|RxNews Recap for Thursday 02-11-10. OPKO Health (OPK) soars on Alzheimers Test. Amicus (FOLD) jumps on Phase 2 data. Cadence Pharma (CADX) drops on FDA CRL|
|By Mary Davila|
|Thursday, 11 February 2010 20:26|
OPKO Health, Inc. (Amex:OPK) saw its shares jump 11.5% today as the company announced the development of a simple diagnostic blood test for Alzheimer’s disease. The test, designed to detect elevated levels of antibodies unique to Alzheimer’s disease, was approximately 95% accurate in initial testing.
The novel Alzheimer’s disease-specific antibodies were discovered using a proprietary platform being developed by OPKO that appears to be capable of identifying such biomarkers for any disease to which the immune system reacts, including cancer, autoimmune disease, neurodegenerative and infectious diseases. OPKO will perform additional studies required for regulatory approval and commercial use. The test could be useful in identifying patients for clinical trials for new Alzheimer’s drugs as well as to confirm the diagnosis in a clinical setting.
Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO, stated, "OPKO has begun to develop a range of new diagnostic tests for other neurological diseases, as well as cancers, starting with those for which early diagnosis is particularly important."
Shares of OPKO rose 20 cents to close the day at $1.94. Volume was nearly 10 times the daily average.
Amicus Therapeutics (Nasdaq: FOLD) announced today additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal(migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida. The Company also presented encouraging data from preclinical studies evaluating the combination of pharmacological chaperones and enzyme replacement therapy (ERT) for Fabry disease and Pompe disease as well as from preclinical studies examining the use of pharmacological chaperones for the treatment of Parkinson's disease.
John F. Crowley, Chairman and CEO of Amicus Therapeutics, added, "We are very pleased with the continued positive Amigal data and remain confident that our Phase 3 program will be successful. Our focus is the completion of enrollment in Study 011 this year and the commencement of Study 012. We are also very encouraged by the results of our preclinical studies of the chaperone-ERT combination approach as well as the advancements with our Parkinson's program. We look forward to moving these applications of our technology forward in 2010."
Shares closed up 38 cents or 11.38% to $3.72 and were up another 3% in the after hours market.
Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for intravenous (IV) acetaminophen.
In the Complete Response letter, the FDA only indicated that deficiencies were observed during the FDA's facility inspection of Cadence's third party manufacturer, which was completed on February 5, 2010. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval.
The Company's third party manufacturer intends to respond promptly to the observations, and Cadence plans to request a meeting with the FDA to ensure that the deficiencies have been adequately addressed to meet the requirements for NDA approval.
Cadence noted that the U.S. Food and Drug Administration did not cite any safety or efficacy issues for the drug, nor did it request any additional studies to be conducted prior to approval.
Canaccord Adams analyst Adam Cutler, who termed the manufacturing issues as minor, said more importantly there were no safety or efficacy issues and expects the drug to get an approval later this year.
"People can view the approval most likely to be a 'when' issue not an 'if' issue," said the analyst, who has a "buy" rating on Cadence' shares.
Shares fell 7.98% on the news to close the day down 82 cents to $9.46.
In news from after the market close:
Cephalon, Inc. (Nasdaq: CEPH) after the bell today reported 2009 net sales of $2.152 billion, an 11 percent increase compared to net sales of $1.943 billion for 2008. Basic income per common share for the year was $4.74. Excluding amortization expense and certain other items, adjusted net income for full year 2009 was $469 million, a 28 percent increase over the previous year. This exceeded the company's adjusted net income guidance range of $457 to $464 million for 2009. Basic adjusted income per common share for the year was $6.48 in 2009 and $5.39 in 2008. "2009 was a year of extraordinary innovation and growth," said Frank Baldino, Jr., Ph.D., Chairman and CEO. "For the year we reported positive clinical study results on several of our drug candidates, advanced five new compounds into man and continued to acquire promising assets. We continue our steadfast commitment to patients while building an enduring, diversified business for our shareholders."
Theravance, Inc. (NASDAQ:THRX) reported today its financial results for the fourth quarter and full year ended December 31, 2009. Revenue for the full year was $24.4 million which included $0.8 million in royalties related to sales of VIBATIV (telavancin) which was launched during the fourth quarter. Net loss for the fourth quarter and full year of 2009 was $22.2 million and $85.3 million, respectively, compared with $15.9 million and $93.6 million for the same periods of 2008. Net loss per share was $0.35 and $1.35 for the fourth quarter and full year of 2009, respectively, compared with a net loss per share of $0.26 and $1.53 for the same periods of 2008.
"It was a very exciting fourth quarter for Theravance with the initiation of the large Phase 3 RELOVAIR? program with GSK in COPD and the commercial launch of VIBATIV for complicated skin and skin structure infections in the United States with our partner, Astellas, as well as approval in Canada," said Rick E Winningham, Chief Executive Officer. "Enrollment in the Phase 3 RELOVAIR program in COPD is progressing well. I am particularly pleased that VIBATIV is receiving positive reception from physicians in the U.S. and that Astellas generated net sales of $4.3 million following the November launch. 2009 was a productive year for Theravance and we look forward to the progress of the RELOVAIR program and further development of our pipeline in 2010."
ZymoGenetics, Inc. (NASDAQ:ZGEN ) today reported its financial results for the fourth quarter and year ended December 31, 2009. For the fourth quarter, the company had net income of $13.6 million, or $0.19 per diluted share, compared to a net loss of $9.2 million, or $0.13 per share, for the same quarter in the prior year. For the full year 2009, the company reported a net loss of $43.0 million, or $0.62 per share, compared to a net loss of $116.2 million, or $1.69 per share, for the prior year. The profitable fourth quarter of 2009 resulted from the one-time recognition of $34.4 million of previously deferred revenue triggered by amendments to the RECOTHROM® Thrombin, topical (Recombinant) license and co-promotion agreements with Bayer. The decrease in the net loss for the full year was attributable to increased license and collaboration revenues from the PEG-Interferon lambda collaboration with Bristol-Myers Squibb; the recognition of deferred revenue resulting from the amendments to the Bayer agreements; increased RECOTHROM sales, which tripled versus the prior year; and reduced research and development expenses.
In other news Thursday:
Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients. The Norvir tablets and the Norvir soft-gelatin capsules both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. Norvir is used in combination with other antiretroviral medications to treat HIV. All forms of Norvir, including the soft-gel capsule and liquid form, remain available in the United States.
"Norvir has been a critical component of HIV treatment for many patients. The innovation behind the development of the Norvir tablet is the direct result of years of effort by Abbott scientists to address the needs of people living with HIV," said Scott Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. "Abbott has been dedicated to finding new and more convenient ways for patients to manage their HIV through the development of novel diagnostics testing methods and medications for more than 20 years."
Advanced Cell Technology, Inc.(OTCBB:ACTC) reported that a range of therapeutic cell types obtained from induced pluripotent stem (iPS) cells exhibit abnormal expansion and early cellular aging.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) shares rose over 7.5% as the company announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. Alexza filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials. In February 2010, Alexza established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation (NYSE: BVF), to develop and commercialize AZ-004 in the U.S. and Canada.
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial results for the quarter and year ended December 31, 2009. For the three months ended December 31, 2009, Alexion Pharmaceuticals, Inc. ("Alexion" or, the "Company") reported net product sales of Soliris® (eculizumab) of $110.6 million, reflecting strong additions of new patients, compared to $77.4 million for the same period in 2008.
Biodel, Inc. (Nasdaq: BIOD ) announced today that its chief executive officer, Dr. Sol Steiner, will present results from the company’s two Phase 3 studies with VIAject® ultra-rapid-acting recombinant human insulin in a platform presentation at the 3rd International Conference on Advanced Technologies and Treatments for Diabetes in Basel, Switzerland, on Friday, February 12, 2010, at 1pm central European time. The presentation, entitled "Clinical Findings for Patients Treated with VIAject®, An Ultra-Rapid Acting Formulation of Recombinant Human Insulin," will review and update key data from the VIAject® clinical development program. Dr. Steiner’s presentation will be available on the company’s website, www.Biodel.com, after the presentation.
Shares of Biodel were up a hefty 44 cents or 12.75% on double the normal volume to close the day at $3.89
BioMed Realty Trust, Inc. (NYSE: BMR), a real estate investment trust focused on Providing Real Estate to the Life Science Industry®, today announced financial results for the fourth quarter and full-year ended December 31, 2009. "BioMed's robust business model and disciplined execution were clearly evident from the strong results of the fourth quarter and full-year 2009," said Alan D. Gold, BioMed's Chairman and Chief Executive Officer. "Powerful long-term demand drivers for the life science industry continue to fuel drug research and development efforts throughout the seven core life science markets which, in turn, attract capital used to fund mission-critical laboratory space. Despite macro-economic headwinds, BioMed succeeded in leasing more than 1.5 million square feet of laboratory and office space in 2009 and delivering over one million square feet of space from our development pipeline, which was collectively 91% leased at year-end, to premier research institutions and large, publicly traded companies. These exceptional results in 2009, and throughout our five-year history, demonstrate the ability of our outstanding team of professionals to support the life science industry's real estate needs and position the company well for future growth opportunities, continuing to create value for our shareholders." The company's tenants primarily include biotechnology and pharmaceutical companies, scientific research institutions, government agencies and other entities involved in the life science industry. BioMed owns or has interests in 69 properties, representing 112 buildings with approximately 10.5 million rentable square feet. The company's properties are located predominantly in the major U.S. life science markets of Boston, San Diego, San Francisco, Seattle, Maryland, Pennsylvania and New York/New Jersey, which have well-established reputations as centers for scientific research.
BSD Medical Corporation (NASDAQ:BSDM) today announced that it entered into a securities purchase agreement with two institutional investors for the sale of 1,176,471 shares of its common stock in a registered direct offering at $1.70 per share. In addition, warrants to purchase 882,354 shares of common stock in the aggregate will be issued to the investors. The warrants are exercisable beginning six months and one day after closing, expire 5 years after becoming exercisable and have an exercise price of $2.04 per share. Gross proceeds of the offering, before deducting placement agent fees and other estimated offering expenses payable by BSD Medical Corporation, are expected to be approximately $2 million. These securities are being offered through a prospectus supplement pursuant to the Company’s effective shelf registration statement and base prospectus contained therein. Shares of BSD traded down 21 cents to close at $1.70.
Cambridge Heart, Inc. (OTCBB- CAMH), today announced that the Company has completed the development phase of its Microvolt T-wave Alternans (MTWA) OEM Module, and has submitted a 510(k) application for regulatory approval with the U.S. Food and Drug Administration (FDA).
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, in combination with carbidopa has been initiated in adult attention deficit hyperactivity disorder (ADHD).
ADHD is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, and other disruptive behavioral issues. ADHD is the second most common neuropsychiatric disorder affecting 4.4% of the U.S. adult population, or between 8-9 million individuals. As adult ADHD is characterized as a disorder of decreased norepinephrine (NE) activity in the pre-frontal cortex, it is hypothesized that by limiting the peripheral metabolism of Droxidopa into NE through co-administration of carbidopa, the enhanced central levels of Droxidopa may have a positive therapeutic effect in adult ADHD.
China Pediatric Pharmaceuticals, Inc. (OTC Bulletin Board: CPDU), today announced it has recently closed a private placement financing.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) saw its shares jump 18.27% or 33 cents to $2.33 on heavier than normal volume. Cyclacel is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. Three orally-available Cyclacel drugs are in clinical development.
Emergency Medical Services Corporation (NYSE: EMS) today announces results for the fourth quarter and year ended December 31, 2009.
William A. Sanger, Chairman and Chief Executive Officer, said, "EMSC had another banner year in 2009. In more than 13 million patient encounters, our clinicians provided care with an emphasis on quality, safety, compassion and dignity. We produced strong organic growth, won a significant number of new contracts, and enhanced our market position with targeted acquisitions. We believe the actions taken in 2009 position us well for the opportunities in 2010 and beyond." Shares closed up $2.03 to close at $53.88.
Genzyme Corporation (NASDAQ: GENZ) announced today two-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate (formerly Genz-112638). Continued improvements were observed across all endpoints, including bone disease, at the two-year timepoint, compared with baseline.
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV) today announced that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska™ (intranasal ketamine) showed that top line results for its primary endpoint were statistically significant. Previously, Javelin had reported that the top line results for its primary endpoint were not statistically significant. The previously disclosed top line results, based upon data captured by an external vendor, had inconsistencies whose presence was verified by a third party biostatistics company engaged by Javelin that thoroughly reexamined the trial’s conduct and the initial primary analysis. The third party’s correction of these inaccuracies yielded today’s results. As previously disclosed, global patient satisfaction scores for Ereska were also statistically superior to placebo. All other secondary endpoints, while numerically superior to placebo, did not achieve statistical significance. Ereska, a nonopioid analgesic, was generally well tolerated in the trial. The Company plans to meet with the FDA to review the trial’s results and discuss Ereska’s registration program. Shares of Javelin closed the day up .07 or 5.88% to $1.26.
Kendle (Nasdaq: KNDL) announced today that it will release its fourth quarter and full-year 2009 financial results after the market closes on Wednesday, Feb. 24, 2010.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the fourth quarter and year ended December 31, 2009. "Momenta is poised for a pivotal year in 2010," commented Craig A. Wheeler, President and Chief Executive Officer. "We continue to believe the FDA will approve the ANDA for generic Lovenox®. Together with our collaborative partner Sandoz, we are prepared for a potential launch. The FDA review of the ANDA for the second complex mixture product in our pipeline, generic Copaxone®, is also well underway. Our novel drug candidates, products of Momenta's proprietary analytical platform, are advancing. We begin 2010 financially strong and committed to developing needed medications that will deliver value to patients," he concluded.
NovaMed, Inc. (Nasdaq: NOVA ), a leading operator of ambulatory surgery centers in partnership with physicians, today announced results for the fourth quarter and year ended December 31, 2009. Total net revenue grew to $39,809,000, up 10% from $36,177,000 in the prior year fourth quarter. Same-facility net revenue growth was 6% for the quarter. "NovaMed continues to execute well in a difficult environment as demonstrated by our fourth quarter results and the significant improvement in our same-facility revenue growth," commented Thomas S. Hall, Chairman, President and Chief Executive Officer of NovaMed, Inc. "December was a very strong month for surgical procedures performed in our surgery centers. While we are encouraged by the continuing improvement in same-facility revenue growth, we remain cautious as to how this trend will develop over the next several quarters. Our strong cash flow from operations of $6.3 million was 3.5 times net income from continuing operations attributable to NovaMed. With capital expenditures of $416,000 in the quarter, our free cash flow of $5.9 million continued to allow us to deleverage our balance sheet in the fourth quarter."
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has hired David Isserman to serve as its Chief Marketing Officer.
OXiGENE, Inc. (Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today a restructuring plan designed to focus resources on the company's highest-value clinical assets and reduce its cash utilization.
The company plans to cut its workforce in half, as the company will stop enrolling new patients in a trial for its thyroid cancer treatment. The biopharmaceutical company now plans to focus its Phase II Zybrestat trial in non-small-cell lung cancer.
Oxigene said the restructuring will cost $600,000, while saving the company $2.6 million annually, beginning in the second quarter.
Last week, VaxGen Inc. (OTCBB:VXGN) shareholders voted down a $22 million buyout offer from Oxigene.
Shares of Oxigene fell 5.3% to close the day at $1.23.
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported publication of data in the online edition of the journal Current Cancer Therapy Reviews that supports the clinical potential of the company's novel brain cancer agent Cotara® for the treatment of patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer.(1) Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. Cotara is currently being tested in a Phase II clinical trial in recurrent GBM patients.
The new data from investigators at the Huntsman Cancer Institute at the University of Utah Medical Center and researchers at Peregrine Pharmaceuticals reports on long-term patient follow-up from an earlier Phase I trial in 28 GBM patients with recurrent disease. Data presented from the study showed that seven of 28, or 25% of the patients survived more than one year after treatment and three of the 28, or 10.7% of the GBM patients treated in this study have survived more than five years after treatment, including two patients who have survived more than nine years, a positive finding compared to the 3.4% five-year survival rate from initial diagnosis reported by the U.S. Brain Tumor Registry. Additionally, the median survival time of the 28 patients was 38 weeks, a 58% increase over the historical median survival time of 24 weeks for GBM patients treated with standard-of-care therapy.
Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that additional data from the Company's pivotal Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease was presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010 in Miami, Florida, during an oral session titled, "Novel Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal Clinical Trial with Plant Cell Expressed Recombinant Glucocerebrosidase (prGCD) - taliglucerase alfa." The oral presentation was made by Hanna Rosenbaum M.D., Director of Hematology Day Care Unit, RAMBAM Medical Center, Haifa, Israel, and study investigator.
"I believe the data from the Phase III trial demonstrates that taliglucerase alfa is well tolerated and clinically effective in treating Gaucher disease," said Dr. Hanna Rosenbaum.
pSivida Corp. (NASDAQ: PSDV), a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back-of-the-eye diseases, today announced financial results for its second quarter and six months ended December 31, 2009.
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and Celera Corporation (NASDAQ:CRA) today announced an agreement under which QIAGEN will distribute a Celera molecular multiplex assay. The assay is the next generation version of QIAGEN's ResPlex II assay for detection of respiratory pathogens. Multiplex assays allow testing for a multiple number of different pathogens in a single run. Financial details were not disclosed.
Under the terms of the agreement, QIAGEN has the exclusive worldwide rights to distribute this multiplex test kit, which will be manufactured by Celera. The new ResPlex assay detects 19 different pathogens associated with respiratory infections and is designed for use with LiquiChip (Luminex) 100 and 200 instrument platforms.
Roche NimbleGen (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY) announced today that Beijing-based genomic services provider CapitalBio has officially joined the Roche NimbleGen Certified Service Provider (CSP) Program.
Rexahn Pharmaceuticals, Inc. (Amex:RNN), continued to trade higher today after a story and CEO interview featured here yesterday on BioMedReports highlighted the companies "multi-indication" therapeutics that position the company for long-term success. Shares were up 16 cents or 20% to $.95 and continued higher in the after hours session.
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today presented positive results from its first phase III study (TKT 032) evaluating safety and efficacy of velaglucerase alfa, its investigational enzyme replacement therapy for the treatment of Type 1 Gaucher disease.
Vical Incorporated (Nasdaq:VICL) today reported financial results for the year ended December 31, 2009. Vical had cash and investments of approximately $53 million at year-end 2009. The company raised approximately $33 million of net proceeds from the sale of equity securities during 2009, and approximately $3 million of additional net proceeds from the sale of equity securities to date in 2010.
Revenues for 2009 were $12.7 million, compared with revenues of $8.0 million for 2008. The net loss for 2009 was $28.6 million, or $0.61 per share, compared with a net loss of $36.9 million, or $0.93 per share, for 2008. The net cash burn for 2009, excluding financing activities, was approximately $22 million, compared with approximately $34 million for 2008. The decline in net cash burn was driven primarily by cost savings resulting from the company's November 2008 restructuring and staff reduction, as well as the increase in revenues. The company is projecting a net cash burn for 2010 of between $20 million and $24 million, including anticipated receipts from new or expanded partnerships not currently contracted.
Shares traded higher by 23 cents or 8% to close at $3.10.
Viral Genetics (Pink Sheets: VRAL) -- saw its shares jump over 24% today on heavier than usual volume as the company provided an update on the "State of the Company".
Our mission is to bring new drug compounds to the marketplace. And we've never been in a stronger position to deliver on that promise. We've built the solid foundation needed to take drug therapies from the laboratory to the marketplace. After years in development, we believe several of our most promising compounds are moving closer to clinical trials.
During 2009, Viral Genetics made significant strides on two fronts -- scientific and financial. Our drug compounds seem to be showing great potential. Additionally, we've built an infrastructure that enables us to use money wisely. We have retired nearly all of our external debt, enabling us to leverage any additional funding to advance new drug therapies -- rather than making interest payments to creditors.
XenaCare Holdings, Inc. (OTCBB:XCHO), a company specializing in the marketing and retail distribution of consumer healthcare products, announced today that it has begun distributing and selling Cobroxin through mass food and drug retail chains in the Northeast, Southeast, Middle Atlantic and Midwest regions.