CPL News - Archived

  • 160 jobs to go at Schering-Plough in Cork

    Sep
    09

    Management at the Schering-Plough pharmaceutical plant at Brinny in west Cork have said they will be cutting the work force there by 160 over the next three years.

    In a meeting with staff which is continuing, management have said that where possible it will try to achieve the job cuts through voluntary redundancy.

    Schering-Plough Site Director John Howell also said that a transformation programme which the company is going through presented everybody at the plant with an opportunity to secure further investment at the site in the future.

    Mr Howell said the cost reduction programme was designed to secure the future of the plant within the Merck global network.

    Last year, Schering-Plough merged with the multinational pharmaceutical company Merck in a deal valued at the time at $41bn.

    Schering-Plough currently employs just over 500 people in west Cork.

    Source: www.rte.ie 
    Date: 09.09.2010

  • Vitamin B could delay Alzheimer's

    Sep
    09

    Vitamin B could prove to be a revolutionary weapon against age-related memory loss and, the results of a groundbreaking study suggest.

    The research showed that large daily doses of B vitamins can halve the rate of brain shrinkage in elderly people with mild cognitive impairment (MCI), a precursor to Alzheimer’s and other forms of dementia.

    Brain atrophy, which is a natural part of ageing, is known to happen faster in people with MCI who go on to develop Alzheimer’s.

    The British-led scientists believe the vitamin treatment could delay or even prevent development of the disease. They are now seeking funding for another trial which will put this theory to the test.

    The research, published in the online journal Public Library of Science ONE, is controversial because it defies current scientific dogma about the way to tackle Alzheimer’s. It suggests simply taking vitamins can achieve results that have so far evaded pharmaceutical companies, despite millions of pounds being spent on experimental dementia drugs.

    Researchers at Oxford University, assisted by colleagues in Norway, used an advanced magnetic resonance imaging (MRI) technique to study brain shrinkage in 168 volunteers over the age of 70 with diagnosed MCI.

    Over a period of two years, half were given a daily tablet containing high doses of the B vitamins folate, B6 and B12. The rest received a “dummy” placebo pill with no active ingredients.

    At the end of the trial the effects of the vitamin treatment were found to be dramatic, and most pronounced in participants who started out with the highest rates of brain shrinkage.

    On average, taking B vitamins slowed the rate of brain atrophy by 30 per cent, and in some cases reductions as high as 53 per cent were seen.

    Prof David Smith, one of the study leaders from the Department of Pharmacology at Oxford University, said: “This is a very striking, dramatic result. It’s much more than we could have predicted.

    “It is our hope that this simple and safe treatment will delay the development of Alzheimer’s disease in many people who suffer from mild memory problems.”

    But he warned people not to rush into taking mega doses of B vitamins to ward off mental decline, even though the study results were “immensely promising”.

    The long-term effects of taking big doses of the vitamins were not known, and there was some evidence that high folate intake could be linked to cancer, he said. However, asked if he would try the vitamin treatment if he was diagnosed with MCI Prof Smith said he would “with no hesitation”.

    Although the trial was not designed to measure thinking ability, the researchers found that individuals with the lowest rates of shrinkage had the highest mental test scores.

    MCI causes memory lapses and language problems that are noticeable but not bad enough to disrupt daily life. However, it is a known risk factor for Alzheimer’s and other kinds of dementia. Half of those people with MCI go onto to develop dementia within five years.

    Brain shrinkage at the rate of around 0.5 per cent a year is normal for individuals over the age of 60 without MCI. For those with MCI, it is twice as fast on average and in people with Alzheimer’s, the brain can lose 2.5 per cent of its volume each year.

    To date, most Alzheimer’s research has focused on the beta-amyloid protein deposits that accumulate in the brains of patients. But despite some promising early research the strategy has not so far proved successful in humans.

    Prof Smith and his colleagues now hope to conduct a further trial specifically aimed at testing whether B vitamins can delay or prevent the onset of Alzheimer’s. If the funding is found, results can expected in around five years.

    Source: www.irishtimes.com
    Date: 09.09.2010

  • Allergan settles Botox case for $600m

    Sep
    02

    Allergan settles Botox case for $600m

    Allergan has agreed to pay $600 million to settle a federal probe of its marketing practices for the injectable wrinkle smoother Botox.

    Allergan will record nonrecurring pre-tax charges of $610 million to $615 million in its third fiscal quarter related to the settlement with the US Department of Justice.

    The settlement was announced by the company late yesterday. The Justice Department declined immediate comment.

    The investigation centered on the company's marketing of Botox for certain therapeutic treatments, such as pain, that had not been approved by US health authorities.

    Allergan agreed to plead guilty to a misdemeanor "misbranding" charge covering the period 2000 through 2005 and pay $375 million.

    Allergan also agreed to pay $225 million to resolve civil claims asserted by DOJ under the civil False Claims Act.

    As part of its plea, Allergan agreed that between 2000 through 2005, its marketing of Botox resulted in uses for the therapeutic treatment of headache, pain, spasticity and juvenile cerebral palsy. These were considered "off-label" uses because Botox had not been approved for those uses during that time period, and the labeling for Botox did not contain directions for those uses.

    In March 2010, the US Food and Drug Administration approved Botox for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity. The label now includes directions for that use, the company said.

    Based on positive Phase III trials announced in September 2008, Allergan has filed for FDA approval of Botox for the treatment of chronic migraine and expects a ruling before the end of 2010.

    Allergan is also in Phase III clinical trials investigating the use of Botox to treat neurogenic and idiopathic overactive bladder.

    While Botox is approved in 70 countries, including the UK and Canada, to treat symptoms associated with juvenile cerebral palsy, it does not have that approval in the United States, where it is currently used off-label. Allergan said it is in discussions with the FDA regarding additional clinical development for juvenile cerebral palsy in the United States.

    Reuters

    Source: www.irishtimes.com
    Date: 02.09.2010

  • Lenihan officially opens Helsinns R&D Centre

    Sep
    01

    Minister Lenihan performs official opening of Helsinn’s new R&D Centre of Excellence in Dublin

    Centre will play a significant role in Helsinn Group’s pipeline of new products 

    "Helsinn is pleased to confirm the completion of this Investment in our R&D Centre on time and in budget which will be of significant benefit for the future of our international business, by centralising the development and commercialisation of Oral Solid Dosage products to ensure better management of our resources and flexibility to better serve our partners worldwide" - Mr. Riccardo Braglia - Chief Executive Officer of the Helsinn Group

    Minister for Finance, Mr Brian Lenihan T.D., today (Wednesday 1st September 2010) performed the official opening of the new R&D Centre of Excellence for Helsinn in Mulhuddart, Co. Dublin. The centre, which will play a significant role in Helsinn Group’s pipeline of new products including the NK-1 inhibitor Netupitant for treatment of emesis due to chemotherapy, and the novel ghrelin analogue Anamorelin for treatment of cachexia, involved an investment of €13 million, supported by the Irish Government through IDA Ireland.  The investment is expected to create up to 10 high-value research positions over the next few years.

    Helsinn, a privately owned pharmaceutical company, announced its plans to establish the facility in April 2009, and following a successful construction phase the plant is now ready to commence operations. The centre will be responsible for Research and Development for Oral Solid Dosage (OSD) at the company’s Helsinn Birex Pharmaceuticals facility, which currently produces a range of drug products at its site at Mulhuddart, Dublin. 

    Helsinn’s core business is the in-licensing of early to late-stage pharmaceutical compounds in therapeutic niche areas for development and subsequent commercial manufacture and distribution. The company is primarily active in oncology supportive care, anti-inflammatory and gastrointestinal treatments. The investment is part of Helsinn’s strategic decision to strengthen its in-house development capability enabling better control of cost and time in bringing new therapies to patients worldwide.

    Speaking at the official opening the Minister said “I am delighted to officially open Helsinn’s Centre of Excellence in Dublin today.  This investment is highly significant for Ireland as it places Helsinn’s Irish operation at the centre of Helsinn Group’s worldwide R&D operations.  The Irish Centre of Knowledge and Learning for OSD products will play a pivotal role in facilitating the growth of Helsinn’s worldwide business by acting as a launch site for new products within its portfolio. This investment is a further endorsement of Ireland as a prime location for highly innovative companies carrying out key strategic activities”.  

    Helsinn’s Irish operation was established in 1990, when it acquired Birex Pharmaceuticals in Dublin. To-date Helsinn has invested a total of over €60 million in Ireland and continuously invests in its plants in order to maintain high quality and safety, to increase overall production capacity and to offer its partners up-to-date products, technologies and services. It now employs a total of 145 people at its Helsinn Birex Pharmaceuticals facility from which it supplies global markets with a range of products including its highly successful product Palonosetron which is effective for treatment of chemotherapy induced nausea and vomiting, as well as Nimesulide (anti-inflammatory) and KleanPrep (pre-colonoscopy treatment).

    Mr. Riccardo Braglia, Chief Executive Officer of the Helsinn Group said, “Helsinn is pleased to confirm the completion of this Investment in our R&D Centre on time and in budget which will be of significant benefit for the future of our international business, by centralising the development and commercialisation of Oral Solid Dosage products to ensure better management of our resources and flexibility to better serve our partners worldwide.”

    About Helsinn
    Helsinn, a family owned company headquartered in Lugano, Switzerland, with subsidiaries in Ireland and USA, was established in 1976. Helsinn, with a workforce of around 450 employees in Switzerland, Ireland and USA, reported a 2009 turnover of over CHF 305 million (about EUR 232 million), covering 85 countries worldwide, with over 20% of this turnover invested in R&D. 

    About Helsinn in Ireland
    Helsinn has operated in Ireland since 1990 and its Irish manufacturing facilities are EU certified for manufacture of pharmaceutical products and were successfully inspected by the US Food and Drug Administration earlier this year. The company manufactures and packages the group’s products in compliance with EU, US FDA and all major international health and environmental requirements, thus guaranteeing Helsinn’s clients the highest possible assurance of quality and reliability.

    Source: www.idaireland.com

    Date: September 1st 2010

  • Genzyme rejects Sanofi bid offer

    Aug
    30

    US biotech firm Genzyme broke its five-week silence to reject an $18.5 billion takeover proposal by French drugmaker Sanofi-Aventis today, dismissing it as opportunistic and too low.

    Sanofi chief executive Chris Viehbacher confirmed his $69 per share non-binding cash offer for Genzyme yesterday, hinting he could make a hostile takeover bid following several unsuccessful attempts to hold talks with Genzyme management.

    Genzyme hit back today, saying that Sanofi's proposal showed no improvement in price since Mr Viehbacher first wrote to management in July and failed to form the basis for talks.

    "The Genzyme board is not prepared to engage in merger negotiations with Sanofi based upon an opportunistic proposal with an unrealistic starting price that dramatically undervalues the company," Genzyme CEO Henri Termeer said in a letter to Mr Viehbacher.

    The French group stopped short of making a direct approach to Genzyme shareholders yesterday, and Mr Viehbacher sounded a conciliatory tone in an interview with Les Echos newspaper that nonetheless suggested there was a limit to his patience.

    "We want to show that we are determined and serious, without being threatening straightaway. Quite some time can go by yet," Mr Viehbacher -- dubbed the "Smiling Killer" by some staff for his cost-cutting zeal -- said in the interview.

    Genzyme shares were up 4.3 per cent to $70.55 in pre-market trade in New York, following its rejection of Sanofi's offer.

    Sanofi shares were up 0.9 per cent at €45.655, while the Stoxx 600 European health care index gained 0.7 per cent.

    Mr Viehbacher said yesterday that disclosing Sanofi's non-binding offer would give Genzyme shareholders a chance to see the "significant shareholder value and compelling strategic fit inherent in a combination of the two companies".

    Some analysts suggested Genzyme, which is trying to fix manufacturing problems that led to shortages of two of its top drugs and had hit its stock price, may not get a better offer and that a hostile bid by Sanofi could even be lower.

    Roche Holding cut its bid to buy out shareholders in Genentech in 2008 when it turned hostile after Genentech rejected a previous offer, although it subsequently sweetened its offer in 2009.

    Analysts have said they expect a deal to be finalised in the range of $74 to $77 a share. If Sanofi walks away, analysts see shares of Genzyme falling to the low $50-range. Some say it could take at least a year for them to rebuild the lost value.

    The Jefferies analysts saw a potential offer of $75 a share and said Sanofi may prefer "the long game of waiting" until Genzyme's annual meeting in May to let shareholders vote on a hostile bid.

    Genzyme is the world's dominant supplier of drugs to treat Gaucher and Fabry disease -- rare, inherited disorders in which patients lack key enzymes for breaking down fats.

    News of Sanofi's initial approach emerged late in July and the drugmaker sent a written expression of interest on July 29th.

    Sanofi said Genzyme rebuffed the offer on August 11th but after some persuasion agreed to a meeting of financial advisers on August 24th.

    Reuters 

    Source: www.irishtimes.com
    Date: 30th August 2010

  • Irish-made drug could provide breakthrough

    Aug
    30

    Irish-made drug could provide breakthrough in heart failure care

    A new drug made in Ireland could cut the risk of heart failure by 26%, it has emerged.

    The findings were outlined by the European Society of Cardiology Congress in Sweden and will be published in the Lancet medical Journal.

    The study involved more than 6,500 patients from 37 countries.

    It found that the drug, Ivabradine, which is manufactured in Co Wicklow, reduced death and hospitalisation due to heart failure by 26% in patients with moderate to severe heart failure.

    Source: www.breakingnews.ie 
    Date: 30/08/2010 - 09:15:15

  • Medtronic sales dip spooks device secto

    Aug
    25

    ednesday, August 25 08:22:19

    Medtronic has posted a surprising decline in quarterly sales and cut its forecast due to weak demand for its medical devices and pressure on prices.

    The results sent its shares down nearly 12 pc to a 15-month low.

    The world's No. 1 stand-alone medical device maker, a bellwether, reported quarterly profit in line with expectations, but its weak sales and outlook weighed on the shares of rivals such as cardiovascular device companies Boston Scientific and St. Jude Medical and orthopedic device makers Stryker and Zimmer.

    Analysts said results in two key Medtronic divisions, cardiac rhythm and spine, were particularly disappointing.

    "This is very scary for the entire industry -- you have utilization dropping and price deflation ... and we're probably not even close to the half-way point in this cycle," said analyst Tim Nelson of FAF Advisors, an asset management firm.

    In a telephone interview, Medtronic Chairman and Chief Executive Officer Bill Hawkins said he was especially surprised by the weakness in its spine unit, the company's second-largest after Cardiac Rhythm Management, which makes implantable heart defibrillators, better known as ICDs, and pacemakers.

    The decline in demand, Hawkins said, "was possibly exaggerated because of the (seasonally slow) summer months, but what we are hearing from hospitals and insurance companies indicates that it's probably more."

    He said as hospitals continue to purchase physician practices they become increasingly focused on the profitability of procedures and have pushed back on prices.

    "We get price through innovation. There's a direct relationship with our pipeline, which is very full," he said, noting that the company should be able to demand higher prices for new products once they are launched.

    He acknowledged that the company did not benefit, as many had expected, from Boston Scientific's temporary shipment halt of ICDs in the spring. Medtronic ended the quarter with a 47 percent share of the ICD market, the same share it had before Boston Scientific halted shipments.

    Jan Wald, an analyst with Noble Financial Group, said the cardiac rhythm devices business fell short of his expectations.

    Wald had expected weaker sales in the spine division "just because the spine market has been terrible for everyone."

    Medtronic cut its revenue growth outlook to a range of 2 to 5 pc for the fiscal year begun in April, down from the 5 to 8 pc it forecast in June.

    Medtronic's full-year earnings per share forecast includes about 5c of dilution from the acquisition of Invatec and ATS Medical.

    For the fiscal first quarter ended July 30, Medtronic net earnings were USD 830m, or 76c per share, up from USD 445m, or 40c per share a year earlier, when the company took a charge for restructuring and litigation.

    Excluding one-time items, earnings were 80c a share, matching an average forecast by analysts.

    Revenue was USD 3.77bn, down 4pc from a year earlier and below the USD 3.95 bn expected by analysts.

    Source: www.businessworld.ie
    Date: Wednesday, August 25 08:22:19

  • United Drug buys UK-based firm as it expands..

    Aug
    16

    UNITED Drug -- Ireland's largest pharmaceutical wholesaler -- said it bought a UK-based medical marketing company for as much as $21m (€16.2m) as it expands its marketing interests.

    United Drug bought the UK-based company InforMed Group for £11.4m (€13.8m) in cash and a further £5.9m (€7m) in bonuses if certain targets are met over the next three years.

    The deal will expand United Drug's operations in the UK and the US where the company already offers services such as event management and the promotion of customers' drugs among doctors.

    Expansion

    United Drug has expanded far beyond its origins supplying medicines to local chemists and now offers nursing services to Britain's National Health Services as well as medical marketing for pharmaceutical and biotechnology companies.

    It has previously bought companies such as Ashfield, Universal ProCon and Business Edge to move into the marketing sector. "The acquisition significantly adds to our offering, both in the UK and the US, in the growing contract sales and marketing services division," United Drug chief executive Liam FitzGerald said yesterday.

    "InforMed has an excellent management team and I am delighted to welcome them to the group."

    Macclesfield-based InforMed employs 80 people to do medical writing and publication planning, market research, business analysis, sales training and consultancy, United Drug said.

    - Thomas Molloy

    Source: Irish Independent

    Date: Thursday August 12 2010

  • 150 new jobs at Monaghan mushroom plant

    Aug
    16

    A new state-of-the-art mushroom growing facility is to provide 150 extra jobs.

    The new facility for Monaghan Mushrooms is among the most modern plants of its kind in Europe.

    The plant at Tyholland, Co Monaghan, is able to grow up to 6,000 tonnes of the fungi each year.

    Agriculture Minister Brendan Smith will officially open the 12m euro project today.

    Founded in the 1981 by local man Ronnie Wilson, Monaghan Mushrooms now employs 2,297 people across Ireland, the UK and Canada.

    He believes the new development will have a very positive impact on the company as well as bring employment to the area.

    The new facility is made up of 18 individual mushroom growing houses amounting to more than 21,000 square metres.

    Source: www.businessworld.ie

    Date: Monday, August 16 07:59:49

  • Cork scientists get E10m funding boost

    Aug
    16

    Two groups of scientists at Tyndall National Institute in Cork will each receive up to E5m to develop research in to electronics and medical devices.

    The hope is that the research could yield new products for the electronics and medical devices industries, according to the Minister for Enterprise, Trade and Innovation, Batt O'Keeffe TD.

    The two industry-led research centres are focusing on applied nanotechonology and microelectronics to drive new innovation and product design across the medical and electronics sectors.

    At Tyndall, researchers in nanotechnology are developing integrated circuits for sensors and medical devices, while another group of researchers is designing microelectronics circuits.

    The centre will develop and licence intellectual property in microelectronics to firms that can take the technology to the global marketplace.

    Firms including Intel, Analog Devices, Creganna and Seagate are helping both research teams to bring a commercial and market-orientated focus to their work.

    Minister O'Keeffe said the Government's investment in the Competence Centres Programme will rise to E90m over the next six years.

    "Collaborative company-led research will get under way in the research centres which will rise from six this year to 15 in 2016.

    "Clusters of firms will work together to overcome common research challenges and drive opportunities for innovation, growth and jobs," he added.

    Source: www.businessworld.ie

    Date: Friday, August 13 17:14:35