NN&I - August 2010

Business 16 Nephrology News & Issues August 2010Subscribe to our free eNewsletter at www.nephronline.com BriefsRenal Advantage acquires five new centers Renal Advantage Inc. acquired four dialysis centers in Alabama and one in Florida, the company said July 7. The Alabama centers are located in Oxford, Anniston, Jacksonville, and Talladega, and the Florida center is in Sarasota. Renal Advantage now has six centers in Alabama and 12 in Florida. Overall, they have 154 centers in 19 states, covering more than 12,000 patients. Cell therapy company AlloCure names new CEO The biotech company AlloCure Inc., which specializes in cell therapy for kidney disease, appointed Robert M. Brenner, MD, as its new president and chief executive, the company said July 6. Brenner previously was senior vice president of medical affairs at AMAG Pharmaceuticals, and for nine years made leading contributions to Amgen's global develop -ment efforts in nephrology and renal anemia. Rockwell plans Phase 3 trial for iron-replacement therapy Rockwell Medical said July 8 that it completed the end of a PROD/SERVICES 6/14/10 7/14/10 Change% ChangeAngioDynam (ANGO)$14.81 $15.58 $0.77 5.20%BaxterIntnl (BAX)$41.46 $43.71 $2.25 5.43%CantelMedical (CMN)$17.10 $17.14 $0.04 0.23%Covidien (COV)$41.58 $40.99 -$0.59 -1.42%C.R. Bard (BCR)$79.80 $79.66 -$0.14 -0.18%DaVita (DVA)$65.19 $61.52 $3.67 -5.63%Fresenius (FMS)$52.88 $54.32 $1.44 2.72%MannKind (MNKD)$6.43 $6.53 $0.10 1.56%Medtronic (MDT)$38.82 $37.96 -$0.86 2.22%MesaLabs (MLAB)$23.20 $24.16 $0.96 4.14%Nephros (NEPH)$0.56 $0.20 -$0.36 -64.29%NxStageMed (NXTM)$13.77 $14.37 $0.60 4.36%RockwellMed (RMTI)$4.68 $5.28 $0.60 12.82%SpireCorp (SPIR)$3.51 $3.67 $0.16 4.56%PHARMAAbbottLabs (ABT)$47.33 $47.67 $0.34 0.72%Affymax (AFFY)$22.76 $6.33 -$16.43 -72.19%AMAGPharma (AMAG)$34.03 $37.30 $3.27 9.61%Amgen (AMGN)$54.07 $52.76 -$1.31 -2.42%AmylinPharma (AMLN)$17.79 $19.00 $1.21 6.80%Exelixis (EXEL)$4.71 $3.62 -$1.09 -10.42%GenzymeCorp (GENZ)$49.50 $53.89 $4.39 8.87%Hospira (HSP)$53.91 $58.90 $4.99 9.26%ImpaxLabs (IPXL)$20.92 $18.74 -$2.18 -10.42%Roche (RHHBY)$34.01 $35.49 $1.48 4.35%Sanofi-Aventis (SNY)$30.79 $30.98 -$0.19 0.62%Shire (SHPGY)$62.70 $66.71 $4.01 6.40%TevaPharma (TEVA)$53.28 $54.34 $1.06 1.99%WatsonPharma (WPI)$42.70 $43.23 $0.53 1.24%Taking StockNephros Inc. reported July 8 that the U.S. Food and Drug Administration issued a formal response to the company's 510(k) application for its hemodiafiltration system that said the agency was unable to reach a substantial equivalence deter -mination for the product. "We are disappointed both by the FDA's decision to reject our application and by the fact that the company was not pro- vided an opportunity to address the current comments prior to a final decision being rendered," said Paul A. Mieyal, acting CEO of Nephros. Mieyal said that 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 and then requested an in-person meeting to discuss the issues raised in the current FDA letter as well as the pro-cess for moving forward. Based upon the in-person meeting with the FDA reviewers, the company will determine the appropriate course of action, which could include filing a new 510(k) application or filing an appeal related to the current application. Upon news of the formal response from the FDA, Nephros' stock fell from 48 cents per share to 21 cents per share. Aug. 19, its shares closed at $2.53. They opened in 2004 at $6.Nephros hits snag with the FDA over new treatmentPhase 2 meeting with the U.S. Food and Drug Administration regarding the company's lead drug candidate Soluble Ferric Pyrophosphate (SFP), a continuous iron-replacement thera-py. As a result of the meeting, Rockwell has confirmed that a change in hemoglobin levels is an approvable endpoint for the Phase 3 trial design. Renal CarePartners opens new facility in Philadelphia Renal CarePartners Inc. opened a new dialysis clinic in Philadelphia June 17, which will offer 21 hemodialysis sta-tions and both peritoneal and home dialysis programs. The opening marks its first in Pennsylvania. Dianna Falkowitz, MD, acts as the medical director of the facility. Business_NN&I_0810_7.indd 16 7/15/10 1:26:44 PM