A New Year! Must Be Time For a S&N Takeover Rumour!

This week’s widely reported rumours that Johnson & Johnson had made a takeover approach for UK-based Smith & Nephew shows that whilst we may have a new year upon us some things never change. The question is will this finally be the year that things actually happen?

Ever since the orthopaedic market decreed that size does matter, and that S&N just doesn’t have the scale to survive on its own globally, speculation has ebbed and flowed in time with the seasons about the company’s future. The latest rumours appear to be no different and all represent very plausible plots. Guessing the one that does happen is another thing entirely.

Leading the market rumour columns this week has been fever pitch speculation that J&J’s hotly-contested battle with Zimmer in the worldwide orthopaedic markets has led to an opportunistic takeover approach for S&N that was swiftly rebutted by the latter. Denials of any dealings were formally issued by both management teams but that didn’t stop a market – thirsty for a megadeal deal to kickstart 2011 – driving up S&N’s shares by over 10 per cent in just one day of trading.

When the J&J rumour died down, it was time for another suitor to return from a hiatus – a possible offer from private equity owned-Biomet. This one at least has some traction. S&N almost merged with Biomet a few years ago but was outbid by a private equity consortium but whether the two companies would still want each other – and be allowed to do so – is a moot point. Medtronic is another party that has been named as a potential suitor, although they seem to be more focused on expanding their cardiovascular business rather than achieving sizeable growth in orthopaedics.

And then there’s the hotly anticipated return of the private equity market, a sector that was so massively wounded by the credit downturn over the last few years. Billion dollar bids have been relatively scarce in all markets, let alone orthopaedics, but there are signs that investors are slowly returning to the fold. Could this be the deal clincher?

So why is S&N the focus of such unrelenting attention? Well for some of its rivals it represents a chance to secure market leadership or solidify their position as a worldwide player. For all its perceived faults, the company continues to record strong revenues from orthopaedics, woundcare and endoscopy, and enjoys strong growth margins in both the US and Europe. It’s also shown itself to be highly resilient. Europe’s largest medical device group has survived the blow of losing out to successive battles with Zimmer and private equity groups for Centerpulse and Biomet, respectively, as well as the retirement of its talisman, Sir Christopher O’Donnell in 2007. It even sorted out the debacle of its Plus Orthopaedics acquisition intact.

In the cold light of the day, however, is this the right time to pounce on S&N anyway? Indeed, there are clear antitrust issues with most of the companies that have looked at S&N. It’s doubtful that either Zimmer or DePuy would be allowed to swallow S&N whole, whilst other companies like Stryker overlap S&N in areas such as Endoscopy and would face scrutiny too. With all the major orthopaedic companies (including S&N) treading a fine line with authorities over selling practices in the industry is it worth tackling with authorities in both the US and Europe at this moment?

And the regulatory climate isn’t going to be as easy to negotiate as it used to be, particularly as UK observers have suddenly woken up to the comparative ease at which UK companies have been picked off by foreign predators. The UK government is under increasing pressure to make it a little bit harder for US companies to take over the remaining crown jewels of UK business. Already much of the gain in S&N’s share price over the five days since the media attention reached fever pitch has been lost as reality sets in that it may not be a good time for a US company to swallow up another top UK company.

So whilst J&J may indeed have eyes on S&N it remains to be seen whether the two companies are on course for an inevitable tie-up. It’s probably more likely that if J&J does go for S&N it would be in a defensive manner – similar to the way it sought to defend its share of the cardiovascular market when it got involved with the battle with Boston Scientific for control of Guidant. In that case, J&J used its hefty cash resources to force Boston Scientific into paying well over the odds for the Guidant business and saddling its rivals with a hefty debt burden it’s still trying to shake off to this day. A far-fetched scenario? Well anything can happen in the orthopaedic industry, but it would certainly prefer to have S&N to itself rather than see a combined Biomiet/S&N or ambitious private equity group emerge as another major rival.

All this is itself speculation and shows that, as far as S&N is concerned, anything could happen and the story finale is still to be written. One can’t help feel that the well thought out plots of the speculators, whatever they may be, will turn out to be half as exciting as the actual ending. It certainly shows that being an S&N shareholder is not an uninteresting past-time and that such speculation will keep on occurring, whatever the denials that are issued.

A thank you to Lawrence Miller for that article, Lawrence is Espicom’s medical newletters team-leader, and editor of Medical Industry Week and Orthopaedic Business News.

Espicom Business Intelligence – New Medical Technology & Pharmaceutical Reports List

In today’s post on the Medical Technology Blog,  is a list of Espicom’s most recent reports from July to the present day, I have included our Pharmaceutical reports as well in case there’s an area of interest for anyone, please click on the links below to be taken to the relevant report page;

Medical:

  1. Global Advanced Wound Care Market to 2015 – Competitor Analysis *

  2. Orthopaedics – Surveying the Global Orthopaedics Market Landscape *

  3. Who’s Developing What in Cardiovascular Devices in 2010

  4. Orthopaedic Markets in Western Europe 2010

  5. The Global Market for Orthobiologic Products

  6. The African Medical Device Market: Facts and Figures 2010

  7. Effectively Selling Medical Equipment in Western Europe

  8. The World Medical Markets Fact Book 2010

  9. World Medical Market Forecasts to 2015

  10. All Change in the Coronary Stent Market

* Denotes latest reports

Pharmaceutical:

  1. Global Biosimilars: Identifying 2nd Generation Opportunities *

  2. Drug Delivery – Surveying the Global Competitive Landscape *

  3. Pharmaceutical Companies Performance Tables 2010 *

  4. Cancer Drug Blockbusters – Prospects & Challenges for Cancer Drugs

  5. Multiple Sclerosis Drug Discoveries – What the Future Holds

  6. Epigenetics – Current & Future Applications

  7. MRSA Drug Futures

  8. Biomarkers – Applications & Trends

  9. The World Pharmaceutical Markets Fact Book 2010

  10. Lung Cancer: Global Incidence, Prevalence and Mortality to 2015

  11. The Indian Pharmaceutical Industry 2010: Strategies in a Changing World

* Denotes latest reports

Thanks for reading, Paul Espicom Business Intelligence.

Do you have a medical technology subject or device that you would  like a report or article written for? If so contact me directly at paul_hoff@espicom.com

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Reva – Bioreabsorbable Drug-Eluting Stents News

Reva raises A$77.5 million as investors take a bet on the next big thing in stent technology – bioreabsorbable drug-eluting stents

Welcome back to the Medical Technology Blog. This is the last post of the year as I finish today for the Christmas holidays, please read on…

Reva Medical, a start-up company focused on the development and eventual commercialisation of its bioreabsorbable stent products, has successfully raised A$77.5 million (net) from an initial public offering (IPO) through an issue of CHESS depositary interests (CDIs) on the Australian Securities Exchange.

Based in San Diego, CA, the company has received approximately US$100 million in funding to date and attracted the attention of both Boston Scientific and Medtronic, both of which have previously made sizeable investments in the company. Boston Scientific’s participation included an option to acquire Reva at a later date. However, as a result of the share issue, these merger plans have now been terminated – at least for the time being – with Boston Scientific holding onto an option to distribute Reva’s products should they reach the market. Medtronic is also maintaining its support and has invested a further A$10.5 million in the Reva share placement. Reva plans to use A$38.9 million of the proceeds to support development work, with A$31.4 million invested in ReZolve and A$7.5 million other programmes. A further A$10.3 million will be spent on funding the pilot and pivotal CE mark trials, A$24.2 million on working capital and the remaining A$4.2 million on manufacturing. Overall, the proceeds are expected to support Reva’s development over the next three years.

Billed as the “next major advance in coronary stent technology”, Reva’s core technology, known as ReZolve, is a non-permanent implant that combines a “slide and lock” stent design with a polymer. In development for over ten years, the device claims a number of significant advantages as it is designed to provide the same benefits as traditional metal stents, with the additional benefit of being dissolved by the body over time after treatment of the artery. The reabsorption of the stent minimises clotting risk and reduces the need for long-term drug therapy. In addition to cardiovascular disease, this technology could also be applied for the treatment of other conditions, including peripheral artery disease and spinal trauma surgery. With regards to the latter, Reva is currently seeking a partner interested in licensing its side-chain crystallisable  polymer for use as a flowable cement.

Reva has held an exclusive licence since 2004 for its polymer material from Rutgers University in New Jersey for use in stents, stent coating and embolics. In July 2010, Reva entered into a new licence agreement with Rutgers which broadened the company’s exclusive rights to the original polymer group and all new polymer compositions developed to cover all vascular applications. The company also intends to use sirolimus, an anti-restenotic drug used in other DESs. A target dose of 80µg of sirolimus is coated onto the outside surface of the ReZolve stent using a polymer solution containing the drug.

Reva is targeting a competitive coronary stent market that was valued at over US$5.3 billion in 2009, with drug-eluting stents (DESs) taking up US$4.4 million of this total. The company finds itself in potential competition with the likes of Johnson & Johnson (Cordis), Abbott Laboratories, Boston Scientific and Medtronic, which collectively accounted for 95 per cent of all DES sales in 2009.

Primary competition for Reva’s products is expected from both traditional DESs and other bioreabsorbable stents. Whilst a number of companies are working to develop bioreabsorbable or polymer stents, so far only two have reached the clinical trial stage. Abbott Laboratories is developing its Bioresorbable Vascular Scaffold (BVS), which is forecasted to reach the European market before Reva’s Resolve stent, and Biotronik, which is developing its second generation Dreams magnesium-based reabsorbable stent. Biotronik began clinical trials of its device in July 2010.

Reva is now in the process of finalising the design of the ReZolve stent, with a 50-patient pilot human, non-randomised trial scheduled to commence in Brazil and Germany during the second quarter of 2011, with patients followed at one, six and 12 month intervals after implant of the device, and annually thereafter, for a period of up to five years. Positive findings could then led to enrolment in a 350-patient trial at centres in the EU, Brazil, Australia and New Zealand, in the first and second quarters of 2012, with a full to securing marketing approval in Europe by the end of 2013. If successful in generating such sales, Reva anticipates using the revenue to fund the US human clinical trials, as well as other development activities. Highlighting the tough regulatory climate for DES technology in the US and the associated costs incurred, Reva’s proposed US trial programme, in contrast to Europe, would involve at least 2,000 patients.

Thank you to Lawrence Miller for that article, Lawrence is Espicom’s medical newsletters team leader, and editor-in-chief of Medical Industry Week

A big thank you to all my readers, Happy Christmas and a prosperous New Year to one and all.

Paul

Axcan to takeover Eurand for US$580 million

Eurand, a manufacturer of enhanced pharmaceutical and biopharmaceutical products, has accepted a US$583 million takeover offer from Axcan holdings, a leading pharma company focused on gastro-intestinal disorders. Axcan is going to acquire all outstanding shares of Elan for US$12.00 per share, making for a diluted equity value of US$583 million. The deal is subject to a condition that a minimum of 80 per cent of Eurand shares are tendered, as well as receipt of antitrust approval.

Independent directors at Eurand – made up of non-management and non-majority shareholder Directors – unanimously voted in favour of the union with Axcan, and also recommended that its shareholders accept the offer. It is thought the transaction will close in the second quarter of 2011.

In the last few years, Eurand has transformed itself from a licence and development drug formulation company into a fully-integrated specialty pharma business, through the development and launch, in particular, of Zenpep (pancrelipase) delayed-release capsules. Gearoid Faherty, Eurand’s Chairman and CEO, is expected to remain in these roles until the end of this year. At that time, John J Fraher, currently Chief Commercial Officer of Eurand, will become CEO and Angelo C Malahias, Chairman of Eurand’s Special Committee, will become Non-executive Chairman.

The rationale behind the deal is that the combined Eurand/Axcan company will have a bigger presence in the specialty pharma sector. Dr Frank Verweil, the current President and CEO of Axcan, believes that merging the two companies’ portfolios will create a new organisation with a bigger product offering, broader geographic reach and more robust R&D pipeline.

Thanks to Sophie Bracken for this article, Sophie is editor of Espicom’s newsletter Drug Delivery Insight click on the link now to start your subscription!

Roche To Lose Almost 5000 Jobs in Economy Drive

“Operational Excellence” programme affects 6,000 jobs at Roche

Welcome back to the Medical Technology Blog, posts have been thin on the ground as i’ve been on holiday. Today’s post concerns the sad news that some major changes are happening at Roche, which will directly affect the workforce, please read on…

In response to mounting cost pressures in healthcare – particularly in the US and Europe – and to bigger hurdles for the approval and pricing of new medicines, Roche has started the “Operational Excellence” programme to change the way it spends its cash. A company focused on research-based healthcare in pharmaceuticals and diagnostics, Roche is hoping to generate savings of around SFr 1.8 billion in 2011, with forecast savings of SFr 2.4 billion in 2012 and beyond.

The Operational Excellence programme plans unfortunately include the reduction of Roche’s workforce, by about 4,800 employees worldwide – 6 per cent of the group’s employees – over the next two years. Another 800 jobs will be transferred to other Roche sites and 700 positions will be outsourced to other parties, making for a total combination of 6,300 affected employees. Roche has put aside SFr 2.7 billion to cover the cost of this restructuring for 2010 to 2012.

The most affected division for job losses will be Pharmaceuticals – mainly in the division’s worldwide sales and marketing organisation and manufacturing. Total Roche redundancies worldwide are expected to total 2,600 in these positions. Roche puts these job cuts mainly down to the setback of the company’s diabetes drug, taspoglutide, and structural adjustments the primary care sales organisations – mainly in the US and Europe. Also affected will be some Technical Operations activities, which will be reorganised in California, US; Mannheim, Germany; and other sites in the network, meaning the loss of 750 positions across this area. Roche is also looking for buyers for its Florence, SC and Boulder, CO sites, which would mean the loss of a further 600 jobs.

In line with the Operational Excellence ethic, Roche has also decided to pull the plug on some development activities – most from the US. Some, however, will be transferred to other Roche sites or third parties. Roughly 800 positions will be affected by this plan. Roche is further cutting certain activities in research and early development, including RNA interference research in Kulmbach, Germany; and in Nutley, NJ and Madison, WI. Plans include reorganising some internal functions, in order to free up resources for pipeline Phase II studies of new molecular entities; around 600 positions will be affected.

Roche’s Diagnostics division aims to consolidate three of its sites – a move that the company believes will “optimise seamless collaboration and cost structures in development and manufacturing”. This plan calls for the closure of the Graz, Austria site and transfer of developmental and manufacturing of blood gas diagnostics to Rotkreuz, Switzerland – home of Roche’s Professional Diagnostics division’s HQ.

In the Diabetes Care division, most activities will be based in Mannheim, Germany. The plan is to out-source manufacturing and close its Bugdorf, Switzerland site. Diagnostic chemical manufacturing and analytical services will be discontinued in Mannheim and transferred to Penzburg, Germany.

Redundancies are always an unfortunate side-effect of any company undertaking a restructuring plan, but Roche hopes to carry out its reduction in a “socially responsible” way, including informing the affected employees as soon as possible, and offering them assistance and support. Despite the changing healthcare market, Roche believes it is approaching this project from a position of strength. The company’s exposure to patent expiries over the next few years is comparatively low, and the group has 14 product groups that each generate over SFr 1 billion per year. The company’s late-stage development portfolio includes six drug candidates that are effective in specific patient populations, which could help advance personalised healthcare. Roche also has other important drug candidates in late-stage development for cancer, central nervous system diseases and metabolic disorders.

Thanks to Sophie Bracken for this article, Sophie is the editor of Espicom’s excellent business news service Drug Delivery Insight which tracks the important commercial and technology developments that are shaping the drug delivery industry.

Astellas Pharma Files MAA with Japan’s Ministry of Health

Astellas chases Japanese approval for degarelix prompting milestone payment

Hello once again to The Medical Technology Blog. Company and drug news which relates to drug delivery technology today, please read on…

Astellas Pharma, based in Tokyo, Japan, has filed an MAA with the country’s Ministry for Health, Labour and Welfare for a one-month formulation of degarelix acetate, which it licensed from Ferring in January 2006. The MAA filing earns Ferring a EUR 10 million milestone payment from Astellas.

Astellas is seeking approval in Japan of degarelix as a treatment of prostate cancer – an indication for the drug that is already approved in the US and EU. Degarelix is a gonadtrophin-releasing hormone (GnRH) blocker with a subcutaneously-injectable formulation. The GnRH hormone is produced in the hypothalamus and plays a part in the production of testosterone, by binding to the receptors of the pituitary gland. Testosterone has been known to encourage prostate cancer to grow and spread. To prevent this, degarelix inhibits the binding of GnRH receptors and controls the growth of prostate cancer by suppressing the production of testosterone.

Safety data prove that degarelix seems to be safe and well-tolerated, and, following results from Phase I and II studies in Japan, Astellas decided to submit the MAA by using international Phase III data and skipping plans for a Phase III study in Japan.

This latest development highlights the potential that Astellas clearly has on the urology market in Japan, and the treatment of prostate cancer in particular through a new mechanism of action. The company is already marketing treatments for overactive bladder (Vesicare) and for functional symptoms of benign prostate hyperplasia (Harnal). The Japanese company views urology as the “bridgehead” of entry into the oncology market in Japan.

This article was provided by Sophie Bracken, editor of Drug Delivery Insight Espicom’s business news sevice designed to keep you in touch with the latest developments in the rapidly expanding and dynamic drug delivery market.

You might also like to sign up to our free Drug Delivery Newsletter at the top of the page!

Thanks for reading, come back soon, Paul


Endologix Makes Beeline for Fellow AAA-Focused Company

Image representing Nellix as depicted in Crunc...
Image via CrunchBase

Welcome back to the Medical Technology Blog. Apologies for the lack of posts, but i’ve been off work with the dreaded ‘manflu’. As i didn’t fancy sneeezing my germs round the office I took the week out, today’s post involves company news, please read on…

Irvine, CA-based Endologix, focused on the development and marketing of its patented Powerlink technology for the treatment of abdominal aortic aneurysms (AAAs), has made a move to acquire fellow AAA-focused company, Nellix. The deal values Nellix for US$15 million in stock at closing, plus additional milestone-based stock payments of up to US$39 million. The acquisition, expected to be complete in the fourth quarter of 2010, also comes with a US$15 million equity investment in Endologix from Essex Woodlands Health Ventures, the majority shareholder of Nellix.

Privately-held Nellix has developed a device that is designed to address and expand the indication for the less-invasive treatment of AAAs and thoracic aortic aneurysms (TAAs). Enabling the treatment of all aneurysms with a low-profile delivery system and endograft, the Nellix device is said to have the potential to double the market size for endovascular aneurysms repair (EVAR), which exceeded US$800 million in 2008. It is forecasted that the AAA market could exceed US$1.7 billion by 2012.

AAA is a weakening of the aorta wall, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, can become increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75 per cent, making it a leading cause of death in the US.

Nellix’ technology platform seals and fills an aortic aneurysm sac, preventing device migration and potentially improving clinical outcomes. This enables the product to treat a wide range of AAA anatomies, including those that are outside of the indications for existing EVAR devices, including patients with aortic neck lengths of 5mm or less, widths as wide as 34mms, and patients with iliac aneurysm diameters >23mm.

Endologix is clearly a fan of Nellix as the company’s President and CEO referred to Nellix as the ‘most revolutionary EVAR technology in the world’, which is expected to help position Endologix as a leader in aortic aneurysm treatment. In the near future, the company plans to devote resources to build a direct salesforce in Europe, which will provide a channel to launch the Nellix system in the region from 2012 and provide a significant growth opportunity for Endologix’ existing and future products. In addition, the fresh capital from Essex Woodlands will be used to support the transition and development of Nellix’ technology in anticipation of a full commercial European release in 2012. The capital will also be used to build a direct salesforce in Europe and initiate the IDE clinical trial programme in the US.

This article was provided by Sophie Sanderson, editor of Espicom’s fortnightly updated newsletter, Cardiovascular Device Business if you liked this article please click on the link to start your subscription, and you might also like to take a look at Medical Industy Week.

Thanks for reading, kind regards, Paul

Drug Delivery Company Cuts Workforce

SurModics renews its business focus but employees set to pay the price

Whilst conducting its annual strategic planning review, SurModics, a surface modification and drug-delivery company, has come to the conclusion that the businesses in which it competes would be best served by a more focused approach. As a result, the company has honed its energy onto three units – Medical Device, Pharmaceuticals and In Vitro Diagnostics – in the hope of improving its sales and business development activities.

In order to achieve this, Eden Prairie, MN-based SurModics has taken the difficult decision to cut its workforce by around 13 per cent, in order to reduce its cost structure. It is hoped the “difficult but necessary” move will bring the company’s operating expenses more in line with its revenue. As a consequent of the redundancies, SurModics will take a one-time restructuring charge of US$1.3 to US$1.7 million in the first quarter of 2011, but expects to save around US3.0 to US$3.5 million annually.

SurModics believes that in the long-run its customers will benefit from the organisational changes, which it hopes will enhance accountability, improve efficiency and allow the company to use its resources more effectively.

In Medical Devices, SurModics’ surface modification technologies are designed to improve access, deliverability and predictable deployment of medical devices, as well as drug-delivery coasting technologies to provide site-specific drug-delivery from the surface of a medical device. End markets include coronary, peripheral, neurovascular and urology, among others.

The company’s Birmingham, AL-based Pharmaceuticals business incorporates a range of drug-delivery for injectable therapeutics, including microparticles, nanoparticles and implants. Customers of this division include pharma and biotech companies addressing a range of applications including ophthalmology, oncology, dermatology and neurology, among others.

The In Vitro Diagnostics consists of component products and technologies for diagnostic test kits and biomedical research applications. Products include microarray slide technologies, protein stabilisation reagents, substrates and antigens.

This article was kindly provided by Sophie Bracken who is the editor of Espicom’s excellent publication Drug Delivery Insight

Pfizer Snaps Up King Pharmaceuticals

Pfizer grabs a slice of growing pain relief market

Welcome back to The Medical Technology Blog.

The pain relief market is rapidly growing, with US physicians writing around 320 million prescriptions to treat pain in 2009. In a bid to get in on the action, Pfizer has moved swiftly to snap up King Pharmaceuticals, a diversified specialty pharmaceutical discovery and clinical development company, headquartered in Bristol, TN. King’s leadership in new formulations of pain treatments, designed to discourage methods of misuse and abuse, will provide Pfizer with a series of new drug-delivery platforms.

Pfizer expects the purchase of King to expand its business profile, providing immediate revenues from King’s portfolio, which includes a prescription pharma business focused on delivering new pain treatments designed to discourage misuse and abuse. Pfizer will also get its hands on King’s Meridian auto-injector business for emergency drug-delivery, which develops and manufactures the EpiPen and is a long-term critical supplier to the US Department of Defense; as well as an animal health business that offers feed-additives for a wide range of species. Pfizer believes that not only are these three business complimentary to its own businesses, they are also a perfect fit with its own Primary Care, Established Products and Animal Health business units.

Under the terms of the acquisition, Pfizer will acquire King for US$3.6 billion in cash, or US$14.25 per share, a hefty premium of approximately 40 per cent to King’s closing price as of 11th October, the day before the US giant made its move. The transaction was approved by the Boards of both companies and is expected to be enhancing to Pfizer’s adjusted diluted EPS by approximately US$0.02 annually in 2011 and 2012, and approximately US$0.03 US$0.04 annually from 2013 to 2015.

Pfizer targeted King because, it said, it was “highly impressed” by the company’s products and technology in the pain relief disease area, as well as by its success in advancing promising compounds in its pipeline. Pfizer also believes that the combination of the companies’ respective portfolios in the area of unment clinical need is highly complementary, which will allow its business to offer a fuller spectrum of pain relief and management.

In the next issue of The Medical Technology Blog,  SurModics renews its business focus but employees set to pay the price…

Clinical Study Seeks Cure for Parkinsons Disease

18F PET scan shows decreased dopamine activity...
Image via Wikipedia

MJFF launches biomarker initiative study aimed at finding a cure for Parkinsons Disease

In its latest quest to find a cure for Parkinson’s disease (PD), the Michael J Fox Foundation for Parkinson’s Research (MJFF) has unveiled further details of its Parkinson’s Progression Markers Initiative (PPMI), the first-ever large-scale clinical study exclusively focused on identifying and validating PD biomarkers. The study forms a major part of MJFF’s goal to develop a cure for PD within the coming decade. Since it began in 2000, the foundation has spent over US$205 million in specialised research in the field, either directly or through partnerships, which has helped the foundation learn more about the disease; develop better treatments for patients; and, ultimately, move a step closer to ending PD.

The latest five-year study, expected to cost US$40 million over five years, will be funded by the foundation with a lead gift from Lily Safra, a Board member of MJFF, and through the support of industry partners that include Pfizer and GE Healthcare. The PPMI study will be led by principal investigator, Dr Kenneth L Marek, President and Senior Scientist, Institute for Neurodegenerative Disorders, New Haven, CT.

The study will be carried out at 18 sites in the US and Europe, and will track 400 people newly-diagnosed with PD and 200 who do not have the disease. The study is testing the most promising biomarker candidates at present through neuroimaging, the collection of blood, urine, and spinal fluid, and clinical and behavioural tests. Valid measures could allow scientists to predict, objectively diagnose and monitor diseases, as well as definitively determine which medications work and which will not. The goal of the collaboration is to help increase the pace of biomarker validation and clinical testing, as well as accelerate the pace of discovery.

Recruitment of study volunteers is now under way at six sites, with all sites expected to be recruiting by year-end. Sites participating in the PPMI include the University of Alabama; Arizona Parkinson’s Disease Consortium; Baylor College of Medicine; Institute for Neurodegenerative Disorders; Northwestern University; the Parkinson’s Institute and Clinical Center; Boston University; Oregon Health & Science University; and the University of Pennsylvania. Additional sites will also join the study in Atlanta, GA; Tampa, FL; Baltimore, MD; Rochester, NY; Seattle, WA; Innsbruck, Austria; Kassel/Marburg, Germany; Tuebingen, Germany; and Naples, Italy.

Described as an observational study as opposed to an interventional trial, the PPMI will not test any experimental drug. Participants will be contributing to a large body of data and biological specimens whose aim is to further biomarker research. The PPMI will make biological samples and collect clinical data from a single, large and well-characterised cohort available to qualified researchers around the world, to help spark further innovation and collaboration, in order to develop new, more effective treatments more quickly.

When considering the implications of this research for the industry, a biomarker could dramatically reduce both the cost and time of development – since to bring a new central nervous therapy to market requires an investment of over US$1 billion and takes over nine years. Current US annual sales of PD therapies are estimated at US$800 million – however, this could increase to US$2 to US$3 billion with the advent of a disease-modifying therapy.

In the past, PD biomarkers have represented a key area of R&D for MJFF, with approximately US$25 million invested to date over several years. As the foundation embarks on PPMI, it believes more strongly than ever that the discovery of PD biomarkers is a high-impact use of its resources, and that this study will pay dividends towards better treatments and a cure.

This article was taken from an issue of our Espicom’s excellent publication Diagnostics Focus which is edited by Sophie Sanderson

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