Merck Serono’s easypod launched in EU

by emma 31. October 2011 17:14

Medtech Product News

Merck Serono has launched its easypod Connect, which monitors injection data collected by the easypod auto-injector in patients receiving growth hormones, in Europe.

The medical software is designed to display patients’ injection history from the easypod electronic auto-injector on a secured online database.

Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono, said: “easypod Connect is a new approach enabling health care providers to monitor patients' adherence to growth hormone treatment, with the goal of better understanding its impact on treatment outcomes and more objectively adapting the treatment regimen to a single patient.”

easypod Connect provides healthcare professionals with reports and data from the patient’s injection history, which both monitors and analyses patients treatment adherence.

The easypod Connect Observational Study (ECOS) has already been in use since its launch at the end of 2010, offering the additional functionality to combine and manage injection patient records with growth and/or clinical outcome data.

Thomas Bols, Vice President of Corporate Health Policy and Market Access at Merck Serono, said: “By monitoring injections and thereby adherence to growth hormone, easypod Connect gives health care providers important information to consider when making decisions for their patients to improve treatment outcomes.”

easypod Connect has already been launched in Canada and Australia. The medical device has not been submitted for use in the US.

ViroPharma buys DuoCort

by emma 31. October 2011 11:32

Pharma Industry News

ViroPharma has signed a definitive agreement to acquire Swedish-based DuoCort Pharma AB for an initial $33.6 million – but only if Plenadren is approved by the European Commission (EC).

Under the terms of the agreement, the deal will be closed after the tablet’s approval, after the EC’s confirmation of Plenadren’s orphan drug designation, and an amended agreement with the product’s contract manufacturer.

Vincent Milano, ViroPharma's President and CEO, says the deal is in line with the company’s “objective of broadening our orphan drug portfolio”.

Further milestone patients of up to $131 million associated with manufacturing, sales thresholds and territory expansion have also been agreed as part of the acquisition.

Plenadren is a once daily dual-release oral glucocorticoid tablet with a release profile designed to closely mimic the body's natural secretion pattern of cortisol. ViroPharma now anticipates the commercial launch of the treatment – which it says will be the first “true innovation in over 50 years” – of adrenal insufficiency in the EU within a year. It estimates that peak annual sales for Plenadren could reach up to $50 million.

The Committee for Orphan Medicinal Products confirmed in September that Plenadren’s orphan designation would be maintained and protected for a decade of market exclusivity.

Medtech market report: France

by emma 28. October 2011 11:30

57340808

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

Next month, Medtech Business will look at the medical technologies market in Germany.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence. *All figures are in US $. For further details of the 66 markets covered, please visit www.espicom.com/outlookm1

Antimicrobial dressing can heal advanced wounds

by emma 28. October 2011 10:50

Hydrofera Blue

A new antimicrobial dressing suitable for severe and highly exudating wounds has been launched in the UK.

Hydrofera Blue (pictured) from Swindon-based company Synergy Health has been developed from blood purification technology.

The dressing is made from poly-vinyl alcohol (PVA) foam that can absorb up to 25 times its own mass in fluids, while binding and eliminating endotoxins.

The foam is combined with two active organic pigments, Gentian Violet and Methylene Blue, which have broad-spectrum bactericidal properties.

The unique construction of Hydrofera Blue means that no antimicrobial chemicals are deposited in the wound.

The combination of pigments was invented by Dr Edward Shanbrom, a pioneer in the use of natural products to cleanse blood.

Hydrofera Blue is effective against the most common pathogens that affect wounds in the UK, including E. coli and MRSA.

The sponge-like foam base of the dressing means that it is both comfortable and durable, and contours easily to the wound bed.

The product has been used extensively in the US since 2003, but until now has not been available to the UK healthcare market. Synergy Health is currently evaluating its use in acute and community settings.

Hydrofera Blue is available in a range of sizes for wounds varying from moderate to heavily exudating. Tunnel and ostomy versions are also available.

Rachel Downham, Woundcare Product Manager for Synergy Health, said: “Hydrofera Blue provides a real step change in advanced wound care management. It has the potential to increase the rate of wound healing and improve pain and odour control, offering big advantages from both a patient comfort and a cost reduction perspective.”

Synergy Health delivers a range of specialist outsourced services to clients in healthcare and health management.

Dementia generic launched in UK

by emma 28. October 2011 10:34

Pharma Product News

Mylan has launched its Rivastigmine capsules to treat dementia in Alzheimer’s patients, the first generic version of Novartis’ Exelon in the UK.

Robert J. Coury, Mylan’s Chairman and CEO, said that the drug is Mylan’s second recent first-to-market generic to be launched in the UK, following the company's launch of Modafinil tablets, the generic version of Cephalon's Provigil, earlier this year.

He said that the launch marks the company’s continued “commitment of providing high quality and affordable medicines to patients around the world”.

Mylan provides global generic and specialty pharmaceuticals in 150 countries and territories.

Industry and academia partner to improve speed to market

by emma 26. October 2011 16:53

Pharma Industry News

UK pharmaceutical companies conducting early stage clinical trials will be able to collaborate more extensively with leading medical academics following the government’s launch of two pioneering partnership programmes designed to accelerate the development of innovative treatments from lab to patient.

The first two National Institute for Health Research (NIHR) translational partnerships – in respiratory and joint-related inflammatory diseases – will give life science companies access to a ‘unique network of top clinical scientists’ in government-funded research facilities, leading universities and the NHS.

The government says the partnerships will also provide unparalleled access to ‘cohorts of well-characterised patients’ – cutting through red tape to speed up the recruitment and testing of NHS patients, and ensuring quicker access to life-changing new therapies.

Access to the Partnerships will be via the NIHR Office for Clinical Research Infrastructure (NOCRI), meaning that when a company wants to collaborate, only one legal agreement is required rather than having to negotiate with each NHS Trust and University.

The new initiative represents an attempt to address a sharp decline in the UK’s reputation as a world-class location for medical research, and also reflect a growing appetite across the pharmaceutical industry to find efficiencies in its R&D model through greater collaboration with external specialists.

David Willetts, Minister for Universities and Science, said the research partnerships would provide a unique model for collaboration between the life sciences industry, the NHS and universities. “They will be a key driver of growth and innovation, reducing the time it takes to translate research into benefits for patients and the economy,” he said.

The ABPI has welcomed the initiative, citing collaborative working with clinical academic investigators as pivotal to the changing model of drug development for the pharmaceutical industry. “Translational Research Partnerships offer an efficient and effective way for companies to work with some of the UK’s leading translational research experts through NOCRI,” said Dr Allison Jeynes-Ellis, Medical and Innovation Director, ABPI. “Companies will see great advantages to working with the partnerships and consequently they will attract ground-breaking research into the UK.”

The government will provide £1.3 million to help set up the first two partnerships; inflammatory respiratory disease and joint and related inflammatory diseases. The NIHR partnership for translational research on respiratory diseases – such as asthma, COPD, allergies, cystic fibrosis and acute lung injury – includes hospitals and universities in Northern Ireland, Oxford, Manchester, Southampton and London. The partnership in joint and related inflammatory diseases, such as rheumatoid arthritis, osteoarthritis, and synovitis, includes Barts and the London NHS Trust, the University of Birmingham, UCLH and Cambridge University.

Terms of the partnership are likely to include identifying more efficient ways of tapping into suitable patient groups for clinical trials, and unlocking funding beyond life science investment in exchange for shared intellectual property rights for any breakthrough discoveries.

FDA approves Abbott’s AML diagnostic

by emma 25. October 2011 16:49

MB Product News

The FDA has approved Abbott Molecular’s genetic diagnostic, Vysis EGR1 FISH Probe Kit, to detect acute myeloid leukaemia (AML).

The new in vitro test is the third of Abbott’s FISH assays to be cleared for oncology applications in the US in the past two months.

Stafford O'Kelly, Head of Abbott's Molecular Diagnostics Business said that the medical technology “can identify which AML patients have the chromosomal abnormality upon diagnosis and provides physicians with another clinically validated tool to assess a patient's overall prognosis”.

The Kit’s technology detects chromosomal deletion in the bone marrow, and can be used in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of AML diagnosis to determine prognosis.

Each year, more than 12,000 people are diagnosed with AML, which is a rapidly progressive disease. Current standard procedure involves aggressive chemotherapy drugs, while some patients may require a stem-cell transplant to replace unhealthy bone marrow with leukaemia-free stem cells.  

Part of Abbott, Abbott Molecular is a leader in molecular diagnostics, analysing DNA and RNA at the molecular level. Abbott Molecular's tests aim for earlier detection or diagnosis, to provide information of appropriate treatment, and improve monitoring of disease progression.

Abbott is a global healthcare company, which discovers, develops, manufactures and markets pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and commercialises its products in more than 130 countries worldwide.

Child back support launched in UK

by emma 25. October 2011 10:25

PosturePadJunior

A new childcare product designed to improve posture and assist spinal development has been launched by a UK company.

The PosturePadJunior wedge cushion (pictured) from Derby-based Jolly Back Enterprises was developed with support from the Healthcare and Bioscience iNet, which is part-financed by the European Regional Development Fund (ERDF).

Designed by physiotherapist Lorna Taylor, the product was launched during National Back Care Awareness Week.

Taylor received an iNet Innovation, Advice and Guidance grant, which enabled her to design and test the wedge cushion prior to commercialisation. She is working on a DVD to train teachers and nursery managers in manual handling and back care.

The same company launched the Jolly Back chair earlier this year, using the same wedge-shaped cushion technology to prevent or reduce back pain. The product has 23 UK distributors and has sold worldwide.

“As a children’s physio, I am concerned at how child development is being adversely affected by current lifestyles,” said Taylor, who noted that correct positioning of babies can “allow core strengthening of the back and neck”.

Taylor described the PosturePadJunior wedge cushion as “a simple means of naturally supporting the spine for comfort and physical development”.

iNet advisor Dr Ros Graves commented: “Lorna has shown incredible resourcefulness by coming up with simple but effective products and bringing them to market so efficiently. The potential impact of all her ideas is enormous so we are delighted to have been able to help.”

The Healthcare and Bioscience iNet is an initiative delivered by Medilink East Midlands that assists companies and inventors in the healthcare sector to develop new technologies, products and services. It brings together firms, academics and public service representatives.

EC opens J&J and Novartis inquiry

by emma 24. October 2011 15:10

Pf Product News

An antitrust investigation into the contractual arrangements between Johnson & Johnson and the generic branches of Novartis has been opened by the European Commission.

The probe will analyse whether the agreement may have hindered the entry to market of generic versions of Fentanyl in The Netherlands.

Joaquín Almunia, Vice President of the Commission, who is in charge of competition policy, says that any such deals are a “restriction of competition that the Commission will not tolerate”.

If the Commission does find any irregularities, it would potentially represent a breach of EU antitrust rules, in particular Article 101 – which bans practices that restrict competition.

The European Commission says it pays “particularly close attention” to practices in the pharmaceutical industry after a previous inquiry showed that ‘originator’ companies may be paying generic manufacturers to delay the entry of cheaper generics on to the market.

“I regard this sector as a priority in terms of enforcement of competition rules given its importance for consumers and for governments' finances,” said Mr Almunia.

“Pharmaceutical companies are already rewarded for their innovation efforts by the patents they are granted.”

The duration of the investigation depends on a number of factors, the EC says, including the complexity of each case, the extent of co-operation and the exercise of the rights of defence.

Fentanyl is a strong pain killer for chronic pain.

Endoscopic accessory approved in US

by emma 24. October 2011 15:04

MB Product News

The FDA has approved Crospon’s EF-800 external channel endoscopic accessory to deploy the company’s EndoFLIP catheters.

John O'Dea, CEO of Crospon, said that the medical device will enable the catheters to be used in “hard to access parts of the gastrointestinal tract”, for example, “measurement of stomas in the stomach created during bariatric surgery procedures”.

The company received FDA and CE Mark approval to market its EndoFLIP EF-900 gastric tube in July 2011, for use in bariatric surgery to provide support for sleeve gastrectomy, and to allow stomach decompression, gastric fluid drainage and removal.

Based in Ireland, Crospon develops minimally-invasive medical devices for monitoring, diagnosis and therapy in gastroenterology.

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