Several items of interest related to UCB.
1/ The company announced this morning that 2 new members will join the executive committee, splitting the commercial operations: the two new members are the heads of the US and European commercial operations, respectively Greg Duncan, currently Senior Vice President and President of UCB’s North American Operations, and Jean-Christophe Tellier, joining UCB from . Current COO McDade will continue to focus on growth markets outside the US and Europe, overall business development, marketing and prepare for the launch and commercialization of new late stage products.
2/ At the occasion of EULAR (leading European rheumatology conference currently ongoing), UCB announced it will start a blinded and randomised study comparing the effectiveness of Cimzia versus Humira (Abbott, 2010 sales of €5bn). The study will evaluate a week 12 response-based therapeutic decision and assess the impact of an early response and decision on the long-term benefit (after 2 years). This study shows that UCB must feel quite comfortable that Cimzia will outperform Humira (one of the biggest TNF-alpha products on the market) with respect to the early response and subsequent decision making process. The study must also be viewed from UCB current marketing message/strategy that positions Cimzia as an early response product, which is a key USP versus competitors. Indeed, when prescribing Cimzia, physicians and patients know earlier than with other TNFs if the product works or not. About 60% of patients being given Cimzia respond to the product, and this response-decision can be made within 12 weeks (for other products typically the response-decision is to be made in the 4-6 months time-frame). Hence, the assumption is that those patients not responding in the 12 week time frame can be taken off Cimzia, and start with another therapy. This is important from a health-economical and efficient treatment perspective.
3/ Last Friday, the European CHMP provided a positive opinion on the marketing of generic Keppra from Ratiopharm and Teva, two important generic drug players. Assuming standard timelines, we expect the EMA to make a formal marketing authorisation within 2 to 3 months, implying that the real generic Keppra flood in Europe will only start as of August 2011. This is later than we had expected, and positive for the European sales of Keppra. Today, there are two generics on the market in Germany (Sanofi Winthrop and Desitin), two in Switzerland and some approved in Portugal but not yet launched. Our model currently assumes overall FY11 Keppra sales of €690m (Bloomberg consensus €675m), of which €425m in Europe (-30% versus 2010 sales of €606m). However, this European sales drop may be too aggressive. Indeed, Keppra EU saw >10% growth in 1Q11 and if we assume Keppra EU 1H11 sales equalling the 2H10 level ( €319m), current forecasts imply an estimated 2H11 EU sales of only €100m (or a drop of around 70% in 6 months), which seems quite unlikely from a European perspective. Hence, assuming a levelling of the decline in the US and growth in the RoW, current estimates for Keppra may seem too low. We will continue to closely follow the trends.