|Biolase soars on profit outlook, new order. ISTA pharma study hits endpoint. After the bell: Otix Global gets second bid|
|By Mary Davila|
|Monday, 27 September 2010 19:17|
After the bell Monday shares of Otix Global, Inc. (Nasdaq: OTIX) continued to be halted as news emerged that GN ReSound A/S has submitted a proposal to acquire the American hearing aid company for approximately $58 million USD. Prior to the halt in trading shares of Otix shot up more than 16% or $1.38 to $9.81. Last week Otix received a proposal to be acquired by William Demant Holding for $8.60.
Otix Global, Inc., the world's 8th largest hearing aid manufacturer, develops and sells hearing aids under the brand Sonic to hearing care professionals through its own sales companies and an international distributor network.
Pfizer Inc. (NYSE:PFE) after the bell Monday announced the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT® (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer (CRPC) that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee (DMC) found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone. No new or unexpected safety issues were identified. The full data set from this trial is being analyzed and will be presented at an upcoming medical meeting.
BIOLASE Technology, Inc. (NASDAQ:BLTI), the world's leading dental laser company, is proud to announce that Henry Schein, Inc. (NASDAQ:HSIC) has placed an irrevocable $9 million open purchase order for BIOLASE products, $6 million of which will be for the purchase of the revolutionary iLase personal laser, with an option for an additional $3 million of iLase or for other laser systems, including the flagship Waterlase® MD Turbo. This purchase order is expected to be fulfilled by June 2011. Deliveries are to start immediately, and are expected to increase over the course of the 2010 fourth quarter and thereafter. As part of the distribution agreement, Henry Schein has agreed to engage in a substantial marketing campaign to launch the iLase product line throughout North America.
Federico Pignatelli, Chairman and CEO of BIOLASE, commented, "The iLase is a breakthrough product. It is the first completely self-contained, hand-held dental laser that includes the laser, user interface, battery power, and controls in a single, integrated handpiece, without foot pedals or cords. We are proud to have such a well-recognized dental distributor as Henry Schein to endorse our latest product, and to support in a very meaningful way the adoption of laser technology in the dental field." Pignatelli continued, "What is particularly noteworthy about the iLase product is that it can be used, not only by a dentist, but by a dental hygienist as well. This brings the potential number of users to 250,000 in North America alone."
In a separate release the company also announced today that it has completed a corporate-wide reorganization that has achieved the goal of reducing, by approximately 30%, its total current sales breakeven level.
Federico Pignatelli, Chairman and CEO, commented, "This restructuring was performed rapidly, but also with great care. I am pleased to report that the cost reduction was achieved while keeping the company structure intact."
On heavy volume, shares of Biolase soared more than 57%, jumping 47 cents to $1.29.
ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA) today highlighted results from the Company's REMURA (bromfenac ophthalmic solution for dry eye) Phase 2 clinical study. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining as compared to baseline. In addition, patients achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index (OSDI) and in patients' most bothersome ocular symptoms. Patients treated with REMURA maintained the improvements in the signs and symptoms of dry eye disease for 10 days after discontinuing treatment, which was evaluated at the time of the follow up visit. Adverse events were uncommon, and there were no serious ocular or systemic adverse events.
On nearly double the daily volume, shares of ISTA rose more than 5% or 20 cents to $3.97.
As reported earlier today on BioMedReports, Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced positive top-line results from the pivotal trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.
Seventy-five percent of patients in the pivotal trial achieved an objective response as assessed by an independent central review, the primary endpoint of the trial. The median duration of response was greater than six months. The safety profile of brentuximab vedotin in this trial was generally consistent with prior clinical trial experience. A more complete data set will be presented at an upcoming scientific meeting.
More than 12 million shares of Seattle Genetics traded Monday sending the stock up more than 17% or $2.14 to $14.30.
Trimeris, Inc. (Nasdaq: TRMS), announced today that the Company and its partner, F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. ("Roche"), have entered into an agreement relieving Trimeris of any obligation to repay certain deferred marketing expenses. In addition, Trimeris and Roche have jointly settled the U.S. patent infringement suit related to Trimeris’ and Roche’s product FUZEON® (enfuvirtide) with the plaintiff, Novartis Vaccines and Diagnostics, Inc.
The agreement reached today between Roche and Trimeris relates to the parties’ collaboration for the development and commercialization of FUZEON. Under the existing Development and License Agreement between the parties, Trimeris and Roche had agreed that certain expenses related to the selling and marketing of FUZEON that were incurred by Roche in 2004 would be subject to re-payment by Trimeris, assuming certain terms and conditions were met. Pursuant to today’s agreement, Trimeris will no longer be obligated to pay these deferred marketing expenses to Roche.
The re-payment obligation is recorded on the Company’s balance sheet as a single entry under the caption "Accrued marketing costs." This liability was $18.7 million at June 30, 2010. The reversal of this liability will be reflected as income on the Company’s income statement in the third quarter of 2010.
Shares of Trimeris shot up more than 8% or 19 cents, closing the day at $2.48.
CytoSorbents Corporation (OTC.BB:CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced the achievement of ISO 13485:2003 Full Quality Systems certification, a major milestone. ISO 13485 is an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (E.U.). It is a regulatory requirement of the E.U.'s Medical Device Directive and an important step toward attaining European CE Mark approval.
CEL-SCI Corporation (NYSE AMEX:CVM) announced today it has received approval from the Ethical Council Affiliated with the Ministry of Healthcare and Social Development of the Russian Federation for the Phase III clinical trial of Multikine, the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI expects to have three clinical centers in Russia, out of an expected forty-eight clinical centers world-wide. Head and neck cancer is a major cancer in Russia.
Cerus Corporation (NASDAQ:CERS) announced today the favorable outcome of a large French study evaluating transfusion of over 13,000 platelet components treated with the INTERCEPT Blood System. The study has just been published online in the journal Transfusion.
"This study demonstrates that INTERCEPT can be implemented into routine practice, providing protection against transfusion-transmitted pathogens, without impacting either platelet or red blood cell utilization. This observation confirms previous data indicating that the treated platelets are functioning similarly to untreated platelets," said Dr. Laurence Corash, Cerus' chief medical officer. "The investigators also noted that use of INTERCEPT treated platelets resulted in a decrease in the incidence of adverse events following transfusion."
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has initiated enrollment in a multinational, 12-week, double-blind Phase II trial designed to compare the efficacy and tolerability of CH-4051 against methotrexate (MTX) in 250 patients with rheumatoid arthritis (RA) who are experiencing an inadequate response to MTX treatment. CH-4051 is an orally available, non-metabolized antifolate with potent anti-inflammatory properties engineered to provide enhanced clinical benefits to patients without associated liver toxicities or other side effects that often limit the use of chronic MTX therapy.
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