The last couple of weeks have seen positive news for Richter, slightly lifting the gloom over the company’s prospects in an increasingly tough pricing environment. Firstly – and more immediately significantly – the EMA approved Esmya, Richter’s innovative treatment for uterine fibroids. This product was acquired by Richter in October 2010, when it bought the Swiss company, Preglem, and while it is unlikely to be a blockbuster, Richter hopes that it will ultimately achieve sales in the region of €100m pa. Launch will come in Q2 in the UK and Germany, with other countries following once reimbursement has been negotiated. At present, there is no good treatment for uterine fibroids, which are a relatively common gynaecological complaint that can have serious outcomes in the worst cases. Esmya should thus be well received by specialists, as well as being relatively cheap to promote. We presume that detailing in western Europe will mostly be via the sales force that Richter has already established to sell the branded oral contraceptives that it recently acquired from Grünenthal, although this doesn’t cover the UK, so some other solution will have to be put in place there.
Richter’s second piece of good news, released the following day, came in the form of positive data from two phase III clinical trials carried out jointly by Richter and Forest Labs on cariprazine, a novel treatment for schizophrenia discovered by Richter and out-licensed to Forest for the US market. Cariprazine has already demonstrated efficacy in bipolar mania and with the schizophrenia data now in, Forest expects to submit its dossier to the FDA later this year. This will mean a PDUFA date in 2013, so it is to be hoped that the two companies have done enough to satisfy the Agency about cariprazine’s safety, as well as its efficacy. In Europe, Richter is still looking for a co-development partner, meaning that filing is much further off. We also suspect that Richter would need to conduct comparative trials against at least one existing schizophrenia treatment in order to get an acceptable level of reimbursement for cariprazine in Europe (Germany in particular). The lack of head-to-head studies to date may also prove an issue in the US, where an increasing number of modern schizophrenia drugs (Pfizer’s Geodon, for instance) are losing patent protection and hence becoming much cheaper for payers. Psychiatrists will certainly be pleased to have another drug in their armoury, particularly one with a novel mechanism of action, but are unlikely to use cariprazine as a first line therapy if there are good generics available, unless there is clear evidence of superior efficacy.
.While neither Esmya nor cariprazine will bring Richter a huge amount of income in the short term, their success nevertheless moves the company a bit further towards its ultimate goal of becoming innovation-led rather than dependent on generics. Richter also has a third leg to its innovation strategy in the form of its biogenerics jv with Helm of Germany, which could potentially deliver its first marketed product as early as 2014. Since the Richter-Helm BioTec pipeline is not focused either on women’s health or CNS, Richter risks ending up with a rather messy portfolio that will need rounding out with additional products if it is to make the best use of a sales force. However, this is surely a better problem to have than racing to launch enough new generics to offset increasingly intense pricing pressure in CEE, which is the biggest issue that it faces today.
Posted on 14th March 2012