Roche intends to submit its new T-DM1 breast cancer drug for EU and US approval this year following its successful phase III trial.

The biotech giant said its ‘armed antibody’ drug candidate, which combines the active agents of Herceptin and a chemotherapy drug, showed better progression-free survival data than a combination of Tyverb and Xeloda.

T-DM1, developed by Roche in partnership with ImmunoGen, is considered a potential successor to Roche’s blockbuster breast cancer drug Herceptin, which faces completion from biosimilars in 2015.

Herceptin has been approved in the EU for treatment of Her2-positive breast cancer, an aggressive type of cancer linked to a particular gene variant.

T-DM1 combines the antibody trastuzumab from Herceptin with the agent DM1from the chemotherapy drug maytansine.

Roche said that according to the EMILIA trial results, Her2-positive breast cancer patients showed longer progression-free survival than a combination of two major existing products: GSK’s Tyverb and Roche’s Xeloda.

In addition, it caused less side-effects (such as hair loss and reduced white blood cell count) than Herceptin alone, as well as offering the convenience of a combined medication.

The overall survival rates from the EMILIA trial are likely to become available by 2014.

Roche anticipates that T-DM1 will successfully rival generic versions of Herceptin and newer branded medications such as Tyverb.

New guidelines to promote positive collaboration between health organisations and the pharmaceutical industry have been backed by the ABPI.

Guidance on collaboration between healthcare professionals and the pharmaceutical industry outlines best practice through a series of ‘dos and don’ts’ and highlights that active collaboration can deliver improved outcomes of care.

Stephen Whitehead, Chief Executive of the ABPI, says the document will “help assure professionals of the good work they are doing and make all sides aware of their responsibilities”.

The guidelines have been backed by several healthcare organisations, including the Department of Health, the Scottish Government and the Welsh Government. A number of royal colleges have also included their support.

Formulated by the Ethical Standards in Health and Life Sciences Group the guidelines clearly state the existing working environment in which pharmaceutical companies and healthcare professionals operate and the regulations they must abide to.

The ‘dos and don’ts’ in the document aimed at healthcare professionals towards the pharmaceutical industry include treating pharma as a healthcare partner, searching for and developing joint working opportunities and understanding the ABPI Code of Practice.

HCPs were advised not to expect or request any items which breach the Code or to accept any negative accusations or myths against the industry when cooperating, and not to tolerate any unacceptable practices from pharma.

Alternatively, pharma was encouraged to be clear on the objectives when collaborating with HCPs, to ensure all activities are in line with the letter and spirit of the Code, and to keep up to date with the requirements of the Bribery Act.

But the industry was warned against collaborating without demonstrating the value of the partnership to those who may know less about it, expecting healthcare professionals to participate in actions that are outside their professional code of ethics, and engaging in collaboration with HCPs without ensuring that there is a written agreement or contract in place.

“The NHS and pharmaceutical industry share a common agenda to improve patient care and clinical outcomes through high quality and cost effective treatment and care management,” said Stephen Whitehead.

“This collaborative way of working is becoming increasingly common and we already have many examples that show how effective it can be. The publication of this statement by a broad base of health organisations will help assure professionals of the good work they are doing and make all sides aware of their responsibilities. Ultimately, we hope this will encourage further collaborative working and in turn, greater strides will be made in improving the health of patients.”

Roche plans to use the Twitter-based Diabetes Nest social network as a means to interact in real time with diabetes patients, carers and health professionals.

The company’s diabetes care business will sponsor the site, run by agency Ignite Health, which collects, sorts and ranks tweets from diabetes experts.

Roche Diabetes Care will also add a widget with content from the Diabetes Nest to the company’s community web page, Accu-Chek Diabetes Link.

The Diabetes Nest sends the week’s top 10 curated tweets to community members via an e-newsletter.

Rob Muller, Associate Marketing Manager for Roche Diabetes Care, said: “We are very proud to support such a great resource that can help people with diabetes stay up to date with their friends on Twitter, or even help them discover more of the diabetes online community there.”

Fabio Gratton, Chief Experience Officer at Ignite Health, explained the site’s rationale: “Social media have transformed how patients and their caregivers share healthcare information and find support. But the sheer volume of content can be overwhelming.

“So we asked ourselves how we could best help the diabetes community find and engage in the most timely, relevant and important conversations. The result is a simple, intuitive, compelling and ultimately self-sustaining diabetes social media community.”

“The Diabetes Nest highlights many of the most influential voices and topics in the diabetes Twittersphere, helping to raise the collective voice of our community,” commented health blogger Kerri Sparling.

“The Diabetes Nest gives a cumulative snapshot into what real life with diabetes is really like.”

NICE has recommended the use of Xgeva (denosumab) in draft guidance for certain cancer patients whose disease has spread to their bones.

The recommendation covers patients with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, says the condition can have a “major impact on quality of life” and is therefore “pleased” to recommend the treatment.

The guidance stipulates that Xgeva should only be prescribed under the terms of an agreed Patient Access Scheme between Amgen and the DH.

Amgen estimates there are more than 150,000 patients in the UK with solid tumours or bone metastases, of which breast and prostate cancer account for more than 80%.

The spine, pelvis, hip, upper leg bones and skull are most commonly affected by bone metastases with symptoms including pain, and weakening and eventual destruction of the bone.

The majority of patients with the condition are currently treated with bisphosphonates. NICE’s independent Appraisal Committee considered Xgeva as an alternative to standard treatment options where bisphosphonates are not used.

It noted that in clinical trials where Xgeva was directly compared to standard treatment options it improved skeletal-related outcomes. It was also shown to be more clinically effective in patients with breast, prostate and non-small cell lung cancer.

The initial recommendation is now open for consultation.

AstraZeneca has won a US district court ruling in defence of its patent extension for the extended-release version of its antipsychotic drug Seroquel (quetiapine).

After the failure of AZ’s challenge to the FDA’s decision to allow generic competition to Seroquel, the ruling by a district judge in New Jersey gives the UK drug company a significant legal boost.

In addition, a US district judge in Columbia has ruled against allowing AZ a temporary restraining order (TRO) against generic competitors but has criticised the FDA for lack of fairness and transparency.

AZ is seeking an extension of the recently-expired Seroquel patent to cover its extended-release version, Seroquel XR, until December 2012, but the validity of the extension has been denied by a UK court and by the FDA.

US District Judge Joel Pisano in Trenton, New Jersey, ruled that four generic drug manufacturers – Mylan, Anchen, Osmotica and Torrent – have infringed on a valid patent for the extended-release version of quetiapine.

While the generic companies argue that the extended-release formulation applies technology that is in widespread use, Pisano accepted AZ’s argument that only its formulation of Seroquel XR proved it was effective in this case.

In addition, he noted, AZ had achieved a new indication for the XR version as a treatment for bipolar disorder.

Seroquel generated $5.83bn for AZ worldwide in 2011, including $1.4bn from Seroquel XR. However, low-cost generic competition from the above companies and from Teva in Europe threatens to affect AZ’s 2012 revenue severely.

AZ has already settled patent infringement disputes with two other companies, Handa and Intas, which will launch generic copies of Seroquel in 2016.

In a balanced statement on the dispute, Judge Beryl A. Howell of the US District Court for the District of Columbia denied AZ’s request for a TRO on generic versions of Seroquel, but criticised the FDA for unfair handling of the case.

Judge Howell concluded that AZ “has not demonstrated a likelihood of success on the merits, particularly given the deference the Court must provide to agency actions and interpretations of its own organic statute.”

However, she commented that the FDA appeared to have made a “tactical decision” to block AZ from seeking a judicial review of the Agency’s decision. The FDA’s statements “could appear to be less than forthright about the status of FDA decision-making,” she commented.

As a result of “the FDA’s tactics of ‘hiding the ball’ of its position until March 27, 2012,” Judge Howell stated, “consideration of the merits of the legal issues presented by the plaintiff’s complaint has been delayed”. She ordered the FDA to supplement the administrative record with any additional relevant records.

The new Bribery Act makes UK pharma companies legally responsible for any kickbacks their reps or distributors may offer to health officials anywhere in the world. Maxine Vaccine asks whether UK politicians who point the finger at traders can really be serious.

Compliance is the new CRM. In an era of globalised pharmaceutical trading, the UK Bribery Act and the US Foreign Corrupt Practices Act have sent a shock wave of pure terror through the industry. Basically, what the new legislation means is that a company is responsible what anyone acting on its behalf, even under contract, may do to advance its business. A local sales team or freelance distributor on the other side of the world might treat a village doctor to a bottle of whisky in return for a commission – and a biotech company in Cradley Heath might find itself fined out of existence. It’s scary.

According to a new Cegedim report 94% of life science companies now enforce corporate standards for spending on HCPs, while over half have a project team to address compliance issues. However, Cegedim warns that good intentions are not enough: without robust surveillance and reporting systems, those unmarked envelopes may slip through the cracks.

Closer to home, the ABPI Code of Conduct imposes very strict limits on the industry’s freebies and favours to its customers. Marcus Brigstocke raised some nervous laughter at last week’s Pf Awards by suggesting that pharma reps might moonlight as biro salesmen. The rules on hospitality threaten drug reps with wholesale loss of mates. Bourbons are completely banned. Only digestives are permitted, and they must be from Costcutters. In fact, you can offer branded biscuits only when selling generic drugs.

Compliance means more than just obeying those rules you know about in those transactions you personally carry out. You have to find out what all the relevant rules are and then apply them to every commercial interaction that touches your company. Being compliant takes proactive commitment, intelligence and good teamwork. Though when I put ‘Totally compliant’ on my Facebook profile I got some interesting messages.

So it was with some amusement that I read a recent newspaper story: the Conservative Party’s co-treasurer Peter Cruddas told undercover journalists posing as financiers that a minimum donation of £250,000 to Party coffers would gain them direct access to the PM’s policy unit. Make with the cash, he told them, and “things will open up for you”. In case they were unsure what that might be worth, he clarified the point: “It will be awesome for your business.”

Pardon my naive attitude, but WTF? The only part of ‘Foreign Corrupt Practices’ not implied by such promises is the word ‘Foreign’. Perhaps, before they legislate to rein in pharma industry reps, some of these politicians should look in the mirror.

It’s worth noting here that the private healthcare corporations currently in line for a share of the NHS franchise now the new Health Bill has become law are major donors to the Conservative Party, just as they were to Andrew Lansley’s campaign fund when he was Shadow Health Secretary. In addition, the BMJ reports that half of the doctors on the new CCG boards have financial interests in private healthcare companies that will be bidding to provide NHS services.

And meanwhile, we get stamped on for giving away a few biros. Are they having a laugh?

Maxine’s views are not necessarily those of Pharmaceutical Field.

Bayer HealthCare’s Xarelto (rivaroxaban) has been recommended in final draft guidance as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

NICE revised its original decision not to recommend the convenient pill after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the medication.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said she was “pleased” additional information had been supplied enabling NICE to recommend the treatment.

It is estimated there are currently up to 700,000 people with AF in England and Wales. People with the condition are at a higher risk of developing blood clots and subsequent stroke.

However, the risk of stroke can be reduced by the appropriate use of antithrombotic therapy. Xarelto is the first in a class of drugs known as Factor Xa inhibitors, which act at a critical point in the blood-clotting process to prevent clots forming.

It has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular AF who have one or more risk factors and has been demonstrated in a clinical study to be non-inferior to warfarin, the current standard of care.

Professor John Camm, Professor of Clinical Cardiology at St George’s University of London, welcomed its recommendation. He said: “This news could be particularly important for patients who require long-term or lifelong anticoagulation (for non-valvular AF) who may be seeking a simplified regimen.”

Final guidance is now expected as early as next month.

NICE recently published final guidance recommending the use of Pradaxa (dabigatran) – which recently had its UK price reduced by Boehringer Ingelheim – for the same indication.

US company Constellation Pharmaceuticals, a drug discovery partner of Roche’s Genentech, has appointed Dr Keith Dionne as CEO.

Dr Dionne has held senior roles in the pharmaceutical industry, life science investment and life science academic sectors.

He replaces outgoing CEO Dr Mark Goldsmith, who will stay on as Executive Chairman.

Constellation discovers and develops small-molecule drugs for cancer and inflammatory/immune disorders based on epigenetics, the study of gene expression mechanisms beyond DNA.

Dr Dionne most recently served as entrepreneur-in-residence at life science investment firm Third Rock Ventures. His previous roles include CEO of Aurface Logix, CEO of Alantos Pharmaceuticals, and two VP roles (for R&D and technology) at Millennium Pharmaceuticals.

In his previous academic career, Dr Dionne was Adjunct Professor in the Biomedical Department at Brown University.

“With more than 20 years of experience leading US and international biotech companies, research and development teams and successful strategic alliances between companies, Keith is ideally suited to lead this phase of our organisation and advance our leadership in epigenetics drug discovery and development,” said Dr Goldsmith.

Dr Dionne commented: “I’m delighted to join Constellation at this exciting time in the company’s growth and evolution as we approach clinical milestones in our internal programmes and continue to realise the full potential of our platform in conjunction with our broad discovery alliance with Genentech.”

NHS Chief Executive Sir David Nicholson has said he expects the remaining work on the NHS' organisational design to be completed by May.

In a letter to NHS staff following Royal Assent of the Health and Social Care Bill, Sir David said that the future of employees would be confirmed by the end of the year, when the transition will be complete.

But he warned that jobs will undoubtedly be lost by the time new statutory organisations take effect next April.

"The passage of the Bill gives us real clarity and certainty about our future direction,” he said, but “there is an enormous amount to do to prepare for the bulk of the statutory changes”.

In terms of the timetable, the remaining senior appointments will be made within the commissioning structure during May and June. Then, from July to December 2012, the NHS will complete the remaining phases of the transition to ensure new organisations are fully operational from April 2013.

The document outlines a “particular need to retain the skills of certain staff in business critical roles” but admits jobs will be lost with redundancies impacting the budgets of new organisations from 2013/2014. Key milestones for the development of CCGs were also outlined. In July 2012, the first wave of authorisation applications will be accepted – followed by dates in September, October and November.

The NHS Commissioning Board will begin as an Executive Non-Departmental Public Body in October and take on the responsibility for the authorisation of CCGs before it and authorised CCGs take on full statutory powers from April 2013.

In a separate letter released on the same day, Health Secretary Andrew Lansley wrote to NHS staff thanking them for their work during the passage of the Health Bill to Royal Assent.

Mr Lansley said: “The Health and Social Care Act will, in reality, empower NHS clinicians to determine the type of health services needed in their local area, using their clinical expertise and their knowledge to ensure NHS services meet the needs of patients.

“I hope you and your colleagues in the NHS will take advantage of the new freedoms the Act has put in place.”

A new £50m investment fund aims to help UK companies bridge the translation gap between cancer drug discovery and early-stage product development.

The CRT Pioneer Fund, with equal contributions from Cancer Research Technology (CRT) and the European Investment Fund (EIF), aims to take cancer drug candidates from discovery through to phase II clinical trials.

The new fund was welcomed by the Bioindustry Association (BIA), the trade association for the UK bioscience sector, who said it came at “a particularly good time for life sciences in the UK”.

The fund’s starting capital of £25m will be doubled by the founders and/or potentially other investors.

CRT is the commercial arm of Cancer Research UK, whose widespread research networks will provide projects for the investment of at least two-thirds of the new fund, with the rest coming from other academic groups or industry.

David Willetts (pictured), Minister for Universities and Science, said: “In our Strategy for UK Life Sciences we set out ambitious plans to build on the success of the industry by fostering collaboration between our excellent research base and businesses. This initiative from Cancer Research Technology and the European Investment Fund will complement this work extremely well.”

“The creation of this landmark fund addresses the problem of funding the development gap which is restraining cancer drug development in the UK,” said Dr Keith Blundy, CEO of CRT.

“This important investment means we can take forward the most innovative approaches using our in-house drug discovery and development capabilities, to progress promising treatments from the lab all the way to clinical trials, translating our world-class scientific research into new treatments more quickly.”

Richard Pelly, EIF Chief Executive, noted: “This investment targets a stage of the investment spectrum often neglected by the market. The CRT Pioneer Fund will primarily follow a licensing model rather than creating companies.”

Glyn Edwards, BIA Interim Chief Executive, commented: “The launch of the CRT Pioneer Fund will provide another financing option for companies and academics in the UK looking to translate their cancer drug discoveries into clinical development.

“The fund arrives at a particularly good time for life sciences in the UK, following the launch last week by the Wellcome Trust of a £200 million venture fund and GlaxoSmithKline’s decision to invest £500 million in biopharmaceutical manufacturing in the UK.”