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As a result of this new strategic focus, which does not includecardiovascular disease, PDL plans to sell its commercial assets, including itsCardene(R), Retavase(R) and IV Busulfex(R) products, as well as the ularitidedevelopment-stage cardiovascular product. Separately, following a recent androutine Data Monitoring Committee (DMC) evaluation of data from the ongoingRESTORE 1 pivotal trial, the company has decided to terminate the Nuvion(visilizumab) phase 3 program in ulcerative colitis due to insufficientefficacy and an inferior safety profile in the visilizumab arm compared to IVsteroids alone. In light of these developments, the company will realign itsorganization this Fall to support its new strategy.
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The company will hold a conference call on Tuesday, August 28th at 5:15 pmET to discuss these decisions and respond to questions. A webcast of theconference call will be available through the PDL website: http://www.pdl.com.
"We believe our planned strategic shift, which leverages our coretechnical strengths and expertise in monoclonal antibodies as adevelopment-stage company, is in the best long-term interests of ourstockholders," said L. Patrick Gage, Ph.D., executive chairman of PDL's boardof directors. "Although we're surprised and disappointed by the Nuvionresults in IVSR-UC, we're fortunate to have a portfolio of multiple candidatesconsistent with our longer-term focus in the targeted areas of oncology andimmunology, as well as sufficient resources to advance these opportunities."
Nuvion (visilizumab) Pivotal Program Termination
Following review of data communicated by the Nuvion DMC this past Friday,August 24, PDL has decided that it will no longer pursue its phase 3 programof visilizumab in IVSR-UC, including both the RESTORE 1 and RESTORE 2 studies.The DMC interim evaluation included data from 91 patients in the RESTORE 1trial at the 45-day primary endpoint. The analysis showed insufficientefficacy and an inferior safety profile in the visilizumab arm compared to IVsteroids alone. The company is currently reviewing whether to continue theongoing dose-ranging trial while it thoroughly evaluates the broaderimplications of these very recent results to the overall visilizumab program.
New Strategic Direction and Organizational Alignment
PDL has revised its corporate strategy to take advantage of its deepclinical and pre-clinical portfolio, and leverage its ability to innovate inthe science and development of monoclonal antibodies. PDL will focus itsresearch and development initiatives and strengthen its expertise in twotherapeutic areas -- oncology and select immunological diseases. In oncology,the company's programs include volociximab in a number of solid tumors,HuLuc63 in multiple myeloma, PDL 192 in preclinical development and severaladditional research stage candidates. PDL's immunological programs includedaclizumab in multiple sclerosis and other indications, visilizumab in variouspotential indications and several preclinical candidates. The company isplanning a research and development update in mid-November to detail thestatus of its R&D initiatives.
Based primarily on its strategic shift to focus on discovery anddevelopment of antibodies in oncology and select immunological diseases, PDLis conducting a thorough review of its organization, and anticipates asizeable workforce reduction, to ensure that its structure and scope ofoperations are appropriately aligned with the new strategy.
Planned Sale of Commercial Operations
Given the change in strategic direction of the company an
