Medica 2011

The Medical Technology Blog

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Abbott’s plan to break itself up into two businesses – one for medical products and one for research pharmaceuticals – has suddenly got the analysts’ thinking caps on.

Barely a moment after the surprise news went public, the talk was on the future of both businesses and their chances of survival. Overall, the changes have been welcomed and represent a key moment in the 123 year old company’s history. It’s been there before, on a smaller scale of course, with the formation and successful spin-off of its hospital products business into Hospira in 2007, which has since enjoyed strong growth.

Both of Abbott’s divisions have grown in stature and offer contrasting demands in terms of resources so the split into two businesses is bound to improve clarity amongst the investment community. The medical products business will have 2011 revenues of approximately US$22 billion and the research-based pharma unit will have an estimated US$18 billion sales turnover. However, without the protection of the other, both companies could swiftly find themselves the target of deal makers.

With clarity comes opportunity. Abbott’s upstart research business finds itself just outside of the biggest players of the pharmaceutical market, but with a hot drug on its hands in the form of Humira – an anti-inflammatory drug that posted sales of US$6.5 million in 2010. In a market where the focus is on product pipelines, particularly blockbuster ones, the unnamed Abbott business has a relatively strong pipeline.

Whilst the spin-off is impressively detailed, there’s the nagging doubt that the company, like Johnson & Johnson, continues to find it hard to break up the relationship of medical devices and pharmaceuticals, a model long since ditched by the likes of Bristol-Myers Squibb, Allergan and Pfizer. The medical device business, which is particularly strong in cardiovascular devices and ophthalmic products, sits uneasily amongst the slightly larger divisions of generics, and nutritional products. Whilst Generics enjoys double-digit sales growth, such targets remain elusive in the medical device field for Abbott.

Still, Rome wasn’t built in a day and the spin-off plan is likely to keep investors happy for the moment at least. The company has shown in recent times that it isn’t afraid of ditching certain markets if it feels warranted. The company’s ruthless and swift exit from the spine market when the going got too tough being a classic case in mind.

Whilst this blog is not saying that Abbott’s commitment to medical devices is likely to wane in the short-term – the current spin-off alone will take at least a year to complete at least, but one wonders how long it will take before investors start questioning to rationale of keeping a medical device/pharma mix over the long term. Would an opportunistic offer from Medtronic or an attractive offer from a private equity group change things? One suspects that all the time the company keeps posting sales growth and delivers the financial numbers, Abbott’s investors won’t mind a bit either way.

Thanks to Lawrence Miller for providing this article, Lawrence is Espicom’s medical newsletter team leader and editor of Medical Industry Week




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Medical Futures & Cipher Pharmaceuticals in Tramadol Deal

The Medical Technology Blog

Medical Futures to gain a slice of Canadian tramadol market through deal with Cipher

Medical Futures, a Canada-based pharma company, has signed a pact for Cipher Pharmaceuticals to distribute Durela in Canada. Patent-protected Durela is a once-a-day formulation of tramadol for the treatment of moderate- to moderately-severe chronic pain in adults. It was approved by Health Canada in August and has immediate- and extended-release properties.

As for the particulars of the distribution deal, Cipher will receive an upfront payment from Medical Futures of C$300,000, and could also be eligible for future payments, dependant on net sales milestones. Also, Cipher will get its hands on a double-digit royalty on new sales. Cipher has further responsibily for product supply and manufacturing, which will be taken care of by its supplier, Galephar Pharmaceutical Research.

Medical Futures’ CEO, Colin Campbell, says he is excited to offer Durela in Canada, believing that the product “strengthens and demonstrates [Cipher’s] commitment to providing top tier solutions to the Canadian market”. It appears Cipher is equally delighted with the deal, as it provides valuable royalty revenue to the company. Cipher also recently shook hands on a US$5.5 million US distribution deal for Durela with Vertical Pharmaceuticals, with the former set to receive a payment of US$1 million on the first commercial sale of the product.

With sales of over US$60 million in 2010, the seemingly robust Canadian tramadol market looks like a sure thing for both parties. Medical Futures plans to launch Durela in the first quarter of 2012.

Thanks to Sophie Bracken for this article, Sophie edits Espicom’s business publication Drug Delivery Insight.



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Cardiovascular Device Business News

The Medical Technology Blog

Photograph of the Taxus drug-eluting stent, fr...

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Last post of the week in The Medical Technology Blog comes from the Cardiovascular Device Business, Espicom’s business publication. Please read on…

Swedish researchers compare risk of stent thrombosis and restenosis in new vs old DESs

Findings from the complete Swedish Coronary Angiography and Angioplasty Registry (SCAAR) have demonstrated that percutaneous coronary intervention (PCI) with ‘new generation’ drug-eluting stents (DESs) was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with ‘old generation’ DESs.

Although many trials and studies support the overall early- and mid-term safety and efficacy of first-generation DESs, there has been concern regarding their long-term safety, especially regarding the potential risk of late stent thrombosis as well as late restenosis. New drug-eluting stents (n-DESs) have been developed with the purpose of overcoming the current limitations of the older generation drug-eluting stents (o-DESs).

The purpose of this study was to evaluate the long-term outcome in all patients who underwent stent implantation with bare-metal stents (BMS), o-DESs and n-DESs in Sweden, using SCAAR, a national registry with complete consecutive enrolment. The latter holds data on consecutive patients from 29 centres that perform coronary angiography and PCI in Sweden. The registry is sponsored by the Swedish Health Authorities and is independent of commercial funding. The technology is developed and administered by the Uppsala University Clinical Research Center. All consecutive patients undergoing coronary angiography or PCI are included. Information with respect to restenosis and stent thrombosis has been registered for patients undergoing any subsequent coronary angiography for a clinical reason since the beginning of 2004.

The current study included 94,384 stent implantations in Sweden (BMS, n=64631; o-DES, n=19202; n-DES, n=10551), from November 2006 to October 2010. Follow-up was performed up to two years post-intervention. The performance up to two years of different types n-DES was evaluated in an unselected, large, real-world population – including patients with myocardial infarction, three-vessel and/or left main disease, bifurcation lesions, graft disease, restenotic lesions and chronic total occlusions. The main findings from this study are that PCI with n-DESs was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with o-DESs. These findings can be useful for the management of patients with a high-risk profile that could benefit more from these new devices.

Further studies are said to be needed in order to attempt to discriminate whether one of the three components of the n-DES – the polymer, the stent alloy, the eluting-drug – is mainly involved in decreasing the incidence of stent thrombosis and restenosis. Improved stent designs with thinner struts and more biocompatible polymers may have an important impact on drug elution profiles, endothelial coverage and functional recovery.



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Zimmer’s cash-saving scheme begins with Statesville site closure

The Medical Technology Blog

 Orthopaedics Business News

Zimmer has put the wheels in motion regarding its plan to close its operations in Statesville, NC as part of a restructuring of its manufacturing facilities.

Warsaw, IN-based Zimmer has filed a notice with the North Carolina Department of Commerce of its impending plans, with the first redundancies widely expected to take place in October. The phase-out of the Statesville plant will be completed in March 2012. It is not clear how many Zimmer employees at the plant will lose their jobs, but the site currently employs around 125 people.

The Statesville facility was opened in 1980 and makes tourniquet cuffs, traction devices, slings and braces. The closure is part of Zimmer’s “global restructuring and transformation initiatives” that were unveiled in January this year. The Statesville site closure is part of this strategy that aims to save over US$100 million for the company, which looks set to lose its title of world’s largest orthopaedic company to DePuy by the end of the year. The company has also said it will be “reducing management layers and consolidating global sourcing to drive vendor cost reduction”. This could well mean that in the near future, Zimmer could be axing non-essential executive positions from its Warsaw headquarters, and perhaps even terminating deals it has with component suppliers and distributors, as it strives to save that US$100 million.

thank you to Sophie Bracken, editor of Orthopaedics Business News for providing this article.



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Will Axis-Shield give into rising pressure of takeover offer from Alere?

The Medical Technology Blog

Alere, a key player in the rapid point-of-care and laboratory diagnostics market with products that focus on infectious disease, cardiology, oncology, drug abuse and women’s health, has brushed aside negative feedback from Axis-Shield and pushed ahead with a cash offer for the UK-based company.

As part of the offer, Axis-Shield’s shareholders will be offered £4.60 (or approximately US$7.51) for each Axis-Shield share held by them, valuing the transaction at approximately £230 million (or approximately US$375 million). The offer will be conditional upon Alere receiving valid acceptances in respect of not less than 90 per cent of Axis-Shield shares to which the offer relates and not less than 90 per cent of the voting rights carried by those shares.

In June, Alere had made an indicative non-binding proposal to acquire Axis-Shield, however, the latter rejected the proposal and also turned down an offer to conduct further discussions with Alere. At the time, Alere revealed that it was keen to work towards a recommended takeover offer for Axis-Shield and that it would welcome the opportunity to discuss a possible transaction in a constructive manner. The company said its proposal was “a means to facilitate discussions” with Axis-Shield and its shareholders. Now, in a move that adds further pressure on its target, Alere has made an additional open market purchase of approximately 6.4 per cent of Axis-Shield’s share capital.

Axis-Shield is an international in vitro diagnostics company, headquartered in Dundee, UK, with R&D and manufacturing bases in Dundee and Oslo. The group specialises in the supply of instruments and tests for the rapidly growing physician’s office testing market and the development, manufacture and marketing of diagnostic kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes. During 2010, the company made significant advances with the continued growth of its international in vitro diagnostics business and revenues exceeded £100 million for the first time.

Alere believes it’s all cash offer is highly attractive for Axis-Shield shareholders, representing a ‘compelling value proposition’ with a high degree of certainty at a substantial premium to the undisturbed share price. In addition, the company expects Axis-Shield will be complementary to its existing businesses and that it can help develop and grow the Axis-Shield product portfolio to be a clear leader worldwide in its core markets.

Over the forthcoming weeks, the question remains as to whether Axis-Shield will succumb to the pressure to reach an agreement Alere, and whether the latter, with revenues of over US$2.1 billion behind it for 2010, has done enough to win over the UK-based company.



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The Increasing Scope of Lawyers in Healthcare

The Medical Technology Blog

In the third instalment of her guest blog, Louise Campbell, an undergraduate law student with the University of Southampton, examines the increasing scope of lawyers in healthcare

Nowadays, law firms have become as important partners to the medical industry as the scientists, sales executives, marketing managers and CEOs that are driving the company forwards.  This blog looks at some of these areas in more detail and illustrates that lawyers are as important in the work environment as are in the courtroom.

Commercial Agreements

Lawyers are often employed to aid the creation of commercial agreements between companies. They will assist in negotiating the terms of the contract and, once agreed, will draft and facilitate the signing and exchange of the relevant documents and contracts. The nature of the terms and of the agreement will naturally vary, but some of the most common used in the healthcare industry include:

  • Patent Licence agreements: key terms may include: the scope of the licence, its exclusivity and the territory it covers the licence, which often includes or excludes all countries that have granted patent protection to the invention. Others encompass remuneration, royalties and how such payment(s) are made; and duration, how long the agreement is to last
  • R&D collaboration: where two or more enterprises agree to collaborate developing new products or processes. To commercialise the results of the collaboration, the agreement often extends to the exploitation of the results. Collaboration can also extend to higher education institutions
  • Confidentiality agreements
  • Contract manufacture and supply agreements:  As a guide, key terms may include: interpretation; orders for products; manufacturer obligations; inspection and testing; delivery; rejection of products; warranty and indemnity; prices and payment;  how to vary the terms of the contract in the future if necessary; intellectual property;  confidentiality and; termination
  • Distribution and agency agreements: An Agency Agreement involves appointing a third party to act on its behalf, marketing and selling its products and services – often in exchange for commission. The distribution agreement transfers the ownership of goods to the distributor prior to their ultimate sale. Flexibility in such agreements allows for sales targets and territories to be negotiated
  • Co-marketing and co-promotion agreements: Co-marketing is where two companies cooperate with separate distribution channels. This sometimes includes profit sharing. Co-promotion on the other hand, is where two or more companies use each other’s salesforces as well as their own, to promote the same brand or range of brands

Corporate Services

Corporate compliance, in other words, meeting statutory obligations surrounding how a company operate, reporting and particularly directors’ duties towards shareholders are covered by legislation. Companies are regarded as legal persons and failure to meet the various requirements may result in fines and other punishments for directors and officers.
In the UK, the most recent updating of legislation governance is The Companies Act 2006 which supersedes previous regulations. It is the longest Act of Parliament in British history, containing 1,300 schedules in 15 sections. Given the considerable size of the legislation, lawyers are useful in determining which sections are relevant to the company and advising as appropriate.

Lawyers may also provide useful guidance in raising funds and the most suitable process in which to do this. Some examples of common practices are raising money through debt financing or equity financing. Debt financing is when a firm raises money for working capital or capital expenditures by selling bonds, bills, or notes to individual and/or institutional investors. In return for lending the money, the individuals or institutions become creditors and receive a promise that the principal and interest on the debt will be repaid. Equity financing is where shares are issued in a public offering. In return for the money paid, shareholders receive ownership interests in the corporation.  A recent example of this in action is Archimedes Pharma successfully raising £65 million round of new funding in 2010. That particular deal is believed to be Europe’s biggest single fund raising round for a bio-pharma company in 15 years.

Should a company wish to merge or acquire another company, a legal mergers and acquisitions team ensures that this is completed effectively. Lawyers are heavily involved in the due diligence side of this, analysing the target firm’s business history, its assets, its capital, and its organisational structure.  They will also negotiate, draft and facilitate the signing of contracts and help manage the integration process after the merger or acquisition is complete.

Intellectual Property and due diligence

Protecting and defending innovations in this sector is essential. Companies may call upon lawyers for help with applying for intellectual property rights, such as patents and trademarks, and perhaps identifying a particular strategy with regards to this.

Due diligence is a routine practice in the healthcare sector prior to investments and public offerings, mergers and acquisitions, private equity and venture capital transactions. These transactions involve providing capital to private businesses to speed up their development. The completion of a successful venture capital or private equity deal requires the deal to progress through a multistage process including due diligence. Due diligence is also a key element in licensing and collaboration agreements.

Dispute Resolution

For when it all goes wrong, lawyers are often the first port of call for resolving a dispute either through going to court or an out of court arbitration or mediation process.

In terms of IP disputes, often these centre on enforcement and/or infringement of IP rights and disputes over ownership. A recent example of this was the patent dispute between Ranbaxy (UK) Ltd and AstraZeneca AB in which Ranbaxy, the claimant, successfully achieved declaration of non-infringement and revocation of a European patent owned by AstraZeneca, the defendant pharmaceutical company.

For contract disputes, the most cost effective way of settling the disagreement is through out of court means as litigation costs can be huge.

Product liability is key area for disputes. Lawyers can be on hand to aid defence or settlement of product liability claims. Strategic advice and representation in multi-claimant litigation is also offered by many law firms as well as assistance with international coordination of product liability actions. They may also advise on what steps to take after realising any safety concerns or objections raised by regulatory authorities such as product recalls, additional safety instructions or temporary restrictions on use. The unmissable DePuy ASR hip replacement litigation is a prime example of this.

Regulatory and Competition compliance

The healthcare industry has been increasingly subject to regulatory and competition (antitrust) measures, including regulation of clinical trials, freedom of information and advertising.  Lawyers are often asked to take the hassle out of contacting the relevant regulatory authorities and advise on ensuring compliance with these regulations.

With regards to competition law, ultimately companies must not abuse their dominant market position should they be in such a position of strength. Co-marketing and promotion agreements, as an example, can be subject to intense scrutiny by the national and European competition authorities as can any mergers and acquisitions. Lawyers can help set up a compliance programme or advise on how to minimise and reduce any risk of violating competition laws. One example of this was when AstraZeneca lost a claim that false representations to the European Patent Office constituted an abuse of their dominant market position.

Infrastructure, Tax and Employment

Tax lawyers are useful in ensuring that the corporation is tax efficient and drafting documentation to allocate tax risks between parties in the agreed manner.

Lawyers are also involved in the transactions for the design, construction and maintenance of new and existing healthcare infrastructure.

Employment lawyers can aid in drafting employment contracts, tailored to the needs of the business, and consultancy agreements which strike the right balance between safeguarding your interests and commercial and economic flexibility. In some cases, healthcare corporations will need to place restrictive covenants on their employees to prevent them from exposing confidential information or intellectual property and lawyers can advise on the best ways to do this also.



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The Medical Technology Blog

The weekend’s nearly here and we finish off with an article from Orthopaedic Business News by Espicom’s medical news editor Sophie Bracken.

CellSonic Medical, an India and UK-based developer and manufacturer of machines and consumables for wound healing, orthopaedic, urology and skin care in the medical, veterinary and cosmetic markets, is looking for worldwide distributors for its products, which span the areas of lithotripsy, urology, surgery, laparoscopy and dermatology, and also include cosmetic creams and gels. All of CellSonic’s products possess CE mark approval.

The CellSonic medical device is a lithotripter with variable power for use in hospitals and clinics to treat bones, wounds and sports injuries. The device produces a shockwave that is focused by the parabola in the head. According to CellSonic, the company has miniaturised the lithotripter, making it “safe, reliable, easy to use and reduced to price to reach a worldwide market for wound healing”. Calcified shoulder is the most commonly treated condition with shockwaves. Tennis and golfer’s elbow are also commonly treated with the technique. A power boost can be provided for machines that require a bone-healing facility.

According to CellSonic, its system can cost half that of electro-magnetic machines and claims to be cheapest in the medical, veterinary and cosmetic markets. The distributor will exclusively offer CellSonic’s full range and undertake all sales functions.

Have a great weekend, thanks for reading, Paul.



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The Medical Technology Blog

US regulatory bodies respond to rapid rise of modern wireless technology and apps for medical devices

Latest news from Medical Industry Week

The proliferation of broadband and wireless-enabled medical devices has prompted the FDA and US Federal Communications Commission (FCC) to issue a joint plan aimed at bringing clarity to the issue.

Although these devices represent the opportunity to enhance health and reduce the costs of healthcare, they aren’t without a few risks too. The devices, which include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems, are increasingly playing a major role in treatments.

The US government agencies have come to the conclusion that clear guidelines are needed to make sure these devices are operated in a safe, reliable and secure manner. The FDA, in particular, is of the opinion that the industry, healthcare providers, patients, and other interested stakeholders in the medical environment should have clear regulatory pathways, processes and standards to bring the technology to market.

Although specific details are thin on the ground at the moment, the aim still pretty noble enough. “All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology” – the communiqué boldly claims.  At the end of the day though, by clarifying each agency’s scope of authority with respect to these devices, the hope is that interested parties will get a clearer picture of the regulatory process, streamline the application process, and make sure that innovation doesn’t get stifled through bureaucracy.
The move comes as the FDA grapples with even more complex issue of software applications (apps), the likes of which are increasingly been used in mobile medical technology, such as mobile phones, tablet computers and PDAs.

In general, the FDA’s position is that if a mobile app is intended for use in performing a medical device function it is a medical device, regardless of the platform on which it is run. This can range from mobile apps used on mobile phones to analyse glucose meter readings.

In consultation with the US public, the agency is looking to establish formal guidance that define a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. The offending apps could be used as an accessory to medical device already regulated by the FDA transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.

There’s an obvious need for some kind of monitoring in this area. Nowadays an app can be used by a healthcare professional to make a specific diagnosis by viewing a medical image on a mobile phone or tablet, whilst some apps can turn a smartphone into an ECG machine and be used to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack. Understandably, the FDA is of the opinion that these particular mobile apps pose the same or similar potential risk to the public health as currently regulated devices if they fail to function as intended.

The FDA has set a deadline for 19th October 2011 for interest parties – including manufacturers and app developers, to submit comments relating to the agency’s draft policy document, with a view to formulating clear guidance on the matter once and for all.  One thing is for sure, it’s a good idea to revise the present guidelines – the FDA’s last significant attempt to address the topic was made in 1989!

Thanks to Lawrence Miller for yet another great article, Lawrence is the Espicom’s editor for Medical Industry Week, and medical newsletter teamleader. For more articles like this, or to start your subscription please click on the link to Medical Industry Week

 



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Silence pours cash into development projects

The Medical Technology Blog

Last post on the Medical Technology blog before i shoot off on my hols, so no posts till i get back. Today’s article comes from Drug Delivery Insight, please read on…

Leading RNA interference (RNAi) company Silence Therapeutics has been busy lately. The UK-based firm tapped investors for nearly £6 million in funds last month, and has wasted no time in putting it to use. The company believes the funds, which were raised by both new and existing shareholders, will place it on a much improved financial footing.

The first slice of the funding was allocated to plan the closure of Silence’s US operations, which are located in Redwood City, CA. The US closure is expected to take place in the third quarter of this year, but the company’s German operations will remain open. As a result of the closure of the US base, Silence’s CEO, Phil Haworth, will step down once a replacement is found.

The second chunk of funding will be put towards Silence’s ongoing R&D efforts. The first portion will be used to complete the company’s ongoing Phase I trial of Atu027 for the treatment of advanced solid cancer, and is earmarked for completion during the second half of this year. Also, a Phase Ib trial of Atu027 in particular tumour types will be started in mid-2012. IND applications for Atu027 in solid will also be paid for by the funding in the second half of next year, and preclinical development will be stepped up for Silence’s Atu111 programme. The latter provides systematic delivery to the lung for treatment of pulmonary diseases.

Representing Silence’s most advanced drug candidate, Atu027 is a liposomal siRNA formulation targeting PKN3 for the treatment of advanced solid cancer that incorporats the company’s very own AtuPlex delivery technology. The company says it has proven its value by inhibiting the growth of blood vessels, thereby inhibiting blood supply to the tumour. Half-time results from the Phase I solid tumour trial of Atu027 are “encouraging”, as the drug has so far shown to be safe and well-tolerated. Silence hopes to finish the Phase I trial in the second half of this year, and release data before year-end.  The release of updated data from the trial was made at the recently-convened ASCO meeting in Chicago, IL.

Atu111, for the treatment of acute lung injury, is Silence’s most advanced candidate outside of the oncology field. It combines the company’s DACC drug-delivery system with AtuRNAi. The product’s target is being kept under wraps by Silence at the moment, but preclinical models using the DACC delivery system have shown sustained knockdown of up to three weeks in the lung endothelium.

As far as collaborative partners go, Silence is getting ready to start a Phase IIb trial for PF-‘655 in the second half of 2011, which is licensed to Quark Pharmaceuticals and Pfizer for the treatment of diabetic macular oedema.  Silence hopes Quark and Pfizer will report data from the trial later this year. Quark is also developing QPI-1002 for the treatment of delayed graft function and acute kidney injury in partnership with Novartis. In September 2010, quark kicked off a Phase II trial of QPI-1002 for the treatment of delayed graft function and plans to begin a second Phase II trial of the product in acute kidney injury during the course of this year.

Thanks to Sophie Bracken for this article, Sophie is editor of Drug Delivery Insight at Espicom Business Intelligence.



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