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Les Biotechnologies - Genopole - Réussir ensemble en Biotechnologie - 0 views

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    "« les biotechnologies sont l'application de la science et de la technologie à des organismes vivants, de même qu'à ses composantes, produits et modélisations, pour modifier des matériaux vivants ou non vivants aux fins de la production de connaissances, de biens et de services »."
hamelinclara

Biopharmaceutics - Wikipedia, the free encyclopedia - 0 views

  • Biopharmaceutics is the field of study concerning biopharmaceuticals, medical drugs (see pharmacology) produced using biotechnology. They include proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source
  • Biopharmaceuticals may be produced from microbial cells (e.g. recombinant E. coli or yeast cultures), mammalian cell lines (see cell culture) and plant cell cultures (see plant tissue culture) and moss plants in bioreactors of various configurations, including photo-bioreactors.[4] Important issues of concern are cost of production (a low volume, high purity product is desirable) and microbial contamination (by bacteria, viruses, mycoplasma, etc.). Alternative platforms of production which are being tested include whole plants (plant-made pharmaceuticals).
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R&D Spending on the Rise - 0 views

  • BIG R&D SPENDERS Company R&D Spend in Rs Crore Ranbaxy 331 Dr Reddys Labs 283 Sun Pharmaceutical 146 Wockhardt 94 Lupin 87 Cadila Healthcare 71 Torrent Pharmaceuticals 51 Biocon 27 Panacea Biotec 24  
  • GLOBAL BIOTECH R&D PRODUCTIVITY ON THE RISE The productivity of big pharma has been remarkable over the past 25 years. In each of the last 10 years, the pharmaceutical industry has ranked at the top of Fortune.s .most profitable. industry list. But this top ranking has eluded the industry in recent years, during which the productivity of the biotech sector. for many years poor in the aggregate.has strengthened markedly. An emerging distinction between biotech and big pharma is the productivity of R&D. According to Arthur D Levinson, chairman and CEO, Genentech, R&D spending by large pharmaceutical companies has been steadily increasing over time, while the number of new drug approvals (NDAs) coming out of these companies has been decreasing. In 2004, the pharmaceutical industry spent about $50 billion on R&D, compared to $16 billion spent on R&D by publicly traded US biotech companies, and an estimated $20 billion spent by the global biotech industry. In spite of its large R&D expenditures, big pharmas. NDAs have been declining steadily, while biotechs have accounted for an increasing share of NDAs over the past five years. In 2003, the biotech industry hit a milestone when it surpassed big pharma in the number of new drug approvals from the Food and Drug Administration (FDA) in a given year. The trend continued to favor biotech in 2004. In 2005, an estimated 35 new pharmaceutical or biotechnology products with sales potential of at least $150 million each will enter the market. Of these, 20 are expected to be products from biotechnology companies, and will be marketed directly by these companies or in collaboration with pharmaceutical partners. In addition, there are more than 700 compounds from biotech firms at various stages of development, with more than 400 compounds in clinical trials. More than four out of five therapies currently in drug development are founded on biotech discoveries or employ biotech tools.                                                                                                       Source: Ernst & Young
hamelinclara

DALLAS, Feb. 8. 2013: Pharmaceutical Market & Biotechnology Industry 2013 Outlook in Ne... - 0 views

  • Key Topics Covered Value Based Pricing- Strength of Innovation Vs Fiscal Pressures Major therapy areas to shape up pharma business going forward Europe – Regulatory Pressures and Increasing Pro Generic Stance Will US fall to Pricing Pressures? Emerging Markets and their importance in Growth of Large Cap Pharma Global Pharma -Drugs Losing Patent Protection By 2017 Impact of patent expiry in w.r.t. 2012 total revenue thru 2017 Global Pharma Research Pipeline (PhII And PhIII)- 2013 Global Pharma Milestones in 2013 Roche: Breast Cancer Franchise And Actemra To Drive Near Term Growth, And Multiple Blockbusters In Pipeline To Take Care Of Long Term Growth GlaxoSmithKline: Next Generation Bronchodilators, Melanoma, Hiv And Emerging Market To Lead The Way While Regulatory Overhang In Respiratory And EU Pricing Pressure Persist Bristol-Myers Squibb: Pressures To Dominate In The Near Term, Pipeline Will Take Longer To Deliver AstraZeneca: 2013 Will Be A Transition Year And AZN May Have To Take Some Bold Initiatives Eli Lilly: Late Stage Pipeline Fickle And Risky Merck: News-flow from Mega-trial on MRK's cardiology Franchise would reshape Merck's Growth Prospects Novartis: Back on a Growth Trajectory Novo Nordisk: Hemophilia Franchise and Thrice Weekly Degludec – The Future Drivers Pfizer: M&A Only Can Drive Further Upside In The Near Term Sanofi: Solid Base Business, But Upside From Pipeline Will Take Longer To Come About Global Pharma Sector Industry Tables
  • provides valuations and an in depth analyses of biotech companies, their launched drug portfolio and promising drug candidates in the pipeline.
hamelinclara

Global Pharmaceutical & Biotechnology Outlook 2013: Mature Biotech : ReportsnReports - 0 views

  • Profitable Biotech (Mature Biotech) and non-Profitable Biotech companies (Rising stars)
  • In the next five years the distinction between mature biotech companies and large global pharma is likely to disappear as investment in R&D and acquisition start delivering and Market Cap match the large global pharma. Dividend and consolidation could be the future drivers and continue to attract long term investors.
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Eurofins France - 1 views

  • Eurofins Scientific France Le groupe français de biotechnologies Eurofins Scientific, fondé à Nantes en 1987, figure parmi les premiers prestataires mondiaux sur le marché de la bioanalyse. Il dispose d'un vaste portefeuille de technologies et de méthodes d'analyses (plus de 100.000 à ce jour). Fort d'un réseau international de plus de 170 laboratoires répartis dans 33 pays Eurofins emploie plus de 13.000 personnes.
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Trius: In An About Face, Congress Is Helping Biotech Companies That Are Developing Anti... - 0 views

  • The implications for Trius (TSRX) and other leading biotechnology companies involved in antibiotics development are profound.
  • ost large pharmaceutical and biotechnology firms have avoided antibiotics for much of the past two decades in large part due to the intrusion of Congress into the regulatory process
  • The most visible sign of this shift in attitude came from Congress with the passage of the Generating Antibiotics Incentives Now Act or GAIN which became effective on October 1, 2012. This was intended to spur development of new antibiotics through streamlining a regulatory process which has been oppressive for much of the last decade. Responding to the prompting of Congress, I expect the FDA to approach regulatory approval of new antibiotics with the same sense of urgency as drugs for cancer. The end result will be quicker approval of new drugs and new indications for existing antibiotics.
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  • Antibiotics were major drivers of sales growth for the pharmaceutical industry in the 1970s, 1980s and early 1990s which caught the attention of the industry's many critics. A consensus developed among politicians, consumer groups and payors that there was no need for new antibiotics as most bacteria were susceptible to existing products. They saw new antibiotics as offering no advantages over existing drugs even though they were priced many times higher. Faced with this hostile environment, drug companies began to de-emphasize antibiotic research and focus on trendy new areas like depression, cholesterol lowering, gastrointestinal reflux disease, etc.
  • Adding to the move away from antibiotic development was considerable scrutiny about side effects that the industry came under in the early part of the 2000s. A major catalyst for this was the Vioxx side effect issues that caused Merck (MRK) to withdraw this anti-inflammatory drug from the market in 2004
  • ooking beyond the GAIN Act, infectious disease experts, FDA and industry are working on proposals for a new restricted approval pathway that would speed the development of new antibacterial drugs and could address some of the economic disincentives that have driven most pharma companies out of the space. A drug's safety and effectiveness would be studied in substantially smaller, more rapid, and less expensive clinical trials, like those typically used to support Orphan Drug approvals. They would be narrowly indicated for use in small, well-defined populations of patients for whom the drugs' benefits have been shown to outweigh their risks. It would slash the number of patients required to gain approval from about 1,400 for the typical antibiotic indication to 100 or less, cut development time in half, and reduce regulatory uncertainty
hamelinclara

Merck Serono choisit les biosimilaires avec Dr Reddy's : BioPharmAnalyses - 1 views

  • Longtemps confiné à un nombre restreint d’acteurs spécialisés, le marché des biosimilaires est aujourd’hui en pleine expansion. Au moment où le principal marché pharmaceutique s’apprête à leur ouvrir ses portes avec la finalisation en cours aux Etats-Unis d’une réglementation sur les « follow-on biologics » – équivalent de la terminologie européenne biosimilaire – , la perte, dans les cinq prochaines années, des brevets de quelques uns des principaux blockbusters biotech, à l’image des  anticorps monoclonaux Mabthera® (rituximab), Herceptin® (trastuzumab) ou encore Remicade® (infliximab), a certes de quoi attiser les convoitises…
  • Sur ce marché qu’une étude récente de Frost&Sullivan estime à près de quatre milliards de $ en Europe en 2017, la compétition promet d’être rude.
  • Il s’agit notamment de Sandoz, Teva, Lonza, BiogenIdec, Samsung, Amgen, Hospira, Watson Pharmaceuticals, Baxter, Momenta Pharmaceuticals, Fujifilm, Kyowa Hakko Kirin, Daiichi Sankyo, Boehringer Ingelheim, Stada ou encore Gedeon Richter… et enfin, tout dernier en date, l’allemand Merck KGaA…
hamelinclara

Le marché du façonnage pharmaceutique en France : Eurostaf étude de marché - 0 views

  • Le façonnage pharmaceutique : un modèle porté par les laboratoires génériqueurs Un marché issu de la fin d’un modèle, celui des blockbusters Le déclin des blockbusters a permis le développement d’un marché à part entière : le façonnage pharmaceutique. Des PME dynamiques ont repris les usines en surcapacité de laboratoires Big Phrama pour les convertir en unités de production multi-produits et multi-clients, accroissant la rentabilité des sites. Ces façonniers se positionnent sur des produits matures dont le modèle économique est basé sur les volumes, entrainant des gains de productivité. Les façonniers sont devenus en une décennie des partenaires privilégiés des laboratoires génériqueurs ayant des problématiques identiques.
  • Concurrence exacerbée, marges limitées : l’environnement économique du façonnage est à un tournant Entre politique industrielle volontariste et limitation des dépenses de santé, certains acteurs montrent des signes de faiblesse Bien que le gouvernement souhaite favoriser ce tissu industriel à forte valeur ajoutée, la situation économique de la France le contraint à limiter ses dépenses de santé publique via une série de mesures pour 2012 : augmentation du nombre de déremboursement de médicaments, baisse des prix des génériques principalement et augmentation du taux de TVA. Le façonnage pharmaceutique a souffert en 2009 du fait d’un déstockage massif des officines en réponse à la crise économique. Le marché du façonnage pharmaceutique est certes toujours en croissance, mais les difficultés conjoncturelles fragilisent les acteurs les plus petits. Ces nouvelles évolutions réglementaires viennent jouer sur les marges des façonniers déjà sous pression. Depuis 2009, trois façonniers ont été contraints de cesser leur activité.
  • Innovation, conquête de nouveaux marchés, consolidation, le façonnage dispose encore de relais de croissance importants Le façonnage pharmaceutique entre dans une ère de consolidation d’actifs productifs et de développement Après une vague de croissance basée dans un premier temps sur le rachat de sites, le marché entre dans une phase de consolidation. Les opportunités de croissance demeurent solides. L’outil productif a bénéficié d’investissements importants afin de permettre au façonnage français de relever de nouveaux challenges comme les biotechnologies qui demeurent encore sous-exploitées, des exportations peu ou pas développées, ou encore se doter de normes internationales de fabrication (ISO13485, ISO9001, cGMP). L’enjeu du secteur est de se positionner sur des segments de marché à forte valeur ajoutée. Quelles sont les perspectives du marché à horizon 2015 ? Comment les industriels se préparent-ils à relever ces défis ?
hamelinclara

Welcome to NicOx - Bienvenue chez NicOx - 0 views

  • NicOx is building an international late-stage development and commercial ophthalmic group. NicOx is also developing New Molecular Entities through the application of its proprietary nitric oxide-donating R&D platform. NicOx is headquartered in France and is listed on Euronext Paris.
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International Research - Brazil - Research and Trends - PMMI - 0 views

  • PHARMACEUTICAL INDUSTRY ANALYSIS Brazil has the 11th largest pharmaceutical market globally with annual sales topping US$17bn. Brazil launched a major 10-year biotechnology initiative in 2007 that provides incentives for private-sector R&D and production. There are some 550 pharmaceutical firms in Brazil. Of the top ten companies by sales in 2008, the first six are all foreign multinational drug makers. Sanofi-Aventis (US$1,229mn in sales) and Novartis (US$1,116mn) are clear leaders, followed by Roche (US$735mn), Pfizer (US$666mn) AstraZeneca (US$584mn) and Eli Lilly (US$545mn). Local firms Aché (US$456mn), EMS Sigma Pharma (US$445mn), Eurofarma (US$424mn) and Biosintética (US$382mn) fill the remaining spots. While this shows the strength of innovation for foreign drugmakers, the presence of five local firms highlights strong competition, as well as the growing use of generic drugs in Brazil. Other leading local producers include Aché/Biosintética, Medley and Libbs. From 2009-2014 BMI forecasts a CAGR of 11.63% for patented drug market in US dollar terms. The projected continuation of sales expansions is one of the key reasons that multinational research-based drugmakers continue to invest in Brazil despite generic competition having eroded some market potential since their inception in 2000. Industry association PróGenéricos has estimated that generics will account for 30% of the market by 2010. Investment reportedly totaled around US$400mn between 1999 and 2006, illustrating not only an expansion of capacity, but also the repositioning of product lines in favor of genuine generics. SOURCE: Business Monitor International
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How Big Pharma Gets Bigger, And What Little Pharma Can Do About It - Seeking Alpha - 0 views

  • Most of these costs, writes the author Avik Roy, have to do with one specific aspect of the pipeline - phase III
  • Overall, Phase III trials now represent about 40 percent of pharmaceutical companies' R&D expenditures.
  • Phase III trials have become bigger, more complicated, more restrictive, and more time consuming as the years pass. Why should this be so? Is medical technology really getting all that more complicated that progressively more restrictive phase III trials are the only thing standing between global health and a renegade pharmaceutical industry intent on poisoning the human race with wildly experimental drugs?
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  • two primary reasons
  • While bureaucrats get a thrill regulating, Big Pharma encourages it. Think about it this way.
  • Three of the most generous also happen to have the most pipeline drugs in phase III this year: Novartis (NVS), Roche (RHHBY.OB), and Sanofi-Aventis (SNY).
  • Let's start with Novartis. Novartis' last dividend was a very generous $2.48 per share annually. That's 4.6% per share since last dividend, and totals over $6B in dividends, which was an impressive 62% of its 2012 income. It spent close to $7B (page 50) in research and development costs in 2012, with around 20 drugs (pages 32-35) currently in phase III trials. No small cap would be able to afford such largesse, but that number is only 12% of its annual revenue. With government keeping out competition and subsidizing consumption, Novartis is sailing the corporatist sweet spot. At least it is nominally returning the favor to its shareholders with a dividend large enough to offset the risk of holding a stock that is near its all-time highs.Roche comes up right behind Novartis with 19 drugs in the pipeline at the all-expensive Phase III. It spent a similar amount of money on R&D as Novartis did at a hefty $8B, which was about 17% of its 2011 revenue. RHHBY is at a similar juncture as NVS. Nearing all-time highs and sailing in the same protected sweet spot. At a $1.84 dividend it is also quite generous with its shareholders, totaling 4.27% per share annually, a total amount of $6.355B forked over to shareholders, which totals just under 60% of its 2012 income, just shy of Novartis'.
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