NN&I - May 2010
Business 26 Nephrology News & Issues May 2010www.nephronline.com PROD/SERVICES 3/15/10 4/14/10 Change% ChangeAngioDynam (ANGO)$15.47 $15.69 $0.22 1.42%BaxterIntnl (BAX)$58.37 $59.28 $0.91 1.56%CantelMedical (CMN)$19.83 $19.78 $0.05 -0.25%Covidien (COV)$50.55 $51.46 $0.91 1.80%C.R. Bard (BCR)$83.13 $86.14 $3.01 3.62%DaVita (DVA)$62.58 $65.21 $2.63 4.20%DialysisCorp (DCAI)$6.52 $11.21 $4.69 71.93%Fresenius (FMS)$54.92 $56.63 $1.71 3.11%MannKind (MNKD)$7.89 $6.85 -$1.04 -13.18%Medtronic (MDT)$45.81 $45.71 -$0.10 -0.22%MesaLabs (MLAB)$25.12 $25.51 $0.39 1.55%Nephros (NEPH)$0.99 $0.90 -$0.09 -9.09%NxStageMed (NXTM)$11.00 $12.00 $1.00 9.09%RockwellMed (RMTI)$6.04 $5.73 -$0.31 -5.13%SpireCorp(SPIR)$4.80 $3.88 -0.92 -19.17%PHARMAAbbottLabs (ABT)$54.80 $52.31 -$2.49 -4.54%Affymax (AFFY)$20.98 $23.85 $2.87 13.68%AMAGPharma (AMAG)$35.36 $35.13 -$0.23 -0.65%Amgen (AMGN)$56.89 $60.68 $3.79 6.66%AmylinPharma (AMLN)$23.50 $22.71 -$0.79 -3.36%Exelixis$6.27 $6.34 $0.07 1.12%GenzymeCorp (GENZ)$57.22 $52.66 -$4.56 -7.97%Hospira (HSP)$54.82 $57.97 $3.15 5.75%ImpaxLabs (IPXL)$17.23 $17.45 $0.22 1.28%Roche (RHHBY)$41.25 $41.20 -$0.05 -0.12%Sanofi-Aventis (SNY)$38.56 $37.50 -$1.06 -2.75%Shire (SHPGY)$67.04 $66.33 -$0.71 -1.06%TevaPharma (TEVA)$60.98 $62.01 $1.03 1.69%WatsonPharma (WPI)$40.28 $42.30 $2.02 5.01% Baxter clarifies status on cyclerLast month, NN&I reported that the U.S. Food & Drug Administration had issued a Class 1 recall of Baxter's HomeChoice peritoneal cycler "after reports of prob-lems regulating the dialysate flow." Specifically, Baxter issued the recall after receiving reports of increased intraperitoneal volume (IIPV), or overfill of the abdominal cavity. These reports resulted from prescription and/ or patient use errors, such as bypassing alarms, Baxter reports. Changes to device labeling and software are underway to address these issues. Patients are receiv- ing new Patient At-Home Guides, and clinicians have received trainers guides containing expanded informa-tion about IIPV--the symptoms, warnings and cautions--and how to address IIPV, should it occur. Baxter has also developed and is validating a software modification to address this issue and plans to submit a 510(k) to the FDA at mid-year. The software update will include additional user interface messages and alarms, change default settings, and allowable ranges to reduce risk of excessive accumulation of fluid in the peritoneal cavityTaking StockAMAG, Takeda sign licensing agreement; AMAG Pharmaceuticals Inc. and Takeda Pharmaceut- ical Company Ltd. entered into a licensing agreement April 1 for AMAG's IV iron drug Feraheme in all therapeu-tic indications.Under the agreement, Takeda received an exclusive license to market Feraheme in Europe, Canada, Turkey, and the Commonwealth of Independent States and Asia Pacific countries, excluding Japan, China, and Taiwan. AMAG received $60 million up front and is eligible to receive as much as $220 million in development and com-mercial milestones. Additionally, AMAG will receive tiered, double-digit royalties based on net sales of Feraheme in the licensed territories. Nephros 2009 revenue increased 81%Meanwhile, AMAG was sued March 28 by shareholders claiming the company withheld vital information prior to its $173.7 million public offering in January. Silverstrand Investments is charging that AMAG suppressed adverse reactions in some patients using Feraheme. The suit names AMAG CEO Brian Pereira and CFO David Arkowitz as defen-dants. It also seeks class-action status for the case. AMAG said the allegations were without merit and said it would "vigorously defend" the suit. Financial results released April 2 by hemofiltration system maker Nephros Inc. show 2009 product revenues were nearly $2.7 million, an 81% increase over 2008. In the quarter that ended Dec. 31, Nephros reported net product revenues of approximately $792,000 compared with $440,000 in the same period in 2008, an increase of 80%.The improvement is primarily attributable to a $213,000 increase in revenue related to a contract with the Office of Naval Research. Business0510_7.indd 26 4/19/10 2:10:45 PM
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