Tuesday, November 20, 2012

UCB and NewBridge enter into an exclusive partnership agreement to promote UCB's core products in the AfMET markets

UCB and NewBridge Pharmaceuticals, a specialty therapeutics company focused on commercializing pharmaceuticals, biologics, diagnostics and medical devices serving the AfMET markets (Africa, Middle East, Turkey & Caspian regions), today announced an exclusive partnership agreement to make UCB’s core products Cimzia®, Vimpat® and Neupro® available in several Middle East and African countries.

Under the agreement, NewBridge acquires the rights to Cimzia®, Vimpat® and Neupro® from the RX Group, UCB’s previous partner in the region. UCB will now operate with its new partner for the region and will supply NewBridge with the three products on exclusive basis. NewBridge will also be responsible for managing the local regulatory approval process, future commercialization, and pharmacovigilance in each of the relevant countries. This transaction does not impact UCB's financial guidance for 2012.

Joe Henein, President and CEO of NewBridge explained: “This transaction represents a major milestone for NewBridge as we execute on our high growth strategy to provide access to innovative therapeutics in our core markets of the Middle East and Africa. We strongly believe that Cimzia®, Vimpat® and Neupro® have great potential in our territory and will contribute significantly to the physicians’ abilities to treat patients with immunologic and CNS afflictions respectively, thereby improving quality of life for these patients.”

About Cimzia®
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia® for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderately to severely active rheumatoid arthritis. Cimzia® in combination with MTX is approved in the EU for the treatment of moderate to severe active RA in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.
Please visit www.cimzia.com for full prescribing information for CIMZIA®.

About Neupro®
Neupro® (rotigotine) is approved in the European Union for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease, as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or on-off fluctuations). Neupro® is also approved in the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Neupro® (rotigotine)in the US is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease and moderate-to-severe primary Restless Legs Syndrome (RLS). For more information about Neupro visit www.neupro.com.

About Vimpat® (lacosamide)
Vimpat® (film-coated tablets, syrup and solution for infusion) was launched in the European Union in 2008 as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. Vimpat® solution for infusion may be used when oral administration is temporarily not feasible. Vimpat® syrup (10mg/ml) was approved for use in the European Union in 2012.
The maximum recommended daily dose for Vimpat® in the European Union and the U.S. is 400 mg/day.
Vimpat® tablets and injection were launched in the US in May 2009 as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. Vimpat® injection is a short-term replacement when oral administration is temporarily not feasible. Vimpat® oral solution was launched in June 2010.
The availability of the oral tablets, oral solution, and IV injection allows for consistent treatment in a hospital setting. The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat® -treated patients, and greater than placebo, were dizziness, headache, nausea and diplopia. Additional important safety information for Vimpat® is available at the end of the press release.
About UCBUCB, 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 8 000 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).

About NewBridge Pharmaceuticals
NewBridge Pharmaceuticals is a specialty therapeutics company focused on pharmaceuticals, biologics, and medical diagnostics serving the AfMET markets (Middle East, Africa, Turkey, and Caspian regions) to address the unmet medical needs of diseases with high regional prevalence. Headquartered in UAE with strong local and international business network, NewBridge is uniquely positioned as the partner-of-choice for companies seeking to create value for their medical products in the high growth emerging AfMET markets. NewBridge was founded by Burrill & Company Venture Capital arm and by the Kuwait Investment Authority’s National Technology Enterprise Company – (NTEC°
For more information please visit www.nbpharma.com .

Source - UCB Press Release

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