UCB First Three Months Interim Report 2017: UCB with a good start into 2017
Brussels (Belgium), 24 April 2017 – 7:00 (CEST) – regulated information
- Revenue increased to € 1.12 billion, by 15%; main products grew by 20% to € 853 million
- R&D update: Phase 3 study for Japan started evaluating Cimzia® (certolizumab pegol) in psoriasis and psoriatic arthritis; Vimpat® (lacosamide) in the U.S. filed for children (> 4yrs); phase 2a study started with rozanolixizumab (UCB7665) in myasthenia gravis (MG)
- Financial outlook 2017 confirmed
Revenue for the first three months of 2017 increased to € 1.12 billion, by 15% at actual and 14% at constant exchange rates (CER). This was supported by the one-time other revenue of € 56 million recognized in February 2017 for out-licensing of the OTC-allergy drug Xyzal® (levoceterizine). Core driver of the continued growth are UCB's main products, Cimzia®, Vimpat®, Keppra®, Briviact® and Neupro® with combined net sales of € 853 million, a plus of 20%.
In January 2017, UCB and its partner Dermira announced positive topline results from CIMPACT, a Phase 3, placebo- and active-controlled clinical trial evaluating Cimzia® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. This completed the positive results from CIMPASI-2 and CIMPASI-1 in Q4 2016. The submissions of marketing applications to regulatory authorities are expected in Q3 2017.
In February 2017, to support line extension for Japan, a phase 3 study evaluating Cimzia® in adult patients with psoriasis and psoriatic arthritis started with first results expected in Q4 2018.
In March 2017, the FDA (U.S. Food and Drug Administration) issued a complete response letter in connection with the review of a proposed new indication for Cimzia® to treat polyarticular juvenile idiopathic arthritis (pJIA). The FDA letter concerns the reliability of the submitted pharmacokinetic data. UCB is working with both the FDA and the third party bioanalytical laboratory concerned to work on the issue and to agree on next steps to bring Cimzia® to juvenile patients. This does not affect any other program with Cimzia®.
In January 2017, UCB filed a supplemental New Drug Application with the U.S. authorities for Briviact® (brivaracetam) as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.
In February, the phase 2a study with padsevonil (UCB0942) - aimed at highly drug resistant epilepsy patients, who failed four anti-epileptic drugs and have at least four seizures/week - showed positive top line results and will progress into further development. Detailed results will be presented at future scientific meetings.
In March, Vimpat® (lacosamide) filing has been accepted by the U.S. FDA for pediatric patients living with partial-onset epilepsy at four years and older, based on extrapolation of data. For this pediatric group, filing is under review by the European authority.
Also in March, Vimpat® in a phase 3 study achieved positive results as adjunctive therapy in patients with epilepsy (partial-onset seizure; ≥ 4 to <17 years of age). Detailed results will be presented at future scientific meetings and will be submitted to regulatory authorities
In March, a phase 2a study started with rozanolixizumab (UCB7665) in myasthenia gravis (MG), a rare, debilitating neurological auto-immune disease. First results are expected in Q2 2018.
All other clinical development programs are continuing as planned.
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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 7 500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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