By Randall Osborne
West Coast Editor
Taking aim next at the lucrative oncology-related anemia indication, Amgen Inc. won approval from the FDA for Aranesp (darbepoetin alfa) as a treatment for anemia associated with chronic renal failure, including those on dialysis and those who are not.
?It?s the industry?s next blockbuster,? said Eric Schmidt, an analyst with S.G. Cowen Securities Corp. in New York. ?They already have two, and this is pretty much a shoo-in to be their third.?
The extended-release Aranesp allows for fewer injections than epoetin alfa, which is marketed as Epogen by Amgen and as Procrit by New Brunswick, N.J.-based Johnson & Johnson, a licensee and Amgen competitor in the anemia field. Each of the recombinant erythropoietic proteins, often called EPO, is designed to stimulate production of oxygen-carrying red blood cells.
Amgen?s other blockbuster is Neupogen (filgrastim), a white blood cell booster.
Anthony Gringeri, vice president of product development for Amgen, during a conference call Tuesday pointed to the chief benefit of Aranesp, approved in Europe in June: It can be dosed once per week, as compared to Epogen or Procrit, which are dosed up to three times per week.
?Some patients have been treated successfully every two weeks,? Gringeri said, explaining that Aranesp was devised by ?changing the amino-acid backbone? and adding new carbohydrate chains. Aranesp has been studied in more than 8,000 patients with chronic renal failure, some for more than three years, he said.
The company plans this week to submit a supplemental biologics license application for a label extension that would include anemia related to chemotherapy, a condition suffered by 50 percent to 60 percent of cancer patients.
Earlier this year, Amgen disclosed Phase III data showing Aranesp performed well in cancer patients, without significant safety concerns. (See BioWorld Today, May 15, 2001.)
?It should be a relatively straight shot to approval [in oncology],? Schmidt told BioWorld Today, adding that ?oncology is probably the better market, and pre-dialysis is just the first. J&J probably has close to $2 billion of sales in oncology, if not more, and $200 million in pre-dialysis.?
Amgen, he added, ?obviously has a lot of experience in dialysis and pre-dialysis patients, but clearly they?re also very focused on the oncology area.?
Michael Beckerich, spokesman for Amgen, said the Aranesp ?story is only beginning,? adding quickly that ?we can?t promote in oncology and we won?t promote in oncology? ? yet.
?Initially, [chronic renal insufficiency] is the focus for us,? he told BioWorld Today. ?Market research shows us J&J has only penetrated 25 percent of the CRI market, and certainly in oncology, there are a lot of patients not getting treatment. And one of the barriers is how frequently people have to get shots.?
Beckerich called the oncology anemia market ?very large,? with current estimates as high as $5 billion.
Schmidt said in a research note that Europe means a potential $1 billion market for Aranesp, split roughly evenly between dialysis and oncology. The company already has cornered the more than $2 billion U.S. dialysis market, but Epogen is excluded from pre-dialysis and oncology through an agreement with J&J ? which has ?largely ignored? the former market, Schmidt said.
Even with oncology competition in the U.S., Amgen believes Aranesp?s less frequent dosing could prove useful enough to oncologists that they will prescribe it off label, Schmidt said, although Medicare probably won?t reimburse off-label use of any oncology product.
Said Beckerich: ?It?s case by case, and as more oncologists submit off-label use for any drug, that helps the cause for the drug getting reimbursed. It?s essentially up to the demand created by physicians. What we can do in oncology is present our data, get it published, and medical professionals and reimbursement officials in managed care can make their decisions.?
Regarding J&J, he added, ?There?s room enough for both of us.?
Amgen?s stock (NASDAQ:AMGN) closed Tuesday at $59.38, down $1.47, which surprised Schmidt, who acknowledged the market was depressed as a result of last week?s terrorist attacks.
?You might expect there to be a bit of a pop [in the stock price],? Schmidt said, but ?there?s not a whole lot of momentum left? in the market as a result of the attacks.
?Amgen?s also pretty pricey,? he said, adding that the company is ?clearly in line for [renewed growth] in top- and bottom-line earnings.?