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Biotech / Medical : Protein Design Labs (PDLI): Stock strong -- Ignore unavailable to you. Want to Upgrade?

To: idos who wrote (372)	8/28/2007 4:09:29 PM
From: tuck	Read Replies (2) \| Respond to of 407

>>PDL BioPharma Announces Significant Strategic and Portfolio Changes to Focus on Antibody Discovery and Development Tuesday August 28, 4:05 pm ET - Company Plans Sale of Commercial Operations - - Nuvion(R) Pivotal Trial Program Terminated - - Company Plans Organizational Realignment - FREMONT, Calif., Aug. 28 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI - News) today announced a significant strategic change to focus the company on the discovery and development of novel antibodies in oncology and select immunological diseases, following a months-long business and portfolio review. As a result of this new strategic focus, which does not include cardiovascular disease, PDL plans to sell its commercial assets, including its Cardene®, Retavase® and IV Busulfex® products, as well as the ularitide development-stage cardiovascular product. Separately, following a recent and routine Data Monitoring Committee (DMC) evaluation of data from the ongoing RESTORE 1 pivotal trial, the company has decided to terminate the Nuvion (visilizumab) phase 3 program in ulcerative colitis due to insufficient efficacy and an inferior safety profile in the visilizumab arm compared to IV steroids alone. In light of these developments, the company will realign its organization this Fall to support its new strategy. The company will hold a conference call on Tuesday, August 28th at 5:15 pm ET to discuss these decisions and respond to questions. A webcast of the conference call will be available through the PDL website: pdl.com. "We believe our planned strategic shift, which leverages our core technical strengths and expertise in monoclonal antibodies as a development-stage company, is in the best long-term interests of our stockholders," said L. Patrick Gage, Ph.D., executive chairman of PDL's board of directors. "Although we're surprised and disappointed by the Nuvion results in IVSR-UC, we're fortunate to have a portfolio of multiple candidates consistent with our longer-term focus in the targeted areas of oncology and immunology, 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 program of 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 1 trial at the 45-day primary endpoint. The analysis showed insufficient efficacy and an inferior safety profile in the visilizumab arm compared to IV steroids alone. The company is currently reviewing whether to continue the ongoing dose-ranging trial while it thoroughly evaluates the broader implications 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 deep clinical and pre-clinical portfolio, and leverage its ability to innovate in the science and development of monoclonal antibodies. PDL will focus its research and development initiatives and strengthen its expertise in two therapeutic 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 several additional research stage candidates. PDL's immunological programs include daclizumab in multiple sclerosis and other indications, visilizumab in various potential indications and several preclinical candidates. The company is planning a research and development update in mid-November to detail the status of its R&D initiatives. Based primarily on its strategic shift to focus on discovery and development of antibodies in oncology and select immunological diseases, PDL is conducting a thorough review of its organization, and anticipates a sizeable workforce reduction, to ensure that its structure and scope of operations are appropriately aligned with the new strategy. Planned Sale of Commercial Operations Given the change in strategic direction of the company and current timing of its pipeline, the company has determined that its commercial products and cardiovascular development programs are no longer a strategic fit. As a result, the company has engaged Merrill Lynch & Co. to advise it on the sale of the rights to Cardene, Retavase, IV Busulfex and ularitide, and related assets, in one or more transactions. The company is seeking to retain staff in approximately 250 positions that support its commercial and cardiovascular products through the completion of the planned sale(s), but expects to eliminate these positions in connection with the sales of the company's commercial assets, which would be in addition to the workforce reduction anticipated in connection with aligning the organization to the company's new strategy. PDL has not finalized its plans for the optimal use of proceeds from the sale of these assets, but will provide updates on these and other financial options at the appropriate time. The company anticipates that its earnings will be significantly reduced in the near term following the sale of the marketed products, which generated $187.2 million in revenues in the 12 months ended June 30, 2007. Given the uncertain timing of and charges related to the planned transaction(s) and overall realignment, the company has suspended its financial guidance for 2007. "Our marketed products have been an important component of the financial value of PDL, but they simply no longer fit with our new direction and timeline for commercialization of our internal development products. These products, and our valued employees who have supported them, have contributed to the company's revenue and cash flow growth in recent years," said Mark McDade, PDL's chief executive officer. "We believe we have created significant value in these important products and the supporting operations, and we're now looking for the right buyer that can build upon this value that has been created by PDL, while we move forward with implementation of our new strategic direction."<< snip Off a bit so far AH. Not sure if the Nuvion news has been expected. Cheers, Tuck

To: idos who wrote (372)	8/29/2007 4:04:40 PM
From: tuck	Read Replies (1) \| Respond to of 407

Drama continues, actually: >>Third Point Demands that L. Patrick Gage Resign Immediately as Chairman and Member of PDL's Board of Directors and that Management and the Board Focus on the Prompt Sale of the Company Wednesday August 29, 3:48 pm ET NEW YORK, Aug. 29 /PRNewswire-FirstCall/ -- In a letter sent today to the Board of Directors of PDL BioPharma, Inc. (Nasdaq: PDLI - News), Third Point demanded that L. Patrick Gage immediately resign as Chairman and Member of the Board of Directors and that Management and the Board focus on the prompt sale of the company. A copy of the letter appears below: August 29, 2007 Samuel Broder, M.D. Ms. Karen A. Dawes Mr. Bradford S. Goodwin Mr. Joseph Klein III Laurence Jay Korn, Ph.D. Mr. Mark McDade Dr. Richard Murray John S. Saxe, Esq. L. Patrick Gage, Ph.D PDL BioPharma, Inc. 34801 Campus Drive Fremont, CA 94555 PDL Board Members: In the August 28th conference call, PDL BioPharma ("PDL" or the "Company") Chairman, Patrick Gage, sent a confusing and unwelcome message about PDL's strategy. Dr. Gage's message is especially disconcerting because we believe a significant majority of PDL's shareholders and board members share the view that the Company should be sold in its entirety or in pieces and that the entire proceeds should be returned to shareholders. Only eight days before the conference call, the Company announced that the board was continuing its ongoing corporate strategic review in conjunction with Merrill Lynch & Co. While we understand that the announced sale of the Company's commercial operations is simply the first step in exploring the sale of the entire Company, Dr. Gage failed to communicate this clearly. Instead, he gave the impression that repositioning the Company could be an alternative to selling the Company. Dr. Gage's destructive, "go-it-alone" research and development approach (contrary to the wishes of PDL's shareholders) -- combined with his history as chief apologist for Mark McDade's failed strategies and his own spotty record as a Board member at other public companies (witness the poor stock price performance of Neose Technologies, where he is also Chairman, as well as the similarly dismal performance of ArQule during his time on that Board) -- lead us to respectfully request that Dr. Gage step down from his role as Chairman and a member of the Board. We believe that his chances for re-election to the Company's staggered board at the next annual meeting are slim, and his "lame duck" status further impairs his credibility. Although we are mystified as to why it took so long, we view favorably the belated adoption of Third Point's recommendations: that PDL has agreed to sell its specialty pharmaceuticals business, drastically reduce operating and r&d costs, and retain an investment banker to examine all options to maximize value for shareholders. We also acknowledge the resignation of Mark McDade as CEO, which we have also been advocating. We were, however, perplexed as to why he was present on yesterday's conference call, and why he has retained anything more than a consulting role at the Company. A prompt sale of all of PDL, in whole or in pieces, will generate significant value for shareholders. In this regard, while we are of course disappointed by the termination of Phase III trials of Nuvion after 6 years of development -- a failure that underscores the Company's inability to successfully commercialize drugs -- we remain convinced that there is substantial value and interest in the Company's royalty stream, commercial products, manufacturing assets and pipeline of promising drugs, provided they are placed under the management of companies better suited to exploit the assets and successfully develop and commercialize the pipeline. Nuvion was not a major component of our estimated value of PDL, and we continue to believe that PDL's shareholders would realize a substantial premium in a change of control transaction. We reiterate the previous offer of the Third Point nominees to serve on the board, where they can be expected to work constructively with management, other board members and representatives of Merrill Lynch to bring the strategic review to the successful conclusion of maximizing value for all PDL shareholders. Sincerely, Daniel S. Loeb << Cheers, Tuck