ICON and BMS Further Partnership

ICON, already global clinical development partner to Bristol Myers-Squibb, have added to the agreement by announcing a preferred provider agreement with BMS in early-phase studies, reports inpharm.com.

The agreement includes full service clinical pharmacology and exploratory clinical studies, based in Manchester in the UK and elsewhere around the world. ICON will also be responsible for all the scientific support services during the trials, such as biostatistics and clinical monitoring, amongst a variety of others.

Dr Mario Rocci, president of ICON Development Solutions, is looking forward to “demonstrating the same values and efficiencies to BMS’s early phase clinical programmes” as they do with phase II-IV studies. Under this new agreement, ICON expects to be able to report “significant cost savings and productivity” by putting it’s global network to use.

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NICE Recommends MSD’s Drug for Spine Disease

The National Institute for Clinical Excellence (NICE) has recommended pharmaceutical company Merck Sharp & Dohme’s (MSD) Simponi as an option for treating ankylosing spondylitis, reports pharmatimes.com.

The drug is recommended in treating the disease, which affects the spine, in severe cases when used as directed for other tumour necrosis factor inhibitor treatments. MSD will also provide the drug at the same price for both 50mg and 100mg doses, meaning annual treatment costs are slightly over £9,000. NICE does not consider this an excessive price.

Ankylosing spondylitis has no known cause and can lead bones and joints to fuse together. Professor Carole Longson of NICE was pleased to recommend Simponi for “this progressive and irreversible condition.” MSD’s drug is more cost effective than the two current drugs used to treat the condition, so was appraised sooner than it may otherwise have been. The drug can only be taken if it is proved over a twelve week period the disease is active and conventional steroid treatment has failed.

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Amgen Creates 100 New Jobs in Dublin

Amgen, one of the largest manufacturers of pharmaceutical products in the world, has announced it is opening a new factory in Dublin, reports careersportal.ie.

The building of the new manufacturing plant, to be based in Dun Laoghaire, by the pharmaceutical product developer, is to create up to 100 jobs in the area. Added to the pharmaceutical roles created by the new site, construction workers will be needed, so as many as 400 jobs will be temporarily created.

The opening of the plant comes just months after Amgen purchased Pfizer’s old site nearby. Amgen, founded thirty years ago, has quickly established itself as a major force in the global pharmaceutical business, with over 500 staff in the UK alone.

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GSK Invests in Biotech Start Up

Pharmaceutical company GlaxoSmithKline has given a press release detailing an investment in biotechnology company Autifony Therapeutics Limited.

The £1.25 million investment is to be put into the start up in return for a 25% equity stake, alongside £10 million from other investors including SV Life Sciences. £400,000 is to be put into development data for hearing loss, patent applications and several ion channel modulated compounds.

As part of the agreement, GSK will be eligible to receive another 550,000 shares upon pre-determined milestones being achieved. Upon this, further investment will be made by the consortium of other investors which will reduce GSK’s stake to 13%.

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GSK Partner’s Engima in Diagnostics

GlaxoSmithKline has struck a deal with Enigma Diagnostics to develop new diagnostic tests, reports inpharm.com.

The Enigma ML system is to be exclusively supplied and marketed across Europe and the world as part of the deal. Enigma is also to develop respiratory tests for GSK in order to quickly deliver a raw sample within a medical setting. GSK will be able to generate revenue from future tests in various therapies including infectious diseases.

Enigma chairman John McKinley believes the partnership will “deliver much needed ‘test and treat’ capability to infectious diseases management.” Eddie Gray, president of GSK’s European Pharmaceutical division, says that the joint venture is designed to “improve patient care through the provision of rapid, state of the art diagnostic tests.” Details of the transaction have not been disclosed, though GSK have made an up front payment, coupled with funding for research and bonuses for targets met.

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Top Chemists Warn of Government Cuts

Top chemists, including seven Nobel laureates, have written to the government to warn of the impact of cuts on scientific research essential for a wide range of industries from biotechnology to agriculture, reports the Guardian.

Professors from Imperial College London, Oxford and Bristol universities, amongst others, argue that cuts would “irreparably damage” the UK economy’s global competitiveness, forcing scientists to look for jobs overseas. According to the Royal Society of Chemistry, the sector and ones linked to it contribute £258 billion to the UK economy annually, supporting around 6 million jobs.

The area most affected by these cuts will be synthetic organic chemistry, currently receiving £44 million in funding. An accompanying letter signed by heads of companies such as Novartis, said that synthetic organic chemistry influences everything from molecular archaeology to molecular zoology, and to even “think of disadvantaging and disabling such important scientific innovation beggars belief.”

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Analysts Worry About Pharma Outsourcing

Analysts are criticising CROs on the downside of the strategic relationships being put in place with big pharmaceutical companies, reports fiercebiotech.com.

Icon is cutting its 2011 financial guidance as it has to make large investments due to an outsourcing deal it has with Pfizer. Pfizer is currently outsourcing vast amounts of its research because of the cuts to their research budgets, and so companies such as Icon and Parexel are becoming the main suppliers of Pfizer’s research, something worrying analysts. Eric Caldwell noted in a story for Outsourcing Pharma that Icon will face “additional challenges ahead and we’ve taken a sharp pencil to our forward estimates.”

Icon is committed to the deal with Pfizer, however, taking on as many as 800 new staff in order to ensure there is enough manpower to do the research. Icon CEO Peter Gray believes “the major achievement of the quarter was [the] selection by Pfizer” as a clinical development partner. Gray went on to add that Icon is increasing hiring and expects to increase costs over the next two quarters as his company gears up to take on the work given by Pfizer.

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AstraZeneca AXANUM Approved Across EU

Pharmaceutical company AstraZeneca have announced that their new low dose ASA, (also known as aspirin) AXANUM, has received approval across the EU and Norway.

AXANUM is recommended for preventing heart attacks or strokes in patients who need daily low dose ASA treatment and are at risk of gastric ulcers. Those who are both at risk of cardiovascular problems and are taking aspirin are at an increased risk of stomach ulcers, with gastric or intestinal problems the main reason for stopping the usage of low dose ASA. However, by stopping treatment, the risk of cardiovascular problems is vastly increased.

AstraZeneca’s new drug is designed to stop gastric ulcers from forming, meaning continuous protection is provided against heart problems and stomach issues. The EU approved the drug and it is now subjected approval and pricing in each country. Tony Zook, of AstraZeneca’s Global Commercial Organisation wants “to bring this medicine to patients as soon as possible,” by working effectively with the health authorities.

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Synexus to Begin MCI Studies

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Manchester based Synexus, a company specialising in the running of clinical trials on behalf of pharmaceutical companies, has gained a contract to conduct a mild cognitive impairment (MCI) study, reports pharmaceuticalbusinessreview.com.

Synexus, who work with pharmaceutical, biotech and CRO companies globally, signed an agreement late in 2010 with Roger Bullock to develop effective clinical trials in the MCI field. The company is in negotiations with a number of clients to undertake further trials.

CEO Christophe Berthoux has seen an increase in those who are looking to involve themselves and invest large amounts of money into novel MCI treatments. Berthoux believes his company is seeing this increase because “sponsors want to partner with clinical trials companies that actually deliver the number of patients needed to get their study underway.”

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Angel Biotech to Increase Staff

Angel Biotechnology has announced a link with WH Partnerships Ltd to increase biomanufacturing facilities by up to fivefold, reports pharmaceutical-jobs.com.

Angel is re-commissioning a site in Newcastle Upon Tyne in conjunction with WH Partnerships, resulting in new biotech jobs and initially employing ten people. The facility is expected to be up and running early in 2012, with current activities going into preparing the site and bringing it up to operational standards. This is important, with the Newcastle site being able to conduct everything from phase I trials to manufacturing for cell therapy companies.

Angel “expects the level of interest from US companies pursuing development opportunities in the UK to continue to grow” which will hopefully mean further expansion. The company’s facility in Scotland is currently fully occupied, so the Newcastle expansion is a necessary step forward for Angel. Despite an operating loss in the first half of 2011, the company is upbeat, putting the loss down to “the phasing of revenue milestones” and an increase in staff effecting gross margin levels.

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