Astellas Pharma and UCB announced during the long Christmas weekend that UCB Japan has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Cimzia (Generic name: Certolizumab Pegol). Cimzia, under joint development in Japan, has been approved as a 200 mg syringe for subcutaneous injection for the treatment of adult patients with rheumatoid arthritis (RA) who have had an inadequate response to conventional treatment (including inhibition of progression of bone structural damage). Certolizumab pegol is currently commercialized in over 30 countries in such regions as Europe and the United States. In January 2012 Astellas and UCB entered into the agreement to jointly develop and commercialize certolizumab pegol for rheumatoid arthritis in Japan. Under the terms of this agreement UCB will manufacture and supply the product for commercialization and Astellas will exclusively manage distribution and sales. In January 2012, UCB Japan filed an application for marketing approval for certolizumab pegol in Japan. Astellas will make a payment to UCB for the marketing authorization milestone.
Next to this, the Japanese MHLW has also approved Neupro (rotigotine transdermal patch) for the treatment of Parkinson’s disease (PD) and for the symptomatic treatment of moderate-to-severe idiopathic Restless Legs Syndrome (RLS) in adults. In 2002 Otsuka Pharmaceutical acquired the exclusive rights for developing and marketing Neupro in Japan. UCB is responsible for development and marketing in all other regions worldwide. With the Japanese approval rotigotine is approved in 35 countries and over 120,000 patients have been treated with rotigotine worldwide.
This double success in Japan is in line with our expectations and has no impact on our earnings forecasts.
We reiterate that UCB’s share price has enjoyed a massive rally, surfing on good management of short-term expectations, strong pipeline assets, sector momentum and to some extent take-over rumours. The mid-to-long term drivers for growth are in place, and we believe the current trading levels are reflecting the fair value of the current and future prospects. Our DCF analysis points to € 44/share. Despite the high premium versus peers, we see limited downward risk in the coming months as there is no pivotal pipeline news expected and UCB has shown in the past to be resilient in economic downturns. We advise investors to Hold the stock.