Otsuka and Lundbeck to co-promote Abilify in UK

by JoelLane 8. March 2013 11:42

abilify Pharmaceutical companies Otsuka and Lundbeck have expanded their collaboration to include the promotion of schizophrenia drug Abilify (aripiprazole) in 14 EU countries from 1 April.

The two companies will co-promote Abilify, which is currently marketed by Otsuka, in the UK and six other European countries.

Lundbeck will promote the antipsychotic drug in Ireland and six other EU countries.

The collaboration covers all forms of Abilify that are available: three oral formulations and the rapid intramuscular injectable version.

Abilify is now the biggest-selling drug in the US, despite the limited incidence of schizophrenia (an estimated 1% of the population).

Otsuka and Lundbeck will jointly promote Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the UK, while Lundbeck will promote it in Austria, Belgium, Ireland, the Netherlands, Poland, Portugal and Romania.

Taro Iwamoto, President of Otsuka, said: “The agreement will further strengthen the Abilify brand in Europe and also position Otsuka and Lundbeck to successfully develop and launch up to five more new products there.”

The partners are about to launch a new monthly injectable version, Abilify Maintena, in the US, and submitted it to for EMA approval in December 2012.

Ulf Wiinberg, CEO of Lundbeck, commented: “Abilify Maintena represents a treatment option for patients and their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching this first product as part of our extensive global alliance.”

Aripiprazole is a partial D2 dopamine receptor agonist that has been shown to reduce the risk of relapses in people suffering from schizophrenia.

Otsuka and Lundbeck signed an agreement to collaborate in the development and promotion of drugs to treat central nervous system disorders in November 2011.

EC approves Rebif label extension

by JoelLane 25. January 2012 13:42

Pf product news The European Commission (EC) has approved a label extension for Rebif (interferon beta-1a), Merck Serono’s drug for relapsing multiple sclerosis (MS), to cover treatment for early stages of the disease.

The new indication, which applies to all EU member states, includes the use of Rebif in patients who have experienced a single ‘demyelinating event’ or symptom of MS (such as a characteristic visual or muscular episode).

The approval was based on the results of the REFLEX study, which showed that Rebif could delay or prevent the onset of full MS in this patient population.

Rebif is an injectable interferon drug used to reduce nerve inflammation. It was approved for use in treating relapsing MS (the most common form of the disease) in Europe in 1998.

The REFLEX study was a two-year, placebo-controlled Phase III trial with 517 patients considered at risk of developing MS due to a recent isolated demyelinating event and brain scans indicating early signs of MS.

The incidence of conversion to MS (by McDonald criteria) was 86% in the placebo group and 62% in patients who received Rebif three times a week, showing that Rebif reduced the risk of conversion to MS over two years by 51%.

Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono, said: “Multiple sclerosis has an initial stage when clinical manifestations are not pronounced but irreversible neurological damage is taking place. Throughout the European Union, neurologists will now be able to prescribe Rebif for patients with early signs of this devastating disease.”

MS, a chronic inflammatory condition of the central nervous system, affects an estimated two million people worldwide, causing disability and death.

Based in Geneva, Germany, Merck Serono is the biopharmaceutical division of global pharmaceutical corporation Merck KGaA.

Double approval for Bioness’ hand paralysis system

by emma 6. October 2011 14:00

MB product news

US rehabilitation therapy company Bioness has received CE Mark Approval and FDA clearance for its Ness H200 Wireless system for hand paralysis patients.

The advanced wireless hand rehabilitation device uses mild Functional Electrical Stimulation (FES) to help patients to grasp and release objects while performing daily life activities.

The Ness H200 Wireless system aims to improve hand function, increase therapy time and encourage motor recovery in those suffering from hand paralysis resulting from stroke or other central nervous system disorders.

Todd Cushman, Senior Vice President of Global Business Development and Marketing for Bioness, said: “It is well known in rehabilitation that frequency of therapy and training has a direct impact on outcomes. Simply put, the more patients are able to be active and integrate therapy into their day to day lives, the better their outcomes.”

The device consists of three components: a wireless, lightweight stimulation support (orthosis); a small handheld remote that communicates wirelessly with the system; and a clinician’s programmer that allows patient activity tracking.

The company expects the equipment will become commercially available to neurorehabilitation hospitals and centres in the US and Europe, as well as to consumers for home use, later this year.

Based in California, Bioness specialises in neurostimulation devices to restore mobility and independence to people suffering from nerve damage.

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