DYNEPO®

It's the first erythropoietin produced in a human cell line with the Gene-activated(R) method developed by Transkaryotic Therapies, which was acquired by Shire Pharmaceuticals at 2005.

According to the reports of 2 phase III studies presented for the first time (below), DYNEPO® can effectively maintain haemoglobin at the target levels (10-12 g/dL), controling anaemia in patients with chronic kidney disease (CKD).

1. M Smyth, KJ Martin, RP Pratt. Epoetin delta (Dynepo®), erythropoietin produced by a human cell line, is as effective as epoetin alfa in patients with renal anaemia, including those with diabetic nephropathy. Poster presented at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD), 14-17 September 2006, Copenhagen-Malmoe, Denmark-Sweden.

2. JTC Kwan, M Smyth, RD Pratt. Human cell line derived erythropoietin (epoetin delta, Dynepo®) administered subcutaneously is effective in the management of anaemia associated with chronic kidney disease. Poster presented at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD), 14-17 September 2006, Copenhagen-Malmoe, Denmark-Sweden.

But it didn't seem to be worth pleasure. Lately, The Court of Appeals for the Federal Circuit just affirmed the District Court's decision that Transkaryotic Therapies and Aventis Pharmaceuticals Inc. infringe Amgen's erythropoietin patent estate. It may be a very long distance for launch of DYNEPO® in the US and UK.

Although DYNEPO® had been approved in the European Union at 2002, probably due to the litigation with Amgen, it still not available from Shire.

I don't look forward to this product, although it's more similar, even identical, to endogenous erythropoietin. Erythropoietin derived from mammalian, such as epoetin alpha & beta, had been used for the past decade, and very rare risk was reported, except PRCA caused by neutralizing antibodies. Why people change their choice if DYNEPO® doesn't have other advantages, like prolonged half-life as well as Aranesp®.

But, athletes will like it, since it's difficult to distinguish DYNEPO® with endogenous erythropoietin from urine test. It has been a new member of hard to deal with in the anti-doping list.