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  • 1. 1 Trendsmeme™ | White PaperCardiologyWhat’s Next for the ShrinkingCardiovascular Drug Market?The Multibillion-Dollar Cardiovascular Drug Market Takes a HitThe World Health Organization (WHO) classifies cardiovascular disease as the leading causeof death globally. The cardiovascular drug market is likewise among the top therapeuticcategories in terms of overall prescription drug sales. Leading contributors to this market areseveral multibillion-dollar drugs for hyperlipidemia (high cholesterol), hypertension, and heartdisease (Figure 1). Indeed, the top-selling prescription drug ever to reach the market was Pfizer’scholesterol-lowering statin Lipitor, which posted peak annual sales in excess of $13 billion.Blockbuster Cardiovascular Drugs Figure 1 12,000 10,000 8,000 $US millions 6,000 4,000 2,000 2011 Revenues, WW 0 2010 Revenues, WW Lipitor Plavix Diovan Benicar franchise Avapro Zetia Cozaar/Hyzaar Vytorin Norvasc Atacand ExforgeSource: Medmeme LLC. © Medmeme LLC. 2012Going forward, however, the cardiovascular drug market is set to take a major hit from severalhigh-profile patent expiries (see Table 1). Indeed, the major cardiovascular drug companies’focus on line extensions and fixed combinations of existing medications in recent years (as astrategy for extending their top-selling agents’ life cycles) has left a dearth of novel drugs in© 2012, Medmeme LLC. | +1 212-725-5992 | |
  • 2. 2 Trendsmeme™ | White Paperthe pipeline. Table 2 shows some of the leading CV drug franchises; apart from these, few newcardiovascular drugs have reached the market over the past decade.Patent Expiries for Leading Cardiovascular Drugs Table 1 Product Patent Expiry Diovan Sept, 2012 Atacand June, 2012 Plavix May, 2012 Avapro March, 2012 Lipitor Nov, 2011 Caduet Nov, 2012 Cozaar/Hyzaar Feb, 2010Source: Medmeme LLC. © Medmeme LLC. 2012Leading Cardiovascular Drug Franchises Table 2 Brand Name Generic Name Indications U.S. Launch Year Novartis Diovan valsartan Hypertension, HF, post-MI 1996 Diovan HCT valsartan-HCT Hypertension, HF, post-MI 1998 Exforge amlodipine- Hypertension 2007 valsartan Exforge HCT amlodipine- Hypertension 2009 valsartan-HCT Tekturna/Rasilez Aliskiren Hypertension 2007 Tekturna HCT/ aliskiren-HCT Hypertension 2008 Rasilez HCT Valturna/Rasival* aliskiren-valsartan Hypertension 2009* Tekamlo/Rasilamlo aliskiren-amlodipine Hypertension 2010 Amturnide/Rasitrio aliskiren- Hypertension 2010 amlodipine-HCT (Continued)© 2012, Medmeme LLC. | +1 212-725-5992 | |
  • 3. 3 Trendsmeme™ | White PaperLeading Cardiovascular Drug Franchises (Continued) Table 2 Brand Name Generic Name Indications U.S. Launch Year Pfizer Norvasc amlodipine Hypertension, angina 1992 Lipitor atorvastatin Hyperlipidemia, prevention of CV 1996 disease Caduet amlodipine- Hypertension, CAD, 2004 atorvastatin hyperlipidemia, prevention of CV disease, Fredrickson Types IIa, IIb, III, and IV Merck Zocor simvastatin Hyperlipidemia, reductions in risk 1991 of CHD mortality and CV events Cozaar Losartan Hypertension, hypertension 1995 with LVH, nephropathy in Type 2 diabetics Hyzaar losartan-HCT Hypertension, hypertension with 1995 LVH Zetia ezetimibe Hyperlipidemia (monotherapy 2002 and combination therapy), HoFH, homozygous sitosterolemia Vytorin ezetimibe- Hyperlipidemia, HoFH 2004 simvastatin Daiichi-Sankyo Benicar Olmesartan Hypertension 2002 medoxomil Benicar HCT Olmesartan Hypertension 2003 medoxomil Azor Amlodipine- Hypertension 2007 olmesartan medoxomil Tribenzor Amlodipine- Hypertension 2010 olmesartan medoxomil-HCT*Novartis has agreed to voluntarily withdraw Valturna/Rasival from the U.S. and Swiss markets for safety reasons (Rasival never reachedthe broader EU markets).Source: Medmeme LLC. © Medmeme LLC. 2012© 2012, Medmeme LLC. | +1 212-725-5992 | |
  • 4. 4 Trendsmeme™ | White PaperWhat Pipeline Drugs Could Sustain the Market?There are several drugs with novel mechanisms in late-stage trials for cardiovascular disease,including renin inhibitors for hypertension, CETP inhibitors for hyperlipidemia, and a variety ofapproaches for acute heart failure (AHF). Below is a snapshot of the broader discussion providedin the Medmeme report titled Trendsmeme™ Report: Cardiology.Renin Inhibitors. Based on results from the ALTITUDE trial—which was halted by Novartis inlate 2011 based on findings of increased adverse events (risk of stroke and renal complications)and no apparent benefits among type 2 diabetes patients taking the company’s renin inhibitoraliskiren (Tekturna/Rasilez) on top of an ACE inhibitor or ARB—Novartis withdrew its follow-on Valturna (aliskiren-valsartan) from the market and added a warning to aliskiren’s labeladvising against use with ACE inhibitors or ARBs in patients with diabetes and/or moderaterenal impairment. It is not yet clear how these findings will affect sales of aliskiren-containingproducts (Tekturna, Tekturna-HCT, Tekamlo, Amturnide), but Novartis could potentially take abig hit, especially since the company was banking on the aliskiren product franchise to softenthe blow from Diovan’s patent expiry in September of this year (Diovan sales exceeded $5.6billion in 2011). Moreover, renin inhibitors as a class are now under a cloud of doubt, leaving thehypertension market again relying on fixed combinations of older agents (e.g., CCBs, ARBs).CETP Inhibitors. One new class of cholesterol-lowering drugs—the cholesteryl ester transferprotein (CETP) inhibitors—has shown some promise as add-on therapy to statins. Their future,however, remains up in the air after some high-profile Phase III failures including Pfizer’storcetrapib and Roche’s more recent discontinuation of dalcetrapib. At present, both Merck andLilly are investigating their own CETP inhibitors in late-stage trials for dyslipidemia (anacetrapiband evacetrapib, respectively).New Treatments for Acute Heart Failure. There are several investigational therapies in mid-to-latestage clinical development for AHF that represent novel approaches to treatment, making this anarea to watch over the next few years.• Novartis is investigating RLX 030, a drug that mimics human relaxin-2, in Phase III trials for AHF.• Cytogenetics and Amgen have an IV formulation of the cardiac-specific myosin activator omecamtiv mecarbil in Phase IIb trials for AHF.• Cardiorentis is investigating its synthesized form of urodilatin called ularitide in Phase III trials for AHF.© 2012, Medmeme LLC. | +1 212-725-5992 | |
  • 5. 5 About Medmeme Medmeme, LLC, is a global database company that offers comprehensive knowledge about the people, institutions, and research that drive medical practice in all major therapeutic areas. Founded in 2006, Medmeme serves pharmaceutical and biotechnology clients worldwide, including 16 of the leading 20 pharmaceutical companies. Our proprietary database of thought leaders, medical meetings, clinical trials, and Centers-of- Excellence provides intelligence that allows clients to reach the most important channels through which medical information travels. Detailed profiles of medical science experts, including their medical contributions, levels of influence, and professional networks, allow clients to strengthen product messaging by enlisting thought leaders whose opinions increasingly shape medical practice. In addition, by identifying effective research practices, investigators, and sites, our products help clients improve clinical trial effectiveness while reducing costs. Our Approach Medmeme’s approach is designed to help clients meet the multifaceted challenges facing the healthcare industry, including demand for specialty medical treatments with better outcomes, the high costs of developing these treatments, and pressure from patients and payers to keep treatment costs under control. Finding a better balance among these challenges requires gathering more focused and detailed medical knowledge. To achieve this goal, Medmeme has developed a unique system of finding, validating, and analyzing data using proprietary algorithms and platforms that deliver in-depth information across drugs and disease areas in 50 countries. The quality, breadth, and detail of our data set us apart: • Credible - We use only the most reliable sources, such as governments, medical societies, and accredited medical institutions • Accurate - Medmeme processes data using proprietary algorithms, first to normalize it to standardize fields for easy comparison, followed by a disambiguation process that prevents duplication. Data is then integrated across database platforms to provide a comprehensive view of each therapeutic area. • Comprehensive - We aggregate 50 million data points from more than 60,000 sources worldwide. Ten-year historical records encompass clinical trials, meetings, publications, grants, patents, treatment guidelines, and more. • Forward-looking - Updated daily, our database includes information on emerging as well as developed markets, and on promising as well as established thought leaders. Flexible Solutions Medmeme can offer database solutions based on client-specified needs, including segmentation by disease, therapeutic area, compound, drug class, development phase, country/region, keyword, and more. Client-specified search parameters provide targeted information to support functions across the organization. Medmeme offers annual subscriptions to our proprietary database platforms. We also provide syndicated reports for those who want data compiled by therapeutic area. Discounts for longer subscriptions and multiple-product purchases make it economical to acquire greater quantities of information.© 2012, Medmeme LLC. | +1 212-725-5992 | |
  • 6. 6 About Medmeme About Medmeme Syndicated Reports Medmeme reports slice the data by therapeutic categories from more than 60,000 URLs yielding 50 million data points, the professional bodies of work of over 1.5 million key opinion leaders, more than 6.3 million medical conference presentations, over 600,000 clinical trials in 50 countries, and information from governments, societies, and institutions to map, measure, and project the pathways of future market movement. Medmeme’s data-intensive reports compile and analyze trends over time to show the top conferences, the top journals, the top contributors, the top institutions, and more, to illustrate—using easily navigated text and extensive tables and graphs—the most successful approaches to creating awareness, interest, and demand in any therapeutic category. • Trendsmeme™ Reports – These reports cover key indications, companies, and drugs to reveal dominant player positioning as well as relevant issues and developments in treatment and the marketplace. They explain the status of a therapeutic category and the major trends that are driving change and influencing R&D success. • Intellmeme™ Reports – Reports that identify the disease areas and drugs that receive the most attention—that is, the largest share-of-voice—from peer-reviewed medical journals, societies, meetings and congresses, and key opinion leaders. They illustrate trends over time and highlight strategic options. • C-O-E/meme™ Reports – These reports pinpoint the top 50 medical centers-of-excellence by specific therapeutic categories, giving guidance for selection of partners to conduct clinical research, recruit KOLs for specific disease expertise and affiliations, provide educational initiatives, and more. The reports are a direct derivative of Medmeme’s on-line, continuously updated, searchable database product platform C-O-E/meme™. • Trialmeme™ Reports – The reports identify, by location, leading clinical trial sites worldwide, including principal and site investigators, trial status, entity conducting the trial, drug, and where the results have been presented. This knowledge can help reduce both trial timelines and costs of future trials by providing historic perspective to sponsors and CROs. The reports are a direct derivative of Medmeme’s on-line, continuously updated, searchable database product platform Trialmeme™. These syndicated reports can be purchased separately, based on therapeutic category of interest, or by series at discounted pricing. To learn more about the reports, see products/syndicated-reports. To purchase Reports or for more information, contact Ray Wright, Vice President, Sales Yan Barshay, Executive Vice President Mahesh Naithani, CEO +1 508-278-4595 +1 212-725-5992 +1 212-725-5990© 2012, Medmeme LLC. | +1 212-725-5992 | |