Building on a strong foundation

ICON selected as a preferred provider for early-phase clinical development by Bristol-Myers Squibb

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DUBLIN—Building on an existingstrategic partnership for global clinical development, Bristol-MyersSquibb Co. (BMS) has chosen ICON PLC, a Dublin-based global providerof outsourced development services to the pharmaceutical,biotechnology and medical device industries, as a preferred providerfor full-service clinical pharmacology and exploratory clinicalstudies.

In June 2010, BMS announced the signingof agreements with ICON and PAREXEL International, as two leading providersof clinical development services, for joint strategic, operationaland capability support of the company's clinical developmentprogram.
Under the agreements, ICON and PAREXELwere to provide global support for the execution of BMS's clinicalstudies to support its full development pipeline over the followingthree years.

"These partnerships will increase theoperational capability of our clinical development organization, andsupport our industry-leading position in productivity andinnovation," said Brian Daniels, senior vice president of globaldevelopment for BMS at the time. "Working with ICON and PAREXEL,two leaders in clinical research, Bristol-Myers Squibb will enhancesupport for our robust pipeline and improve our ability to deliverinnovative medicines to patients with serious disease."

Under this latest agreement with BMS,for preferred-provider status that adds early-phase development tothe mix, ICON will provide a broad range of clinical pharmacology andexploratory clinical trial services, including study conduct inICON's Clinical Pharmacology Units located in San Antonio, Texas;Omaha, Neb.; and Manchester, United Kingdom. ICON will also provideall supporting scientific services, such as protocol design anddevelopment, project management, clinical monitoring, medicalmonitoring/pharmacovigilance, data management, biostatistics,pharmacokinetics and medical writing.

There is a fairly direct line from theprevious agreement to the current one, Mario L. Rocci Jr., presidentof ICON Development Solutions, tells ddn.

"As often is the case, ICON'sperformance in the Phase II to III and central lab partnershipscertainly helped pave the way for our early-phase partnership. It'sa testament to the fundamental principle that if you do a good jobfor a client at a good price you will earn more business from them,"Rocci says.

The combination of agreements is goodfor ICON's short-term and long-term goals, Rocci notes, adding that"ICON is well-positioned for the strategic partnership model manypharmaceutical companies are seeking as they respond to the growingpressure to reduce development timelines and decrease overalldevelopment costs. This award is a very important indication thatICON's full-service clinical platform spanning the developmentcontinuum is in line with what sponsors are looking for in astrategic partner. Performing the clinical development of BMScompounds from early phase through late phase will put the BMS/ICONrelationship in a unique position for fully realizing efficienciesand leveraging expertise."

Previous to the early-phase preferredprovider relationship status, ICON did a small amount of clinicalpharmacology support for BMS, Rocci says, but this new addition totheir work together " provides both BMS and ICON with continuity inthe development of a compound from early through late stage."

He also noted, in the officialstatement about the deal, that "we look forward to demonstratingthe same value and efficiencies to BMS's early-phase clinicalprograms. Our global network of clinical research units, scientistsand project teams, underpinned by world-class technology, will drivesignificant cost savings and productivity."
ICON specializes in the strategicdevelopment, management and analysis of programs that supportclinical development from compound selection to Phase I through IVclinical studies, and the company currently has approximately 7,800employees, operating from 77 locations in 39 countries.

The preferred status conferred by BMSfollows news of another relationship announced in late May of thisyear, when ICON launched a strategic partnership with Pfizer Inc.that will see ICON serve as one of two preferred providers ofclinical trial implementation services for Pfizer.

That partnership was touted as beingpart of Pfizer's comprehensive program of change in research anddevelopment "to sharpen research focus, deliver differentiatedinnovation, and create a more flexible cost base through externalpartnerships for certain R&D services."

Intended to be fully implemented overan 18- to 24-month period, the partnership will reportedly enablePfizer to focus internally on its core capability in clinical trialdesign, while leveraging the strengths and scale of ICON to implementclinical development programs with greater efficiency and rigor.

Under that partnership agreement,Pfizer retains scientific ownership of the clinical developmentprocess and maintains strict oversight and quality standards relatingto patient safety and regulatory compliance. Pfizer is leveragingICON's expertise in the areas of program initiation and management;site and country feasibility; data management and reporting set-up;program study drug logistics; scientific and medical communications;and quality assurance.

ICON reports $310M in new businessfor Q2

DUBLIN, Ireland—ICON PLC recentlyreported that net revenue for the second quarter was $233 million, anincrease of 4.2 percent on the prior year. Year-to-date, net revenueswere $462 million, representing a 4.4 percent increase over the sameperiod last year.
Income from operations was $15.5million, or 6.7 percent of revenue, compared to $25.7 million, or11.5 percent, for the same quarter last year. Net income was $13million, or 21 cents per share on a diluted basis, compared with$22.9 million, or 38 cents per share, last year.

Year-to-date income from operations was$31.5 million before restructuring charges, compared to $52.5 millionlast year, representing a margin of 6.8 percent in 2011 and a marginof 11.8 percent in 2010. Net income was $25.9 million, or 42 centsper share before restructuring charges, compared with $45 million, or74 cents per share, last year.
"Our second quarter was in line withour guidance, and new business bookings continued to strengthen,leading to our order backlog exceeding $2 billion for the firsttime," said CEO Peter Gray in an earnings release. "Theinvestments we have been making in developing the business areprogressing satisfactorily."

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