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Intense growth of Cimzia, Vimpat and Neupro

UCB announced today its interim report for the first nine months of 2010.

“With more than 170 000 patients benefiting from UCB’s new medicines we are pleased with the positive launch trajectory of Cimzia, Vimpat and Neupro”, said Roch Doliveux, CEO of UCB.

“The new medicines reached combined sales of EUR 289 million in the first nine months. Through these core products and progress in our pipeline, UCB is building a strong foundation for sustainable future company growth.”

Revenue in the first nine months of 2010 increased by 6% to EUR 2.4 billion mainly as a result of the solid performance of core products Cimzia, Vimpat and Neupro, which compensated for generic competition to the mature product portfolio.

Underlying profitability (recurring EBITDA) and net profit performance were in line with the company’s expectations.

Core product launches
The core products Cimzia, Vimpat and Neupro delivered solid growth reaching combined sales of EUR 289 million in the first nine months of 2010 with multiple launches still underway in several countries.

Cimzia (certolizumab pegol) for Crohn’s disease (CD) and rheumatoid arthritis (RA), reached net sales of EUR 138 million in the first nine months of 2010 and is building good momentum in a competitive market. The roll-out of Cimzia in the US and in Europe continues with now more than 18 000 patients treated with the drug worldwide. Cimzia is available in 19 countries with further launches in major European countries and international markets expected by the end of this year. The number of prescriptions for Cimzia in the treatment of Crohn’s disease (CD) and rheumatoid arthritis (RA) in the U.S. is growing faster than the total market with a 22.6% and a 3.8% share of new prescriptions (NRx) in the CD and RA segments of the subcutaneous anti-TNF market respectively.

The new anti-epileptic drug, Vimpat (lacosamide) is making a good start in the 20 markets where UCB has launched with net sales of EUR 91 million and more than 84 000 patients benefiting from the drug at the end of the first nine months of the year. Available in Europe and in the US as an add-on therapy for the treatment of partial-onset seizures, Vimpat continues to gain market share. The successful launch in the US epilepsy market is reflected by a strong prescription take-off: 1.6% NRx share of the anti-epileptic drug market. Additionally, Vimpat is growing well in Europe with a treatment day share (TDx) among anti-epileptic drugs (AEDs) of 1.3% in Germany, for example.

Neupro (rotigotine), the patch for Parkinson’s disease and restless legs syndrome (RLS) had net sales of EUR 59 million in the 20 markets where the drug has been launched, with more than 68 000 patients currently being treated with the drug. Neupro’s treatment day share (TDx) in Parkinson’s disease has reached 16.5% in Spain, for example.

Mature products
Net sales of the anti-epileptic drug Keppra (levetiracetam) increased by a single digit percentage during the first nine months of 2010 when the continued market leadership of Keppra in Europe and in international markets compensated for its generic erosion in the U.S. Data exclusivity for Keppra expired in the European Union on 29 September 2010. In Japan, UCB and its partner Otsuka Pharmaceutical successfully launched E Keppra in September for adjunctive therapy in partial-onset seizures in adults with epilepsy. Zyrtec (cetirizine) sales are lower than last year due to the divestment of smaller emerging markets to GSK in the first quarter of 2009. Xyzal (levocetirizine), for allergy, had reduced net sales following entry of generic competition in the European market. Venlafaxine XR showed strong growth despite generic competition since July 2010. Net sales of Tussionex (hydrocodone polistirex and chlorpheniramine polistirex) declined due to the mild cough and cold season in the US earlier in the year and due to the reduced promotion of the drug following UCB’s exit from the US primary care market, in anticipation of generic competition which arrived in October 2010.

R&D update: immunology
Two Phase III trials (Embody 1 & 2) for epratuzumab in systemic lupus erythematosus (SLE) are expected to start as planned by the end of this year.

UCB’s collaboration with its partner Amgen to develop CDP7851 (“sclerostin-antibody”) is progressing well. The top line results of the Phase II programme for CDP7851 in post-menopausal osteoporosis (PMO) are expected earlier than previously anticipated, ie in the second half of 2011. Another Phase II trial using the same drug candidate is ongoing in fracture healing, with first headline results expected in 2012.

The Phase III studies for Cimzia in psoriatic arthritis and ankylosing spondylitis are on track with key results expected in the fourth quarter of 2011. A Phase III trial in juvenile rheumatoid arthritis is still under discussion with U.S. and EU regulators to finalise the study design.

CDP6038 (anti-IL 6) is in development for the treatment of autoimmune diseases and a Phase IIb programme is expected to start during the first half of 2011.

R&D update: central nervous system (CNS)
A Phase III development programme for Vimpat as monotherapy in partial-onset seizures in the EU will be initiated as planned by the end of this year. The primary generalised tonic-clonic seizures (Phase II) as well as the paediatric (Phase II) and the U.S.-monotherapy (Phase III) development programmes in partial-onset seizures are ongoing as planned.

The additional Phase III study for brivaracetam as add-on therapy in partial onset seizures will start by the end of this year.

UCB’s filing of Xyrem (sodium oxybate) in fibromyalgia is under review by the European Medicines Agency (EMA) and UCB expects feedback from the European authorities during the first half of 2011.

In October, UCB and Synosia signed a strategic alliance in neurology. UCB has exclusive worldwide rights to the development compound SYN-115 and rights to a second compound, SYN-118, for non-orphan indications. Both compounds are currently in Phase II development for Parkinson’s disease. A Phase IIb study of SYN-115 is expected to begin in Q1 2011.