Pharmaceutical giant Merck Serono and leading industry service provider Quintiles have formed a five-year clinical development partnership.

The unique collaboration aims to optimise productivity in the design and execution of clinical drug trials, speeding the development of new treatment options in Merck Serono’s core therapy areas: neurology, oncology and immunology.

Merck Serono will shape and lead the partnership’s drug development programme; Quintiles will direct the planning and conducting of clinical trials and contribute to ongoing trial design.

Quintiles will be the sole primary provider of Merck Serono’s outsourced drug development services. It will also participate in strategic decisions regarding the development of the pharma company’s portfolio.

The partnership reflects the pivotal role of contract research organisations and other service providers in the global pharmaceutical industry.

“By combining the strengths of Merck Serono and Quintiles, we are creating a new model in clinical development that will unlock the knowledge and insights of both companies,” said Annalisa Jenkins, Executive VP and Head of Global Development and Medical at Merck Serono.

“This is an innovative and unique collaboration that will help to translate the highest-quality science into efficiency and agility throughout our clinical trials, while enhancing our competitive position in an increasingly challenging environment of clinical drug development.”

Tom Pike (pictured), CEO of Quintiles, commented: “We view this as a key step forward not only for our two companies, but for the way the industry approaches the development of new therapies for the patients we ultimately serve.”

Merck Serono is the biopharmaceutical division of Merck, based in Darmstadt, Germany. Quintiles is the largest global provider of drug development and commercial outsourcing services to the pharmaceutical industry.

Steve Turley, Managing Director of Lundbeck, has been re-elected Chair of the European Medicines Group (EMG), the UK voice of pharmaceutical companies based in continental Europe.

Robin Bhattacherjee, General Manager of Actelion, was re-elected vice-Chair of the EMG; and Mike Sumpter, CEO of Servier Laboratories, was elected Treasurer.

Issues highlighted at the EMG’s twelfth AGM included the impact of NHS reform on European-based companies and European perceptions of the UK as a pharmaceutical market and research base.

The EMG’s 15 member companies are Actelion, Almirall, Bayer, Boehringer Ingelheim, Ferring, Lundbeck, Menarini, Merck Serono, Norgine, Novartis, Novo Nordisk, Roche, Sanofi, Servier and UCB.

Steve Turley (pictured) commented: “We have members ranging from the UK’s biggest pharmaceutical companies, through biotechnology specialists to emerging organisations. Yet we all share common challenges and can benefit from being able to view these through a European-focused lens.”

“How the implementation of the NHS reforms affects European-based companies is a key issue this year,” noted Robin Bhattacherjee.

“Upwards of 60% of the medicines our members have introduced in the last decade have not been subject to a NICE health technology appraisal, so... local decision making in the CCGs about the use of these remains a major focus for EMG.”

Mike Sumpter noted: “Globally the UK is viewed as a tough market where innovative new medicines aren’t adopted as readily as similar economies.

“We want to work closely with our NHS stakeholder partners to demonstrate that the UK and the NHS is worth investing in.”

Lundbeck is based in Denmark, Actelion in Switzerland and Servier in France; all three companies have major UK operations.

Workers at Merck Serono’s doomed headquarters in Geneva are planning strike action if Merck does not extend the timeframe for consultation with union leaders over job cuts.

Employees have already staged ‘coffee and croissant’ protests and have now threatened industrial action at the planned closure of the plant.

Merck estimates that up to 500 jobs will be lost and 750 transferred. However, trade union Unia claims that up to 1,500 positions will be affected in total.

A spokesperson for the Swiss employee group said the terms and condition provided by Merck under its transfer plans are “really unattractive and mean lower quality of life if accepted”.

Merck revealed its efficiency plans back in April as part of measures aimed to make net savings in the Serono division of €300m by 2014. It estimates the restructuring costs will be approximately €600m.

Karl-Ludwig Kley, Chairman of Merck’s Executive Board, said the company faces “unprecedented market shifts and increasing competition in key areas” and is “fortunate” it can address these issues from a “position of relative strength”.

He warned that if Merck does not take action it faces “tackling these issues from a much weaker position”.

Mr Kley added that the efficiency programme is not solely reserved for Merck Serono and will “affect all businesses in all regions” but remains convinced the plans “will lay the foundation” for Merck to build on new opportunities.

Profits after tax nearly halved (-48.7%) at Merck despite sales at Merck Serono and Merck Millipore divisions witnessing growth.

Total group revenues increased by 3.2% to €2.6 billion as overall sales improved by 3.5% to €2.5 billion.

However, profits fell to €177m in the first three months of the year compared with €344m in the same period a year ago.

Karl-Ludwig Kley, Chairman of the Executive Board at Merck, admitted the company had delivered only “a reasonable operating performance” in the first quarter of 2012.

Merck revealed at the end of last month it planned drastic cutbacks in its Serono division cutting 500 jobs and transferring another 750 as part of plans to close its Geneva headquarters.

But despite the planned cuts, the division’s Q1 sales grew by 5.4% as global demand for Rebif generated income of €430m and demand for Erbitux earned €214m.

Its Merck Millipore division also saw sales increase by 7.3% to €653, driven by solid results from its Lab Solutions and Process Solutions business units.

Merck now predicts modest increase in profits for the full year for its Serono division before the planned efficiency savings and an increase in profits in line with sales at Merck Millipore.

Merck KGaA plans to cut back its biopharmaceutical division Merck Serono, cutting 500 jobs and transferring another 750 as it closes its Geneva headquarters.

The company plans workforce reductions across all global operations, and will

relocate Geneva-based R&D functions to Germany, the US and China.

The cutbacks, a response to falling profits and growing competitive and market pressures, will shift the division’s centre of gravity from Switzerland to Germany.

Stefan Oschmann, the Merck Executive Board member responsible for Merck Serono, said: “The planned measures for Merck Serono’s operations in Switzerland are needed to ensure our global competitive position in a rapidly changing market and to secure the long-term future of the company.

“We are committed to working closely with key stakeholders, especially affected employees, to find socially responsible solutions, including exploring potential entrepreneur partnership programs and redeployment proposals.”

Merck Serono will consolidate all headquarter functions in Darmstadt, Germany, and transfer key R&D positions from Geneva to Darmstadt, Beijing and Boston – taking advantage of the latter’s well-established biotech hub.

Of the division’s 1,250 current positions in Geneva, over 750 will be transferred and the remainder will be lost.

Merck Serono will maintain its manufacturing presence in Switzerland, including its biotech production sites in Aubonne and Corsier-sur-Vevey. Its manufacturing operations in Coinsins will be transferred to Aubonne, and 80 jobs will be lost across the three sites.

A consultation process with employees will start on April 25, and will include attempts to identify redeployment opportunities.

In addition, a dedicated team will try to help employees identify potential spin-off and start-up opportunities. Merck Serono is prepared to commit up to €30m in seed funding to support these projects.

The division plans to commence relocations and workforce reductions in the second half of 2012, to be concluded in the first half of 2013.

Cancer patients are not prescribed the most appropriate treatment for their disease due to a lack of access in receiving biomarker test results, a new report has found.

Market research from 100 oncologists found that more than half of cancer specialists (53%) admit to prescribing a treatment which is not necessarily the most appropriate due to a lack of data.

Dr Tim Iveson, Consultant Medical Oncologist, Southampton General Hospital and member of Bowel Cancer UK's Medical Board, says the findings are “extremely worrying”.

The report – conducted by Merck Serono – also reveals that a further 40% of specialists said they were unable to prescribe the best appropriate treatment due to delays in biomarker tests results.

Biomarker tests are crucial in determining whether a personalised treatment may be more effective than standard options.

However, nearly three quarters (74%) of specialists either agree or strongly agree that biomarker tests differ between in availability regions after 22% of respondents admitted to prescribing personalised medicines without appropriate biomarker tests.

Almost half of respondents said the biomarker test results take at least two weeks to be returned and the unsatisfactory delay risks treatments being interrupted, potentially impacting outcomes.

Additionally, the report found that almost one in four doctors (22%) were more likely to offer personalised medication to private patients as opposed to an NHS one.

Dr Iveson said the findings were “simply not acceptable” and called for more partnerships between the NHS and pharma to ensure patients are given the same level of treatment across the country.

“In bowel cancer, we are making headway, with biomarker testing standardised and provided to every patient by the pharmaceutical industry,” he commented. “We need more collaborations like this between the NHS, the pharmaceutical industry and Government to ensure better use of stretched NHS resources and to make sure that individual patients are receiving the very best treatment possible that will lead to the best outcomes and where possible extend life.”

The report was sent to MPs on the same day the DH revealed new guidance on the Cancer Drugs Fund in an attempt to increase the speed with which patients receive treatment.

Merck KGaA intends to focus on cutting jobs and reducing costs over the next two years, with no major acquisitions planned.

The ‘German Merck’ plans voluntary redundancies in Germany and will cut its costs through 2018, with a first phase until the end of 2013.

Merck CEO Karl-Ludwig Kley (pictured) told shareholders that given opportunities, the company would “continue to strengthen our business through in-licensing or targeted acquisitions.”

The company claimed there is “no alternative” to shedding staff.

The acquisition of life science research company Millipore in 2010 helped Merck KGaA to achieve an 11% increase in revenue over 2011, and the company predicts a slight revenue increase over 2012.

However, Merck’s net profit for 2011 fell by 2%, and increasing competitive and market pressures are predicted over the next few years.

The company’s austerity restructure is expected to last through 2013, during which time it plans to avoid major takeovers.

This decision follows a number of pipeline setbacks, including the FDA’s rejection of Merck Serono’s MS drug cladribine in 2011.

Kley’s statement contrasts with the view expressed recently by Lilly CEO John Lechleiter: “I don’t think we can save our way out of the enormous challenge we face. The best course is to maintain our focus on advancing our pipeline.”

Merck KGaA saw record-breaking levels of revenue in 2011 as sales topped €10 billion for the first time.

Revenue was up 10.6% to €10.2 billion following the 2010 acquisition of the Millipore Corporation and growth in the Group’s four divisions – Merck Serono, Merck Millipore, Consumer Healthcare and Performance Materials.

Karl-Ludwig Kley, Chairman of Merck’s Executive Board, said the Group delivered a “good operational result in a challenging year” but confirmed that despite topping €10bn in revenue job cuts would still be made.

The company revealed last month it plans to cut jobs across all businesses and regions under new efficiency plans it aims will reduce costs and exploit new growth opportunities. (Read here)

Mr Kley says that the efficiency plans recognise the “competitive and market pressures” Merck faces in the future.

Despite the record breaking levels of revenue, overall operating result was down 11.5% to €985 million and net profits decreased 2.3% to 617 million Euros.

Sales increased by 17% to €2.78 billion and gross margin rose by 8.4% to €7.4bn. However, marketing and selling expenses were up 7.1% to €2.39bn and royalty, licence and commissioning expenses increased after increased sales of Rebif and Erbitux. R&D costs also jumped to €1.5bn after expensive late-stage clinical trials by Merck Serono.

Total revenues of Merck Serono increased 2.9% to €5.92bn compared to €5.75bn in 2010, which was described as a “solid performance” by the Group. Global sales of Rebif topped €1.69bn after increased demand in the US. Targeted cancer treatment Erbitux recorded sales of €855 million due to strong growth in emerging markets.

In Merck’s other divisions, Merck Millipore almost increased sales by half (48%) to €2.39 billion after growth in North America, Latin America and Asia. Its consumer health care arm saw revenue increase 5.1% to €484 million in 2011, and its Performance Materials division increased revenue slightly by 1% to €1.46bn.

The Group’s Executive Board now expects total revenues to increase slightly in 2012 and 2013.

Merck KGaA has entered into a partnership agreement with Threshold Pharmaceuticals over the development and commercialisation of TH-302 – an investigational cancer treatment.

Threshold will receive an initial payment of $25m as well as potential milestone payments of up to $525m for the treatment currently in Phase III investigations.

Susan Jane Herbert, Head of Global Business Development and Strategy at Merck Serono, says the deal “provides an important opportunity in several different tumour types to expand our oncology development programme”.

TH-302 is designed to work by releasing its active ingredient to combat areas of tissue with a low level of oxygen – a condition known as hypoxia.

Hypoxia is common in tumours because of poor blood vessel growth and occurs in the bone marrow of patients with haematological cancers.

If the product receives approval from relevant health authorities, Merck will initially be responsible for the commercialisation in the US. Threshold also has the option to co-promote the drug in the country.

Outside the US, Merck will be solely responsible for the commercialisation of the medication with Threshold receiving a tiered, double-digit royalty on sales. Merck will also pay 70% of worldwide development costs.

The results from a Phase II trial comparing TH-302’s use, in combination with chemotherapeutic gemcitabine, to gemcitabine alone in patients with first-line pancreatic cancer are expected to be announced later this month.

NICE has issued final guidance to the NHS not recommending the use of Erbitux (cetuximab), Avastin (bevacizumab) and Vectibix (panitumumab) for the treatment of metastatic colorectal cancer that has progressed after chemotherapy.

Concerns were raised by NICE’s Appraisal Committee surrounding the clinical evidence of the products, especially the use of Avastin.

Sir Andrew Dillon, NICE Chief Executive, says the Institute is “disappointed” not to be able to add the three drugs to the six other recommended options available to the NHS.

No appeals were received on the final draft guidance which did not recommend the treatments after the evidence was considered.

Uncertainness were raised over the data supplied by Roche on Avastin plus non-oxaliplatin chemotherapy of its overall survival gain when used as a second or third-line treatment for those who had not responded to first-line or second-line chemotherapy.

Similar queries were also asked by the Committee of the estimates supplied by Merck Serono on Erbitux plus Campto based on the mixed treatment comparison, and on the magnitude of the survival benefit of Vectibix relative to best supportive care provided by Amgen.

“We have to be confident that the benefits that drugs offer patients really do justify what the NHS will have to pay for them,” said Sir Andrew.

“The independent appraisal committee which drafted the recommendations does not feel it has enough evidence, especially in the case of bevacizumab, to feel confident in recommending these drugs for use on the NHS.”

Campto (irinotecan), Eloxatin (oxaliplatin), Xeloda (capecitabine), tegafur with uracil and Erbitux (cetuximab) have all previously been recommended for various stages of colorectal cancer for use on the NHS.