Amgen To Study Aranesp Anemia Indication In Heart Failure Patients

Amgen is considering an appropriate design for a Phase III trial evaluating Aranesp (darbepoetin alfa) to treat anemia in patients with congestive heart failure.

The company has already collected data from a Phase II trial evaluating whether anemia is a treatable risk factor for CHF, Exec VP-R&D Roger Perlmutter said during a second quarter earnings call July 19.

In designing a pivotal program for Aranesp thus far, Amgen has "defined very well the entry of the patients...with respect to the degree of failure and hemoglobin levels below 12.5," he said.

"We would anticipate that we could begin enrolling a study like that in not too long a time," Perlmutter said. "We would have to enroll a pretty good number of patients - a few thousand - in order to have reasonable power."

The trial will likely adopt a primary endpoint that is common to CHF trials: all-cause mortality.

Amgen is pursuing the indication based in part on studies suggesting that treatment of CHF patients with erythropoietic agents improves cardiac performance (¹ (Also see "Amgen 2004 R&D Goals Focus On Oncology, Osteoporosis Products" - Pink Sheet, 29 Mar, 2004.), p. 33).

In designing a clinical program, Amgen had to consider the precarious health of the patient population. "Patients with CHF often are just barely compensated. Anything we do that adjusts their physiology can cause decompensation, and we wanted to make sure that we had a way to gently elevate hemoglobin," Perlmutter said.

Aranesp rang in solid sales growth during the second quarter, with worldwide sales up 36% to $837 mil. Growth in the U.S. market was even stronger, with sales increasing 41% to $536 mil.

Growth was driven primarily by demand through market share gains, and to a lesser extent, growth of the EPO market. Amgen had predicted the opposite outcome ahead of the switch to the ASP plus 6% reimbursement model (² (Also see "Aranesp Growth Tied To Market Penetration, Not Share Gains, Amgen Says" - Pink Sheet, 15 Nov, 2004.), p. 19).

However, it was Aranesp share gains that offset any effect of the switch to an average sales price model under Medicare Part B. Under ASP plus 6%, Aranesp is reimbursed at $18.45, down 13% from its 2004 Part B reimbursement rate.

"The clinical imperative to treat anemia and neutropenia prevailed over the declining economics associated with the new ASP-based reimbursement system," Exec VP Global Commercial Operations George Morrow said.

The Centers for Medicare & Medicaid Services' "quality of care" demonstration project was also a primary growth driver. The one-year program compensates oncologists for evaluating patients' fatigue, nausea and pain (³ (Also see "Oncologists Embrace Part B Demo, Amgen Says; Big Test In Two Months" - Pink Sheet, 7 Feb, 2005.), p. 13).

Morrow reiterated Amgen's support for the project and said he expects "some variation" of the program to be implemented next year. A bill to continue the demonstration project through 2006 (HR 261) cleared the House Energy & Commerce Committee July 20.

Amgen also issued a positive "preliminary assessment" of another pricing change - the 2006 Hospital Outpatient Prospective Payment System proposed rule, issued July 18. Reimbursement under the OPPS rule would be ASP plus 8%.

The competitive dynamics in the EPO market, which have led to pricing variability in recent years, have since stabilized, Morrow said.

"The last significant contracting initiative happened last February, when J&J rolled out the new contract. We responded within days, and it's been pretty stable since then," he told investors.

In February, Amgen cautioned investors about the potential for continued declines in the published average sales price for Aranesp and Johnson & Johnson's Procrit due to competitive tactics (⁴ (Also see "Oncologists Embrace Part B Demo, Amgen Says; Big Test In Two Months" - Pink Sheet, 7 Feb, 2005.), p. 13).

Like Amgen, J&J reported stabilized prices for Procrit (epoetin alfa) during a same-day earnings call. The pricing situation "has become much more stable than what we experienced over the last couple of years," J&J CFO Bob Darretta said.

Procrit growth was less robust than that for Aranesp; worldwide Procrit sales rose just 3% to $846 mil. in the second quarter. In the U.S., sales dropped 3% to $566 mil.