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A CenterWatch Publication Volume 16, Issue 12. Copyright © 2012 by CenterWatch. All rights reserved. March 26, 2012 page 4 » page 5 » CenterWatch Information Services The CenterWatch Monthly A monthly newsletter featuring in-depth stories on the clinical trials industry and grant opportunities. Annual subscriptions start at $399. JobWatch www.centerwatch.com/jobwatch A web-based service listing clinical research jobs, career resources and a searchable resume database. Clinical Trials Listing Service™ www.centerwatch.com/clinical-trials/listings An international listing service of actively enrolling clinical trials to support sponsors and CROs in their patient enrollment initiatives. Market Research Services Custom surveys for organizations to gain competitive insight into the market and their business. Contact Steve Zisson, (617) 948-5142, [email protected] Drugs in Clinical Trials Database A searchable database of 4,000+ detailed profiles of new drugs in development in hundreds of disease conditions worldwide. Request a 5-day trial. Contact Sales, (617) 948-5100, [email protected] CenterWatch Publications CenterWatch publishes a wide range of CME-accredited training guides, directories, brochures and drug intelligence information. Visit http://store.centerwatch.com. CenterWatch Main and Editorial Offices 10 Winthrop Square, Fifth Floor, Boston, MA 02110 Tel (617) 948-5100 Fax (617) 948-5101 [email protected] Breaking News and Market Intelligence for the Clinical Trials Industry Abbott names new research-based company AbbVie…2 Canadian government renews partnership with Rx&D to boost nation’s clinical trial industry…3 The Pulse on Latin America…6 Drug & Device Pipeline News…7 CenterWatch has identified 18 drugs and devices that have entered a new trial phase this week. Trial Results…8 CenterWatch reports on results for four drugs. Visit www.centerwatch.com for real-time updates on drugs in clinical trials. Biotech Review…9 Biotech briefs from BioWorld Today. CWMarketPlace…10 Industry service provider profiles. S trategic partnership agreements between sponsors and CROs have been all the rage over the last year or so. But are they working out well? While the curtain has been largely drawn on that, except for the occasional comment from a CRO or sponsor, the industry now has its first real look. Research and consulting firm The Avoca Group surveyed sponsors and CROs about their interactions in the out- sourcing space, and in doing so asked some very provocative questions about strategic partnership agreements. Perhaps the most revealing: Have you ever discontinued one? The results of Avoca’s annual State of Clin- ical Outsourcing Industry Survey, just released this month, showed a whopping 22% of the 244 respondents (147 sponsors and 97 clinical service providers) had discontinued a strategic partnership agreement—and not because a sponsor decided to go from, say, four partners down to two. Rather, quality was the issue. Poor quality and performance was cited by 85% of those who said they had severed a strategic partnership agree- ment. To Patricia Leuchten, CEO of The Avoca Group, this came as a shock. “Companies i nVentiv Health is about to surge more deeply into the functional service pro- vider (FSP) space. Last week the CRO announced it was buying Kforce Clinical Research, the clini- cally focused arm of publicly traded, Tampa, Fla.-based staffing firm Kforce, which in the last few years has grown its clinical staffing division into a robust FSP offering. inVentiv is paying $50 million for Kforce Clinical. The deal is expected to close by the end of the month. inVentiv—which started out primarily as a staffing, sales and communications firm serving pharma companies, but then grew exponentially last year with its purchase of i3 and Pharmanet—already has a leader- ship position in the staffing and FSP space. But the addition of Kforce Clinical gives the company even more depth and flexibility in that realm, said Gregg Dearhammer, president of FSP/Staffing for inVentiv, and formerly president and CEO of i3 Statprobe before inVentiv bought i3. “We believe that now, with the Kforce ad- dition, we have an interesting offering that not many can match,” said Dearhammer. “We can now offer short-term staffing and complex FSP help all under the same roof so that when sponsors’ staffing needs shift and change, they don’t have to go elsewhere for help. We can offer flexibility if they change their minds.” Neal McCarthy, managing director of investment firm Fairmount Partners and a Survey: Sponsor-CRO strategic partnerships don’t always work, poor quality and performance cited inVentiv to acquire Kforce Clinical Research, adding more FSP depth to its staffing services

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  • 1.Breaking News andMarket Intelligence for March 26, 2012 the Clinical Trials IndustryAbbott names new research-basedA CenterWatch Publicationcompany AbbVie2Canadian government renews partnership withRx&D to boost nations clinical trial industry3inVentiv to acquire Kforce Clinical Research,The Pulse on Latin America6adding more FSP depth to its staffing servicesiDrug & Device Pipeline News7nVentiv Health is about to surge more But the addition of Kforce Clinical gives the CenterWatch has identified 18 drugsdeeply into the functional service pro- company even more depth and flexibility and devices that have entered a newvider (FSP) space.in that realm, said Gregg Dearhammer, trial phase this week.Last week the CRO announced it waspresident of FSP/Staffing for inVentiv, andbuying Kforce Clinical Research, the clini- formerly president and CEO of i3 StatprobeTrial Results8CenterWatch reports on results forcally focused arm of publicly traded, Tampa,before inVentiv bought i3.four drugs. Visit www.centerwatch.comFla.-based staffing firm Kforce, which in the We believe that now, with the Kforce ad- for real-time updates on drugs inlast few years has grown its clinical staffingdition, we have an interesting offering thatclinical trials.division into a robust FSP offering.not many can match, said Dearhammer.inVentiv is paying $50 million for Kforce We can now offer short-term staffing and Biotech Review9Clinical. The deal is expected to close by thecomplex FSP help all under the same roof so Biotech briefs from BioWorld Today.end of the month. that when sponsors staffing needs shift andCWMarketPlace10inVentivwhich started out primarily as change, they dont have to go elsewhere for Industry service provider profiles.a staffing, sales and communications firm help. We can offer flexibility if they changeserving pharma companies, but then grew their minds. CenterWatch Information Servicesexponentially last year with its purchase ofNeal McCarthy, managing director ofThe CenterWatch Monthlyi3 and Pharmanetalready has a leader-investment firm Fairmount Partners and aA monthly newsletter featuring in-depth storiesship position in the staffing and FSP space. page 4 on the clinical trials industry and grant opportunities.Annual subscriptions start at $399.JobWatchSurvey: Sponsor-CRO strategic partnerships dontwww.centerwatch.com/jobwatchA web-based service listing clinical research jobs,always work, poor quality and performance cited career resources and a searchable resume database.SClinical Trials Listing Service trategic partnership agreementsThe results of Avocas annual State of Clin-www.centerwatch.com/clinical-trials/listingsAn international listing service of actively enrolling between sponsors and CROs have ical Outsourcing Industry Survey, just releasedclinical trials to support sponsors and CROs in their been all the rage over the last year orthis month, showed a whopping 22% ofpatient enrollment initiatives.so. But are they working out well?the 244 respondents (147 sponsors and 97Market Research ServicesWhile the curtain has been largely drawnclinical service providers) had discontinuedCustom surveys for organizations to gain competitiveon that, except for the occasional commenta strategic partnership agreementand not insight into the market and their business. Contact SteveZisson, (617) 948-5142, [email protected] a CRO or sponsor, the industry now has because a sponsor decided to go from, say,Drugs in Clinical Trials Databaseits first real look. Research and consultingfour partners down to two. Rather, qualityA searchable database of 4,000+ detailed profiles of newfirm The Avoca Group surveyed sponsorswas the issue. Poor quality and performance drugs in development in hundreds of disease conditionsand CROs about their interactions in the out- was cited by 85% of those who said they worldwide. Request a 5-day trial. Contact Sales,(617) 948-5100, [email protected] space, and in doing so asked somehad severed a strategic partnership agree-CenterWatch Publicationsvery provocative questions about strategicment. CenterWatch publishes a wide range of CME-accreditedpartnership agreements. To Patricia Leuchten, CEO of The Avocatraining guides, directories, brochures and drug intelligenceinformation. Visit http://store.centerwatch.com.Perhaps the most revealing: Have youGroup, this came as a shock. Companiesever discontinued one? page 5 CenterWatch Main and Editorial Offices10 Winthrop Square, Fifth Floor, Boston, MA 02110Tel (617) 948-5100 Fax (617) 948-5101Volume 16, Issue 12. Copyright 2012 by CenterWatch. All rights [email protected]

2. CWWeekly March 26, 2012 2 of 10Industry BriefsSponsorsincluding custom quantitative research and The Trudeau Institute, a Saranac Lake,analytics; qualitative research; key opinion N.Y.-based research center, has expanded the Abbott has dubbed its new, independent leader identification and mapping; message scope of its biomedical research by creat- research-based pharmaceutical companytracking, including Rapid Recall (SM) mes- ing a nonprofit CRO, the Trudeau Institute AbbVie (pronounced Abb-vee), which itsage effectiveness studies; syndicated auditsContract Research Organization (TICRO). will launch by the end of 2012. Abbott chose including the Metropolitan Area Promotion- The expansion is in response to the drug the name as a combination of Abbott andal Audit, which tracks promotional activityindustrys increased reliance on CROs for vie, which is a reference to the Latin root vi across 15 specialty therapeutic areas; and specialty research to reduce the costs and meaning life.The beginning of the namea range of SDI Health medical and promo- delays associated with the development of connects the new company to Abbott and tional audits acquired from IMS Health.new vaccines and therapeutics. As experts in its heritage of pioneering science. The vie the immunological, biological and molecular calls attention to the vital work the company CRO QED Clinical Services has createdbasis of infectious diseases and immune dis- will continue to advance to improve the livesa wholly owned subsidiary, QED Clinicalorders, Trudeau scientists will offer their ex- of people around the world, said Richard A. Services India Private Limited, in Ahmedabad,pertise and models through TICRO. The new Gonzalez, executive vice president of global India, to enhance its global delivery of clinicalCRO will provide project-specific expertise to pharmaceuticals at Abbott. Gonzalez will trials. The subsidiary adds operational andbiopharmaceutical companies and academic head AbbVie as chairman and CEO. Last Oc-therapeutic expertise to QED, and expands itsresearchers, assist clients with the design tober Abbott announced it would separate capacity and capability to offer more global and execution of efficient studies with into two publicly traded companies, one in coverage. QED operations in India will bewell-defined endpoints and help accelerate diversified medical products and the other spearheaded by country head and director the drug development process. The Institute in research-based pharmaceuticals. AbbVie, of operations Ali Saijad Bohra, who has ledhopes to develop translational research part- the research-based company, will include clinical monitoring, FSP models and projectnerships with biotech and pharmaceutical Abbotts current portfolio of pharmaceuti- management across India, Southeast Asia, companies and help bring new therapeutics cals and biologics. The diversified medicalJapan, South Korea and Australia. India and to patients safely and more efficiently. products company, which will retain thethe Asia Pacific region will continue to have Abbott name, will consist of Abbotts existing focus and will remain key markets for the R&D trends diversified medical products portfolio.drug development activities for biopharma-ceutical companies on account of a variety of The quality of dementia research in the U.K.CROs/Service providersbenefits, said Bohra. In addition to conduct- is second only to the U.S., despite the lowing trials in India, QED India will act as a hub number of scientists working in the field, and Campbell Alliance, an inVentiv Healthfor QEDs Asia Pacific operations for controlfinding a cure can be accelerated by increas- company and management consulting firm,and oversight of its local partners across the ing the number of dementia researchers and has launched Encuity Research, a marketregion. The creation of QED Clinical, India investment, according to the Intellectual research and analytics subsidiary. The means that we can better meet the global Property & Science business of Thomson launch immediately follows the acquisition development needs of our sponsors by Reuters. The findings are featured in an of SDI Healths promotional and medicalgiving access to vast patient populations viaAlzheimers U.K. research report titled Defeat- audit businesses from IMS Health, whichregional experts on the ground, said CEOing Dementia. The analysis revealed the U.K. closed March 20. The audit businesses Thomas Ogorka.page 3 acquired from IMS will be combined with our existing market research and analytics CWWeekly (ISSN 1528-5731) 2012 CenterWatch, LLC. All rights reserved. service lines to create a business that will Cheryl Appel Rosenfeld Editor-in-ChiefNo part of this publication may be distributed orTracy Lawton Drug Intelligencereproduced in any form or by any means without the drive accelerated growth for us in the mar-Melissa Nazzaro Advertising express written consent of the publisher. Permission ket research segment, said Nader Naeymi-Heather Johnston Advertisingrequests can be obtained via fax at (617) 948-5101 orHolly Rose Production emailed at [email protected] Rad, CEO of Campbell Alliance. Encuity Single-user annual subscriptions are $249. Research, to be based in Newton, Penn.,Send news submissions to Cheryl Appel Rosenfeld Reprints and discounted multi-reader or corporateTel (617) 948-5172 Fax (617) 948-5101 subscription rates are available. will provide services to the [email protected] [email protected] or call (617) 948-5100. and biotech industry in five specific areasCopyright 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612 3. CWWeekly March 26, 20123 of 10Industry Briefs (continued from page 2) published more research on dementia than Canada through a competitive, peer-reviewedworldwide chairman, pharmaceuticals any other country except the U.S. and ranksprocess and improve the coordination ofgroup, Johnson & Johnson. second in the world after Sweden in citation research activities. Rx&D member companies impact, the number of times U.K. researchhave set an objective to match CIHR clinical The Wellcome Trusts board of governors is referenced in dementia studies around research commitments dollar for dollar.has approved the creation of a new business the globe. Despite its high performance that will invest in emerging businesses and and influence, dementia research capacity Index Ventures, a venture capital firm,technologies in the healthcare and life sci- in the U.K. is low when compared to cancer,has launched its first fund solely dedicated ences sectors. The business initial capital will stroke and heart disease. For every dementia to investing in the life sciences sector. Thebe $317 million, drawn from the Wellcome research scientist there are six who workfund, $198 million, includes investments Trusts endowment. The business is currently on cancer. The study was commissioned by from several of Indexs largest existing operating under the working title Project the U.K.s leading dementia research charity,limited partners and two companies,Sigma and will be a directly owned and Alzheimers Research U.K., in an effort to GlaxoSmithKline (GSK) and the venturemanaged business. It will provide financial raise awareness and increase investmentcapital affiliate of the Janssen pharmaceu-resources to advance the Wellcome Trusts for the underfunded field. The reports 14 tical companies of Johnson & Johnson.vision of achieving extraordinary improve- recommendations to the U.K. government With this investment in the fund, the twoments in human and animal health by sup- include forming a cohesive national strategy,global pharmaceutical companies will porting the brightest minds in biomedical increasing social awareness of the need forshare their expertise by participating inresearch and the medical humanities. The dementia research, simplifying funding and the funds scientific advisory board. IndexWellcome Trust is known as an investor that reporting procedures, revising scientific ca-will maintain full decision making rightstakes a long-term view. Sigma will extend reer paths, strengthening research networksto the portfolio companies and the fundthis successful approach to direct invest- and streamlining the regulatory process. rules and procedures will follow previousments in emerging healthcare technologies,Index Ventures funds. This pharma/ventureto give small and medium-sized companies Canadas Research Based Pharmaceuti- partnership model is intended to stimulate the support they require to fulfill their cal Companies (Rx&D) and the Canadianpromising, early-stage R&D innovation. potential, said Sir Mark Walport, director, Institutes of Health Research (CIHR) haveIndexs asset centric model focuses on Wellcome Trust. Sigma will also enable renewed a partnership to strengthen clinical investment in companies with just one or Wellcome Trust to take and retain ownership research conducted in Canada. The partner- two projects, rather than companies with positions in the companies. It will be able to ship seeks to strengthen Canadas position multiple programs. The fund will primar- contribute proactively to their development as a preferred location to conduct clinicalily consider opportunities across Europe,over the long term, for example by bringing research. The partnership will play a key role but also in the U.S., with assets that havetogether complementary expertise from in the implementation of the Strategy forfirst-in-class or best-in-class mechanisms ofdifferent companies and scientific fields. Patient-Oriented Research, a national initiative action and target areas of unmet medical Although Sigma has the primary goal of to ensure better translation of research find- need. We believe that supporting andgenerating returns for the Wellcome Trust, ings into clinical practice that was announced nurturing start-ups and encouraging entre- its investments will also provide emerging in August 2011. CIHR and Rx&D member preneurship and innovation will be goodbusinesses with a valuable new source of companies will fund clinical research across for the entire industry, said Dr. Paul Stoffels,funding and guidance.Copyright 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612 4. CWWeekly March 26, 20124 of 10Features (continued from page 1)Kforce Dearhammer said the model is still goingclose watcher of the space, said the combina- It really is an interesting time, strong. Of the top 20 sponsors, 80% to 90%tion of the Smith Hanley and MedFocus brandcurrently use the FSP model for one or more and I think that flexibility andnameswhich inVentiv started out with functions, he said.Pharmanets staffing group, i3s meaningful creativity is key right now.Interestingly, theres no uniformity in exact-staffing arm and now Kforce Clinical makes ly which functions are outsourced, so it is hardinVentiv a very big player in the space. Gregg Dearhammer, president, to predict where the model may be going overThe combination of the three, plusFSP/Staffing, inVentivtime, said Dearhammer. Some companies willKforce should put them well over $300use it for data management and not clinical,million, and that is likely the largest clinical while others will use it for clinical and not datastaffing group, substantially ahead of RPS,redeploy Kforce employees working on that management, he said. Its all over the placewhich was a large staffing and functionalcontract to our other contracts. and it depends on their culture, their historyoutsourcing firm but is transitioning to a full- inVentiv would not say how many and the size of their portfolio.service CRO, he said. employees the Kforce Clinical acquisition Thus, this is a good time to be the marketOne downside of the acquisition, though, includes. leader, he said.is that Kforce Clinical is losing one of its Kforce Clinical operates only domestically, It really is an interesting time, and I thinkbiggest clients, though the companiesand this was hindering it, said Dearhammer. that flexibility and creativity is key right now.would not divulge the clients name. KforceThats one of the reasons its parent companyinVentiv has 550 biotech, pharma and lifeClinical posted revenue of $106.2 million in sold. Its one of the strong reasons theyre sciences clients and 13,000 employees in 402011, but inVentiv said its expecting its new joining us, he said. They have customerscountries. Its privately owned by inVentivacquisition to have annualized revenue ofthat wanted them to expand into Europe, Group Holdings, an organization sponsoredabout $70 million for this year. The contractbut that was not in their strategic plan.by affiliates of Thomas H. Lee Partners,is winding down, but Kforce Clinical willAnd thats an upside for inVentiv. One ofLiberty Lane Partners and members of thework on it through 2012, said Dearhammer.the attractive parts of this is we can immedi-inVentiv management team.And though the contract constituted half ofately go through their list of customers whoOther large players in the staffing/FSPKforce Clinicals revenue for 2011, Dearham- have been asking for services in Europe and space include Icons DOCs group, the Clin-mer said inVentiv wasnt put off.say, Okay, we can do this for you now, saidForce division of Cross Country, On Assign-We knew it; we went in with eyes wide Dearhammer. ments clinical staffing group and privateopen, he said. But we know how that is;Though Pfizer recently eschewed the staffing companies including ASG (part ofwere going through the same thing withFSP modelin which a sponsor outsources Ockham) and Aerotek/Maxim Healthcare.a customer. And we know we can easilyall work across a particular function Suz Redfearn The long road to successfulCall or visit our website today to seehow we can help you get a better return clinical trials just got shorter.on your clinical trial investment.Call 1.888.COVANCE Heres how Xcellerate can helpwww.covance.com/Xcellerate guide you to success. Copyright 2012. Covance Inc. All rights reserved.Copyright 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612 5. CWWeekly March 26, 2012 5 of 10Features (continued from page 1)Surveyhow long these things tend to take. Amongput a lot of time, energy and resources intoWe have seen somethem, 40% said process improvement canestablishing these partnerships, she said. take between one and two yearsthoughcompanies struggle withWhen you choose a partner, the assumptionabout a quarter of this group said theiris that youre in for the long haul, so theyrethe implementation of theexpectations in this area were never met. Ausually really savvy and careful about due overall strategy. Sometimeslittle more than half said if cost savings arediligence. their operational teams are to be achieved, it usually takes one year orBut sometimes, all that due diligence lessthough almost 25% said cost savings not clear on what it means todoesnt translate into seamless collaboration were never achieved. Just over half saidbetween multiple departments once thebe in that particular strategicimproved quality, if it were to be seen, wouldpartnership is in place, said Leuchten. As partnership. There can be gapsbe apparent in a year or less. And yet, 21% ofpart of our consulting practice, we have seen those respondents said quality improvementin communication, and thesome companies struggle with the imple- was never achieved.mentation of the overall strategy. Sometimes change-management aspects The Avoca Group, said Leuchten, planstheir operational teams are not clear on have been difficult.to keep an eye on the strategic partner-what it means to be in that particular strate-ship agreement trend to see if the numbersgic partnership. There can be gaps in com-Patricia Leuchten, CEO, The Avoca Groupimprove.munication, and the change-managementKicking off the strategic partnershipaspects have been difficult. agreement trend back in 2008 was Eli LillysMany companies have strategic partner-But sponsors expectations are not always announcement it had inked large deals withship agreements in place but will not speakbeing met. With regard to cost savings, 16%Covance, Quintiles and i3 Statprobe. Therepublicly about them. The Avoca survey shed said the partnerships were failing to meet was no noticeable partnership movementlight on that, too. Of 147 sponsors, 47% saidtheir expectations, and 36% said their ex- among other companies for two years,their company had at least one strategic pectations were being met only sometimes.but then in 2010 a flurry of public partner-partnership in place (49% didnt know).The sparing of internal resources showed ing began. Some of the larger deals haveAmong those who said their company had even less success. Twenty-one percent said included Bristol-Myers Squibb choosingsuch agreements, 58% said the companythe partnerships were failing to meet theirParexel as its clinical development partner;had two to three in place; 21% had one inexpectations, and 33% said their expecta-GlaxoSmithKline selecting PPD and Parexelplace; 16% had four to six in place; and 2%tions were only sometimes being met. For for clinical development; Sanofi-Aventishad six or more in place.operational/process improvement, 17% saidchoosing Covance for all of its drug develop-When asked what their companys main the partnerships were failing to meet theirment; and Pfizer selecting Parexel and Iconobjectives were in launching strategic expectations, and 40% said their expecta-for clinical development.partnerships, the top five responses were: tions were only sometimes being met.Analysts and other industry observers sayreduced costs, improved quality, improved But are they expecting too much, tooas the work of drug development shifts moreefficiency in use of internal staff, accesssoon? Maybe. Those who have had strategicand more to CROs, several more such agree-to operational expertise and process partnerships in place for three years or more, ments will come.improvement. and thus have the long view, were asked Suz Redfearn Specialized Clinical Trial Management Systems from http://www.ForteResearch.com/allegroCopyright 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612 6. CWWeekly March 26, 2012 6 of 10The Pulse on Latin AmericaBy Marlene LlpizThe consequence of the important role the pharmaceutical industry has played in the prevention, improvement and cureof illnesses and diseases has been not only anincrease in life expectancy, but also an improve- nomic growth of each country. Pharmaceutical companies establish clear and specific variables based on their objectives and purposes in developing innovative drugs and devices. Modern science and technology and measure the safety of the drug more than its efficacy. They also corroborate and assess the effects on other organs and systems. Often, over 200 patients are involved, and the new molecule is compared either to one already marketedment in the quality of life of humans worldwide. are used to search and select molecules asor to placebo. Questionnaires on quality of lifeThis is no different in Latin America, where candidates for future drugs, including genomics,and data on pharmacoeconomics also can bepharmaceutical products and medical devicesDNA splicing and bioinformatics for structuring used to contribute further knowledge on lifereach the region several years after being testedand innovating new molecules. expectancy rates and marketing forecasts. Theseand marketed in other countries. Nonetheless,It is often said that of 10,000 new molecules,trials are complex and are conducted at manythey serve their purpose of preventing diseasesafter 15 years and $900 million invested, onlysites, often lasting two to three years.and curing common, as well as degenerative one drug reaches the market. Pre-clinical andPhase III trials measure efficacy more thanand quickly debilitating, ailments.clinical research have clearly demonstrated the the safety, while considering tolerability. Used to The drug industrys aims include selecting aefficacy and safety of the drug, first in the labo- register a drug at country regulatory agencies,target population while analyzing the market ratory, then in animals and finally in humans.these studies are conducted at several sites inneeds for developing molecules, pinpointingIn Latin America as well as in other nationsseveral countries worldwide, often lasting threea formula that can be used for several dis-globally, pre-clinical trials often are conducted to four years. Additional information on qualityeases and conducting research in areas such as in selected countries. Before being tested in of life and health economics often is gathered.pharmagenomics for personalizing treatment tohumans, a new molecule must be proven safe inThe pharmaceutical industry has trans-specific populations. Pharmaceutical companies several animal experimental models. This stageformed the way it views and focuses ondetermine early on whether certain molecules lasts an average of two to three years, minimiz-therapeutic indications. Seventy years ago,should continue into clinical trials.ing the risk of its exposure to humans. physicians and drug companies were concerned Pharmaceutical research in Latin AmericaThe clinical portion includes several distinctwith curing diseases involving parasites, diges-moves forward concomitantly with a countrys stages. Phase Is main objective is to assess the tive and respiratory tract infections. Betweentechnological and scientific development. Phar-drugs effect on a target organ, determine the1960 and 2000 transmitted diseases decreased,maceutical medicine is aimed at preventing,exact dosage and corroborate the molecules while deaths involving different types of cancer,treating and curing diseases, improving qualitypharmacological properties. This phase includes accidents and violence increased. Today, weof life and lengthening life expectancy. Hugetoxicology, pharmacodynamic and pharmacoki- have options for treating heart disease, diabetescorporations with offices in Mexico, Argentina netic studies that specify the absorption, distri-mellitus and malignant tumors.and Brazil, for example, gather new knowledgebution, metabolism and excretion of a drug. TheLatin America is a rich region for all clinicalfavoring the development of innovative drugs volunteers generally are healthy and comprise trials, in which clinical research can grow andand devices for countrywide and regional health20 to 50 subjects. Usually they are conducted atexpand while providing a new outlook forimprovement. Along the way, they strengthena specialized center for carefully monitoring and healthcare and increased life expectancy.the relationship with the local and national analyzing pharmacological results and can lasthealth authorities to expedite the availability of about six months to two years.Dr. Marlene Llpiz is president of AMEIFAC-Mexiconew medicines to consumers. This also improves Phase II trials aim at corroborating thefor the 2011-13 term, secretary for IFAPP and CEOthe commercial sector, while favoring the eco- desired effect on the target organ or disease,of Clinica Responsable Operativa Mexicana, S.C.Copyright 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612 7. CWWeekly March 26, 2012 7 of 10Drug & Device Pipeline News Company Drug/Device Medical Condition StatusSponsor Info Alnylam ALN-TTR02 TTR-mediatedPhase I trials initiated enrolling 32 (617) 551-8200 Pharmaceuticals amyloidosis subjects in the U.K.www.alnylam.com RepligenRG2833Friedreichs ataxia Phase I trials initiated enrolling 20 (781) .250-0111 subjects in Turin, Italywww.repligen.com Trillium Therapeutics TTI-1612interstitial cystitis Phase I trials initiated enrolling 28 (416) 595-0627 women in Canada www.trilliumtherapeutics.com JennerexJX-594colorectal cancer Phase I/II trials initiated enrolling (415) 281-8886 42 subjects internationally www.jennerex.com Celgene pomalidomidesystemic sclerosis, Phase II trials planned for 88(908) 673-9000 interstitial lung disease subjects internationallywww.celegene.com GlaxoSmithKline belimumab kidney transplant Phase II trials planned for 20(888) 825-5249 rejection subjects in the U.K.www.gsk.com Convergence CNV1014802trigeminal neuralgiaPhase II trials initiated enrolling +44 (0)1223 755 501 Pharmaceuticals 30 subjects internationally www.convergencepharma.com Mesoblast Mesenchymal chronic low back pain Phase II trials initiated enrolling (212) 880-2060 Precursor Cells 100 subjects in the U.S.www.mesoblast.com Pfizeraxitinibadenoid cystic carcinoma Phase II trials initiated enrolling(646) 888-423532 subjects in the U.S.www.pfizer.com PROLOR BiotechhGH-CTP pediatrics with growthPhase II trials initiated across(866) 644-7811 hormone deficiencyinternational sites www.prolorbiotech.com SK Biopharmaceuticals YKP10811chronic constipationPhase II trials initiated enrolling (201) 421-3842 100 subjects in the U.S.www.skbp.com TOPICAluliconazoledistal subungualPhase IIb/III trials planned(650) 209-3700 Pharmaceuticals onychomycosis enrolling 300 subjects in the U.S.www.topicapharma.com Novo Nordiskliraglutide obesity/sleep apnea Phase III trials planned for 300(609) 987-5800 subjects in North America www.novonordisk.com PaxVaxPXVX-0200 cholera vaccine Phase III trials planned in the U.S.(858) 450-9595 www.paxvax.com Abbottadalimumabhidradenitis suppurativaTwo phase III trials initiated(847) 937-6100 enrolling 600 subjects globally www.abbott.com CSL Behring fibrinogenhemorrhage during Phase III trials initiated 200(610) 878-4000 concentrate (human) aortic aneurysm surgery subjects internationallywww.cslbehring.com Lexicon telotristat etipratecarcinoid syndromeOrphan drug designation (281) 863-3000 Pharmaceuticals granted by the FDAwww.lexgen.com QLT Visudynecentral serousOrphan drug designation (800) 663-5486 chorioretinopathy granted by the FDAwww.qltinc.com MAGIs Clinical Research Conference 2012 East Clinical Trial Operations, Regulatory Compliance, Contracts & Budgets May 20 - 23, 2012 Hyatt Regency Crystal City, Arlington, VA REGISTER WITH CW152 AND SAVE $100!www.magiworld.orgCopyright 2012. Duplication or sharing of this publication is strictly prohibited.CWW1612 8. CWWeekly March 26, 2012 8 of 10Trial ResultsCardiovascularefficacy parameters showed improve- treatment with either PA32540 or 325mgment, with the low dose of PH-10 (0.002%) enteric-coated aspirin once daily. The pri- Xention issued results from a phase Iproviding uniformly consistent improve- mary endpoint, a significant reduction in trial of XEN-D0103 for the treatment ofment, while reduced therapeutic activitythe cumulative incidence of gastric ulcers atrial fibrillation. This combined single- was observed at the two higher doses. following administration of PA32540 versus and multiple-ascending oral dose study After 28 days of treatment with PH-10 (all325mg enteric-coated aspirin over six enrolled 30 healthy subjects in the U.K. The strengths), 23-29% of subjects achieved months, was met in both studies. Second- study evaluated the safety and pharmaco- complete or nearly complete resolutionary endpoints were also reached, including kinetics of various dosages of XEN-D0103.of all PSI components, compared to no a reduction in gastroduodenal ulceration Treatment was well tolerated and dem-subjects in the placebo arm. In the low-and a reduction in discontinuation due onstrated good pharmacokinetic proper- dose PH-10 arm, 38% of subjects reportedto upper gastrointestinal adverse events. ties. No significant adverse events were no itching after 28 days compared withPOZEN plans to file for regulatory approval reported. An analysis of electrocardiogram 14% of those receiving placebo. PH-10 atin the third quarter of 2012. data collected from the first cohort of 30 0.002% and 0.005% exhibited maximum healthy subjects indicated XEN-D0103 had improvement in Plaque Response Assess- Neurology no effect on the QTcF interval. This absence ment, with the improvements for 0.002% of any detectable effect on QTcF confirmed achieving high significance (p < 0.001) Addex Therapeutics issued results from the atrial selectivity of XEN-D0103. Xention after two weeks of treatment; all strengths a phase IIa trial of dipraglurant for the plans to move into phase II trials shortly.were superior to placebo after 28 days, treatment of Parkinsons disease levodopa-with the highest strength exhibiting theinduced dyskinesia (PD-LID). This double-Dermatology least activity. The company plans to move blind, placebo-controlled study enrolled 76forward with development. subjects with moderate or severe PD-LID. Provectus reported results from a phaseThe subjects followed a dose-titration IIc trial of PH-10 (Rose Bengal) for psoriasis. Gastroenterology regimen, receiving 50mg doses from day This multicenter, randomized, controlled one to day 14 and then 100mg from day 14 study (PH-10-PS-23) enrolled 99 subjects POZEN released results from two phase III until day 28. Dipraglurant met the primary with mild to moderate plaque psoriasis trials of PA32540, a coordinated-delivery objective of the study by exhibiting a good who received placebo or PH-10 (0.01%,tablet of immediate-release omeprazolesafety and tolerability profile. Dipraglurant 0.005% or 0.002%) applied once daily toand delayed-release aspirin, under devel- also demonstrated statistically significant affected skin areas for 28 days. The primary opment for the secondary prevention ofreduction in LID severity with both 50mg efficacy endpoint was treatment success, cardiovascular disease in subjects at riskand 100mg doses. Efficacy was measured assessed at day 29 after initial PH-10 treat-for aspirin-induced ulcers. The random- using the modified Abnormal Involuntary ment. Success was defined as 0 or 1 on all ized, double-blind, multi-center studiesMovement Scale (mAIMS). Peak mAIMS Psoriasis Severity Index (PSI) componentsenrolled 1,049 subjects at risk for develop-was significantly reduced on Day 1 (50mg; and 0 or 1 on the Plaque Response scale. ing aspirin-associated ulcers and already p = 0.042) and on Day 14 (100mg; p = The Pruritus (itching) Self Assessment scale taking aspirin at 325mg once daily for at 0.038). Addex is seeking a partner to move was also measured. Results for all three least three months. The subjects received development forward. Next issue: April 4! The April JobWatch e-Publication will be on-site at JobWatch The Source for Clinical Jobs and Career Resourc ResearchesApril 2012 JobWatch centerwatch.com/jobwatchthe ACRP conference in Houston, April 14-17postOpen PositionsClinical Operations Coordinators Monitoring Project Management Regulatory Affairs your job postings, company profiles and educational Research Scientists Education and Events Next issue: Apr. 4 Conferences Training Programs Webinars events by Mar. 30th to be included!Academic Programs the e-Publication!Company Profiles Ad deadline: Mar. 30Additional ResourcesJoin our JobWatch Groupon LinkedIn Maximize your exposure! Contact [email protected] for rates and information.centerwatch.com/jobwatchCopyright 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612 9. CWWeekly March 26, 20129 of 10Biotech Review The Senate is heading for a vote on theexclusivities for new and improved drugs, the pipelines more productive by enabling Jumpstart Our Business Startups (JOBS) Act.report said. Or it could weigh in on patent researchers to better predict treatment H.R. 3606, which recently passed the House term extensions and reforms. Those optionsoutcomes, improve development and lead 390-23, would benefit emerging growthmay involve tweaking the 1984 Hatch-to more specific and effective approaches. companies by providing a five-year on-ramp Waxman Act that has helped speed generics to the public market, raising the SECs Regula-to market and encouraged price-lowering Merck has helped launch a new non- tion A cap to $50 million, increasing the SECcompetition. The cost of developing a drugprofit translational institute in San Diego, registration shareholder threshold to 1,000has doubled since the early 1980s, to morethe California Institute for Biomedical and opening the door to crowd funding. Inthan $1 billion, whereas new generics, whichResearch (Calibr), to accelerate translation Senate debate Sen. Jack Reid (D-R.I.) offeredget free access to the brand drugs R&D of basic biomedical research into commer- a substitute bill with more protections forunder Hatch-Waxman, cost about $1 million cialized medicines. Merck will fund Calibr investors. But industry groups including the to $2 million. Contributing to the high costs $90 million over seven years in exchange for Biotechnology Industry Organizationfor a new drug is the increased expense ofan option to exclusively license any protein (BIO) are urging the Senate to pass the Houseconducting clinical trials. The number of trialsor small-molecule candidates derived. Pete bill as is. If the bill passes, small biotechs likenecessary to file a new drug application hasSchultz, director of Calibr and a professor of Regulus Therapeutics of La Jolla, Calif.,doubled in the past 30 years, and the numberchemistry at the Scripps Research Institute, could see immediate benefits. Regulus CEOof subjects needed in those trials has tripled, said Calibr would be a 501(c)(3) organiza- Kleanthis Xanthopoulos said his companythe CRS said. The success rate in bringing ation and would form collaborations with currently spends $1 million to $2 million each drug to market was 4% between 2005 andother nonprofits, leveraging translational year to comply with Sarbanes-Oxley require-2009. As a result of the increased costs andcapabilities and expertise to advance early- ments. When opportunity costs are added, risks, the rate of return on investment in astage science to the clinical proof-of-concept the cost of compliance accounts for up tonew drug has dropped by 12% over thestage. Companies working with Calibr could 10% of Regulus total annual budget of $25 past three decades, according to the report.then form partnerships with Merck for clini- million to $30 million.Prior to Hatch-Waxman, a drugmaker had no cal development. Calibr would be a place forgeneric competition for an average of three pharma and academic scientists to meet as MediVector of Boston was awarded a $138.5years after patent expiration, which meantequal partners. Calibr will offer facilities and million contract from the Department ofan extended time to generate funding forstaff to support partner projects. Although Defenses Joint Project Manager Transfor-R&D, CRS said. Biopharma has developed aMerck will be first to license any therapeutics mational Technologies (JPM-TMT) to further number of strategies, including mergers and that make it past proof-of-concept, partner develop favipiravir (T-705), a broad-spectrumacquisitions, branded generics or biosimilars,companies could shop them elsewhere if therapeutic against multiple influenza reformulations of the original brand product, Merck declines. Participation in Calibr will viruses, including the 2009 H1N1 pandemicprice increases or deals to lower the costbe granted to academic scientists based on virus and drug-resistant strains. JPM-TMT said of the drug. However, other than delayed- proposals judged on novelty, biomedical phase III trials could begin this fall.release formulations to delay generics, mostimpact and technical feasibility. of those strategies wont slow the patent As branded drugs with more than $117 drop-off or spur innovation, CRS found.The stories included in Biotech Review billion in U.S. sales fall off patent by 2016,have been provided to CenterWatch with Congress may need to maintain the proper The National Center for Advancingfull permission of BioWorld Today and its balance of lower drug prices through ac- Translational Sciences (NCATS) is teamingpublisher, AHC Media LLC. Copyright cess to generics and an environment that up with Eli Lilly to profile the effects of2012 AHC Media LLC. encourages innovation. That may requirethousands of approved and investigational new or expanded incentives, a Congressionaldrugs. Over the next 12 to 18 months, LillyBioWorld is located at 3525 Piedmont Research Service (CRS) report suggested, will use its Phenotypic Drug Discovery panelRoad, Building 6, Suite 400, Atlanta, GA especially if the U.S. is to maintain its status asto screen NCATS 3,800 drugs to reveal novel30305. U.S.A. Please call (800) 688-2421 or a leader in biopharma innovation. Congress mechanisms or pathways of medicines. The(404) 262-5476 for more information. Or could explore ways to incentivize innova-goal of the profiles, which will be publiclyvisit www.bioworld.com. tion through changes to data or marketingavailable, is to make drug developmentCopyright 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612 10. CWWeekly March 26, 201210 of 10CWMarketPlaceCWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile Pagesposted on CenterWatch.com. 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