No more Mr NICE Guy

by JoelLane 14. May 2013 14:15

Sir Michael Rawlins (resized) US biopharma company Intra-Cellular Therapies, Inc. (ITI) has appointed former NICE Chairman Professor Sir Michael Rawlins to its Board of Directors.

Rawlins’ experience in the field of drug assessment, from both clinical and economic perspectives, will be of value to ITI’s ambitious programme of drug development to treat psychiatric and neurological disorders.

As Chairman of NICE from its inception in 1999 to March 2013, Rawlins had a complex relationship with the pharmaceutical industry, which respected his expertise but sometimes challenged his priorities.

With a background in medical practice and clinical pharmacology, Rawlins recently became President of the Royal Society of Medicine, and has received numerous medical awards.

Sharon Mates, CEO of ICT, said: “We are excited to have Sir Michael Rawlins join our board. His expertise in the cost-effectiveness of new pharmaceuticals and other issues in health economics will be invaluable to Intra-Cellular Therapies.

“I look forward to working closely with Michael as we transition our clinical programs through late-stage development and commercial approval.”

Rawlins commented: “ITI has set itself on a course to develop outstanding new pharmaceuticals to treat CNS diseases, surely an ambitious task, but one in which I am pleased to join and help.”

Based in New York, ITI aims to develop drugs for the treatment of dementia and major psychiatric disorders. Its novel antipsychotic ITI-007 is currently undergoing phase II clinical trials as a treatment for schizophrenia.

Survey finds widespread misconceptions of Parkinson’s disease

by JoelLane 15. April 2013 13:09

Ali-Fox A survey by charity Parkinson’s UK has found that many patients have been affected by public ignorance about the condition.

A stereotyped image of Parkinson’s disease (PD) sufferers as elderly people with tremors has led to 20% of patients being misidentified as drunk.

Half of the patient group have experienced discrimination due to their movement and communication problems.

A famous historical example is the pulp magazine editor Farnsworth Wright, sacked and left to die in poverty despite the perfect clarity of his mind.

Boxer Muhammad Ali and actor Michael J. Fox, among others, have done much to raise public awareness of PD in recent years.

A progressive neurological condition, PD affects over 120,000 people in England, causing both uncontrollable tremors and difficulty with certain types of movement, including facial expressions.

A survey of more than 2,000 people with PD discovered that one in five had been mistaken for being drunk, while one in ten had experienced hostility or verbal abuse because of their condition.

Not surprisingly, over a third said they felt isolated when in public, while over half said they felt afraid. A shocking 10% reported discrimination at work.

One patient, Mark Worsfold, was arrested while watching a road race because his lack of expression (a common PD symptom) struck the police as ‘suspicious’.

Speech, language and facial expressions can also be affected.

Steve Ford, Chief Executive of Parkinson’s UK, said: “Misunderstanding has sentenced people with Parkinson’s to a life of hurtful comments, being refused service in shops and even being shouted at in the street.”

New name for psychiatric drug firm

by JoelLane 9. April 2013 16:26

Depressed-Woman-Public-Domain-300x199 London-based pharma company Dainippon Sumitomo Pharma Europe (DSP Europe) has changed its name to Sunovion Europe.

The new name reflects the development of DSP’s European subsidiary into a more active commercial organisation, shortly to launch a new schizophrenia drug.

Sunovion Europe will focus on products to treat mental health and neurological disorders – including the atypical antipsychotic lurasidone hydrochloride, which it plans to launch in Europe shortly.

The company will also develop and market specialised drugs for disease areas where there is unmet medical need.

Lurasidone hydrochloride, a generic drug, has been submitted to the European Medicines Agency (EMA) for treatment of schizophrenia by DSP’s European partner, Takeda.

Dr Mike Taylor, Managing Director of Sunovion Europe, said: “This represents a significant landmark in the evolution of our European business as we prepare to commercialise our first drug in the UK.

“At Sunovion Europe we focus on the development and introduction of innovative medicines that improve people’s health and well-being. We will continue to focus on psychiatry and neurology, and over time will grow the European business to include other areas.”

Dainippon Sumitomo Pharma (DSP) is a multi-billion dollar company based in Japan. It was formed by the merger in 2005 of Dainippon Pharmaceutical Co. and Sumitomo Pharmaceuticals Co.

With a growing product portfolio and pipeline, DSP aims to become a major supplier of innovative treatments in psychiatry, neurology and oncology.

OTC medicines are derailing drug regimes

by JoelLane 30. October 2012 17:52

st-johns-wort-tincture-capsules web Widely prescribed drugs including insulin, warfarin and aspirin are less effective in patients who take herbal medicines and dietary supplements.

A systematic review of relevant studies showed that popular OTC products such as St John’s wort and magnesium and calcium supplements interact with many prescribed drugs.

The researchers have recommended that GPs find out and record any OTC medicine use by patients for whom they are prescribing.

The review covered 85 studies of interactions between prescribed medicines and herbal medicines or dietary supplements, finding 882 distinct interactions.

The prescribed drugs with the greatest number of reported interactions were warfarin, insulin, aspirin, digoxin and ticlopidine.

The herbal medicines and supplements with the most interactions were St John’s wort, magnesium, calcium, iron and ginkgo – found to interact with 147, 102, 75, 71 and 51 prescribed drugs respectively.

In 42% of cases, the drug interaction was caused by the OTC product altering the pharmacokinetics of the prescribed drug.

Where the interaction meant an outright contraindication (25% of cases), the most frequent involved treatments for gastrointestinal disorders (16.4%), followed by neurological disorders (14.5%).

Professor Edzard Ernst of the University of Exeter said: “We have to become vigilant and finally agree to monitor this sector adequately. Each individual doctor can contribute to this process by routinely including questions about alternative medicine use.”

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.

Medtronic launches spinal stabilisation device

by emma 8. November 2011 16:26

Medtech Product News

Medtronic has launched its T2 Altitude expandable corpectomy device for spinal stabilisation and correction worldwide.

The expandable vertebral body replacement cage features a self-locking mechanism that removes the need for placing a set screw during surgery, using bone graft to create contact to encourage fusion with the device.

Doug King, Senior Vice President and President of Medtronic Spinal, said that the new product demonstrates the company’s “long-term commitment to therapies for complex spine disorders for spinal tumour, trauma and deformity patients”.

Cancer patients can also benefit from the product. If the cancer has spread to the spine, the surgeon may replace the affected vertebrae with the T2 Altitude device.

More than 150,000 spinal fractures occur in North America every year, of which approximately 11,000 are spinal cord injuries.

Based in Memphis, Medtronic Spinal provides advanced treatment through the collaboration with surgeons and researchers to offer affordable, minimally-invasive products and medical technologies for neurological, orthopaedic and spinal conditions.

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