A big plus for Roche today after the European Commission issued a final positive decision for its once- or twice-monthly anaemia drug Mircera for use in chronic kidney disease patients that is valid in all 27 European Union member states.

The news follows a thumbs-up in May from Europe’s scientific advisory board, the Committee for Medicinal Products for Human Use, for the continuous erythropoietin receptor activator that Roche says stimulates red blood cell production in a way that “more closely mimics the body's physiologic processes.”

Specifically, Mircera has been cleared for use once every two weeks in previously untreated patients to correct their anaemia. For patients who have previously been given an erythropoietin-stimulating agent, the dosing is once a month, which Roche hopes will prove to be much more convenient for patients and healthcare professionals. Indeed, data from a recent study found that converting dialysis patients from more frequently administered ESAs to once-monthly Mircera could halve the annual time spent on anaemia management in a dialysis centre.

The approval was based on a dataset from the largest clinical programme ever carried out for an anaemia drug in CKD and was compared to three ESAs: epoetin alfa (Amgen’s Epogen and Johnson & Johnson’s Procrit), epoetin beta (Roche’s NeoRecormon) and darbepoetin alfa (Amgen’s Aranesp).

Globally more than 500 million people, approximately one in 10 of the

general population, have some degree of CKD. Renal anaemia is a common and significant complication of CKD.

The approval comes at an interesting time for ESAs, which have been hit by safety concerns that recently led the US Centers for Medicare and Medicaid Services to limit payments of the anaemia drugs for patients undergoing kidney dialysis. The country’s Food and Drug Administration back in May warned that patients treated with the drugs have a higher risk of “serious and life-threatening side effects and a greater number of deaths" and recommended new clinical trials for the drugs Amgen’s Epogen and Aranesp, and Johnson & Johnson’s Procrit.

Amid these fears over ESAs, US regulators in May issued an approvable letter for Mircera, requesting additional information, though thankfully for Roche no further clinical trials.

Ventana waiting period expires

Meanwhile, Roche yesterday said that the waiting period relating to the tender offer for all outstanding shares in US biotechnology firm Ventana has expired. In June, the Swiss giant launched a hostile bid to acquire the firm for $75 per share in cash, and it says expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act “satisfies one of the conditions to the tender offer”.

In response, Ventana said: “The situation has not changed – our Board of Directors continues to believe that Roche’s bid is wholly inadequate and recommends that stockholders not tender any of their shares to Roche. Not only is the offer significantly below our current market price, it does not even come close to reflecting the intrinsic value of the Company, its strong growth prospects in an accelerating market, and the synergy value of Ventana to Roche.”