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Chicago, 09:00 CDT, 24th June, 2008 - Results from the PREPARED study confirm that Requip-Modutab (ropinirole prolonged release tablets) offers a highly effective and more simplified treatment regimen compared to ropinirole 3x daily, by providing continuous delivery of ropinirole day and night from a single daily dose.

Professor Stocchi, lead trial investigator and Professor of Neurology, IRCCS San Raffaele, Rome, Italy commented: “For PD patients, continuous control of symptoms throughout the day and night is critical. Patients currently experience unpredictability in managing their disease on a daily basis. The results of the PREPARED study verify that Requip-Modutab is extremely effective in treating the complex, unpredictable nature of the disease. By using the Requip-Modutab treatment approach, patients are able to achieve clinically more significant outcomes compared with the intermittent delivery of ropinirole 3x daily. The improvement in symptom control provided by Requip-Modutab should significantly improve patients’ quality of life.”

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Jerusalem, Israel, June 16, 2008 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today the successful completion of ADAGIO, the phase III study designed to demonstrate that AZILECT^® 1 mg tablets can slow down the progression of Parkinson's disease. In the trial, the currently marketed AZILECT^® 1 mg tablets met all three primary end points, as well as the secondary and additional end points, all with statistical significance. The study also confirmed the safety and tolerability of AZILECT^®.

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The new storage conditions are intended to reduce the possible occurrence of crystallisation of the active substance which has been reported in patches of Neupro.

Neupro is a centrally-authorised medicine used for the treatment of Parkinson’s disease. Its active substance, rotigotine, is a dopamine agonist. Neupro is the only medicine for Parkinson’s disease that is administered as a transdermal patch.

See also News item Neupro® recall (27 March 2008)

• Read Full Report

Untrained, unsuspecting consumers are vulnerable to the potentially lethal outcomes of buying medicines online. The EAASM Counterfeiting Superhighway report reveals the scope and repercussions of this dangerous practice through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines.

Key findings from this report:

• 62% of medicines purchased online are fake or substandard (including medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions).
• 95.6% of online pharmacies researched are operating illegally.
• 94% of websites do not have a named, verifiable pharmacist. Over 90% of websites supply prescription-only medicines without a prescription.

The report concludes by providing recommendations based on the research findings and calls all stakeholders including search engines, credit card companies, shipping companies, patient groups and regulators, to take action and halt this dangerous trend.

Article 18 of the Regulation provides that small and medium-sized enterprises (SMEs) developing advanced therapy products may submit to the European Medicines Agency quality and, where available, non-clinical data, for scientific evaluation and certification. Provisions for the evaluation and certification of such data must be laid down by the Commission.

This public consultation document presents preliminary proposals to establish such provisions. The public consultation paper is available here.

Contributions to this public consultation should be sent by e-mail to nicolas.rossignol@ec.europa.eu, before 4 July 2008.

• Alliance MRI Full Press Release

The decision to postpone the Directive has been largely based on the results of the Crozier Study, commissioned by the UK Health and Safety Executive, to calculate and measure worker exposure around MRI equipment. The results demonstrated that the exposure limits in the Directive are definitely exceeded in a variety of MRI work situations, and possibly in all situations.

EU MRI exposure report

The European Commission has now published the report entitled “An Investigation into Occupational Exposure to Electromagnetic Fields for Personnel Working With and Around Medical Magnetic Resonance Imaging Equipment". The findings largely conform with the outcome of the Crozier study when the same situations were modelled. In addition, actual MR procedures were looked at and practical situations identified in which the exposure limits are exceeded.

Transposition in Member States

The EMF Directive been transposed in a number of member states, including Latvia, Lithuania, Estonia the Czech Republic, the Slovak Republic, Austria, and Italy. In Italy the Parliament has just recently voted on a national postponement of the legislation.

• Lund University News Release
• Nature Medicine: 6 April 2008 | doi:10.1038/nm1746

These are the main findings of a study on grafting of new neurons to the brain in patients with Parkinson’s disease. The study, headed by a team of researchers from Lund University in collaboration with London scientists headed by Professor Tamas Revesz, has been published in a recent issue of Nature Medicine.

Neupro® is indicated for the treatment of the signs and symptoms of early and advanced stage idiopathic Parkinson’s disease and is distributed by Schwarz Pharma, a company of UCB Group.

The global recall will cause an out-of-stock situation of Neupro® in the United States. However, please be reassured that Neupro® supply is sufficient in the UK and the rest of the European Union.

Photograph of a Neupro patch affected by "Snowflakes"

Click on image to enlarge

An issue relating to the manufacturing of Neupro® (rotigotine transdermal patch) has resulted in an unexpected visual appearance of some patches, resembling snowflakes (see example picture on reverse). This visual appearance is of no clinical relevance as long as the product meets approved specification. In the European Union, patches other than those of the recalled batches are within the approved specification.

It is important to emphasise that the issue is not one of product contamination or toxicity but rather one of possibly reduced efficacy of some patches. If a significant area of the patch is affected by the snowflake formation, the clinical performance of the product cannot be assured. We are bringing this to your attention so that you are in position to respond to inquiries that you may receive.

It is important that patients do not suddenly stop taking Neupro®, as this may cause adverse effects. If a patient is concerned about snowflakes or any other issue related to their Neupro® therapy, they should speak to their doctor.

If you or your members have any questions, please contact UCB Medical Information on 01753 534655.

Thank you for your understanding and assistance.

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On the 2nd April a letter to GP’s, Retail and Hospital Pharmacists, Neurologists and Geriatricians is also being distributed.

• Alliance MRI Press Release

This important vote represents another major, laudable step forward in the right direction. The European Parliament approved the postponement with a clear majority. Following the positive vote in the Parliament, the next major step in the legislative procedure will be the vote at the Council of Ministers, which is expected at the end of February.

Last year the European Alliance for Access to Safe Medicines (EAASM) commissioned a report written by Dr Jonathan Harper on European Patient Safety and Parallel Pharmaceutical Trade (PPT) – a potential public health disaster?

In the context of ultimate patient safety, a number of recommendations were made by Dr Harper both in terms of general pharmaceutical market functioning, as well as specific recommendations that address the potential problems of European PPT in the context of pharmaceutical supply chain security.

The report was first presented at the official EAASM launch meeting in the European Parliament on 20th November 2007 and has received excellent media coverage in the European press.

Consequently, the EAASM was delighted to see that the report made a significant contribution to a recent statement by Günter Verheugen, Vice President of the European Commission, who agreed that PPT “brings a considerable risk for the safety of patients”.

For more information, please read the article from Pharma Times website.

• Download EC report

On the basis of the outcome of the consultation process in 2007, the Commission intends to propose to the European Parliament and the Council amendments to the current rules on the provision of information to patients by the end of 2008. This proposal will put the interests of patients first and with this perspective should aim at reducing differences in access to information and should ensure the availability of good-quality, objective, reliable and non-promotional information on medicinal products.

For further information and to view the document in other languages, please see http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new.htm