Ongoing Souvenaid US Clinical Trial – Currently Recruiting
The S-Connect study, with 40 sites across the US, is currently recruiting patients. This US trial expands on the previous 12 week, multi-country trial which showed that Souvenaid® improves memory in early stage Alzheimer’s patients.

Get details on the second Souvenaid® clinical trial. See the list of clinical trial sites.

Memory and Nutrition
The effect of nutrition on healthy aging and brain health has become a topic of interest among the scientific community and general public. Research has shown that environmental factors as well as nutrition play a role in the early process leading to the development of memory loss. A growing body of evidence shows that certain diets, such as the Mediterranean diet, are associated with a lower risk of developing dementia or Alzheimer’s Disease. The Mediterranean diet is characterized mostly by a higher intake of fish, vegetables, legumes, fruits, cereals, and unsaturated fatty acids, and a lower intake of saturated fatty acids, dairy, meat, and poultry. Essential brain nutrients include omega-3 fatty acids, choline, anti-oxidants and certain vitamins. Animal studies show that combinations of specific nutrients have a considerable effect on the brain. When combined, these nutrients play a significant role in the building of nerve connections, creating the pathways that allow for communication and memory.

Recent developments of the financing of disease management programs in Germany, Holland and other countries are discusses in more detail there. Are you interested to present a paper during this congress? Please click here, read the call for abstracts and submit an abstract.

B. Braun has delivered innovative healthcare products, services and educational programs that enhance the care and safety of patients and healthcare professionals in the fields of drug delivery, IV therapy, pain control, clinical nutrition, dialysis and vascular intervention.

Companies in the healthcare industry present a sparkling array of product innovations plus tailor-made services

“The short innovation cycle in this industry is a crucial success factor of the world’s No.1 event for the sector – MEDICA. After all, the most exciting innovations are presented here year after year. The second economic stimulus package initiated by the Federal German Government with its associated investment aid to the tune of EUR 1.4 billion for German hospitals attracted to MEDICA a high number of decision-makers, also from domestic hospitals, after several years of abstention”, said Wilhelm Niedergöker in the light of the continued good response from both exhibitors and visitors.

In particular in the field of surgery, which is seen as cost-intensive, visitors to MEDICA 2009 were presented with a wide variety of new innovations that permit significant savings. For example, €22 million could be saved per annum by the use of so called resorbable pins, which are used to stabilise bone (source: study by ZVEI/ SPECTARIS/Droege). Previously, surgeons have typically stabilised fractures of the facial skull using titanium plates and screws. The drawback of this method is that once the fracture has healed, the implants need to be removed, requiring a second operation. Synthetic pins, such as those presented at MEDICA by a medical technology company from Tuttlingen, are dissolved in the body. They are welded to the bone with the aid of ultrasound.

A special operating microscope, which was also presented at MEDICA, allows rapid and improved visualisation of blood flow – enabling burst blood vessels to be seen even in the course of an operation, doing away with the need for complex and costly follow-up operations, according to the manufacturer, as well as reducing the high costs for the treatment of associated diseases. The total savings potential of this innovation is estimated to be approximately €10 million per annum.

Numerous innovations for medical imaging

The developments emerging in the field of imaging were also the topic of many conversations between MEDICA visitors. One fact that is particularly worth mentioning in this respect is a new generation of ultrasound devices designed for use in the diagnosis of nerve diseases. Special surface ultrasonic probes make it possible to not only image the nerve but also the surrounding tissue structures, making nerve tumours, nerve inflammations and injuries visible.

New developments in the field of ultrasound devices should also render good services in anaesthesia. For instance, the new devices for administering local anaesthesia presented at MEDICA 2009 will allow the position of the needle to be verified very precisely when injecting the anaesthetic as well as monitoring its distribution in the target structure for the operation. “The use of ultrasound is undoubtedly the most important current development in regional anaesthesia and has the potential of revolutionizing regional anaesthesia,” said Anaesthesiologist and Chief Physician of the Clinic for Anesthesiology and Intensive Care Medicine at Worms Hospital, PD Dr. Egbert Hüttemann.

In addition to the development of innovative methods, industry is also placing a greater emphasis on tailor-made services, as Jochen Franke, Chairman of the MEDICA Advisory Board, CEO of Philips GmbH Healthcare and chairman of ZVEI, the German Electrical and Electronic Manufacturers’ Association, explains: From requirement analysis and the procurement process through to equipment maintenance, a number of manufacturers offer hospitals tailor-made solutions for their equipment pool – if requested at an all-inclusive price and even covering equipment made by other manufacturers. In this respect, MEDICA provides a window onto the future of what lies in store in terms of integrated workflows in the future.“

Telemedicine is forging ahead – in outpatient as well as inpatient care

Not only in hospital operating theatres or in doctors’ surgeries are the new innovations in the field of medical technology presented at MEDICA 2009 already being put to use. Patients are also being increasingly included in outpatient care, too. The trend towards home medicine and telemedicine applications continues unabated. While in the past electronic thermometers were the only medical devices to be found in private homes, these days we see the advent of measuring devices for a wide variety of vital data such as mini ECG sets, for instance. The opportunities presented by these “self-payer products” in terms of prevention and remote patient monitoring appear to be far from exhausted so far. For example, there were various heart monitoring systems that are incorporated in clothing, which are currently still at the experimental stage, on show at MEDICA 2009. They are comfortable to wear and make for uncomplicated patient monitoring over extended periods of time.

International congress programme proved very popular

The MEDICA Congress once again had a wide range of topics in store this year. The international continuous medical education module in English, which was included in the programme for the first time, attracted a lot of attention. Integral diagnostics and therapy in the fields of oncology, patient monitoring at ORs/ICUs and trends in the area of heart surgery were the main topics that met with great interest. Another international event was dedicated to palliative medical care and special care concepts for people in the final stages of life. Of the lectures delivered in German, those on the most important common diseases, for example, on cardiovascular diseases, diabetes and, in particular this year, depression and hardness of hearing, proved the most popular“, said Dr. Julia Rautenstrauch, Secretary General of MEDICA – German Association for Interdisciplinary Medicine, summing up the encouraging feedback from those who had attended the lectures.

“Hospital Policy after the General Elections” was the guiding theme of the 32^nd German Hospital Conference, attended by 2,215 participants interested in finding out more about the current health policy plans of the various political parties in the German Parliament for the 17^th legislative period and their potential financial impact on hospitals.”

COMPAMED 2009 attracted over 16,000 visitors

Even more visitor attention was attracted by COMPAMED 2009, the trade fair starting in parallel with MEDICA and drawing to a close on Friday (20 November). Over 16,000 of the 138,000 trade visitors took a special interest in the subjects covered by the leading international trade fair for supplies to medical manufacturing. In Halls 8a and 8b a total of 518 exhibitors from 35 nations provided insights into their product and development know-how: from components and individual assemblies, micro system technology and nanotechnology applications to solutions for custom manufacturing, for example, innovations in the field of materials and process technology. Visitors to COMPAMED saw how lasers can be used to bond plastic components to other parts of a system, made of other materials, for instance, as well as being able to find out about new quality assurance processes. One of the processes presented, for example, was a method for applying identification codes, which can now be virtually invisible, even on transparent materials, providing strong protection against product piracy and the resulting low quality of imitation medical and pharmaceutical products. A focal theme of the product marketplace called “High-Tech for Medical Devices” organised by IVAM, the Professional Association for Micro-Technology, and the COMPAMED Forum were aspects of product development and high-technology components for processing medical products.

Dates for MEDICA 2010: 17. 17 to 20 November in Düsseldorf

Dates for COMPAMED 2010: 17. 17 to 19 November in Düsseldorf

Information on MEDICA online: http://www.medica.de

Information on COMPAMED online: http://www.compamed.de

In 2008 Rabouille received a ZonMW grant for a research project on integrin transport. These receptor proteins mediate signaling to epithelial cells and support epithelium adhesion and integrity. Rabouille’s research focuses on the regulation of integrin deposition in time and space in physiological and pathological conditions, including cancer. Indeed, when epithelial cells lose adhesion and attachment to neighboring cells, they can form tumors and metastasize.

The election as EMBO Members is a tribute to the significant contribution to the advancement of science made by each of these researchers. EMBO elects new members annually on the basis of scientific excellence. EMBO Members provide scientific input to the organisation, may participate in committees that guide the execution of EMBO activities, have the opportunity to mentor young scientists and may nominate candidates for the annual membership elections. Leading peer-reviewed journals – The EMBO Journal, EMBO reports and Molecular Systems Biology – span all aspects of molecular biology and reflect how science is shaping the world. EMBO-sponsored training and networking activities impact thousands of scientists every year, promoting collaboration in all areas of molecular biology – within Europe and worldwide.

The report, entitled Georgia health system performance assessment, issued on 17 November 2009, shows that the overall health status of the population has improved since 2000. In some areas, specifically health insurance coverage and primary health care, the country is in the midst of implementing significant reforms to achieve national objectives. The report documents the measures adopted by the Government in recent years to ensure coverage and access by the poorest Georgians to essential health care services through its Medical Insurance Programme. A positive finding highlighted in the report is the extension of health insurance coverage to some 750 000 people living below the poverty line in 2008 a 12% increase compared to 2007.

Nevertheless, in spite of these initial positive strides, the report indicates that significant challenges remain. While we are striving to improve the performance of the health system, and the health system is indeed performing better, this report provides critical information to help us take further action to make our system better, says Alexander Kvitashvili, Georgian Minister of Labour, Health and Social Affairs.

The report shows that a significant challenge remaining is the high burden of out-of-pocket payments for a significant number of people. This creates barriers to access to care when people need it, and also explains why the number of visits to doctors in 2007 was as low as 1.8 per person. The report advises that an increase in public health expenditure, which is still significantly lower than in other countries in Europe and central Asia, coupled with well-targeted investments in the health sector, will have a major impact on improving health and equity in the country.

The international community has a role to play in supporting the Georgian Government in addressing the challenges in the health system over the medium term. Indeed, as noted by Nata Menabde, Deputy Regional Director of the WHO Regional Office for Europe, the report gives sufficient background to better assist Georgia in building a stronger and more efficient health system and public health programmes. This objective is defined by our mandate and we will do our best to fulfil it.

Asad Alam, World Bank Director for the Caucasus Region, echoed this view by reiterating the Banks commitment, working with other partners such as WHO, USAID, the European Commission and other specialized agencies of the United Nations to support ongoing and additional health reform efforts in Georgia over the medium term to help create conditions for the operation of a high-performance health care system, with quality services, safe, efficient and accessible to all, building upon the evidence presented in the report.

Bron: WHO

In the first study, Tatsushi Toda of Japan’s Kobe University and colleagues sequenced the genes of 2,011 participants with the disease and 18,381 others without the disease.

They found that those with the disease had variants of the genes PARK16, BST1, SNCA and LRRK2.

Twin studies
In the second study, researchers led by Andrew Singleton at the National Institutes of Health’s laboratory of neurogenetics in the US analyzed the genes of more than 5,000 patients of European ancestry who suffer from the disease and detected strong links between Parkinson’s and variants of the genes SNCA and MAPT.

The two teams later compared their data and found that variants of PARK16, SNCA and LRRK2 carry risk of Parkinson’s in both Japanese and European populations, while variants of BST1 and MAPT were population-specific.

“With this better understanding of the underlying genetic variants involved in the progress of this disorder, we have more insight into the causes and underlying biology of this disease,” Singleton said. “We hope this new understanding will one day provide us with strategies to delay, or even prevent, the development of Parkinson’s disease.”

Read more: http://www.shanghaidaily.com/article/?id=419744#ixzz0X3tfiuv0

40 Years of MEDICA: World’s leading medical trade fair opens with record participation figures – 4,324 exhibitors from 60 nations
500 suppliers from 35 countries showing their new products and innovations at COMPAMED
From 18 to 21 November 2009 this week, the international medical sector will once again turn its attention to Düsseldorf. That is when the world’s leading medical trade fair, MEDICA 2009, 41st World Forum for Medicine and Congress, along with COMPAMED 2009, High tech solutions for medical technology – 18th International Trade Fair Components, Parts and Raw Materials for Medical Manufacturing (previous year: 137,000 trade visitors), will both open. In 1969 the MEDICA success story, at that time still known as “Diagnostic Week”, began to take shape. At the event’s premiere, 135 exhibitors occupied rented exhibition space of 2,500 square metres. At its 40th anniversary MEDICA 2009 will attract 4,324 exhibitors from 60 nations – a new record figure in the event’s history. COMPAMED, which has been held parallel with MEDICA since 1992, will again be registering a total of over 500 exhibitors from 35 nations this year (COMPAMED duration: 18 to 20 November 2009). Once again all 19 halls at the Düsseldorf Exhibition Centre will be fully booked for the combined event MEDICA and COMPAMED 2009.
After Germany, the largest demand for space at MEDICA 2009 (approximately 50,000 m²) has been registered from Italy (approximately 11,000 m²), China (6,000 m²), the United Kingdom (5,300 m²), USA (5,000 m²), France (4,400 m²) along with the Netherlands (3,000 m²).
According to the latest information provided by the sector associations SPECTARIS and ZVEI (German Electrical and Electronic Manufacturers’ Association), although the German medical device manufacturers are feeling the effects of the economic and financial
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crisis, the trend in domestic business is predominantly stable. For 2009 sales growth of around 2% is expected for the domestic market. In contrast, foreign business tends to be more difficult. In particular, trade with the sales markets of Russia, Turkey, Spain and the United Kingdom was characterized in the first half of the year by sales declines, in some cases reaching double-digit percentages, while trade with the US was also marked by a slightly declining trend. According to the sector associations’ information, in the first half of 2009 growth impulses were generated by trade with China and also the Middle East sales markets. For the whole of 2009, a two-percent decline in sales is expected to a total volume of approximately 17.8 billion Euros (export quota: 65 percent).
In the race for the best innovations the German “MedTech” industry is expected to have good opportunities again in future. Each year companies spend around 15 percent of their turnover on research and development, almost 15 percent of employees work in this sector. In terms of patents and the world trade share, Germany is in second place, right behind the USA.
Industry shows an appetite for innovation at MEDICA
Medical experts can see the innovativeness of the industry for themselves during their visit to MEDICA 2009. In a presentation clearly structured according to product groups, the event will show the entire spectrum of products, systems and services for medical care in doctors’ surgeries and clinics: ranging from medical technology/equipment and electro-medicine, laboratory technology and diagnostic appliances, physiotherapy products and consumables through to information and communication technology for health facilities right up to interior furnishings and Facility Management services.
In relation to the product range trends and apart from the inexorable progress of digitalization in the health service and digital networking of the players in the medical care process, there is also a clearly evident trend towards the increasing use of medical technology in the out-patient sector. In this regard there is an ever stronger trend towards home medicine and telemedicine applications. Whereas the clinical
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thermometer was for a long time the only medical appliance to be found in domestic households, blood pressure gauges or mini ECGs have also long since established themselves in the home. The target group for these so-called self-paying patient products is on the one hand health-conscious people wishing to constantly monitor their physical readings. On the other, numerous applications are also giving rise to treatment options with regard to telecare for chronically ill patients.
At MEDICA 2009 plenty of discussion topics will also be ensured by new developments in the area of imaging processes. Here for example ultra-sonic appliances for nerve disease applications will be presented. In this connection, special surface-ultrasonic transducer probes not only enable a nerve to be displayed but also all the structures surrounding it. This allows the recognition of nerve tumours, nerve inflammations or nerve damage.
In addition to the exhibitors’ product ranges the established programme features at MEDICA also include the MEDICA MEDIA Theme Park (Telemedicine / Hall 15), MEDICA VISION (Research Institutes’ Innovation Forum / Hall 3) and the Physiotherapy Forum (Hall 4). A special feature this year is the “40 Years of MEDICA” Special Show (Hall 10). Here visitors can marvel at medical technology and equipment exhibits from days gone by, for example ECG monitors for emergencies, treatment chairs or even a historic heart-lung machine.
Other key components of MEDICA are the MEDICA Congress with total participants at the last event of around 10,000 along with the German Hospital Conference (Deutscher Krankenhaustag).
For the first time the MEDICA Congress seminar programme will be extended this year to include international lectures in English. The five main themes span a broad range extending from medical imaging through to heart surgery, the latest diagnostic trends and cancer treatment up to palliative medicine.
In the meantime, the 32nd German Hospital Conference will be held on this year’s general theme of “Hospital Policy after the Elections” with its
lectures and discussions focusing on the health policy strategies of the Bundestag parties.
COMPAMED 2009 – High-tech solutions for medical technology
COMPAMED 2009 will be held in parallel with MEDICA 2009. Within the framework of the leading international trade fair for the suppliers’ market in the medical manufacturing sector, from 18 to 20 November 2009 in Düsseldorf once again around 500 exhibitors from 35 nations will be presenting a broad spectrum of new materials, components, upstream supplies and services through to complete contract manufacturing for the medical technology industry. Complex developments from the sectors of nano and micro technology will also be among the themes covered in Halls 8a and 8b at the Düsseldorf Exhibition Centre.
The gap between theory and practice is traditionally bridged by MEDICA and COMPAMED in cooperation with the German Hospital Conference (Deutscher Krankenhaustag, CCD. East). Here, in particular, themes relating to clinic management are covered. The main theme of the 32nd German Hospital Conference is “Shaping the future”. The conference will also pick up on the current restructuring processes at the around 2,100 German clinics.
The exhibition halls are open daily from 10.00 to 18.30 hrs, on Saturday up to 17.00 hrs (MEDICA only).
Further information available on the Internet: http://www.medica.de / http://www.compamed.de

Press pictures online: http://fotoservice.messe-duesseldorf.de/medica

With Robust Pipeline, Broader Product Portfolio and Expanded Global Presence

“With our merger now complete, we are ready to deliver on the promise of a new Merck built on a foundation of scientific innovation and dedication to the well-being of patients around the world,” said Richard T. Clark, chairman, president and chief executive officer of Merck.  “On ‘Day One’ for the new Merck, we are stronger and better equipped to make a difference in the lives of people globally through our broadened, diversified portfolio of innovative medicines and vaccines, and products for consumer and animal health.

“Our integration teams prepared us well for a strong start today, with thorough plans designed to ensure a seamless transition for our customers and employees,” added Mr. Clark.  “The combination of the considerable talents of Schering-Plough and Merck employees across the globe positions Merck to move through this dynamic time for our industry with a clear vision for the future.”

From the outset, Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal and consumer health products.  This portfolio is complemented by a robust pipeline with more than 15 promising late-stage candidates spanning critical therapeutic categories.  Merck now has approximately 106,000 employees and operates in more than 140 countries around the world, including emerging markets.  The company expects to generate more than 50 percent of its revenue outside the United States.

“The people of the new Merck share a passion for the good our medicines and vaccines can do for patients and a commitment to pursuing high-quality results with our customers and partners,” Mr. Clark said.  “Thanks to the talent and dedication of scientists at both companies, the combined company offers an outstanding clinical development pipeline that will greatly increase our ability to deliver important new medicines to patients.”

The company’s corporate headquarters will be in Whitehouse Station, NJ, as previously indicated.  In addition, the company’s U.S. organization for the Global Human Health division and Merck Research Laboratories will be headquartered in Upper Gwynedd, PA.  The former Schering-Plough headquarters in Kenilworth, NJ and Merck’s operations in Rahway, NJ, will continue to be important sites, with large and diverse operations encompassing marketing, manufacturing and research.   At this time, all other sites will continue to operate as they did before the merger.

Key Therapeutic Areas

The new Merck has a broad portfolio of medicines – an engine for consistent, sustainable growth – driven in part by the addition of valuable products with long periods of exclusivity.  By leveraging Merck’s expanded product offerings, the company expects to benefit from additional revenue growth opportunities.  For example, Merck will pursue expanded life-cycle management through the introduction of potential new combinations and formulations of existing products.

The company’s diverse portfolio of adult, adolescent and pediatric vaccines and medicines spans important therapeutic areas, including cardiovascular, diabetes, obesity, bone, respiratory, immunology, dermatology, infectious disease, oncology, neurosciences, ophthalmology, women’s health and endocrinology.

Diversified Businesses

The new Merck’s expanded portfolio also includes leading products from its Animal Health and Consumer Health Care business units.

Merck’s Animal Health business is a world leader with market-leading products for a broad range of species and strong growth potential.  The division has more than 1,000 marketed products and generates approximately $3 billion in revenues.

The company’s Consumer Health Care business has a number of attractive brands such as CLARITIN, COPPERTONE, DR. SCHOLL’S and MIRALAX.

Financial Highlights

Merck is targeting a high single digit non-GAAP EPS¹ compound annual growth rate from 2009 to 2013 (with the 2009 base representing Merck’s previous stand-alone non-GAAP EPS guidance of $3.20 – $3.30).   Additionally, in 2013, Merck is targeting free cash flow to be approximately $15 billion.  The combined company will have a strong balance sheet with cash and investments of approximately $8 billion at the time of the closing.  As previously indicated, Merck expects the transaction to be modestly accretive in 2010.

Merck also continues to expect to achieve substantial incremental cost savings of approximately $3.5 billion annually beyond 2011 which are expected to come from all areas across the combined company.

The strong cash flow and substantial cost savings will enable the company to continue to invest in some of the best investment opportunities, including pipeline candidates with the greatest probability of success, as well as licensing opportunities.  By optimizing its investments, the new Merck will maximize the benefits of strategic growth initiatives and R&D efforts to solidify its position at the forefront of innovation and enhance its scientific and technological leadership.

Additionally, Merck’s Board of Directors continues to be committed to maintaining the dividend at the current level.

Organizational Structure

During the past six months, Merck and Schering-Plough merger integration teams worked hard to successfully maintain the business momentum of the two companies while ensuring operational readiness and business continuity for the merged company.

The integration plans are focused on these priorities: an effective transition for customers and employees; putting the right people in the right jobs; realizing projected merger synergies in the form of cost savings and revenue growth opportunities; and maintaining momentum in the company’s late stage pipeline.

The company took significant steps prior to the merger’s completion to advance its integration planning objectives.  In August, Merck announced the new organizational structure and top leadership team for the combined company.   Last month, approximately 300 executives from Merck and Schering-Plough were named to key country leadership positions to ensure that all markets around the world would be ready for business on the first day of operations for the new Merck.

The company’s previously announced organizational structure takes advantage of the combined strengths of Merck and Schering-Plough to create a more customer-focused, innovative, and diversified global health care company positioned to capitalize on the company’s greatest opportunities for growth, particularly in emerging markets, biologics and vaccines.  Merck has five primary divisions: Global Human Health, Animal Health, Consumer Health Care, Merck Research Laboratories and Merck Manufacturing.

Leadership

The new Merck will benefit from the unparalleled industry experience of senior leaders from both Schering-Plough and Merck, with approximately 40 percent of Schering-Plough’s senior leaders joining the combined company.

As announced in August, the Executive Committee, reporting directly to CEO Dick Clark, includes the following individuals, as well as a Chief Medical Officer who will be named at a later date: Stanley F. Barshay, EVP and president, Consumer Health Care; Richard S. Bowles, Ph.D., chief compliance officer; Willie A. Deese, EVP and president, Merck Manufacturing; Kenneth C. Frazier, EVP and president, Global Human Health; Mirian Graddick-Weir, Ph.D., EVP, Human Resources; Peter N. Kellogg, chief financial officer; Peter S. Kim, Ph.D., EVP and president, Merck Research Laboratories; Raul E. Kohan, president, Animal Health; Bruce N. Kuhlik, general counsel; J. Chris Scalet, chief information officer, Global Services; and Mervyn Turner, Ph.D, chief strategy officer.

Corporate Branding

With the merger complete, Merck will take a global approach to unify and simplify use of its trade name.  The company will use the trade name ‘Merck’ in the United States and Canada and elsewhere use the trade name ‘MSD.’

About Merck

Today’s Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching programs that donate and deliver our products to the people who need them.  Merck.  Be Well.  For more information, visit www.merck.com

¹ Excludes purchase-accounting adjustments, restructuring costs, acquisition-related costs and certain other significant items.

Forward Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995.  Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts.  Such statements are based upon the current beliefs and expectations of Merck’s and Schering-Plough’s management and are subject to significant risks and uncertainties.  Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market

“We are pleased with the decision reached by the Committee today to recommend LUMIGAN^® 0.01% for Marketing Authorization in Europe, which is an important step in the regulatory review process and one step closer to offering glaucoma patients an additional and enhanced treatment option.” said Mr. David Endicott, President, Allergan Ltd., Europe, Africa and the Middle East.  “The new LUMIGAN^® 0.01% formulation is expected to provide the same efficacy physicians have come to rely on with the original LUMIGAN^® formulation with enhanced tolerability, resulting in lower treatment-related discontinuation rates.”

LUMIGAN^® 0.01% is a once-daily prescription eye drop that delivers effective IOP-lowering results with just one-third of the active ingredient found in LUMIGAN^® 0.03%.  In a large, well-controlled clinical trial, 373 patients with chronic open-angle glaucoma or ocular hypertension were randomised receive either LUMIGAN^® 0.01% or 0.03% over a period of 12 months to assess efficacy and safety. This study showed LUMIGAN 0.01% controls IOP as effectively as LUMIGAN 0.03% but is better tolerated and associated with less conjunctival hyperaemia.  Overall, treatment related adverse events were significantly lower in patients treated with LUMIGAN^® 0.01% (p=0.016).

Significantly, there were 3 times less patients who discontinued treatment due to ocular adverse events in the LUMIGAN 0.01% group compared to the LUMIGAN 0.03% treatment group (p=0.043) .¹

The European Committee for Medicinal Products for Human Use (CHMP) is the scientific committee of the European Medicines Agency (EMEA) that makes recommends for Marketing Authorization across 27 member states of the European Union. The European Commission generally follows the CHMP recommendation and grants final Marketing Authorization within a few months following a positive recommendation. Pending the final approval by the European authorities, Allergan anticipates launching LUMIGAN^® 0.01% across the region in the fourth quarter of 2009.

- Ends -

Notes to Editor

About Glaucoma

Glaucoma, a group of eye diseases characterized by damage to the optic nerve, is a leading cause of preventable blindness in the European Union².  It is estimated that more than 100,000 persons in the Netherlands suffer from glaucoma, with more than 70 million people affected across the world.3  A well established risk factor for glaucoma is elevated intraocular eye pressure (IOP), or pressure inside the eye.  A healthy eye produces fluids, called aqueous humor, at the same rate fluids are drained. If the aqueous humor is not removed rapidly enough or the eye fills too rapidly, pressure builds up in the eye, which can result in glaucoma.  This high pressure distorts the shape of the eye and damages the optic nerve.  Maintaining healthy IOP levels may slow the progression of the disease and help prevent loss of vision.

About Allergan

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential – to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

Bron: ® and ™ Marks owned by Allergan, Inc.

The product lines for activity monitoring and telemonitoring systems are aimed at special needs and requirements for all ages and used by healthcare professionals for the optimal treatment of patients.

Munich, 15 October 2009. Health is vital – at any age. Munich-based medical technology company Aipermon develops product lines, which help and encourage people to improve their health and their fitness. For the first time, these health systems are presented as an overall concept to field experts at the Medica Fair (18–21 November in Dusseldorf, Germany), under the motto “Welcome Your Health”.

Fun Healthy with AiperSunny

At a young age fitness and health are often taken for granted. However, current statistics of overweight children, adolescents and young adults tell another story. The AiperSunny is designed to motivate the Generation Z to become more active. This high-tech activity sensor encourages users to more everyday physical activity in an easy and playful fashion: A three-step sunrise on the display indicates when the daily fitness level is achieved. The three-dimensional acceleration sensor counts the time of motion and achieved calorie consumption. The AiperSun software allows users to analyse their progress and to monitor their fitness and physical activity over longer periods of time. The connected web-e™ solution allows for target-oriented online coaching programmes using AiperSunny.

The AiperSunny product line is suitable for prevention providers who wish to reach target groups with devices that are innovative, fun and scientifically founded, i. e. health insurances, healthcare portals or companies with healthcare programmes for employees.

Stay Healthy with the AiperMotion™440 Coaching Concept

With advancing age many people suffer from more complex health issues, which require weight loss and more physical activity. The AiperMotion™440 system has been designed specially to satisfy those needs. The “Energy Balance Coach” calculates definite benchmarks with the three factors nutrition intake, basal consumption (individually calculated) and energy consumption from activities – for successful weight loss and healthy living. The AiperMotion system still includes the AiperView software for short- and longterm documentation of the fitness and weight-loss progress as well as coaching programmes for providers. The AiperMotion system is suitable for providers of scientifically founded programmes for weight-loss and movement promotion.

Get Healthy with Telemonitoring

By offering telemonitoring products the company provides valuable technological support for stabilising and improving the health of often older chronic patients as well as for the long-distance support of weight-loss and movement promotion programmes. Telemonitoring systems are designed for continuous health monitoring and can be used at home after hospital stays or rehabilitation measures. Telemonitoring systems are used by medical call centers, hospitals and rehabiliation facilities for the long-distance support of patients.

Dr. Thomas Schweizer, executive director of Aipermon explains: “Our telemonitoring systems work with various transfer units. They can be used with measuring devices from different manufacturers, flexibly adhering to customers’ needs. Whether they wish to transfer data using a mobile phone, an analogue landline or a computer with internet connection – we have the right solution.”

Aipermon at the Medica 2009: Visit us at the Medica 09 in Hall 15, booth C 39.

About Aipermon

Aipermon GmbH & Co. KG is a manufacturer of telemedical systems based in Munich, Germany. The company offers complete telemonitoring systems for the remote transmission of medical results from home. The systems are employed in studies for the medical care of chronic patients, for movement intervention, movement prevention, and increasingly for medical intervention. In addition, Aipermon has developed AiperSunny activity sensors and AiperMotion 440TM, an Energy Balance Coach. The sensors are used for health promotion and weight loss programmes.

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Patient monitoring is vital to care in operating rooms, emergency rooms, intensive care units and critical care units. It has proven invaluable for respiratory therapy, recovery rooms, outpatient care, transport, radiology, catheterization laboratories and gastroenterology departments, as well as for ambulatory, home and sleep screening applications. Patient monitoring can reduce the risk of infection and other complications, and it can assist in providing for patient comfort. Moreover, patient monitoring products measure, display and document physiological information obtained at regular intervals over time from sensors attached to the patient or other input devices. The qualifier “at regular intervals over time” is used to distinguish patient monitoring devices from diagnostic kits and devices, which are typically used once or a few times to diagnose a patient’s condition and/or plan a course of therapy. Measured parameters include electrocardiogram (ECG), invasive and noninvasive blood pressure, pulse rate, pulse oximetry, body temperature, respiration rate, end-tidal CO2 and other specialized parameters. Products vary from specialized single-parameter instruments to monitors with the ability to measure multiple parameters and interface with other instruments.

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In the new trial, the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY), dabigatran given at 150 mg twice a day reduced the annualized risk of the primary end point, stroke/peripheral embolic events, by 34% (p<0.001) and the risk of hemorrhagic stroke by 74% (p<0.001) compared with warfarin. The higher dabigatran dose was associated with a slightly but significantly (p=0.048) increased risk of MI, a secondary end point.

“I think this is a dramatic study with very definitive results,” Dr Michael D Ezekowitz (Lankenau Institute for Medical Research, Wynnewood PA) told heartwire. “Both doses for different reasons were better than warfarin. So the results of the trial were unequivocal.” Ezekowitz is one of the trial’s lead investigators and a coauthor on the report.

The report’s first author, Dr Stuart J Connolly (McMaster University, Hamilton, ON), was scheduled to report the trial today here at the ESC meeting.

Pointing out that it takes several days to achieve therapeutic warfarin levels and that its effects have to be monitored, Ezekowitz said dabigatran “has a rapid onset of action, there are very few drug-drug interactions and those that occur have proven not to be important, and the patients don’t require any form of monitoring. Operationally, warfarin is a much more difficult drug to use, and dabigatran is obviously much more user friendly for both the patients and the physicians taking care of those patients.”

In an editorial accompanying the published RE-LY report [2], Dr Brian F Gage (Washington University, St Louis, MO) writes, “Because of dabigatran’s twice-daily dosing and greater risk of nonhemorrhagic side effects, patients already taking warfarin with excellent INR [international normalized ratio] control have little to gain by switching to dabigatran.” Dabigatran was associated with more dyspepsia in the trial, and more patients went off the drug than those who went off warfarin.

“In contrast,” he writes, “many other patients who have atrial fibrillation and at least one additional risk factor for stroke could benefit from dabigatran.”

From 951 centers in 44 countries, the trial had randomized 18 113 patients with AF (mean age 71) and at least one other risk factor for stroke to receive blinded treatment with dabigatran at either 110 mg or 150 mg two times per day or unblinded prophylaxis with warfarin adjusted to an INR of 2.0 to 3.0; INR was measured at least once per month. Concomitant aspirin at <100 mg/day “or other antiplatelet agents were permitted,” according to RE-LY investigators. As it turned out, aspirin was taken throughout the trial by about one-fifth of patients on dabigatran and about 17% of those on warfarin.

The AF had to have been ECG-documented at screening for the trial or within the prior six months, and eligibility required that patients have at least one non-AF stroke risk factor, which could include prior stroke or transient ischemic attack (TIA), LVEF <40, NYHA class 2 to 4 heart failure within the prior six months, or either age >75 or age 65 to 74 with diabetes, hypertension, or coronary disease.

Over a median two-year follow-up, the annualized rates of the primary end point were 1.53% for low-dose dabigatran, 1.11% for the high-dose drug, and 1.69% for those on warfarin.

The relative risks vs warfarin were 0.91 (95% CI 0.74-1.11) for the low-dose (p<0.001 for noninferiority) and 0.66 (95% CI 0.53-0.82) for the high-dose group (p<0.001 for superiority).

Annualized mortality was 3.75% and 3.64% for the low- and high-dose groups, respectively, compared with 4.13% for warfarin. The relative risk was 0.91 (95% CI 0.80-1.03) for the low dose (p=0.13) and 0.88 (95% CI 0.77-1.00) for the high dose (p=0.051).

The annualized MI rates were 0.72%, 0.74%, and 0.53%, respectively, for low-dose dabigatran, high-dose dabigatran, and warfarin. The risk trended higher for low-dose dabigatran at 1.35 (95% CI 0.98-1.87; p=0.07) and was significantly higher for in the high-dose group at 1.38 (95% CI 1.00-1.91; p=0.048).

Hemorrhagic stroke rates were 0.12%/year (p<0.001) and 0.10%/year (p<0.001) for the low- and high-dose groups respectively, and 0.38% for warfarin.

The rates for major bleeding were 2.71 (p=0.003 vs warfarin) for the low dose, 3.11 (NS vs warfarin) for the high dose, and 3.36 for warfarin.

Although they were higher with dabigatran, the absolute rates of MI were quite low, Ezekowitz said. And “the effect of dabigatran in reducing stroke and intracerebral bleeds far outweighed the small increase in MI rate, but this is a question we will be looking into in much more detail.”

Significantly more patients taking dabigatran went off the drug, which Ezekowitz attributes largely to the severe dyspepsia, the main side effect that occurred more often with dabigatran than with warfarin.

“We did not find evidence of hepatotoxicity” from dabigatran, write Connolly et al, noting that it was liver toxicity that had derailed the otherwise-promising oral thrombin inhibitor ximelagatran for the same clinical use.

Ezekowitz said his group can’t currently make a recommendation for one dabigatran dose over the other. They’ll be looking at this issue further by exploring whether there were outcomes differences between the 110-mg twice daily and 150-mg twice-daily dosages in any subgroups.

Janneke J. P. Schimmel1 Contact Information, M. de Kleuver2, P. P. Horsting2, M. Spruit3, W. C. H. Jacobs1 and J. van Limbeek1
(1) Department of Research Development and Education, Sint Maartenskliniek, PO Box 9011, 6500 GM Nijmegen, The Netherlands
(2) Department of Orthopaedics, Sint Maartenskliniek, Nijmegen, The Netherlands
(3) Dubai Bone and Joint Centre LLC, Dubai Healthcare City, Dubai, United Arab Emirates

Received: 20 January 2009 Accepted: 12 May 2009 Published online: 31 May 2009
Contact Information Janneke J. P. Schimmel
Email: j.schimmel@maartenskliniek.nl
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