By Matthew Willett
As promised, Amgen Inc. unveiled Aranesp data from trials in oncology at the American Society of Clinical Oncology (ASCO) meeting in San Francisco, and indications look positive for a regulatory filing this year.
Data presented Sunday indicated that Aranesp could reduce red blood cell transfusions in patients receiving multicycle platinum-based chemotherapy regimens, treat chronic anemia of cancer in patients who are not receiving chemotherapy, and correct anemia associated with chemotherapy when administered weekly or biweekly.
It¿s that convenience of dosing, a flexibility that can fit with chemotherapy regimens, that analysts and Amgen officials say could wrest a sizeable chunk of the $1.2 billion worldwide anemia market from its solitary provider, New Brunswick, N.J.-based Johnson & Johnson.
Amgen spokesman Michael Beckerich said the data give Amgen¿s anemia treatment a jump on Johnson & Johnson¿s Procrit, a drug licensed from Amgen and which Amgen sells for other indications as Epogen.
¿The very important data we¿ve been waiting to come out with matched up Aranesp against Procrit,¿ Beckerich told BioWorld Today from the meeting in San Francisco.
¿Essentially, it showed that at a very low dose Aranesp, dosed once a week, or even every other week, is comparable to Epogen. Essentially the study showed that with EPO Aranesp there¿s no loss in efficacy when dosed every other week compared to once a week. That¿s a really important point, that there¿s no loss in efficacy. It¿s a really significant advantage.¿
Aranesp, a recombinant erythropoietic protein, is an extended-release version of Amgen¿s blockbuster Epogen. Both proteins stimulate production of oxygen-carrying red blood cells.
Data from a Phase I/II study of Aranesp showed that the extended-release EPO is effective in dose ranges of 1.5 micrograms/kg to 4.5 micrograms/kg once weekly and 3.0 micrograms/kg to 9.0 micrograms/kg every two weeks.
Other data presented at ASCO indicated that in a 314-patient, double-blind, placebo-controlled, randomized Phase III study in lung cancer patients receiving multicycle platinum-based chemotherapy regimens, the proportion of patients who needed a red blood cell transfusion was reduced by more than 50 percent over the course of the treatment phase.
Deutsche Banc Alex. Brown analyst Dennis Harp said the flexible dosing regimen could be the deciding factor for clinicians seeking anemia treatments for cancer patients.
¿The data look very strong in favor of Aranesp,¿ Harp said. ¿For the first time we saw head-to-head data of Aranesp once a week or once every two weeks against once-a-week EPO, the current standard of care in the oncology setting. In addition, we saw pharmacokinetic data on once-every-three-weeks dosing that suggested that would be feasible. We think Aranesp would provide a variety of convenient dosing regimens for patients to match the chemotherapy regimens they¿re on that would be considerably more flexible than once-a-week Procrit.¿
And if clinicians like Aranesp better, analysts say, the potential for the EPO franchise extension could spell blockbuster. Roth Capital Partners Inc.¿s Fariba Ghodsian said it¿s safe to call it just that.
¿The interesting thing is that Amgen is selling about $2 billion worth of EPO only for the dialysis market in the U.S.,¿ Ghodsian told BioWorld Today. ¿J&J sells their drug Procrit for the pre-dialysis market, cancer and HIV in the U.S. and in all those indications in Europe, and they have about $2 billion in worldwide sales. Clearly, the market for Amgen¿s Aranesp is upwards of $4 billion. On top of that, obviously, the fact that it can be given less frequently makes it the more convenient drug, and I feel Amgen will have a good chance to capture the market, taking it from J&J.¿
Thirty-seven year Wall Street veteran David Saks of GS MedScience was even more optimistic about Amgen. He told BioWorld Today that the news could bode big bucks for Amgen¿s shares (NASDAQ:AMGN), which closed trading Monday at $60.95, up 35 cents.
¿Aranesp is the catalyst that could really put Amgen¿s shares on a major thrust to the promised land of $100,¿ Saks said. ¿The key is the pipeline, and the biggest pipeline issue is getting Aranesp to launch and getting the follow-up for cancer, claiming a one-two punch for that product. If we¿re talking a successful no-holds-barred launch this year followed next year with an expanded approval, Amgen goes on fire.¿
Amgen¿s Beckerich said the approval for Aranesp in the nephrology setting could come ¿any day now,¿ and he said the company still has plans for a filing in the oncology setting this year. Amgen last year filed for approval of Aranesp for treating anemia caused by renal disease.
¿Not only have very low doses been shown to be more effective than the treatment that¿s available, it¿s been shown that Aranesp continues to show a superior and excellent safety profile, and then we also found that we¿ve shown efficacy in anemia in cancer,¿ Beckerich said. ¿Now we have an outstanding report on blood transfusions, and we have two secondary endpoints.
¿Here at Amgen we usually don¿t rush out with too many things. We¿re pretty cautious about putting the cart before the horse,¿ he added. ¿I think we have enough trials now and have done enough testing with Aranesp.¿
Further data presented at ASCO indicated that KGF, Thousand Oaks, Calif.-based Amgen¿s recombinant human keratinocyte growth factor, reduces the duration of mucositis, a severe inflammation of the mucus membranes of the mouth and throat, in patients undergoing chemotherapy.
In still further data from a Phase III trial presented at the meeting, Amgen disclosed its pegfilgrastim is comparable in terms of efficacy and safety to its Neupogen formulation filgrastim, which has been used for more than a decade as a therapy for neutropenia, a drop in white blood cells associated with myelosuppressive chemotherapy.