Sanofi Pasteur has signed a research and development agreement with the University of California, San Diego, for its experimental acne vaccine and treatment.

The R&D pact includes a two-year collaboration with Chun-Ming Huang and team at UC San Diego School of Medicine.

The team’s immunological approach to acne prevention and treatment targets the neutralisation of Propionibacterium inflammation.

Elias Zerhouni, President of Global Research and Development at Sanofi, said that the vaccine and treatment could address an unmet medical need.

“This investigational vaccine and treatment may lead to a better solution for the many who suffer from this skin disease,” said Mr Zerhouni.

According to the vaccine division of Sanofi, the annual market for acne therapeutics is in excess of $3 billion.

Pfizer is to invest $200 million at its Grange Castle biotechnology manufacturing site in Clondalkin, County Dublin.

The new investment will see Pfizer introduce two new processing suites to expand its current production and product testing capabilities.

Frank D’Amelio, Chief Financial Officer, Pfizer, says “Ireland is a prime location for this major investment” after a “long history in pharmaceutical excellence”.

The biotechnology manufacturing facility is already one of the largest in the world and produces two of Pfizer’s main products, Prevnar and Enbrel.

More than 1,100 staff are currently employed at the site. Irish Prime Minister Enda Kenny says that the new investment highlights “the tremendous contribution to Ireland’s life sciences industry since it (Pfizer) first established here in 1969 and this investment is a further demonstration of the company’s continuous commitment”.

In total, Pfizer has 4,300 staff employed across the country in eight separate locations in Cork, Dublin, Kildare and Limerick. Its latest investment means the company’s outlay now exceeds $7 billion in the country.

Sanofi Pasteur is donating a vaccine strain used for polio eradication to the World Health Organization (WHO) to produce oral polio vaccines (OPV).

The vaccines division of Sanofi is providing the original viral seed which is used to produce large volumes of OPV against the type 3 virus.

Olivier Charmeil, President and CEO of Sanofi Pasteur, says the donation is a “logical next step” in the division’s “unconditional support to OPV producers”.

Since its inception in 1988 by WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF, the Global Polio Eradication Initiative reduced the number of polio cases across the globe by 99%.

Sanofi Pasteur has supported the Initiative for the last three decades and recently responded to a request from UNICEF by committing to provide 400 million doses of OPV for use in developing countries. The donation saw the amount of doses provided by Sanofi Pasteur exceed five billion doses of OPV to UNICEF.

“Sanofi Pasteur is a leading contributor to the fight against polio and committed supporter of the Global Polio Eradication Initiative," added Sanofi Pasteur’s President.

WHO will now be in full control of the storage of the vaccine strain and its distribution to vaccine producers across the globe.

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”

A convenient oral treatment patients can take at home to prevent venous thromboembolic events (VTE) following elective total hip or knee replacement surgery is now available in the UK.

Eliquis (apixaban) has been launched through a collaboration between Bristol-Myers Squibb and Pfizer and could help prevent up to 25,000 deaths each year resulting from blood clots.

Dr Ander Cohen, Honorary Consultant Vascular Physician at King's College Hospital, London, says the treatment “represents a new option” for surgeons in the UK.

VTE can lead to two serious conditions: deep vein thrombosis and pulmonary embolism which can lead to death if not treated.

The license of Eliquis is based on the ADVANCE-2 and ADVANCE-3 clinical trials in patients who underwent elective total hip or knee replacements. More than 8,000 patients were assessed during the trials which assessed the efficacy in preventing blood clots and death, and bleeding risk of Eliquis when compared to enoxaparin.

“Clinical data showed that apixaban was more effective than the anticoagulant enoxaparin and importantly, it also showed no increase in bleeding rates compared to enoxaparin,” said Dr Cohen.

Dr Rick Lones, UK Executive Medical Director, BMS, said the two companies “hope to reduce the burden of blood clots” in patients undergoing major surgery after the drug’s release in the UK.

The NHS Alliance and the National Association of Primary Care (NAPC) have joined forces to create an independent body representing Clinical Commissioning Groups (CCGs).

The coalition will be the collective voice for practising clinicians, CCGs and their leaders to ensure that commissioning bodies are fully involved with the new NHS.

Dr Johnny Marshall, Chairman of NAPC, said: “We are seeing many obstacles, from all quarters of the NHS and elsewhere, being placed to deter and restrain the successful engagement and operation of CCGs.”

Dr Michael Dixon, Chairman of the NHS Alliance, commented: “We will listen to and represent CCGs’ views and concerns without compromise, wherever and whenever necessary. We will be a united voice that will serve to balance the top heavy approach often seen in the NHS.

“As the two organisations that have wholeheartedly championed clinical commissioning over the last two decades, we have a long history of commitment and dedication to the clinical commissioning cause.”

The coalition has agreed a number of shared principles. They include:

• NHS commissioning should be a public function exercised by statutory bodies in the public sector alone. NHS commissioners should be free to choose the support they need from whatever source they feel to be appropriate.
• The NHS should be based on an approach that maximises local responsibility and ownership through local determination rather than central direction, meaning that the NHS Commissioning Board should only take responsibility for things that must be done at national level.
• CCG Boards should have GPs as majority members with a strong primary care focus.  Boards will need to ensure the appropriate involvement of other clinicians and managers and have strong representation from local communities and independent directors.
• NHS provision should be appropriately distributed across the public, third and independent sectors according to the public interest. Those providing NHS services should clearly subscribe to NHS values of openness, transparency and accountability and behave in a manner consistent with those values.
• The NHS should develop integrated care, centred on the needs of the patient rather than the providing organisations, supported by appropriate payment systems.

The coalition has also established a number of priorities it sees as essential. They include:

• To lobby the Government to review the role of the NHS Commissioning Board to ensure that it is set up as an organisation that enables rather than controls CCGs’ work.
• CCGs’ self-determination – Clinical Senates, Clinical Networks, and Local Health and Wellbeing Boards should help not hinder CCGs, who must have the final decision with their patients. 
• Work with the Government to ensure that aspiring CCGs receive the funds intended to support their development.
• Oppose suggestions that CCGs should be constrained in their choice of commissioning support.
• Monitor and CQC to demonstrate that they are acting in the public interest. The coalition will seek to ensure that CCGs have the means of challenging their decisions.
• Transparency - the coalition believes that the payment of any quality premium to reward CCGs which commission effectively should be transparent, represent good value for money and be in the public interest. 

Both forces will contribute to and have ownership of the new initiative, whilst acting as individual identities regarding other functions.

Dr Johnny Marshall added: “Our respective organisations bring their particular strengths to the table to enable us to be bigger than the sum of our parts.

“The strength of our two organisations working in partnership on the same agenda should reassure Clinical Commissioning Groups of our commitment to their cause and that of their patients.

“We will strive to ensure that CCGs are not overburdened with NHS bureaucracy and red tape and are set free to deliver innovative and population focused services.”

A steering group is advancing the coalition's collaborative work.

Merck has secured the worldwide exclusive rights to PI-2301, an experimental drug for multiple sclerosis (MS).

The acquisition from Peptimmune Inc covers the development and commercialisation rights for the product which has just completed Phase 1b clinical trials.

Susan Herbert, Head of Global Portfolio Development at the Merck Serono division says the drug “could play a valuable role in the treatment of this debilitating disease”.

The second-generation peptide copolymer is believed to enhance the regulatory response of the immune system. Merck will now investigate the application of the product in autoimmune diseases as it progresses to Phase II clinical trials.

“Over the years we have continuously worked on developing innovative treatment options that meet the individual needs of people living with multiple sclerosis,” said Susan Herbert.

Alkermes (ALKS) has marked its first day of operations at its new Dublin HQ with a long term multi-million dollar manufacturing contract with one of the world’s top pharma companies.

The pharma company’s finished product will be manufactured at Alkermes new Athlone facility in Ireland in a deal which could be worth up to $20m by 2016.

Richard Pops, CEO of Alkermes, said the company was “excited to have our operations based in Ireland, which we view as a gateway to the European Union and global pharmaceutical market”.

The company employs more than 450 staff based in Ireland and more than 1,200 worldwide.

The plant in Athlone is one of three facilities owned by Alkermes where the company manufactures proprietary, partnered and contract-based drug products.

The global pharma industry has outlined steps to address Non-Communicable Diseases (NCDs) in developing countries in light of the UN’s High-Level Meeting on the issue.

A report by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) showed that effective first-line NCD medicines were available in generic form, but in many cases are failing to reach those who need it.

David Brennan, CEO of AstraZeneca and President of the IFPMA, said: “The increasing burden of NCDs in low and middle-income countries poses an economic, social and moral stumbling block to global health and prosperity.”

The document contains findings gathered from an independent policy research programme which focuses on the need for reducing the number of NCD cases in the developing world.

Eduardo Pisani, Director General of the IFPMA, said: “The launch of the first in the series of IFPMA reports illustrates how the research-based pharmaceutical industry is committed to this challenge, and how we want to understand what areas require particular focus.”

The study identified four key areas for the pharma industry to consider:

• Innovative ways to improve NCD medicine adherence
• Overcoming barriers to provide medicine in poor and remote areas where costs and taxes are an issue
• Improving access to primary care
• Removing regulatory restrictions that obstruct medicine availability in developing countries.

These areas provide the focus for the next four studies in the IFPMA NCD research scheme. The aim is that the studies will help the research-based pharmaceutical industry to develop and improve access to NCD medicines in developing countries.

“50% of NCDs are avoidable, therefore prevention measures, including lifestyle modifications – doing more physical exercise, stopping smoking and a healthy diet – are some of the most cost-effective and efficient ways to tackle the magnitude of NCDs across the developing world,” added Mr Pisani.

David Brennan, CEO of AstraZeneca and President of the IFPMA, said: “There is no silver bullet solution because the scale of the problem is so complex. This underscores the importance of partnership to understand what the most significant problems are and to work together to solve them.”

The global pharma industry has outlined steps to address Non-Communicable Diseases (NCDs) in developing countries in light of the UN’s High-Level Meeting on the issue.

A report by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) showed that effective first-line NCD medicines were available in generic form, but in many cases are failing to reach those who need it.

David Brennan, CEO of AstraZeneca and President of the IFPMA, said: “The increasing burden of NCDs in low and middle-income countries poses an economic, social and moral stumbling block to global health and prosperity.”

The document contains findings gathered from an independent policy research programme which focuses on the need for reducing the number of NCD cases in the developing world.

Eduardo Pisani, Director General of the IFPMA, said: “The launch of the first in the series of IFPMA reports illustrates how the research-based pharmaceutical industry is committed to this challenge, and how we want to understand what areas require particular focus.”

The study identified four key areas for the pharma industry to consider:

• Innovative ways to improve NCD medicine adherence
• Overcoming barriers to provide medicine in poor and remote areas where costs and taxes are an issue
• Improving access to primary care
• Removing regulatory restrictions that obstruct medicine availability in developing countries.

These areas provide the focus for the next four studies in the IFPMA NCD research scheme. The aim is that the studies will help the research-based pharmaceutical industry to develop and improve access to NCD medicines in developing countries.

“50% of NCDs are avoidable, therefore prevention measures, including lifestyle modifications – doing more physical exercise, stopping smoking and a healthy diet – are some of the most cost-effective and efficient ways to tackle the magnitude of NCDs across the developing world,” added Mr Pisani.

David Brennan, CEO of AstraZeneca and President of the IFPMA, said: “There is no silver bullet solution because the scale of the problem is so complex. This underscores the importance of partnership to understand what the most significant problems are and to work together to solve them.”