|Affymetrix drops on lower revenue forecast. XenoPort falls after migraine study falters. After the bell: Nephros receives FDA formal response|
|By BioMedReports.com Staff|
|Wednesday, 07 July 2010 19:46|
Below is a list of the companies that made news in the healthcare sector on Wednesday, July 7, 2010.
Nephros, Inc. (OTC Bulletin Board:NEPH.ob), after the bell today reported that the U.S. Food and Drug Administration has issued a formal response to the company's 510(k) application.
On June 30, Nephros received a final decision letter from the FDA for the company's 510(k) submission which stated that the FDA could not reach a substantial equivalence determination for the company's hemodiafiltration (HDF) system.
"We are disappointed both by the FDA's decision to reject our application and by the fact that the company was not provided an opportunity to address the current comments prior to a final decision being rendered," said Paul A. Mieyal, acting CEO of Nephros. "After more than 15 months without a substantive communication, the company expected either an approval or further dialogue as the next step in the process. We feel that the issues raised in the current letter are addressable and have requested an in-person meeting with the review team to discuss options for moving forward."
In news from earlier in the day:
Affymetrix, Inc. (Nasdaq:AFFX) today reported that based on preliminary financial data, the Company expects total revenue for the second quarter of 2010 to be in the range of $71-72 million, as compared to the Company’s previous guidance in the range of $80-82 million. The company expects product revenue for the second quarter of 2010 to be approximately $65-66 million, including instrument sales of approximately $4-5 million and consumable sales of approximately $60-61 million.
The principal factors that contributed to the lower than expected second quarter revenue include:
*Delayed and lengthened capital equipment purchase cycles by academic research customers, particularly in Europe;
*Increased sales of DNA products offset by declines in RNA sales that were related to the integration of recent acquisitions and the realignment of sales territories; as well as
*Material deterioration in both the Euro and British Pound of $1 million in aggregate since the Company provided second quarter guidance on April 21, 2010.
"When the Company previously issued guidance for the second quarter of 2010, we anticipated that growth in product sales would offset an expected decline in services revenue as compared to the second quarter of 2009," stated Kevin M. King, president and CEO. "However, instrument adoption was slower than anticipated, principally due to reduced foreign academic research spending. In Europe, we believe our business was impacted by governmental actions taken to address high levels of debt and weakening currencies."
"Despite the challenges we experienced in the second quarter, we are confident our business is moving in the right direction and we are focused on growing the business beyond the basic research market," continued King.
Shares fell 27% or $1.51 to close the day at $4.04.
GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) announced today that its experimental drug treatment for migraine headaches, GSK1838262/XP13512, failed to show a statistically significant improvement compared to placebo. The phase IIb study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headaches.
The companies reported that GSK1838262 did not demonstrate a statistically significant improvement over placebo on the primary endpoint and that patients taking the placebo experienced a higher than expected response.
The most common adverse event was dizziness, which was generally mild or moderate and did not lead to discontinuation in the majority of patients. Eight patients who received GSK1838262 and two who received placebo experienced serious adverse events during the trial. Of these events, two were deaths in patients receiving GSK1838262. One was due to bronchopneumonia and was assessed by the investigator as not related to the study drug. The second death resulted from an accidental overdose involving medications other than GSK1838262, but the relationship of this event to the study drug could not be established.
"We are disappointed by the results of GSK1838262 in this clinical setting," said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicines Development Center. "Unfortunately, migraine remains an often debilitating and undertreated condition. According to published studies, up to 40 percent of migraine sufferers could benefit from preventative therapies."
Shares of Xenoport tummbled $2.36 to $6.51 on the news.
China-Biotics, Inc. (Nasdaq:CHBT), the leading developer, manufacturer and distributor of probiotics products in China, today announced that China-Biotics' Board of Directors approved a new share repurchase program of up to US$ 20 million of worth of its issued and outstanding common shares from time to time over the next 12 months.
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced that it has entered into an exclusive, world-wide product development and distribution agreement with DiaSorin S.p.A. Under terms of the agreement, DiaSorin will utilize key Meridian technology to develop several infectious disease products for use on their LIAISON® systems. LIAISON is a fully automated, random access system based on chemiluminescense detection. There are over 3,000 LIAISON systems placed in laboratories throughout the world. The agreement is royalty-based with the actual royalty amount to be paid to Meridian dependent on type of test and specific geographic market.
Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that a third multi-center Phase 3 clinical study of Lymphoseek® (NEO3-09) has received investigational review board approval and begun enrollment of subjects diagnosed with breast cancer or melanoma. David Bupp, Neoprobe’s President and CEO, said, "This Phase 3 clinical study is designed to further validate Lymphoseek as a sentinel lymph node tracing agent. Data from this study is not required for the New Drug Application (NDA) for Lymphoseek, which we expect to begin filing with FDA later this summer. The initiation of the third Phase 3 study is another milestone in the development of Lymphoseek and we expect to achieve additional milestones in the coming months for this product."
NexMed, Inc. (Nasdaq: NEXMD), today announced that the Company received a letter, dated July 6, 2010 from The NASDAQ Hearings Panel (the "Panel"), stating that it has met the requirements of the Panel’s decision dated December 17, 2009, as modified February 1, 2010, and the applicable requirements for listing on The NASDAQ Stock Market. Accordingly, the Panel has determined to continue the listing of the Company’s securities on The NASDAQ Stock Market.
Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, noted, "Overcoming the series of deficiencies we have had since October 2008 has been a major objective for management and a noteworthy accomplishment for the Company. Meeting our NASDAQ milestone is the first of many in our growth strategy for 2010 and beyond."
Northwest Biotherapeutics, Inc. (OTC Bulletin Board:NWBO.ob), developer of the DCVax® personalized cancer vaccines, announced today that during the second quarter it raised funding of $2.65 million from investors. The funding included $1.75 million in purchases of restricted common stock of the Company by a number of private investors, together with purchases of restricted Common Stock totaling $900,000 by SDS Capital and by Ms. Linda F. Powers, Chair of the Company's Board. The Company also continued to make progress on restructuring of its balance sheet, through debt conversions and extensions with its largest debt holders. The new investment by SDS Capital was part of a larger restructuring transaction with SDS.
The $1.75 million in purchases of Common Stock by private investors were made at a price of seventy-five cents ($0.75) per share, with ten percent (10%) warrant coverage.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) reported today positive new results from pooled analysis of completed clinical trials of NX-1207, the Company's investigational drug for BPH. The trial data shows that patients receiving NX-1207 recorded significant quantitative improvement in the important symptom of urgent need to urinate. Compared to baseline, symptoms of urgency to urinate were reduced by 52% at 90 days after a single treatment with NX-1207, and this improvement was statistically significant compared to double-blinded placebo control patients
Oncothyreon Inc. (Nasdaq:ONTY) today announced that it has secured a committed equity financing facility under which it may sell up to $20 million of its shares of common stock to Small Cap Biotech Value, Ltd. over a 24-month period. Oncothyreon is not obligated to use the facility and remains free to enter into and consummate other equity and debt financing transactions. Oncothyreon intends to use the proceeds from future sales of securities under the facility, if any, for general corporate purposes.
PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a grant from the National Institute of Health (NIH) to support the development of defensin-mimetic antimicrobial compounds for the treatment of malaria. Malaria is a devastating global disease with up to 3 billion people exposed, and causes more than one million deaths each year as resistance to current therapies increases. PolyMedix’s defensin-mimetic antimicrobial compounds offer a potentially new approach for treating malaria, with a mechanism of action to which resistance is unlikely to develop.
Abbott (NYSE:ABT) will announce its second-quarter 2010 financial results on Wednesday, July 21, 2010, before the market opens.
Artepharm Global Corp. (OTCBB:ARGC) is pleased to announce that an agreement has been signed between The Qater Foundation, The Chinese Federal Government, and a private syndication with the intent of eradicating Malaria from East Africa's Comoros Islands using the Company's Patented ArteQuick Malaria treatment.
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced that following review by the U.S. Food and Drug Administration the Company's Investigational New Drug (IND) application for AVI-4658 is open.
BioMimetic Therapeutics (NASDAQ: BMTI) will report today the final, one year results of its North American Pivotal Study comparing Augment Bone Graft to autograf in foot and ankle fusion surgery
BlueFire Ethanol Fuels, Inc. (OTC Bulletin Board: BFRE), a company focused on changing the world's transportation fuel paradigm through the production of ethanol from non-food cellulosic wastes, today announced that the Department of Energy has determined that BlueFire Ethanol has met the requirements necessary for Phase I of the application process and that the company has been invited to continue on to Phase II for the financing of their Fulton, MS Project.
Bristol-Myers Squibb Company (NYSE: BMY) has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.
CAVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced that following review by the U.S. Food and Drug Administration the Company's Investigational New Drug (IND) application for AVI-4658 is open.
Covance Inc. (NYSE:CVD) is pleased to invite you to listen to its quarterly investor conference call that will be broadcast live over the Internet on Thursday, July 29, 2010 at 9:00 a.m. ET.
Covidien (NYSE: COV), a leading global provider of healthcare products, will host an investor meeting on Wednesday, September 15, 2010, to update the investment communityon the Company and its growth initiatives, strategic priorities and financial outlook.
Dynavax Technologies Corporation (NASDAQ:DVAX) announced today the first human clinical trial in its Universal Flu vaccine program. The Phase 1 trial, which began vaccinating subjects in late June, will assess the safety and immunogenicity of N8295, the novel component of Dynavax's Universal Flu vaccine candidate.
Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2011 First Quarter financial results before the U.S. stock market opens on Tuesday, July 20, 2010.
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the Company will release results for its fourth quarter of Fiscal Year 2010 ended April 30, 2010, prio to the market opening on Tuesday July 13, 2010 and will hold a conference call to discuss its financial results at 10 a.m. Eastern Time.
Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced that it has completed the dosing of the last patient in NIL-CDNP-CT005, an open-label, single-blind, placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure, or ADHF.
OPTIMIZERx Corporation (OTCBB: OPRX) announced today that it has signed an agreement with Carilion Clinic to implement its SampleMD™ solution to allow its doctors and staff a more efficient way to search, select and distribute sample vouchers, prescription co-pay coupons and other support information right from their desktops.
Oragenics, Inc. (OTCBB: ORNI) entered into a Common Stock Purchase Agreement with the Koski Family Limited Partnership, an accredited investor and the Company’s largest shareholder.
Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB) a developer of oral delivery systems, today announced that Oramed entered into a Manufacturing Supply Agreement (MSA) with sanofi-aventis.
Renhuang Pharmaceuticals, Inc. (NYSE Amex: CBP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM"), today announced that, commencing on July 2, 2010, its common stock is trading on the NYSE Amex Market under the ticker symbol "CBP".
Stryker Corporation (NYSE:SYK) announced that it will host a conference call on Tuesday, July 20, 2010 at 4:30 p.m., Eastern Time, to discuss the Company's operating results for the quarter ended June 30, 2010, and provide an operational update.
Sunwin International Neutraceuticals, Inc. (OTCBB:SUWN), one of the top global providers of high quality stevia extracts including Rebaudioside A 98, today announced that the Company has entered into a Stock Sale and Purchase Agreement to sell its 100% ownership interest in Shengya Veterinary Medicine Co., Ltd. to Mr. Laiwang Zhang, the Company's President and Chairman of its Board of Directors.
SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today that it has entered into a license agreement with Clinuvel Pharmaceuticals Limited of Melbourne, Australia.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it will release its second quarter 2010 financial results on Tuesday, July 27, 2010.
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.