midday on Nasdaq, and rose 1.1% on the TASE today. It has a market cap of $33.6 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on October 8, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
| | | | | Topspin Medical Inc. has applied to the US Food and Drug Administration (FDA) for marketing approval for the company’s first-generation imaging intravascular MRI (IVMRI) catheter. The company has completed laboratory tests, preclinical and clinical trials for the catheter.
In July, Topspin signed a distribution agreement for the IVMRI with Johnson & Johnson Israel, under an exclusive three-year contract. Topspin did not disclose the terms of this contract. The IVMRI catheter won EU CE Mark approval a few months ago. | | | Erez Wollberg 7 Oct 07 10:25
Topspin Medical Inc. has applied to the US Food and Drug Administration (FDA) for marketing approval for the company’s first-generation imaging intravascular MRI (IVMRI) catheter. The company has completed laboratory tests, preclinical and clinical trials for the catheter.
Topspin CEO Yaron Tal said, “We’re pleased to announce that we’ve applied to the FDA for marketing approval for the IVMRI catheter in the US after completing all the tests and trials necessary for the application. FDA approval will give the company access to the US market, which is the largest market in the world for invasive cardiology procedures.”
In July, Topspin signed a distribution agreement for the IVMRI with Johnson & Johnson Israel, under an exclusive three-year contract. Topspin did not disclose the terms of this contract. The IVMRI catheter won EU CE Mark approval a few months ago.
Published by Globes [online], Israel business news - www.globes.co.il - on October 7, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007
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