NN&I - August 2010

Business August 2010 Nephrology News & Issues 15Subscribe to our free eNewsletter at www.nephronline.com Concerns over Hematide hurt Affymax and Takeda, boon for competitor AmgenResults from a study released by Affymax Inc. June 21 showed that its investigational anemia drug Hematide led to a greater heart risk among some kidney patients than those who took Amgen Inc.'s Aranesp. The news caused Affymax's stock to fall 69%, the largest price drop ever in Nasdaq trading, and may delay Affymax's bid to win regulatory approv-al for Hematide, its first marketed prod-uct, which aims to challenge Amgen's dominance in treating anemia in kid -ney patients. "We need time to reconsider our regulatory strategy," said Arlene Morris, Affymax's chief executive officer. "The key issue is just the uncertainty right now, not being able to tell people what we're going to do and when we're going to do it." (For details about the clinical trial, see the lead story in our Clinical section on page 20). The dialysis market is about three times larger than the non-dialysis mar -ket, Morris said. "Our data are prom- ising in the dialysis area so we think there's a nice fit with the dialysis mar -ket," Morris said. The results were good news for Amgen, wrote Geoffrey Meacham, an analyst for JPMorgan, in a note to inves -tors. Hematide was considered a major competitor to Amgen's anemia drugs, and the data make it less of a threat, Meacham wrote. Affymax's stocks fell from $15.83 to $7.18 following the release of the study, while Amgen rose $1.32, or 2.4%, to $56.52. Amgen's Aranesp generated sales of $2.7 billion in 2009. Affymax is developing Hematide with Osaka-based Takeda Pharmaceutical Co. Takeda can terminate the collabo-ration with six months written notice or in the event of "certain specified clinical development events or fail -ures," according to Affymax's annual report for 2009. Takeda's "collaboration with Affymax is strong and we remain committed to continue developing Hematide," said Josephine Zammuto, a U.S. spokeswoman for Takeda. The drug was as effective as Epogen or Aranesp in four studies released by Affymax and Takeda. The average follow-up for patients in all four trials was 1.3 years. Hematide was given once every four weeks; both Amgen drugs require more frequent dosing.Home Dialysis Plus Ltd. secured a finan-cial commitment from a private equity firm June 16 to fund up to $50 million for the commercialization of a new home hemodialysis system. The commitment by the firm Warburg Pincus will allow Home Dialysis Plus to further develop its portable dialysis sys-tem that allows patients to experience the benefits of frequent dialysis. Previously, Home Dialysis Plus used investments from the Oregon Nanoscience and Microtechnologies Institute and Oregon State Venture Fund for the product. As part of the contrac-tual agreement with Warburg, the com-pany created 30 new jobs within the region over the past four months.Fresenius expands further into RussiaFresenius Medical Care AG & Co. KGaA acquired Russian dialysis provider Kraevoy Nefrologicheskiy Centr June 30, pushing the company deeper into Russia's 20,000+ renal replacement therapy patient population. The deal will add $25 million in annual revenue, the company said. Fresenius cur -rently operates five dialysis clinics treating around 570 patients in Russia. The newly acquired company currently treats about 1,000 patients in five clinics in the Russian region of Krasnodar, which sits about 750 miles south of Moscow, on the Black Sea. There are no other dialysis providers in Krasnodar, which has an estimated patient growth of more than 10% per year. Fresenius' global chief strategist, Emanuele Gatti, MD, said that challenges fol-lowing this acqusition will include accommodating the large number of patients in Krasnodar who until now have been unable to receive treatment due to a lack of facilities. NxStage Medical Inc.'s Medisystems division signed a five-year blood tubing supply contract with Atlantic Dialysis Management Services June 23. Under the terms of the agreement, Atlantic Dialysis will now use Medisystems' Streamline airless blood tubing sets in all of its facilities. "We believe that the relationship will provide continued clinical improvement and significant operational savings," said J. Ganesh Bhat, MD, co-principal owner of Atlantic Dialysis, adding that being partnered with an established company is essential given the potential financial impact of the looming bundled payment system in 2011. Home Dialysis Plus gets $50M to develop machine NxStage, Atlantic Dialysis sign blood tubing contract Business_NN&I_0810_7.indd 15 7/15/10 1:26:43 PM