Johnson & Johnson is hoping for approval of a supplemental BLA for once-weekly use of Procrit in chemotherapy patients by mid-2004.

The sBLA was submitted in August, according to a J&J pipeline update. The company said it expects a standard review period.

Procrit (epoetin) is labeled for three-times weekly dosing for the treatment of chemotherapy-induced anemia. A once-weekly dose is described as an "alternative" regimen for post-surgical anemia patients.

J&J has struggled to obtain FDA approval for the less frequent dosing schedule in chemotherapy. The company originally projected approval in 2000 (¹ [A#00630170015], p. 20).

Once-weekly use is already standard for Procrit in the oncology setting, according to J&J. However, the absence of explicit labeling has made it difficult for the company to respond to Amgen's launch of the long-acting EPO brand Aranesp (darbepoetin).

Aranesp labeling includes data suggesting that an every-other-week dose of the product can replace once-weekly Procrit (² Also see "Aranesp Oncology Label Includes Emphasis On Longer Half-Life Than Procrit " - Pink Sheet, 29 July, 2002., p. 6).

Since Procrit is not labeled for once-weekly use, J&J promotional materials cannot explicitly discuss Amgen's messages.

Procrit sales are down in 2003. "This decline is the net effect of strong market growth offset by a loss of market share," J&J VP-Investor Relations Helen Short said during an Oct. 14 earnings call.

Third quarter U.S. sales fell 9% to $703 mil.; year to date sales have declined 4% from $2.2 bil. to $2.1 bil.

"We expect an unfavorable comparison for the fourth quarter as well," Short said. However, J&J sees the sequential quarter-to-quarter sales trend as an encouraging sign. First quarter and second quarter 2003 Procrit sales were $723 mil. and $707 mil., respectively.

J&J's response to the Aranesp launch includes pricing changes. "We've taken appropriate measures to level the playing field in that regard. And yes, that does mean we've had a reduction in the average selling price of our product," CFO Robert Darretta said.

In April, J&J said that it would take steps to counter the effect of Aranesp's pricing, which apparently includes a larger "spread" between average wholesale price and actual costs (³ Also see "J&J Modifies Procrit Pricing Practices To Compete With Amgen’s Aranesp " - Pink Sheet, 21 April, 2003., p. 13).

Amgen implemented performance-based contracts with hospital customers that drive Aranesp business following a determination by the Centers for Medicare & Medicaid Services in November that Aranesp is "functionally equivalent" to Procrit and does not warrant higher reimbursement (⁴ Also see "Amgen Discounting Aranesp After Medicare Reimbursement Cut" - Pink Sheet, 27 January, 2003., p. 24).

The other side of J&J's EPO franchise also had a loss for the quarter. J&J-manufactured Eprex , solely marketed ex-U.S., fell 6% for the quarter to $302 mil. Sales for the first nine months were also down 6% to $884 mil.

Last year, Eprex sales were adversely affected by an increased incidence of pure red cell aplasia associated with use of the product in chronic renal failure patients.

J&J attributed the cases of PRCA to increased patient self-administration and mishandling of the product. The company instituted "best handling practices" to ensure the product is not agitated and remains at the appropriate temperature (⁵ Also see "J&J Eprex “Best Handling Practices” Program Aims To Reduce PRCA Cases" - Pink Sheet, 9 December, 2002., p. 23).

"We took strong measures to ensure the safety of the people using the product. We're very pleased with the outcome of those measures," Darretta said.

"The incidence of PRCA has been dramatically reduced, and we do not see that as an issue affecting our ability to grow the product on a go-forward basis."

"Worldwide the incidence has dropped from 3.16 cases per 10,000 patient years in the first half of 2002 to .43 cases per 10,000 patient years in the first half of 2003," J&J's website reports.

J&J posted a strong third quarter in spite of year-over-year losses associated with its EPO franchise (see ⁶ Also see "J&J Patches Together Strong Sales Growth With Ortho EVRA, Duragesic" - Pink Sheet, 20 October, 2003. ).

J&amp;J Procrit Once-Weekly Labeling Resubmitted To FDA

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J&J Procrit Once-Weekly Labeling Resubmitted To FDA