UCB hosts its first Research and Development Day
* Positive phase II results in brivaracetam setting the new standard for epilepsy treatment beyond Keppra®
* Positive phase II results in seletracetam showing potent efficacy in very refractory patients
* Regulatory programme for Cimzia™ in Crohn’s disease is on track to prepare UCB well for the future - Easy to use self-injectable device to be filed upon approval
* First in man studies for anti-depressant, innovative triple target compound, UCB 106607
* Pre-clinical progress on Amgen-partnered sclerostin antibody to treat osteoporosisNew research approaches unveiled from seamless integration of large and small molecule research
Brussels (Belgium), 26 September 2006, 7:00 AM CET – UCB announces its R&D Day in London, providing a comprehensive overview on the most significant projects in research and clinical development.
Roch Doliveux, Chief Executive Officer at UCB, comments: “UCB’s promising R&D pipeline is our biggest asset for the future. Our strong investment in R&D, currently reaching 27% of sales, is focused on generating the innovative medicines that will build UCB into a next generation global biopharmaceutical leader through making a tremendous difference in the treatment of severe diseases with high unmet medical needs.”
Melanie Lee, Executive Vice President, Research & Development, states: “UCB’s bright prospects are mainly driven by the expertise and talent in our R&D organisation. We have developed unique technologies and platforms that are yielding the innovative medicines that will lead UCB’s path into a new era. I am proud to say that here at UCB we have created a stimulating and vibrant environment for our scientists enabling us to shape a biopharmaceutical company of the next generation.”
Melanie Lee, Executive Vice President, Research & Development, concludes: “UCB’s R&D efforts are focused on three core therapeutic areas of expertise: neurology, immunology and oncology, developing innovative medicines that are truly differentiated by the combination of biology with chemistry. UCB has a strategy to leverage discovery efforts in-house as well as capitalising on exciting late stage novel compounds that are available elsewhere, maximising the pipeline from new target discovery through to commercialisation. I am confident that UCB’s pipeline will continue to show innovations, delivering medicines that treat severe diseases. 2006 is an exciting year for UCB as we have achieved major development milestones.”
UCB Research is based in three centers of excellence: Cambridge (UK) for inflammation and Braine-l’Alleud (Belgium) for CNS and Slough (UK) for oncology as well as antibody projects and biological technologies.
Highlights of the UCB R&D Day
Central Nervous System (CNS)
UCB discloses positive phase II clinical data on brivaracetam and seletracetam in the adjunctive treatment of partial onset seizures in epilepsy further strengthening the future of its epilepsy franchise.
Brivaracetam and epilepsy - Positive phase II results
Two phase IIb dose finding studies were conducted with brivaracetam in epilepsy, testing a dose range of 5 to 150 mg/day.
A phase II clinical trial (N01193) evaluating the efficacy and safety of brivaracetam (5, 20 and 50 mg per day) in the adjunctive treatment of adult patients (16-65 years) with refractory partial onset seizures, with or without secondary generalisation, met its primary end point. Brivaracetam was shown to reduce seizure frequency over placebo in patients with partial onset seizures that were not fully controlled despite treatment with one or two concomitant anti-epileptic drugs. At a dose of 50 mg per day, brivaracetam reduced seizure frequency by 53% compared with a 22% seizure reduction with placebo. The responder rates were 56%, 44%, 32% and 17% for the 50 mg, 20 mg, 5 mg and placebo group respectively.
A second phase II study (N01114) confirmed efficacy at 50 mg brivaracetam per day with the higher dose evaluated (150 mg per day) not conferring added efficacy. At a dose of 50 mg per day, brivaracetam reduced seizure frequency by 38% compared with a 19% seizure reduction with placebo. The responder rates were 33%, 40%, 23% for the 150 mg, 50 mg, and placebo group respectively.
In both studies, brivaracetam was well tolerated with no obvious differences in the type, or incidence of adverse events observed between dose groups and placebo. The studies also demonstrated strong efficacy. Both studies included patients who were not controlled by Keppra®, therefore brivaracetam mayprovide benefits to patients who failed on Keppra®.
Peter Verdru, MD, Vice-President, Clinical Research, Neurology/Psychiatry, UCB comments: ‘We are impressed that brivaracetam has shown such potent anti-epileptic activity in these therapeutic studies, as well as favourable tolerability at doses evaluated across the two phase II trials. The combination of this robust efficacy and good tolerability is very promising. Based on these studies we are currently planning phase III trials which will be initiated in the first half of 2007.”
Troy Cox, President, CNS Operations, UCB comments: “It appears that brivaracetam will become the new standard to beat in epilepsy. Such efficacy and tolerability data, which includes patients currently or previously taking Keppra®, strongly suggests that brivaracetam is clearly differentiated.”
Brivaracetam and post-herpetic neuralgia
UCB also announces today clinical results from a phase II study (N01162) evaluating brivaracetam in the treatment of patients (more than 18 years) with post-herpetic neuralgia. In this study the primary end point was not met. However, this trial re-affirmed the favorable tolerability profile of brivaracetam.
Seletracetam and epilepsy - Positive phase II results
Two phase IIa dose exploration studies were conducted with seletracetam in epilepsy (N01191 and N01192) evaluating the efficacy and safety of seletracetam in the adjunctive treatment of partial onset seizures in highly refractory adult patients currently receiving up to three concomitant anti-epileptic drugs.
Study N01192 specifically evaluated the efficacy and safety of seletracetam in patients experiencing partial onset seizures while receiving Keppra® as one of the concomitant drugs.
Study N01191 evaluated the efficacy and safety of seletracetam in patients with refractory epilepsy suffering from partial onset seizures (whether or not secondarily generalized) and treated with one, two or three approved antiepileptic drugs.
In both studies, similar efficacy was observed with seletracetam reducing seizure frequency by approximately 40% from baseline. Seletracetam was also well tolerated over the dose range evaluated (20 mg – 160 mg per day). Efficacy was demonstrated in very refractory patients, including patients failing on Keppra®.
Keppra® XR- Phase III results expected in Q4 2007
UCB provides an update on Keppra® XR, the extended release formulation. Enrollment in a phase III clinical trial has started and results are expected in the fourth quarter of 2007. Keppra® XR may provide a valuable alternative to the currently available treatments; due to its expected advanced profile and once daily convenience and compliance.
UCB 106607 and depressive disorder – Onset of phase I studies
UCB unveils a phase I clinical development programme with UCB 106607, an innovative triple target antidepressant drug candidate with the potential to address unmet medical needs in major depression. Phase I studies were initiated during August this year with results expected in Q1 2007.
CDP 323 in multiple sclerosis – Phase II study expected to start in Q1 2007
UCB provides a top line update on the clinical programme evaluating CDP 323 in healthy volunteers. CDP 323 is a potent and orally active small molecule antagonist of alpha 4-integrin. A phase I trial in human volunteers was successfully completed allowing UCB to progress to a phase II study in Multiple Sclerosis in Q1 2007.The results of phase I studies will be presented at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting to be held in Madrid on 27 September 2006.
UCB presents further insights into the mode of action of its novel compound Cimzia™ (certolizumab pegol), a promising potential treatment in a number of inflammatory diseases. UCB confirms that all ongoing development and regulatory activities are on schedule.
Olav Hellebo, Senior Vice President, Inflammation Operations, comments: “Cimzia™ is a unique example of UCB’s cutting edge research. Cimzia™ is the first PEGylated Fab’ fragment of an anti-TNF antibody, a result of our combined expertise in biology and chemistry. From our Crohn’s development programme, Cimzia™ appears to be well-tolerated with excellent efficacy and a stable and consistent dosing regimen, thus being well positioned in the anti-TNF market.”
Cimzia™ in Crohn’s disease – Easy to use self-injectable device to be filed upon approval
Cimzia™ has demonstrated a significant level of efficacy in the treatment of Crohn’s disease in the PRECiSE 1 and PRECiSE 2 clincial trials. The regulatory submission programme for Cimzia™ in Crohn’s is on schedule with potential approval in the US in H1 2007 and in Europe in H2 2007. An extensive phase IIIb programme has been initiated in both US and Europe: the WELCOME study, involving patients who have lost response or who are intolerant to infliximab, and the MUSIC study, a mucosal healing study. Following the approval of Cimzia™ in Crohn’s disease, UCB is planning to file an easy to use, self-injectable device with both US and European regulatory authorities.
Cimzia™ in rheumatoid arthritis – Results of phase III trials expected in early 2007
The ongoing phase III studies, RAPID 027 and RAPID 050 are on track, with the RAPID 050 trial having recently achieved the last patient, last visit milestone. Dosing is also complete in the RAPID 027 study. Data analysis and key results of both studies are expected in early 2007.
Epratuzumab in Systemic Lupus Erythematosus (SLE)
UCB provides an update on the phase III clinical development programme of Epratuzumab in SLE.
UCB announces that it has voluntarily suspended dosing in the phase III clinical studies in the SLE programme following a routine quality assurance audit of the Immunomedics facilities. In the following discussions with the FDA, the authority placed epratuzumab on a “clinical hold”. European regulatory authorities have been informed and at least one has also put studies on a “clinical hold”. UCB is currently working diligently with Immunomedics to address observations. UCB is particularly concerned that patients that already benefited from epratuzumab are able to resume treatment as soon as possible. UCB is fully committed to the full development of epratuzumab in inflammatory autoimmune disorders.
Oncology - Results of phase II study in non small cell lung cancer expected in Q1 2007
UCB provides an update on CDP791 and CMC544. CDP791 is a specific and potent inhibitor of VEGFR-2 and is currently being evaluated in a phase II study in non-small lung cancer. Results of the phase II study are expected in Q1 2007. CMC 544 is a potent chemotherapeutic, an IgG4 antibody which delivers calicheamicin to CD22 positive cells. The compound is currently being evaluated in phase I/II trials in patients with B cell Non-Hodgkins lymphoma. The compound is being co-developed with Wyeth.
Osteoporosis - UCB entering a new therapeutic area
UCB unveils progress of its collaborative antibody project with Amgen to develop a novel anabolic therapy, entering the field of osteoporosis, a new therapeutic area for UCB. The collaboration with Amgen was established in 2002 and covers antibodies to sclerostin that may potentially treat osteoporosis. The programme is supported by extensive human, genetic and pre-clinical data demonstrating that this novel antibody approach inhibiting sclerostin, has a high potential to transform the treatment of bone disease. The companies have now selected high affinity sclerostin antibodies for further development in clinical studies.
SLAM (Selected Lymphocyte Antibody Method) and Antibody to Hit Technology – UCB unveils new research approaches
SLAM is a method to culture B cells that produce antibodies and to subsequently isolate the antibody encoding genes for further expression in recombinant systems. The original technology was in-licensed from Abgenix. UCB has further developed this technology to make it the cornerstone of its antibody discovery platform allowing the selection of high affinity antibodies from a broad pool for each new target. Within UCB’s laboratories this technology is operated in a high throughput and automated manner enabling a throughput not previously possible for antibody selection.
Antibody to Hit Technology is a new technology arising from the synergy of our biologicals and small molecule chemistry research. The concept is to use advanced antibody technologies to generate very high affinity antibodies that bind a specific target protein, to analyse this alongside structural biology data of the protein being examined and then to marry this with computational chemistry and medicinal chemistry drug design. The integration of these disciplines offers new insight and promise for deriving new molecules for novel targets.
Notes to Editors
UCB is holding a press conference call today at 8.00 AM (London) / 9.00 AM (Brussels) . To enter the conference call, you will need to dial one of the following numbers and mention the password “UCB”
Dial in numbers:
US: 1866 432 7186
The webcast of the R&D Day is available on the Internet at: www.ucb-group.com
UCB (www.ucb-group.com) is a leading global biopharmaceutical company dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in over 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange and its worldwide headquarters are located in Brussels, Belgium.
This news release contains forward-looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance, or achievements of UCB or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward looking statements. The statements in this press release represent UCB’s expectations and beliefs as of the date of this press release. UCB anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while UCB may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing UCB’s expectations or beliefs as of any date subsequent to the date of this press release.
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