Beyond Borders: Global biotechnology report 2010

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European Phase III pipeline by indication, 2009 Autoimmune 12% Metabolic and endocrine 13% Cancer 22% Source: Ernst & Young, MedTRACK and company websites European approvals The EMA was active in approving products for a variety of therapeutic categories, including cancer, neurology, cardiovascular, metabolic disorders and immunology. Most products approved by the EMA were from US-based companies or large pharmaceutical organizations; however, a handful of European-based biotechs secured approvals as well. Belgium-based TiGenix received EMA approval for ChondroCelect, a cartilagerepair therapeutic, in October. The cell-based medicinal product consists of chondrocytes (cartilage-forming cells) that are taken from a healthy region of a Neurology 11% Other 20% Inflammation 9% Infectious disease 6% Cardiovascular 7% patient’s cartilage, grown outside the body, and then surgically re-implanted. Belgiumbased UCB also garnered market approval in Europe for its drug Cimzia for rheumatoid arthritis. Cimzia had previously gained US marketing authorization for moderate-tosevere Crohn’s disease. Other approvals included Ferring Pharmaceutical’s Firmagon in February for patients with advanced prostate cancer. Firmagon was previously approved by the FDA in 2008. Orphan Europe’s product Vedrop was approved for cholestatis, a condition in which the flow of bile from the liver is blocked. Victoza, a Novo Nordisk product, was approved for type 2 diabetes in June. 90 Beyond borders Global biotechnology report 2010 European companies also received FDA approval for a number of products in 2009. GlaxoSmithKline received accelerated approval in October 2009 for Arzerra, a treatment for refractory chronic lymphocytic leukemia. Arzerra, which GSK obtained through a collaboration with Genmab, is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells. Azerra went on to receive conditional approval in Europe in January 2010 for the treatment of refractory chronic lymphocytic leukemia (CLL), but only for the approximately 25% or so of patients who do not respond to the standard therapies fludarabine and alemtuzumab, which EMA has already approved. Lundbeck secured two approvals in 2009. Its Sabril, for treatment of infantile spasms in pediatric patients and refractory complex partial seizures in adults, was approved in August 2009. Earlier in the year, Lundbeck licensed Atryn from GTC Biotherapeutics and received approval for the antithrombin deficiency medication in February. In another licensing deal, Cypress Bioscience licensed Savella from French drug-maker Pierre Fabre and then signed a commercialization agreement with Forest Laboratories. In January, the FDA approved the product for the treatment of fibromyalgia. Milnacipran was originally approved in France in 1996 for major depression episodes but was introduced in the United States for the first time with the fibromyalgia indication. Outcomes-based pricing arrangements Facing mounting pricing pressures, payors are seeking ways to leverage pay-for-performance reimbursement mechanisms. In this environment, risk-sharing pricing arrangements — where
Selected product approvals by European companies, 2009 Company Brand name Generic name Type Month Indication Ferring Pharmaceuticals Genmab/ GlaxoSmithKline Ipsen (licensed to Medicis) Firmagon degarelix Arzerra ofatumumab Dysport Novo Nordisk Victoza Octapharma Wilate recombinant liraglutide vWF/Factor VIII Complex Orphan Europe Vedrop tocofersolan Pierre Fabre (licensed to Cypress Bioscience/Forest Laboratories) Recordati (licensed from Kissei Pharmaceutical) Savella milnacipran Silodyx/Urorec silodosin Source: Ernst & Young, EMA, FDA and company websites drug companies incur some portion of the cost of treating patients that do not respond to an intervention — are becoming increasingly common as payors seek to pay based on health outcomes. This approach has been most visible in the UK, where the National Institute for Health and Clinical Excellence (NICE) makes coverage decisions for the National Health System (NHS). After first appearing a couple of years ago, the number of such arrangements mushroomed in 2009 — a New chemical entity Biologic license Application Biologic license Application New chemical entity Biologic license Application New chemical entity New molecular entity New chemical entity Feb. 2009 Prostate cancer Oct. 2009 (US) Jan. 2010 (EU) Apr. 2009 sign of the times and a potential harbinger of things to come in other global regions. As shown in the accompanying table, the lion’s share of such arrangements continues to be in the UK. Recent examples include Celgene’s arrangement for obtaining coverage for Revlimid, its multiple myeloma drug. NICE initially rejected Revlimid in 2008 on the grounds that the therapy was not cost effective, but Celgene secured approval in April 2009 with an outcomesbased pricing arrangement under which Chronic lymphocytic leukemia (CLL) Cervical dystonia/ frown lines June 2009 Type 2 diabetes Dec. 2009 Jul. 2009 von Willebrand's disease (VWD) Vitamin E deficiency Orphan designation Yes Yes US Yes US Jan. 2009 Fibromyalgia US Feb. 2010 Benign prostatic hyperplasia (BPH) Approved/ registered in EU (previously approved in the US) US (EU approved in Jan. 2010) EU (US approved in Jan. 2010) EU EU (previously approved in the US, Japan) NHS pays for the first two years of treatment in patients who have received at least one prior therapy. If treatment is required after two years, Celgene will cover the costs (excluding related costs such as hospitalization), thereby reducing the financial burden on the NHS. There are signs the trend is starting to spread to other markets. In the US, for instance, Merck signed an agreement with insurance giant CIGNA that provides CIGNA customers increased discounts on Merck’s 91
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Beyond borders Global biotechnology
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Contents The new normal: the global
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The new normal
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Global introduction The new normal
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Of course, this is not a novel deve
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“Since by definition, increasing
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In both of these models, investors
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“For most of the history of the b
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A closer look Reforming US health c
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Perspectives for the new normal Foc
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Perspectives for the new normal Suc
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John Maraganore of Alnylam Pharmace
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Perspectives for the new normal The
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Using FIPNet to supercharge the inn
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New opportunities 24 Beyond borders
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Conversation on emerging markets Ne
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“The biggest challenge for Wester
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China year in review Accelerating r
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addition, the Government committed
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In 2009, overseas-listed Chinese bi
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India year in review Preparing for
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acquired US-based hybrid sorghum se
Page 46 and 47: Japanese biotech IPOs, 2009 Company
Page 48 and 49: drug application for Lurasidone to
Page 50 and 51: The year saw some examples of globa
Page 52 and 53: of today’s increasingly pragmatic
Page 54 and 55: Biotech will provide the technology
Page 56 and 57: Malaysia year in review A strategic
Page 58 and 59: A transformational year 52 Beyond b
Page 60 and 61: Financial performance A transformat
Page 62 and 63: explained by developments at a few
Page 64 and 65: Selected 2009 US biotechnology publ
Page 66 and 67: Growth rate Canada Behind the numbe
Page 68 and 69: Australian biotechnology at a glanc
Page 70 and 71: Financing A higher bar After a dism
Page 72 and 73: the pharmaceutical industry, as pha
Page 74 and 75: The final 2009 IPO to close in the
Page 76 and 77: The IPO market in Europe remains la
Page 78 and 79: Capital raised by Canadian province
Page 80 and 81: developed countries — and whether
Page 82 and 83: Deals A new landscape Given the rea
Page 84 and 85: companies will not make any large u
Page 86 and 87: with Elan (the judge agreed) the pa
Page 88 and 89: Without Roche-Genentech, the value
Page 90 and 91: total potential value of these tran
Page 92 and 93: Products and pipeline Steady growth
Page 94 and 95: FDA product approvals, 1996-2009 Nu
Page 98 and 99: A closer look Uncertain by design:
Page 100 and 101: oral anti-diabetes medications Janu
Page 102 and 103: Perspectives on personalized medici
Page 104 and 105: Moderated by: Gil Forer Ernst & You
Page 106 and 107: “I’m starting to see non-tradit
Page 108 and 109: from infrastructure funds, but they
Page 110 and 111: Data exhibit index 2 The not-quite-
Page 112 and 113: Global biotechnology contacts Globa
Page 114: Ernst & Young thought leadership Wa
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