UCB Interim Report for the first nine months of 2011
Brussels (Belgium), 27 October 2011 – 07:00 (CET) – regulated information – UCB announced today its interim report for the first nine months of 2011.
|"UCB made good progress during the first nine months of the year and is positioned particularly well for the future. We benefit so far from slower than expected generic erosion to Keppra® and we are enjoying robust growth of our core medicines, despite currency effects and a dynamic reimbursement environment", said Roch Doliveux, CEO of UCB. "The next 18 months are important for UCB: the full effect of the generic erosion of Keppra® will be realized and at the same time we will continue to invest heavily in our new medicines and our pipeline portfolio. Once we have seen the generic erosion plateauing during the second half of 2012 - with the growth going forward, we could experience a decade with no major patent loss, sustainable growth and an exciting pipeline coming to market."|
Revenue in the first nine months of 2011 reached EUR 2 451 million driven by the growth of core medicines Cimzia®, Vimpat® and Neupro® combined with the solid performance generated by the established product portfolio, especially Keppra® and compensating for generic erosion of mature products. Underlying profitability (recurring EBITDA) and net profit performance meet the company's expectations.
Continued momentum for core medicines
In the first nine months of 2011, UCB’s core medicines Cimzia®, Vimpat® and Neupro® delivered growth reaching combined sales of EUR 445 million, +54% at actual exchange rates; +60% at constant rates compared with the first nine months in 2010. More than 273 000 patients are now using UCB’s core medicines Cimzia®, Vimpat® and Neupro®. Cimzia® (certolizumab pegol) for Crohn’s disease (CD) and rheumatoid arthritis (RA), reached net sales of EUR 221 million (+60% at actual exchange rates; +67% at constant rates) and is building continuously momentum in a competitive market. More than 30 000 patients are being treated with the drug worldwide. Cimzia® is now available in 24 countries, including the most recent addition of Russia in October. The number of prescriptions for Cimzia® in the treatment of Crohn’s disease (CD) and rheumatoid arthritis (RA) in the U.S. is grouwing faster than the total market with a a 21.2% and a 3.9%1 share of new prescriptions (NRx) in the CD and RA segments of the subcutaneous anti-TNF market respectively. Cimzia® outperformed a weak anti-TNF market in the U.S. and was able to win further preferred formularies which will become effective as of January 2012.
The anti-epileptic drug, Vimpat® (lacosamide) grew by 70%* (+78% at constant rates) in the 24 markets where UCB has launched, with net sales of EUR 154 million and more than 149 000 patients using the drug. In the add-on therapy for the treatment of partial-onset seizures, Vimpat® continues to gain market share and is now the number one add-on agent in the U.S. The successful launch in the U.S. is reflected by a strong 2.2%1 NRx share of the anti-epileptic drug market.
Neupro® (rotigotine), the patch for Parkinson’s disease (PD) and restless legs syndrome (RLS) grew net sales to EUR 70 million (+17%*) in the 25 markets where the drug is now available, with more than 93 000 patients currently being treated with the drug. UCB is on track to bring Neupro® to patients in the U.S. during 2012, subject to regulatory approval.
Keppra® – a substantial franchise
Net sales of the anti-epileptic drug Keppra® (levetiracetam) increased by a mid-single digit percentage rate during the first nine months of 2011. Market leadership of the Keppra® franchise in Europe and in international markets remained solid. The generic erosion in the U.S. continues, especially due to generic versions to Keppra® XR since September 2011. In Europe there have been several generic entries while, in Japan, E Keppra® is showing an excellent launch.
R&D update: immunology
The filing of the marketing authorization for Cimzia® with the Japanese regulatory authorities for the treatment of rheumatoid arthritis (RA) is expected by March 2012.
Near term, UCB will start the first industry sponsored anti-TNF head-to-head study that will assess the relative efficacy of Cimzia® and Humira® (adalimumab) for certain predetermined parameters in the treatment of moderate to severe rheumatoid arthritis (RA). The study will include a 12 week response-based therapeutic decision and assess the impact of an early response and decision on long-term (104 weeks) clinical and patient outcomes.
The Phase 3 trials for Cimzia® in psoriatic arthritis and ankylosing spondylitis are on track with first results expected at the end of 2011.
A Phase 3 trial in juvenile rheumatoid arthritis is under discussion with U.S. and EU regulators and scheduled to start within the first quarter 2012.
Recruitment for the Phase 3 trials (EMBODY™ 1 and EMBODY™ 2) for epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE) is ongoing as planned. First results are expected in the first half of 2014.
CDP7851 ("sclerostin antibody" / AMG 785), a novel therapy for bone loss disorders had positive top-line results from the Phase 2 clinical study comparing CDP7851 to placebo in post-menopausal women with low bone mineral density for the treatment of post-menopausal osteoporosis (PMO). The Phase 3 program will start upon completion of consultations with the regulatory authorities in the U.S. and EU. Two Phase 2 studies, one in tibia and the other one in hip fracture healing, are ongoing with first headline results expected in 2012. Amgen and UCB are collaborating for the development of CDP7851/AMG 785 for the treatment of bone-related conditions, including PMO and fracture healing.
A Phase 2b program for olokizumab (anti-IL 6) being developed for the treatment of moderate to severe rheumatoid arthritis (RA) is currently recruiting. Headline results are expected in the third quarter of 2012.
R&D update: central nervous system (CNS)
For the epilepsy medicine Vimpat® (lacosamide), both the U.S. and the European monotherapy Phase 3 program in partial-onset seizures are on track, with first results expected in Q2 2013 and Q4 2014 respectively. First results from a Vimpat® Phase 2 clinical trial for adjunctive therapy in primary generalised tonic-clonic seizures (PGTCS) are expected at the end of 2011.
A Phase 3 study evaluating brivaracetam as adjunctive therapy in epilepsy is on-going with headline results expected in the first half of 2013.
UCB’s partner Otsuka Pharmaceutical reported in June and October 2011 positive Phase 3 results for Neupro® conducted in Japan in advanced Parkinson’ Disease and restless legs syndrome (RLS) respectively. Filing with the Japanese authorities for both indications is planned for the first quarter 2012.
Outlook 2011 updated
Total revenue is expected to exceed 3.1 billion in 2011 due to slower generic competition to Keppra® and supported by the performance of core medicines. In 2011, UCB’s recurring EBITDA is expected to reach approximately EUR 680 million. Core EPS 2011 are expected to exceed EUR 1.80, based on a 178.5 million weighted average number of outstanding shares.
For further information
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UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
 IMS National Prescription Audit (NPA) Weekly and IMS National Disease Therapeutic Index (NDTI), week ending Oct. 7, 2011
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