Inside this issue:

� FeaturesMDS Pharma to be Split, Sold to Ricercaand Private Investment Firm

UBC Opens First Office in Asia-Pac

� Industry BriefsCROs

Patient Recruitment

Technology

� Company ProfileAn interview with Malgorzata Szerszeniewska, M.D., CEOEastHORN Clinical Services

� Drug & Device Pipeline News

� Trial ResultsCardiovascular

Gastroenterology

Neurology

Oncology

� Biotech Review

Volume 14, Issue 7 | February 15, 2010

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ISSN 1528-5731

Editorial Steve ZissonSara GambrillMolly Rowe

Drug Intelligence Tracy Lawton

Production Steven HasomerisDanielle Wooding

Jason Greeno

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cwweekly

contents

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3MDS Pharma to be Split, Sold to Ricercaand Private Investment Firm

UBC Opens First Office in Asia-Pac

Industry Briefs . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7CROs

Patient Recruitment

Technology

Company Profile . . . . . . . . . . . . . . . . . . . . . . . . . . .9An interview with Malgorzata Szerszeniewska, M.D., CEOEastHORN Clinical Services

Drug & Device Pipeline News . . . . . . . . . . . . . . . .12

Trial Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Cardiovascular

Gastroenterology

Neurology

Oncology

Biotech Review . . . . . . . . . . . . . . . . . . . . . . . . . . .16

February 15, 2010

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MDS announcedplans to divideMDS PharmaServices, thec o m p a n y ’ se a r l y - s t a g econtract re-

search organization (CRO), and sell itoff to two separate companies for $45million, according to published reports.The transactions are expected to closeby April.

Ricerca Biosciences of Concord,Ohio, has agreed to purchase MDSPharma’s discovery through phase IIaoperations in Bothell, Washington;Lyon, France; and Taipei, Taiwan.A new corporation primarily ownedby private investment firms BainCapital Ventures and SV Life Scienceswill purchase MDS’ developmentand regulatory services consultancy,as well as five early-stage facilitiesin Ireland, Nebraska, New Jersey,Arizona and Switzerland.

Ricerca is an early-stage CRO withcapabilities in discovery and medicinalchemistry, API process chemistry,

cGMP manufacturing and scale-up,and IND-enabling toxicology. MDSPharma will add molecular profiling,pharmacology/DMPK and drug safetyassessment to its list of services.

“The addition of these facilities andpersonnel complement Ricerca’s exist-ing facility in Concord, Ohio, and po-sition us as a global, preferred providerof discovery and development services.We have intimate working knowledgeof these facilities; all are steeped indecades of experience and expertise,”said Ricerca chairman and CEO IanLennox in a statement.

Neither deal includes the sale of MDSPharma’s King of Prussia, Pa., executiveoffice or its early clinical research andbioanalysis operations in Montreal,Quebec. The Pennsylvania office willclose immediately, and the Montrealoperations will be decommissionedover the next year with final close oc-curring in early 2011. Approximately225 employees will be laid off as a re-sult of the closure, while another 50jobs will be eliminated from MDSPharma Services’ other locations. Forty

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MDS Pharma to be Split,Sold to Ricerca and Private Investment Firm

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Can your EDC systemdispense medication? Ours can.

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employees from the Montreal officewill become home-based employeesunder the new corporation.

MDS put its early-stage CRO divisionon the block last summer, afterselling its late-stage operations to INCResearch. The company originally saidit would ramp up its focus on earlystage operations and even expandedits Taiwan unit (the facility that is nowbeing purchased by Ricerca) in June.Plans changed in September whenMDS decided to sell off Pharma Serv-ices in its entirety and focus on thecompany’s medical imaging business,MDS Nordion.

After several months of searching foran appropriate buyer, MDS warnedinvestors earlier this month that thesale of the early-stage business willlikely garner lower sale proceeds thanpreviously expected, due to “contin-ued deterioration of market condi-tions, the declining early stagecustomer base and new developmentsin the ongoing strategic reviewprocess.”

MDS told investors that somecustomers have expressed concernabout the company’s restructuring anddecreased focus on early stage, result-ing in a reduction of orders and rev-enues. As a result, the sale proceedsmay not be enough to fund adistribution to shareholders.

CMSEuropean Medicines AgencyFDA Health CanadaHHSNICE

WWW. P O S TA P P R O VA L . O R G

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United BioSourceC o r p o r a t i o n ’ s(UBC’s) new officein Tokyo, Japan, isthe company’s firstoffice in that coun-try and in all of

Asia-Pacific.

The contract research organization(CRO), which has 26 offices world-wide, has conducted work in all ofAsia-Pacific but did not have a legalentity there until now. UBC CEO EthanLeder said the Japan office will havea staff of 12 by the end of thisyear, with almost all of those new toUBC. These employees will supportUBC’s investigator training and certifi-cation services as well as ongoingclinical research monitoring in theregion. UBC has 1,450 employeesworldwide.

The company has hired KumpeiKobayashi as country manager.Kobayashi began his career as a re-search scientist and most recently man-aged operations for i3 Japan. Inaddition to managing the Japanese

office, he will focus on expandingUBC’s operations in Japan.

The Asia-Pacific region, especiallyJapan, has grown increasingly impor-tant to UBC as both regional andworldwide clients have requested in-creased services there.

“We’ve been doing work for Japanesecompanies for a long time, and they’resome of our best customers—in boththe rest of world and in Japan,” Ledersaid. “We felt it was important—notjust with those Japanese companies butwith some of the other ex-Japan com-panies that are developing drugs andmarketing drugs in- country—to be onthe ground.”

Whereas many CROs have openedoffices in other Asia-Pacific countrieswhere there is a large potential patientpopulation, UBC does not rely heavilyon patient recruitment because thecompany focuses on late-stage projectsthat already have enrolled patients.

“Right now, Japan is the most log-ical place for us to set up our first

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UBC Opens First Officein Asia-Pac

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Asia-Pacific office because it has a ro-bust pharmaceutical community thatwe currently support and have foryears, both in the states, in Europe andin Japan. We think we can build off ofthat Asia-Pacific location, and, if needbe, look at other segments of that re-gion for offices,” Leder said.

GlaxoSmithKline (GSK) highlightedJapan’s importance to the drug devel-opment industry in the company’syear-end earnings conference call lastweek. GSK CEO Andrew Witty toldinvestors that he expects Japan to be“big business” for the company in thefuture.

UBC plans to aggressively grow itsglobal footprint in 2010, Leder said,but where the company expands willdepend on existing clients.

“Since inception, we’ve had $220 mil-lion in institutional blue-chip equityinvested in our company. We’re a pri-vate company, so we’re exceedinglywell capitalized. The purpose of thatis to be able to do what makes sense,when it makes sense,” Leder said. “Onthe one hand, we’re not driven byquarterly expectations. On the otherhand, we’re not under-capitalized.We’re well capitalized, so we canmake the necessary investments incapital, resources and people. Ourgoal is to take our good clients and beable to service them. “

UBC acquired two companies in Eu-rope last year, expanding both its serv-ices and service areas. Leder said thecompany will likely look at expandingmore in central and western Europe inthe coming months.

“It would not surprise me if we are asactive [in 2010] as we were lastyear,” Leder said.

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For more information on spon-sor and CRO activity in theAsia-Pac region, see the Febru-ary issue of The CenterWatchMonthly.

CROsIndian contract research organization(CRO) SIRO Clinpharm is partneringwith South Korean CRO DreamCIS toexpand SIRO’s services in the Asia-Pacific region.

The two CROs will offer clinical trialmanagement, medical writing, feasibil-ity and patient planning, pharmacovig-ilance, post marketing surveillance,data management, biostatistics andquality assurance services to clients inSouth Korea and worldwide. The spe-cific terms of the alliance were notmade public.

"Looking at the increasing numberof global clinical trials and the rapidgrowth in the Asian clinical trialsmarket, we were looking at associatingourselves with a CRO having a globalexposure," said DreamCIS presidentWon-Jung Choi in a statement.

SIRO Clinpharm has offices in India,Israel, Europe and the U.S. Thecompany formed a similar alliancewith regulatory services firm Cam-bridge Regulatory Services last fallto provide regulatory expertise toclients conducting clinical trials inEurope.

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BioClinica signed a three-year, multi-million dollar partnership with bio-pharmaceutical company Cephalon forclinical trial technology and support

services. Neither company releasedfinancial terms of the deal.

Under the terms of the agreement, Bio-Clinica will provide data managementservices to Cephalon’s global clinicaltrial operations. Cephalon’s U.S.-baseddata management staff will supportthese efforts. The deal expandsCephalon’s plans to use BioClinica’sExpress electronic data capture productas its default data capture system.

BioClinica also reported its fourthquarter and full-year 2009 earnings lastweek. Service revenues for the quarterwere flat from the fourth quarter 2008at $14.9 million. Income from continu-ing operations was $943,000, or $0.06per fully diluted share, compared withincome of $1.7 million for the same pe-riod 2008.

Service revenues for the full-year were$57.4 million, compared with $56.2million for the same period 2008. In-come from continuing operations, netof taxes was $3 million, or $0.20 perfully diluted share, as compared with$5.8 million, or $0.40 per fully dilutedshare, for the same period 2008.

The CRO expects full-year 2010 serv-ice revenue to be in the range of $61million to $65 million, with earningsper share in the range of $0.25 to $0.29per share.

cwwcww| industry briefs |

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Industry Briefs CWWeekly | 7

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Pivotal Research Centers, a site man-agement organization (SMO) ownedby UK CRO Premier Research Group,has been signed by Cornerstone Phar-maceuticals as an SMO for its single-agent phase I/II clinical trial. The studywill take place at Pivotal’s Peoria,Ariz., location.

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PPD’s full-year income from opera-tions fell 32% in 2009, the contractresearch organization (CRO) re-ported. Revenues for the year werealso down from $1.55 billion in 2008to $1.42 billion.

Full-year 2009 income was $192.9million, compared with $282.4 mil-lion in 2008. Diluted earnings pershare for 2009 were $1.34, comparedwith diluted earnings per share of$1.56 for the same period last year.

PPD’s fourth quarter net revenuesdipped slightly to $357.4 million,compared with $363.1 million in thefourth quarter of 2008. Income fromoperations was $23.9 million, com-pared with $71.7 million for the sameperiod in 2008.

Earlier this month, the company com-pleted the sale of its biomarker serv-ices division, PPD BiomarkerDiscovery Sciences, to Montreal-basedCaprion Proteomics. PPD next plansto spin off its compound partneringbusiness, creating two independentpublic companies. Only the CRObusiness will maintain the PPD name.

Patient RecruitmentPatient recruitment company BBKWorldwide opened an office in LosAngeles to meet growing demand forpatient recruitment services there andworldwide. The company opened aJapan office in 2009, and this newWest Coast location will help BBKbetter serve clients there and in the Pa-cific time zone. The company also hasoffices in Boston, London and Prague.

"Our West Coast clients operate in ahotbed of biopharmaceutical innova-tion. BBK's on-site consultation betterensures their trials are primed for suc-cess with early recruitment strategies,technology, training, and tactical im-plementation support," said BBKfounding principal Joan Bachenheimerin a statement.

TechnologyPhase Forward’s fourth quarter rev-enues jumped 22% but profits wentdown, the company reported.

The technology company’s Q4 rev-enues increased to $58.8 million, upfrom $48.3 million in the same quar-ter 2008. Net loss for the quarter was$68,000, or $0.00 per diluted share,compared with net income of $2.7million, or $0.06 per diluted share, inthe same period last year.

Phase Forward attributed the drop inprofitability to impairment chargesand acquisition costs. The companyacquired Waban Software andMaaguzi last year, as well as Cov-ance’s interactive voice and web re-sponse services business.

Full-year revenues in 2009 were$213.3 million, up 25% from $170.2in 2008. Net income for the yearwas $8 million, or $0.18 per dilutedshare, compared with $13.8 million,or $0.32 per diluted share,in 2008. cww

Industry Briefs CWWeekly | 8

�

What is the backgroundof EastHORN and howdid you get involved?

This company was founded as Unimedin 2004 by Dr. Ales Horacek andchanged management in May 2009. I’dbeen working with the founder for sixyears as a partner of my previous com-panies—Covance and AbCRO. It wasnatural that I would join them after theacquisition of AbCRO by PPD, as I pre-fer to work in a smaller company withless overhead and greater flexibility.

The name change to EastHORN was are-branding— to make this name moremarketable and because we found outthat there are a lot of companies withthe name Unimed in our countries—medical, private practices or outpatientdepartments—and this made locatingour company by a web search mucheasier. That was the reason for thename change. We also wanted to givemore meaning to the name of the com-pany and one that would express a bitof the company profile.

Although the name of the company—EastHORN—is new, this is a companywith a history, and we are buildingEastHORN around this core businessdeveloped by Unimed—this originalcompany with headquarters in CzechRepublic and initially focused on CzechRepublic, Slovakia. They used tohave some operations in Bulgaria and

Macedonia. As EastHORN, we startedgeographical expansion in Central andEastern Europe (CEE) and will con-tinue to grow in this direction. Withheadquarters in Czech Republic andthe largest operations there, we also es-tablished offices in Poland, Bulgariaand Romania. We have contacts inUkraine, Russia and other Balkancountries, and we intend to open officesthere soon. It’s just the first step in ourstrategy to be able to cover all CEEcountries.

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| company profile |

Contract Research Organization

An interview with Malgorzata Szerszeniewska, M.D., CEOEastHORN Clinical Services in CEE

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Company Profile CWWeekly | 9

Year founded: 2004 as Unimed,Renamed in 2009Employees: 40Contractors: 30 across EuropeOffices: Czech Republic, Poland,Romania, Bulgaria; home-basedstaff in Serbia, Ukraine, Russia# phase I units: 1 at ThomayerUniversity Hospital# of beds: 6 wards, 28 bedsContact: Leonard Gold, directorof business development,North AmericaChris Birch, director of businessdevelopment, Europe andAsia/PacificTel #: (908) 317-2846+44 1280 816919Email: leonard.gold@easthorn.euchris.birch@easthorn.euWeb site:www.easthorn.eu

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Why is the CEEregion an importantarea for clinical trials?

The reason CEE is so successful inclinical trials—meaning there are a lotof patients, motivated patients, moti-vated investigators—is very sad, Iwould say. An under-invested health-care system—a much lower level ofpublic healthcare system than in west-ern countries—is the main contribut-ing factor for this situation. As long aswe have this disproportion betweenpeople’s needs and access to the med-ical care, then we will have thegrounds for successful clinical trials.Clinical trials are providing patientswith access to new medicine and muchbetter care.

CEE is a very diverse region with over20 countries. There are some countrieswith much better economic states, likePoland, Czech Republic and Hun-gary—European Union members.These countries are becoming muchmore problematic in terms of site sat-uration, patients’ willingness to par-ticipate in the trials, as well as veryunfriendly and constantly changingregulations, but there is still space forexpansion, for example, in the Balkanregion. Also, Russia is not well-ex-plored, considering the potential pa-tient population, and there are othercountries like former Soviet RepublicsBelarus, Kazakhstan and Azerbaijan,which probably sooner or later will beinvolved in clinical trials and are re-gions EastHORN is considering forthe future.

I think for the next five years at leastwe will maintain somehow the samebenefit from doing clinical trials inCEE considering cost-efficiency but it’smostly related to time-saving. The re-gion offers much faster patient re-cruitment and high quality of data andhigh work efficiency aligned with theWestern business model. These arecrucial factors that differentiate ourregion from other emerging countries.

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What differentiatesEastHORN fromother CROs?

We are a full service company. Wehave a phase I unit based in ThomayerUniversity Hospital in Prague. Thisis a big advantage because this unitis based in a hospital where you haveaccess to not only healthy volunteersbut also patients as well as the hospi-tal facilities, such as imaging servicesor the ITU [intensive care unit] de-partment. This differentiates us fromphase I units located in Czech Repub-lic and CEE. Management and ourclinical staff are based in and comesfrom the region with an excellent un-derstanding of the local environmentand culture and has tried and testedsolutions to overcome challenges theregion brings. Although we seem to bea regional company, we are usuallyperceived as the company with a localmanagement style.

Our biggest advantage that differenti-ates us from competitors is that the en-tire corporate management has globalpharma and CRO experience. AlanWood, who is chairman of the board,and I came from a global company,Covance, but Alan also has biotechpharma company experience. Wemanage this company in a way that isabsolutely focused on anticipation andunderstanding of clients’ needs in adifferent way from other local compa-nies. Comparing us with global com-panies that are present in the region,we are probably similar in terms ofquality and standards of service be-cause we are able to offer service onthe level of the global CRO throughthe highly professional staff. But, wehave a lot of advantages in terms offlexibility of the company, our com-mitment to each and every client re-gardless of size, our managerialinvolvement in each and every project,our efficient issues escalation and de-cision-making process and responsive-ness. This is completely different thanin the global companies. Another ad-vantage is definitely cost-efficiency be-cause our overhead is very minimal.Our core management is based here

where trials are run—in Central andEastern Europe—not in the U.S. or theUK, and decisions are made by peoplewho really know the local realities.

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What challengesdo you face?

I used to work in various countries. Istarted in Poland—this first wave ofCentral and Eastern European coun-tries in terms of clinical trial develop-ment. Five years or even 10 years later,we had new countries appearing onthe market, such as the Balkan coun-tries, with Russia and Ukraine ex-panding. There is a huge differencebetween the situation several years agoand now in all CEE countries. It’s notjust related to the region itself but it’srelated in general to the changes indrug development. Protocols are be-coming more complicated, it’s moredifficult to recruit patients, and regu-lations are more demanding andchanging all the time. Running clinicaltrials requires more resources from thesites, investigators, CROs and spon-sors than in previous years as studiesbecome more complex despite ad-vances in technology.

The biggest challenge specific to theregion is the dynamism of changes,which is not good for the clinical trialsprocess because it requires long-termstability. We are changing much fasterthan other countries and usually thechanges are improvements to attainthe Western standard in various areasof our life. That is why things are notthe same today as they were a yearago in terms of regulations, the labormarket and price and cost.

The biggest challenges relate to regu-latory control and the very often neg-ative approach of our authorities tothe clinical trials business due to vari-ous reasons, including financial bene-fits related to the trial.

Company Profile CWWeekly | 10

�

What are yourplans for the future?

We definitely want to maximize whatwe can get from existing countries,but it’s becoming more difficult. That’swhy we want to be able to run trialsin other countries in the region thatare not very well explored at thismoment. We definitely want to workin the Balkan Peninsula—Serbia,Bosnia-Herzegovina, Montenegro—those countries have huge potential.We want to go to Belarus and thengradually explore other former Sovietrepublics. We will be focused onthe future EU members, includingTurkey, and maybe add Israel to ourlocations considering some similaritieswith CEE.

This is our strategic plan for now, but,as a flexible company, we mightchange our plans depending on the sit-uation in the global and regionaleconomies and other external factorslike regulatory obstacles. We are con-sidering opening offices in some West-ern European countries as theselocations are sometimes very muchneeded by our clients. We are thinkingabout other emerging markets that areunexplored at this moment but weconsider them as a very high potentialin the future. Definitely the Chinesemarket is something that we’d like tolook at, but probably it will take morethan three years as it needs a lot oftime preparing the environment toopen your business there. Africa is aregion that is very difficult but, again,unexplored. Here, we do not have anyprecise plans in terms of coun-tries yet. cww

Editor’s Note: Organizationsfeatured in our profiles havebeen selected byCenterWatch editorial staff.If you would like to beconsidered for a profile, pleasesend an email toeditorial@centerwatch.com.

Company Profile CWWeekly | 11

| drug & device pipeline news |

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Drug & Device Pipeline News CWWeekly | 12

Company Drug/Device Therapeutic Area Status Sponsor Info

Bioheart MyoCell(muscle stem cells)

congestive heartfailure

Phase I trials initiatedin Jordan

(954) 835-1500www.bioheartinc.com

Neogenix Oncology NPC-1C pancreatic orcolorectal cancer

Phase I trials initiated (516) 482-1200www.neogenixoncology.com

PsyadonPharmaceuticals

ecopipam Lesch-Nyhandisease

Phase I trials initiatedin the U.S.

(301) 919-2020www.psyadonrx.com

ArQule ARQ 197 colorectal cancer Phase I/II trialsinitiated

(781) 994-0300www.arquke.com

PenwestPharmaceuticals

A0001 MELAS syndrome Phase IIa trialsinitiated enrolling 30subjects in England

(845) 878-8400www.penw.com

Trigemina intranasal oxytocin chronic dailyheadache

Phase IIa trialsinitiated enrolling 80subjects in the U.S.

(650) 938-0898www.trigemina.com

ArQule ARQ 197 germ cell tumors Phase II trials initiatedenrolling 41 subjectsin the U.S.

(781) 994-0300www.arquke.com

Genta tesetaxel melanoma Phase II trials initiatedin Texas

(908) 286-9800www.genta.com

Osiris Therapeutics/Drexel UniversityCollege of Medicineand HahnemannUniversity Hospital

Prochymal (stemcell therapy)

heart attack Phase II trials initiatedenrolling 220 subjectsin the U.S.

(443) 545-1800www.osiris.com

QR Pharma Posiphen Alzheimer’s disease Phase II trials initiated (484) 253-2296www.qrpharma.com

XOMA XOMA 052 type 2 diabetes Phase IIb trialsinitiated enrolling 325subjects in the U.S.

(510) 204-7200www.xoma.com

Kamada inhaled alpha-1antitrypsin

alpha-1 antitrypsindeficiency

Phase II/III trialsinitiated in Europe

+972 8 9406472www.kamada.com

AntheraPharmaceuticals

A-002 acute coronarysyndrome

Phase III trialsplanned enrolling6,500 subjectsinternationally

(510) 856-5600www.anthera.com

ChelseaTherapeutics

Northera(droxidopa)

neurogenicorthostatichypotension

Phase III trialsplanned enrolling84 subjectsinternationally

(704) 341-1516www.chelseatherapeutics.com

Drug & Device Pipeline News CWWeekly | 13

Company Drug/Device Therapeutic Area Status Sponsor Info

DynavaxTechnologies

Heplisav hepatitis B vaccine Phase III trialsinitiated enrolling2,000 subjects inNorth America

(510) 848-5100www.dynavax.com

QRxPharma MoxDuoIR acute post-surgical pain

Phase III trialsinitiated enrolling 140subjects in the U.S.

(908) 506-2900www.qrxpharma.com

AVI BioPharma AVI-5038 Duchenne musculardystrophy

Orphan drugdesignation grantedby the EMEA

(425) 354-5038www.avibio.com

TalecrisBiotherapeutics

aerosolizedalpha1-proteinaseInhibitor

congenitalalpha1-antitrypsindeficiency

Orphan drugdesignation by theU.S. FDA

(919) 316-6300www.talecris.com

Paladin Labs Abstral breakthroughcancer pain

NDS filed in Canada (514) 340-1112www.paladin-labs.com

Lux Biosciences voclosporin non-infectiousuveitis

MAA filed with theEMEA

(201) 946-0551www.luxbio.com

Lux Biosciences voclosporin non-infectiousuveitis

NDA filed with theFDA

(201) 946-0551www.luxbio.com

Astra Zeneca Crestor heart attackprevention

FDA approved fornew indication

(302) 886-3000www.astrazeneca.com

Daiichi Sankyo Benicar hypertension inchildren

FDA approved fornew indication

(973) 359-2600www.dsi.com

integrated intelligence

Integrating scientific and operational expertise with proprietary technology to generate, analyze and communicate real-world evidence.

Learn more at unitedbiosource.com

cww| trial results |

CardiovascularGenzyme and ISIS reported positiveresults from a phase III study ofmipomersen for the treatment of het-erozygous familial hypercholes-terolemia (heFH). This NorthAmerican, randomized, double-blind,placebo-controlled study enrolled 124subjects with heFH, pre-existing coro-nary artery disease and LDL-C levelsgreater than 100mg/dL. The subjectsreceived a 200mg dose of mipomersenor placebo weekly for 26 weeks. Theprimary endpoint was reached, with ahighly statistically significant 28% re-duction in LDL-cholesterol after 26weeks of treatment, compared with anincrease of 5% for placebo. Forty-fivepercent of the mipomersen-treatedgroup achieved LDL-C levels of lessthan 100mg/dL. The trial also meteach of its three secondary endpointswith statistically significant reductionsin apo-B, total cholesterol, and nonHDL-cholesterol. Mipomersen waswell tolerated. The companies plan tofile for U.S. and European approval inthe first half of 2011.

GastroenterologyOptimer issued positive results from aphase III trial of fidaxomicin for thetreatment of Clostridium difficile. Thisdouble-blind, randomized, parallelgroup trial enrolled 535 adult subjectswith confirmed infection across NorthAmerica and Europe. The subjects re-ceived either fidaxomicin (200mgevery 12 hours) or oral vancomycin

(125mg every six hours) for a 10-daycourse of therapy. The trial met theprimary endpoint of non-inferioritywith 91.7% of subjects treated with fi-daxomicin achieving clinical curecompared with 90.6% for Vancocin.Fidaxomicin also resulted in signifi-cantly lower recurrence rates: 12.8%compared with 25.3% for the Van-cocin arm (p = 0.002) and higherglobal cure rates, defined as cure withno recurrence within four weeks ofcompleting therapy: 79.6% comparedwith 65.5%, respectively (p < 0.001).Fidaxomicin was well tolerated in thestudy. Optimer plans to file an NDAwith the FDA in the second half of2010.

NeurologyCara Therapeutics released positiveresults from a phase II trial of CR845for the treatment of post-operativepain. This U.S.-based, double-blind,placebo-controlled trial enrolled 46 fe-male subjects who had undergone la-paroscopic-assisted hysterectomy. Thesubjects received a single intravenousinfusion of 0.040mg/kg CR845 orplacebo following surgery and uponreporting a moderate-to-severe painintensity level of 5 to 8 on a 0 to 10pain scale. Significant pain reliefwas observed in CR845-treated armover placebo from four to eight hourspost-drug administration, as demostrated by a significant change in painintensity difference scores (p<0.05).In addition, CR845-treated subjectsrequired 32% less morphine than

placebo-treated patients over the 16hours post-drug administration(p<0.05). This morphine-sparingeffect was accompanied by a substan-tial decrease in the incidence of side ef-fects often associated with morphineuse, including an absence of vomitingand a 72% reduction in nausea(p<0.05). CR845 was safe and welltolerated. Cara plans to move forwardwith the development of CR845.

OncologyAmgen reported positive results froma phase III study of denosumab forbone metastases resulting fromprostate cancer. This international,head-to-head, randomized, doubleblind study enrolled 1,901 men withbone metastases from hormone-re-fractory prostate cancer. The subjectsreceived either 120mg of denosumabsubcutaneously every four weeks or4mg Zometa (standard of care) intra-venously as a 15-minute infusionevery four weeks. The primary enpoint was to determine if denosumabis non-inferior to Zometa with respectto the first on-study skeletal-relatedevent (SRE). The composite endpointof four SREs—fracture, radiation tobone, surgery to bone, and spinal cordcompression—was used to measurethe effectiveness of denosumab versusZometa. Denosumab demonstratedsuperiority over Zometa for both de-laying the time to the first on-studySRE and reducing the rate of multipleSREs. Overall rates of adverse eventsand serious adverse events, including

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infections, were generally similar be-tween the two arms. Amgen plans tofile for regulatory approval bythe end of 2010.

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Ernst & Young previously predictedpharma’s acquisition tastes in 2010would run toward international firms,particularly those that provide a toe-hold in emerging markets, and playersin the fragmented branded genericsspace, which is ripe for consolidation.Cephalon’s $590-million purchase ofMepha blends both flavors. Geo-graphically, Frazer, Pa.-basedCephalon boasts strong ex-U.S. salescapabilities in France, the UK, Ger-many, Italy and Spain. MeanwhileAesch, Switzerland-based Mepha isstrongest in Switzerland, the MiddleEast and Africa, Portugal, Poland andUkraine. The two firms have little ge-ographic overlap, which Cephalon ex-ecutives said contributed to theirability to win the “very competitive”bidding for Mepha’s business. TheMepha acquisition “fundamentallydoubles” Cephalon’s presence in Eu-rope and provides new distributionchannels in Eastern Europe and south-east Africa, Cephalon chairman andCEO Frank Baldino said during a con-ference call. The combined companywill have 3,500 employees sellingproducts in 100 countries, and about30% of its sales will come from ex-U.S. sources, Baldino noted.

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In the process of raising its third majorventure round, Pearl Therapeuticspulled in an early $15 million in fund-ing to push its lead program, an in-haled bronchodilator combination forchronic obstructive pulmonary dis-ease, into phase IIb testing next quar-ter. Existing investors Clarus Ventures,New Leaf Venture Partners and 5AMVentures agreed to a convertible loanfacility set to convert to equity in thebiotech at the time of a Series C fi-nancing. Pearl anticipates closing onthe $40-million round in the thirdquarter, which should “take usthrough our phase IIb trials and to thebeginning of phase III” with PT003,

said Perry Karsen, president and CEO.At that time, the company will reviewits options for moving forward, in-cluding the possibility of partnering orseeking an initial public offering.

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Spectrum Pharmaceuticals entered aco-development and commercializa-tion agreement with Copenhagen,Denmark-based TopoTarget for beli-nostat, a histone deacetylase (HDAC)inhibitor, a deal worth a potential$350 million plus royalties on any netsales. Under the terms, Spectrum li-censed the rights to belinostat forNorth America and India, and an op-tion for China, in exchange for an up-front cash payment of $30 million,potential milestone payments of up to$320 million, and 1 million shares ofSpectrum common stock based onachieving certain milestones. Spectrumand TopoTarget will jointly fund de-velopment activities, with 70% of clin-ical trial costs to be taken on bySpectrum, and 30% by TopoTargetfor new trials to be initiated.

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VaxGen’s shareholders shot down aproposed merger with Oxigene—just like a proposed merger withRaven Biotechnologies two years ago.Oxigene was hoping to get VaxGen’s$33 million in cash for the bargainprice of $22 million. With lead drugZybrestat (fosbretabulin) in a pivotalthyroid cancer trial and midstagetrials for lung and ovarian cancers,Oxigene needed money. Last fall,when the merger was first announced,CEO Peter Langecker said Oxigene“could not raise this amount of capitalin a single transaction and at theseterms in today’s market.” And Vax-Gen had no use for its cash: Thebiotech imploded after its AIDSvaccine failed two phase III trials andan $877.5-million governmentcontract for an anthrax vaccine fellapart. Oxigene said that while it was“disappointed” the merger didn’t

go through, the biotech has otheroptions.

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Apeiron Biologics licensed its leadprogram APN01, a recombinant formof human angiotensin convertingenzyme 2 (ACE2), to London-basedGlaxoSmithKline in a deal valuedat up to €236 million (US$329.4million). That figure includes an initialpayment of €13.5 million, whichconsists of an upfront payment and anequity investment in the Vienna, Aus-tria-based firm, as well as milestonepayments. The company also wouldreceive double-digit royalties on even-tual product sales. Apeiron completedthe deal without any venture capitalinvestment, having raised almost €7million from founders, friendsand angel investors.

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