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'Ignore Our Drug Prices', Greece Tells Europe December 21st 2012 No 3630 scripintelligence.com ‘Ignore our drug prices’, Greece Please expect your tells Europe next copy of Scrip Intelligence 11 January 2013. Triple-negative salvage for Eisai’s down-not-out eribulin? National pricing and reimbursement and EUCOPE, which represent pharmaceutical authorities in Europe should not use Greek companies in Europe, have complained that Encouraged by promising signs of activity, medicine prices to set their own prices, the wealthier countries are referencing prices in particularly in certain patient subsets, in Greek health ministry has said on its website. lower-income countries, including Greece. For the earlier line treatment of advanced “The current Greek pricing system is based example, Germany now uses Greek prices in the breast cancer, Eisai is stressing that it on the exceptional and harsh economic, procedure for fixing drug prices if negotiations remains committed to developing its novel social and medical factors that are specific between health insurers and companies fail microtubule dynamics inhibitor Halaven to Greece. The Greek ministry of health asks following the early benefit assessment. (eribulin mesylate) in this setting. competent authorities in other countries Firms are taking a hit. In 2011, a 10% price But additional studies will be needed to not to refer to those prices in their national cut in Greece lost firms €299 million there better elucidate the drug’s benefits as part of pricing and reimbursement decision-making and €799 million in European countries that a more focused strategy following the overall process,” says the announcement. reference Greece in some way, according to negative results from the comparative Study Companies will be hoping that national Global Insights. The global impact was €2.15 301. While no decisions have been made, authorities take note. Drastic price cuts in billion (scripintelligence.com, 2 March 2012). new data from the program suggest that the Greece have been a concern for industry for Industry claims that price referencing triple-negative form of breast cancer (disease some time, not only because of the losses in erodes differential pricing in Europe and negative for human epidermal growth factor Greece, but also because several countries makes it hard for companies to affordable receptor 2 (HER2), estrogen and progesterone determine their own medicine prices by prices in lower-income markets. receptors) may emerge as the lead target. directly or indirectly referencing prices in http://bit.ly/ZDBLJn Turn to page 4 Greece (as well as other markets). Both EFPIA [email protected] season’s greetings from contents/editor’s letter 10 Pharma united against Alameda drug 22 disposal law in US 11 Phase forward for Mitsubishi Tanabe’s Gilenya wannabe 11 Parliament vote turns EU patent dream into reality Mike Ward, 12 R&D Bites Editor, Scrip Intelligence 13 Gilead JAKs up oncology presence with $510m YM buy In the much loved wintry tale written by 1 ‘Ignore our drug prices’, Greece tells Europe 13 Amgen picks up deCODE to validate AA Milne, Pooh, a bear of very little brain, drug targets sets off in the snow for an Expedition to the 1 Triple-negative salvage for Eisai’s North Pole. down-not-out eribulin? 14 Distorting data or scientific disagreement? Court wrangles On the way, he meets his friend 3 Comment: ‘Bad pharma’ with free speech Piglet. Both trudge together through the gets a scolding from Goldacre thickening snowfall, singing songs to steel 15 Another letdown for Lilly as tabalumab themselves against the cold and other fails in RA study 5 HTA bodies likely to block dangers of the wood. European pricing directive 15 FDA panel zaps Zogenix’s Zohydro After a while, they come across the tracks 5 Teva CEO aims to reshape 16 In NICE-land, Nexavar does not exist, of a large, heavy and ferocious beast, the 111-year-old firm so Pfizer can’t compare it with Inlyta Woozle. And the Woozle tracks are then joined by those of a smaller but potentially 6 Bad-mouthing emerging biosimilars 16 Policy & Regulation Briefs equally ferocious animal, the Wizzle. seen as big pharma sabotage tactic 17 Pfizer’s Prevnar 13 will be A little further on, still more tracks suggest 6 Roche’s Humer: ‘Pharma can cut hard to beat as market expands that the original Woozle and Wizzle have development costs 50%’ been joined not only by another Woozle, but ASH: Celgene’s pomalidomide 17 also by another Wizzle. Price boost for Indian R&D, govt mulls shows durable response in MM 7 Pooh and Piglet are entirely fictional. mandatory generic name prescriptions 18 Sanofi mulls insulin production in India They are also wholly delusional. The tracks 7 Four years late, Lilly’s amid rising emerging markets focus of the Woozle and the Wizzle are Pooh solanezumab stays in PhIII 19 Key Kyowa Kirin, DSP drugs and Piglet’s own footprints. Robbed of opened up to Japan generics 8 Pharma fashion: Roche, Elan, LEO and landmarks, the pair have simply gone round Alkermes model the austerity collection 19 Deep brain probe could leapfrog drugs in circles in the snow. in AD/neuro opportunity In Eli Lilly’s case, the destination of its 9 Business Bulletin EXPEDITION was not the North Pole but 20 Pipeline Watch 10 Threats and opportunities for the mystifying and barren landscape of generics in Italy 21 US Capitol Capsule: Tragic act shifts Alzheimer’s disease. EXPEDITION is the political discourse: Will there be series of clinical studies Lilly used to look at ‘meaningful action’ for mental health? whether and how the anti-amyloid antibody Scrip 22 Stockwatch: Dowsing in the solanezumab might slow Alzheimer’s Chief of Content: [email protected] life science dustbowl progression. Managing Editor: [email protected] In its original study, results of which were Asia Editor: [email protected] 24 Appointments/Classified EMEA Editor: [email protected]; reported in August 2012, it was clear that the News Editor: [email protected] drug had no discernable impact on patients India Editor: [email protected] with severe Alzheimer’s disease. But there Washington Editor: [email protected] were signs of efficacy in patients with mild- US West Coast Editor: [email protected] Clinical Research Editor: [email protected] to-moderate disease. The drug slowed the Senior Reporter: [email protected] We would love to hear your comments about rate of loss of cognitive function. On the basis Head of Data & Research: [email protected] Scrip’s coverage. Feel free to tweet us or post of those original data alone, Lilly might have Principal Analysts: [email protected]; a discussion on our LinkedIn group, for your been able to file for approval for an indication [email protected]; [email protected] chance to interact with editor Mike Ward in mild-to-moderate disease. Editorial Intern: [email protected] and the rest of the Scrip Intelligence team. Editorial Assistant: [email protected] But in the event, after discussions with Production: [email protected] Follow us at: @scripnews the US FDA, the company has decided to Chief Content Officer: [email protected] circle around and undertake another round All pictures in this newsletter courtesy of Join us at: linkd.in/scripintelligence www.shutterstock.com unless otherwise stated of EXPEDITION, this time looking at mildly- Customer Services affected patients. Tel: +44 (0)20 7017 5540 or (US) Toll Free: 1 800 997 3892 This may provide stronger data for an Email: [email protected] earlier preventative indication for sola. What To subscribe, visit scripintelligence.com it certainly does do is set back solanezumab’s To advertise, contact [email protected] approval date (and revenue-generation) at Scrip is published by Informa UK Limited. ©Informa UK Ltd 2012: All rights reserved. least four years. ISSN 0143 7690. Lilly has to hope that the milder Wezzle is a real monster. 2 December 21st 2012 @scripnews scripintelligence.com © Informa UK Ltd 2012 COMMENT ‘Bad pharma’ gets a scolding from Goldacre SCOLDACRE: Industry critic tells pharma that full transparency is in industry’s best interests Criticizing the pharmaceutical industry, I’ve at the Cochrane Collaboration. And yet this treatments. But even a second rate drug does recently discovered, is a little like questioning information is vitally important, because we patients some good, undeniably. And so a cult: there are outlandish smears, lurid are increasingly seeing that brief academic perhaps we all allow ourselves to become too denunciations, and implausible outright journal articles can give a very misleading relaxed about these problems. denials. People within the community award picture about what actually happened in a But bad practices have also persisted themselves a point for this behavior, while study. Finally, despite several well-received through lack of vision. When unflattering trial outsiders look on in amazement. I’d like to promises for the future, so far almost no data are glossed over, an individual company speak with those of you who are able to step company has ever shared one single file of can be rewarded with higher sales. This short- outside of this game. individual patient data from a clinical trial. term gain comes at the expense of everyone’s Firstly, while everyone is entitled to their If this was all news to you, I hope you now collective reputation: and it is amazing, own opinions, we all have to work with the accept that important information on clinical since you save lives, that your reputation is same facts. The problem of missing data is trials continues to be withheld from doctors so poor. If you advocated strongly for more real, and ongoing.
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