Biolase soars on profit outlook, new order. ISTA pharma study hits endpoint. After the bell: Otix Global gets second bid Print E-mail
By Mary Davila   
Monday, 27 September 2010 19:17
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 27, 2010.

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.

Earlier Monday:

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.

Also Monday:

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that it has earned two LEED for Commercial Interiors Gold Certifications for its global headquarters and research facility in Cheshire, Conn.

Aoxing Pharmaceutical (NYSE Amex: AXN) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced that the Company will be presenting at the Jefferies' 2010 Global SpecPharma and European Healthcare Conference in London, United Kingdom.

Cascade Technologies Corp. (OTCBB:CSDT) announced today that Dr. Daniel L. Farkas, Chairman and CEO of Spectral Molecular Imaging (SMI), CSDT's wholly-owned subsidiary, delivered a lecture at a major international congress in Rio de Janeiro, Brazil on September 23rd, 2010.

China-Biotics, Inc. (Nasdaq:CHBT)
, the leading developer, manufacturer and distributor of probiotics products in China, today announced that its management will present at the Jefferies 2010 Global SpecPharma and European Healthcare Conference.

China Shenghuo Pharmaceutical Holdings, Inc. (NYSE Amex LLC: KUN) today announced that on September 22, 2010, it received a deficiency letter from the NYSE Amex LLC stating that the Company was not in compliance with Section 1003(a)(i) of the AMEX's continued listing standards as a result of the Company having stockholders' equity of less than $2,000,000, and losses from continuing operations and net losses in two out of its three most recent fiscal years.

Chem Rx Corporation (Pink Sheets:CHRXQ) ("Chem Rx"), the third largest long-term care pharmacy in the United States, today announced that it has reached a "stalking horse" asset purchase agreement to sell substantially all of the assets of the company to PharMerica Corporation (NYSE:PMC), an industry-leading pharmaceutical services company serving residents in long-term facilities and settings.  

China BCT Pharmacy Group, Inc., (OTC Bulletin Board:CNBI) a leading pharmaceutical distributor, retail pharmacy, and manufacturer of pharmaceutical products in Guangxi Province, China, today announced that it has further expanded its retail network throughout Guangxi province by adding 33 retail pharmaceutical stores, bringing the total number of the Company's pharmacies to 170.

China Nepstar Chain Drugstore Ltd. (NYSE:NPD) the largest drugstore chain in China based on the number of directly operated stores, today announced that it will hold its Annual General Meeting of Shareholders ("AGM") for the fiscal year ended December 31, 2009 on October 29, 2010 at 10:00 a.m. Beijing Time.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Company is scheduled to present at the 9th Annual BIO Investor Forum, October 5-6, in San Francisco, CA.

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today announced that Caldolor® (ibuprofen) Injection is gaining momentum and being approved for use in a growing number of medical facilities across the country.

CytoSorbents Corporation (OTCBB: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.

First China Pharmaceutical Group, Inc. (OTCBB: FCPG) is pleased to announce that as of September 15, 2010, First China Pharmaceutical Group, Inc., a Nevada corporation, closed a voluntary share exchange transaction with First China Pharmaceutical Group Limited, a company organized under the laws of Hong Kong ("FCPG.HK").

Hospira, Inc. (NYSE:HSP), the world leader in generic injectable pharmaceuticals, today announced that it has received Australian Therapeutic Goods Administration (TGA) approval for its biosimilar filgrastim product, Nivestim.

Humana Inc. (NYSE: HUM) announced today that RightSourceRxSM, the home-delivery pharmacy for Humana Pharmacy SolutionsSM, a division of Humana Inc., has received the highest national ranking in the “Prescription Delivery” category among mail-order pharmacies in the J.D. Power and Associates 2010 National Pharmacy StudySM.

Jiangbo Pharmaceuticals, Inc. (Nasdaq:JGBO) a pharmaceutical company with its principal operations in China, today announced that the Company will host a conference call at 9:00 a.m. Eastern Time on Thursday, September 30, 2010 to discuss financial results for the fourth quarter fiscal 2010 ended June 30, 2010.

Micro Identification Technologies, Inc. (OTCBB:MMTC), a California-based public company and creator of an advanced rapid microbial identification system, announced today that it will host a 30 minute Webinar on Wednesday, September 29, 2010 at 1:00 pm (PDT).

Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) and Pain, introduced today Nyloxin for Pets, a new pain reliever aimed at treating moderate to severe chronic pain in companion animals.

Oncolytics Biotech Inc. (TSX: ONC, NASDAQ:ONCY), will present a corporate overview of the Company at the 5th annual JMP Securities Healthcare Conference on Tuesday, September 28th, 2010 at 10:00 a.m. EDT.

Oncothyreon Inc. (Nasdaq:ONTY) announced today that Robert Kirkman, M.D., President and Chief Executive Officer, will present at the 5th Annual JMP Securities Healthcare Conference in New York on Tuesday, September 28, 2010, at 10:30 a.m. Eastern Time.

OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced today the initiation of a randomized, controlled, investigator-sponsored Phase 2 trial of OGX-427 in men with metastatic prostate cancer.

Palatin Technologies, Inc. (NYSE Amex:PTN)
, a biopharmaceutical company dedicated to the development of peptide, peptide mimetic and small molecule agonist compounds with a focus on melanocortin and natriuretic peptide receptor systems, today announced results for its fourth quarter and fiscal year ended June 30, 2010.  

PROLOR Biotech, Inc. (NYSE Amex:PBTH)
, a company developing next generation biobetter therapeutic proteins, today announced that data from its longer-acting human growth hormone (hGH-CTP) program will be featured in an oral scientific presentation at the 5th International Congress Of The Growth Hormone Research Society (GRS) and IGF Society on October 4, 2010.

Soligenix, Inc. (Soligenix or the Company) (OTC Bulletin Board:SNGX), a late-stage biopharmaceutical company, announced the results of its recent meeting of shareholders as well as an adjustment to the expected timeline to completion for its confirmatory Phase 3 clinical trial of orBec® in acute gastrointestinal Graft-versus-Host disease (GI GVHD).

Warner Chilcott plc (Nasdaq:WCRX) today announced that its subsidiaries, Warner Chilcott Company, LLC and Warner Chilcott Finance LLC, plan to issue an aggregate principal amount of $500 million of 7-3/4% senior notes due 2018 in a private placement.

Warner Chilcott plc (Nasdaq:WCRX) today announced that it has agreed to terminate its existing co-promotion agreement with Novartis and signed a definitive agreement to purchase the U.S. rights to Enablex® from Novartis for $400 million in cash.

Ziegler (PINKSHEETS:ZGCO), a specialty investment banking firm serving hospital and healthcare systems clients since 1928, announced the promotion of John Hanley to the head of its healthcare investment banking practice.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

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