Roche’s Mircera Clears FDA, But U.S. Launch Appears Stalled

FDA approved Roche's long-acting erythropoiesis-stimulating agent Mircera for the treatment of anemia associated with chronic renal failure in adults Nov. 14, but a near-term launch of the product appears unlikely given Amgen's legal hold on the market.

Amgen won a critical legal victory in October when a Boston jury concluded that Mircera infringes its erythropoietin patents covering Epogen (epoetin) and Aranesp (darbepoetin alfa). Amgen is now moving ahead with a court order blocking Roche from marketing Mircera in the U.S. (¹ (Also see "“World Series” Trial: Verdict Against Mircera Gives Amgen ESA Market Hold" - Pink Sheet, 29 Oct, 2007.), p. 20).

A hearing on the injunction started Nov. 15 and will take place over the course of three additional days in December, wrapping up Dec. 7, according to Roche.

"Roche maintains its position that all of Amgen's patents for epoetin asserted against Roche are invalid and not infringed, and believes the facts and the law support that position," the company stated.

In addition, the firm noted, "Roche believes strongly that it is important for there to be treatment options for patients with CKD and their health care providers and looks forward to presenting its case at a judicial hearing regarding a potential injunction."

Nonetheless, Roche appears to be backing away from a near term U.S. launch following the court decision. The company continues to maintain that it is weighing an appeal, but has yet to commit to the court action.

"We are hopeful that patients and health care providers in the U.S. will be able to have access to Mircera as soon as possible, in a responsible and legal manner," the firm said.

During Roche's third quarter sales and earnings call Oct. 16, Pharmaceuticals CEO William Burns suggested that a verdict in favor of Amgen in the case could block the launch of Mircera.

In a Nov. 14 research note, JP Morgan analyst Geoffrey Meacham also noted that, "Industry contacts suggest that the Mircera sales force is disbanding."

"We expect that Roche will not launch at risk, and that a permanent injunction will be issued in December," he noted. "We previously removed Mircera from our anemia market model and assume no commercial consequence to Amgen from the Mircera FDA approval."

Roche declined to comment on sales staffing for Mircera in the U.S., stating only, "It is really premature for us to be discussing any staffing changes at so early a point in time. We are always adapting our structures to the needs of our business."

Mircera would be the only ESA in the U.S. market to provide once-monthly dosing, as opposed to once-weekly. The product is approved for use once every two weeks to provide correction of anemia, followed by administration once a month or once every two weeks to maintain stable hemoglobin levels.

Mircera also offers added convenience of storage at room temperature for extended periods of time.

In contrast to erythropoietin, Mircera is an erythropoietin receptor activator with greater activity in vivo as well as increased half life. The half life of Mircera is up to six times longer than Aranesp and up to 20 times longer than Epogen, according to Roche.

The U.S. approval was based on 10 studies involving 2,700 patients, including two Phase III correction and four Phase III maintenance studies exploring intravenous and subcutaneous administration.

Mircera was as effective as other ESAs in correcting renal anemia in patients with chronic kidney disease on dialysis and not on dialysis. Patients maintained stable hemoglobin levels when switched to Mircera from a shorter-acting ESA treatment.

Consistent with the EPO class, Mircera carries a boxed warning on risk of death and serious cardiovascular events. Labeling for ESAs was revised most recently in early November, adding a boxed warning for patients with renal failure that calls for using the products to maintain a hemoglobin level between 10 g/dL and 12 g/dL (² (Also see "Amgen Plans Seven ESA Risk Studies After Latest Safety Update To Labeling" - Pink Sheet, 12 Nov, 2007.), p. 3).

"Mircera is not indicated for the treatment of anemia due to cancer chemotherapy," the warning notes. "A dose ranging study of Mircera was terminated early because of significantly more deaths among patients."

Mircera has already been approved in Europe, where it has launched in Austria, Sweden, Germany, the U.K. and Norway.

- Jessica Merrill ([email protected])