RxNews Recap for Thursday 02-04-10. Cyclacel (CYCC) jumps on upgrade Print E-mail
By Mary Davila   
Thursday, 04 February 2010 20:39

Below is a list of the companies that made news in the healthcare sector on Thursday, February 04, 2010.

Cyclacel Pharmaceuticals (Nasdaq:CYCC) rose by 32 cents, or 16.6%, to close the day at $2.30 after Roth Capital analysts initiated coverage of the stock with a buy rating and stock price target of $7.50. Cyclacel Pharmaceuticals Inc. is a development-stage biopharmaceutical company engaged in the discovery, development and commercialization of mechanism-targeted drugs to treat human cancers and other serious disorders.

The Company markets, directly in the United States, Xclair Cream for radiation dermatitis, and Numoisyn Liquid and Numoisyn Lozenges for xerostomia through its wholly owned subsidiary, ALIGN Pharmaceuticals LLC. CYCC focuses primarily on the development of orally available anticancer agents that target the cell cycle with the aim of slowing the progression or shrinking the size of tumors.

Cyclacel will present at the 12th Annual BIO CEO & Investor Conference, being held at the Waldorf Astoria Hotel in New York City, New York. Spiro Rombotis, President and Chief Executive Officer, will provide an overview of the Company and its progress in key programs on Monday, February 8, 2010

In other news Thursday:

Abiomed Inc (Nasdaq:ABMD) maker of Heart pumps posted a narrower-than-expected quarterly loss, helped by a 166 percent increase in the number of patients using its products, but it cut its fiscal 2010 revenue forecast.

For the third quarter ended Dec. 31, the company posted a net loss of $4.6 million, or 12 cents a share, compared with a net loss of $7.7 million, or 21 cents a share, a year earlier.  Total revenue rose 32 percent to $22.8 million, as U.S. sales of the Impella left ventricle heart pump grew 116 percent to $14.5 million.  The company said it had reduced its cash burn to $600,000. Analysts on average were expecting the company to post a loss of 18 cents a share on revenue of $22.6 million, according to Thomson Reuters.

The company also evised its full-year revenue forecast to reflect a fourth-quarter focus on existing site Impella utilization and training, rather than on new Impella site openings and the legacy business. They now see full-year revenue in the range of $84 million to $86 million, down from an earlier view of $86 million to $91 million. Abiomed said it continues to see a growth rate of 50 percent to 60 percent for Impella for the full year. Shares of Abiomed closed at $8.27, up $.26 on the day.

Alkermes, Inc. (NASDAQ: ALKS) today announced that it has developed a novel, proprietary LinkeRx™ technology platform to enable the creation of injectable extended-release versions of antipsychotics and other central nervous system (CNS) therapies.

Allergan, Inc. (NYSE: AGN) today announced operating results for the quarter ended December 31, 2009. Allergan also announced that its Board of Directors has declared a fourth quarter dividend of $0.05 per share, payable on March 12, 2010 to stockholders of record on February 19, 2010.

Aradigm Corporation (OTCBB:ARDM) (the “Company”) announced today that it received the $4 million milestone payment from Zogenix, Inc. (“Zogenix) based upon the first commercial sale in the U.S. of SUMAVEL* DosePro* (sumatriptan injection) needle-free delivery system.

ArQule, Inc. (Nasdaq: ARQL) today announced the initiation of a Phase 2, single agent trial with ARQ 197 in germ cell tumors (GCT), including testicular and non-central nervous system (non-CNS) tumors, and a Phase 1/2 clinical trial designed to evaluate the safety of ARQ 197 administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer (CRC) who possess the wild-type form of the KRAS gene.

AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, today announced that the results and scientific findings of Good Laboratory Practice (GLP)-compliant safety pharmacology and genotoxicity evaluations of AVI-4658, a drug candidate being developed by AVI for the treatment of Duchenne Muscular Dystrophy (DMD), were published online in the International Journal of Toxicology. The publication, "Safety Pharmacology and Genotoxicity Evaluation of AVI-4658," reports that the GLP-compliant preclinical studies revealed no study related effects on health status, even when dosed at the maximum feasible dose, and there were no reports of injection site reactions. It was also reported that the genotoxicity evaluation of AVI-4658 revealed no genotoxic potential, even at very high concentrations. These results suggest AVI-4658 may have a wide therapeutic window for chronic dosing and supported the initiation of the Phase 1b/2 clinical trial of AVI-4658 that is ongoing in the United Kingdom. Shares closed the day at $1.42, down 4%.

BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services, has signed a three-year, multi-million dollar deal with Cephalon, Inc. for clinical trial technology and support services. As part of the Service Agreement, US-based data management staff at Cephalon will be hired by BioClinica to support clinical efforts of Cephalon.

BioClinica will provide end-to-end clinical data management services to Cephalon global clinical trial operations. Specific tasks include data management planning, clinical study set-up for electronic data capture (EDC), medical coding, adverse event reconciliation, clinical data management, and training for the clinical sites and investigators. The deal also expands plans by Cephalon to use BioClinica’s ExpressTM electronic data capture (EDC) product as the default data capture system across clinical trial phases, from Phases I through IV. BioClinica will work with other functional service providers selected as part of Cephalon’s initiative to optimize operational efficiency. BioClinica said it will see its role with Cephalon extended from one of a technology provider to that of a “key services partner”. Shares closed the day up $.20 to finish at $4.50.

BioCryst Pharmaceuticals (NASDAQ: BCRX) shares of the Birmingham, Alabama-based biopharmaceutical company jumped higher early toady after announcing fourth quarter earnings that beat consensus by 26 cents. The company earned $15.2 million or 35 cents a share in the three months ended December 31, and total revenue spiked by 60% to $54.9 million. BioCryst's intravenous H1N1 antiviral, peramivir, made up $22.5 million of the company's Q4 revenue boosted by the U.S. Department of Health and Human Services order of 10,000 courses. In addition the company earned a $7 million milestone payment from partner Shionogi & Co.
BioCryst president and CEO John Stonehouse said, "We ended 2009 with a strong balance sheet and greater financial flexibility to advance our programs." Stonehouse noted that peramivir was the company's first revenue-generating discovery, as well as the first to receive marketing authorization from health officials. Shares ended the day off $.24 to close at $6.99.

Bond Laboratories, Inc. (OTCBB:BNLB), a manufacturer of functional beverages and nutritional products, today announced the addition of two more MillerCoors® distributors in Tennessee for its Resurrection™ Anti-Hangover drink. This expands its coverage to over half the state. Mid-South Distributing, Inc. services fourteen counties and SEC Enterprises, Inc. services seventeen counties throughout southern and middle parts of Tennessee. Shares were up over 21% to close the day at $.51.

Cross Country Healthcare, Inc. (Nasdaq:CCRN) will hold its quarterly conference call to discuss its fourth quarter and year-end 2009 financial results on Thursday, March 4, 2010, at 10:00 a.m. Eastern Time.

Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment system for metastatic cancers to the liver, announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial. The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.
"We remain very optimistic that the Phase III trial will achieve a successful endpoint," said Eamonn P. Hobbs, President and CEO of Delcath. "Assuming a successful trial endpoint, we remain committed to filing our NDA with the FDA in April," Mr. Hobbs added.

Exelixis, Inc. (NASDAQ: EXEL) announced today that George A. Scangos, PhD, the company’s president and chief executive officer, will present at the 12th Annual BioCEO & Investor Conference at 8:30 a.m. EST / 5:30 a.m. PST on Tuesday, February 9, 2010 in New York.

Illumina, Inc. (NASDAQ:ILMN) the maker tools for genetic analysis, after the bell reported better-than-expected Q4 profit, helped by strong revenue growth. The company also reiterated its 2010 earnings and revenue view.  Fourth-quarter net income was $11.7 million, or 9 cents a share, compared with $26.1 million, or 20 cents a share in the year-ago period. Excluding special items but including stock option expenses, the company earned 21 cents a share, beating consensus estimates by 1 cent, according to Thomson Reuters. Revenue for the quarter rose 12 percent to $180.6 million. Analysts were forecasting revenue of $173.0 million.  For 2010, the company still expects to earn 90 cents to $1 a share, while revenue is expected to grow about 20 percent. Shares of the company closed down 3.25% to close at $36.62 and fell further in the after hours session.

ImmunoCellular Therapeutics (OTCBB: IMUC) announced today that Manish Singh, Ph.D., President and CEO will be presenting at the 2010 BIO CEO & Investor Conference on Tuesday, February 9th at 10 a.m. eastern time.

Invacare Corporation (NYSE: IVC) today announced its financial results for the quarter and year ended December 31, 2009 and provided guidance for 2010.  Commenting on Invacare's 2009 results and 2010 guidance, A. Malachi Mixon, III, Chairman and Chief Executive Officer, stated, "Despite a challenging reimbursement and economic environment, 2009 was a strong year for Invacare on all critical measures. Adjusted earnings per share increased 17% for the year to $1.58 versus $1.35 in 2008. The Company generated free cash flow in 2009 of $141.6 million as compared to $59.9 million in 2008, allowing the company to reduce debt outstanding by $157.2 million and lower its ratio of debt to adjusted EBITDA to 2.3 as of the end of 2009. In 2010, based on the midpoint of its guidance at $1.75 per share, Invacare forecasts 10% growth in adjusted earnings per share. This improvement will be built upon 2009's successful cost reductions as well as a return to organic sales growth, both driven by globalization and exciting new product introductions. The Company plans to use its projected strong free cash flow in 2010 of $65 million to $75 million to continue to retire debt or pursue accretive acquisitions as available. The management team at Invacare is committed to delivering improved performance to its shareholders."

Mixon went on to say, “The primary reimbursement risk for Invacare in 2010 which is not addressed in the guidance above is related to health care reform in the United States. However, the likelihood of a massive health care reform bill has been diminished by the outcome of the Senate election in Massachusetts. The Obama Administration's number one priority seems to have moved from health care to jobs and the economy. As a result, the Company is optimistic that the medical device excise tax will not materialize, although there is still discussion in Congress on how to achieve health care reform in the future. As discussed in an earlier filing, the Company has been evaluating its options to offset the impact of the proposed medical device excise tax on the Company’s financial results, if a bill with such a provision were to pass.”

MedCath Corporation (Nasdaq: MDTH),  a healthcare provider focused on high acuity healthcare services and  the parent company of TexSan Heart Hospital in San Antonio, reported lower earnings for its first quarter of 2010 ended Dec. 31.

The company reported a net loss of $2.6 million for the period, compared to a net gain of $2.2 million from the year ago period. Net revenue for the first quarter decreased 2 percent to $147.4 million, compared to $150.2 million for the first quarter of 2009.

MedCath officials say the revenue decline was due in part to lower cases and net revenue from cardiovascular services, primarily heart surgeries.  “Although we are disappointed with our core cardiovascular net patient revenue this quarter, we are encouraged by our overall increase in admissions and outpatient cases,” says Ed French, MedCath’s president and CEO.

Charlotte, N.C.-based MedCath owns and operates specialty hospitals that diagnose and treat cardiovascular diseases. It has interests in and operates nine hospitals around the country with a total of 676 licensed beds.

Medizone International, Inc. (OTCBB: MZEI) announced today that every full scale test run completed thus far in its hospital room mock up facility has resulted in the total elimination of all bacteria present in the room. In this current phase of development, Medizone's scientific team will attempt to confirm, in a more realistic hospital setting, recent laboratory findings indicating extremely high antibacterial efficacy for its novel technology (6-7.2 log reductions) against the primary causative agents of hospital acquired infections (HAIs), sometimes referred to as "Super Bugs". Shares closed the day at $.28 up nearly 4% on the day.

Mylan Inc. (Nasdaq: MYL) today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg. This product is the generic version of Caduet® Tablets, which combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 2.5/10 mg, 2.5/20 mg, 2.5/40 mg and 10/40 mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Pfizer filed the lawsuit in the U.S. District Court for the District of Delaware.

Pfizer Inc. (NYSE: PFE) and DxS (NASDAQ: QGEN) Frankfurt, Prime Standard: QIA) today announced that they have entered into an agreement to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM).

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today reported the results of its fourth quarter of 2009 and year ended December 31, 2009.

Pharmacyclics, Inc. (Nasdaq: PCYC) was up more than 9% on heavy volume and no apparent news. The Sunnyvale CA based biopharmaceutical company focuses on developing and commercializing small-molecule drugs for the treatment of immune mediated disease and cancer. Shares finished the day at $4.55.

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the presentation of preclinical data on a series of novel compounds that simultaneously blocked two critical pathways involved in the growth and survival of cancer cells. The compounds were identified as part of the Company’s ongoing oncology drug discovery efforts. The data are being presented in both oral and poster sessions at the American Association for Cancer Research (AACR) conference on Protein Translation and Cancer in Coronado, CA.

“Progenics’ identification of these small-molecule compounds as part of our discovery program underscores our long-standing commitment to oncology drug development,” stated Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer of Progenics. “In laboratory studies, the synthetic, small-molecule compounds blocked both phosphoinositide 3-kinase (PI3K), which is a key regulator of one molecular signaling pathway, and MNK, an oncogenic kinase in the Ras pathway. We look forward to exploring the therapeutic potential of this series of compounds which are being optimized for clinical development.” Shares closed at $4.50, up $.10 on the day and continued to rise in after hours.

pSivida Corp. (NASDAQ:PSDV), a leading drug delivery company, today announced that its financial results for the second quarter of fiscal year 2010 will be released after market close on Thursday, February 11, 2010, followed the same day by a conference call and live webcast to discuss those results and its business scheduled for 4:30 p.m. ET.

Senomyx, Inc. (NASDAQ:SNMX), a company focused on using proprietary taste receptor-based technologies to discover novel flavor ingredients for the food, beverage, and ingredient supply industries, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2009.

Sequenom, Inc. (Nasdaq: SQNM) today announced the launch of the SensiGene Fetal RHD Genotyping test by Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM). This is the company's first laboratory developed test powered by its SEQureDx technology.

"The introduction of this test is an important development in improving patient care for pregnant women in both the United States and in Europe," said Dr. Wolfgang Holzgreve, director at the University Hospital, Freiburg and Sequenom clinical advisory board member. "Fetal RHD genotyping utilizing real-time PCR has been widely used in Europe for over a decade, and has led to better patient management and is even considered for reduction of unnecessary treatment with Anti-D immune globulin. Based upon Sequenom's validation study, the SensiGene Fetal RHD Genotyping test appears to offer a higher level of sensitivity and specificity compared with the real-time PCR methodology.""Launching the first test based on our SEQureDx technology is an important milestone for Sequenom and our CLIA lab - the Sequenom Center for Molecular Medicine," stated Shawn M. Marcell, vice president, molecular diagnostics. "We believe this test represents a significant and important advancement for prenatal care. Our ability to launch this test and bring it to patients is, in no small part, directly related to the strong support of the Fetal Medicine Foundation, UK, which supplied clinical samples to us."

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that it will report financial results for the fourth quarter and year ended December 31, 2009 on Thursday, February 11, 2010, after the U.S. financial markets close.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today provided an update on recent progress in its late-stage development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF), reported consolidated financial results for the year ended December 31, 2009 and provided financial guidance for 2010.

VirtualScopics, Inc. (Nasdaq:VSCP), a leading provider of quantitative imaging for clinical trials, today announced that its project balance exceeds $41 million compared to $24 million at the same time a year ago, representing a greater than 70% increase. The company defines project balance as the amount remaining to be earned from active projects and awards, and commonly referred to as backlog within the industry. The average duration of the projects included within the backlog is approximately forty-five months and the company anticipates that awarded contracts will be signed within the next several months as the projects near their start dates.

Vice President of Business Development, Rosemary Shull stated, "These results are not only a great reflection of the strength of our business development efforts in 2009, but of the confidence our customers have in our operational performance and ability to deliver high quality results on a consistent basis." She added, "The continued growth of our backlog, which has risen from $15 million just two years ago, has been driven by both new business efforts and a greater penetration within existing customers." Ms. Shull concluded," We are looking forward to another solid year in 2010." Shares were up nearly 9% to close at $1.06

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