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Dendreon Corporation (DNDN)

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Dendreon Corporation is focused on research, development and commercialization of cancer immunotherapies.

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Company Analysis

Seattle, WA based Dendreon is focused on the discovery, development and commercialization of therapies that trigger the human immune system to fight cancer. The company's most advanced product candidate is Provenge (Sipuleucel-T), which received favorable review from an Food and Drug Administration (FDA) panel on March 29, 2007.[1] FDA approval for Provenge is expected in May 2007.

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Product Pipeline

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Provenge (Sipuleucel-T)

Provenge works by targetting the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers.[2]

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FDA Review Progress on Provenge

* On March 29, 2007, an FDA advisory panel voted in favor of Provenge, despite the vaccine missing endpoints in trials. On two Phase III clinical trials, study D9901 and study D9902A, Provenge missed all primary and secondary endpoints of slowing tumor growth, disease progression and related pain.[3] However the drug has been shown to be safe and prolongs patient survival by an average of 4.5 months. Full FDA approval is expected by May 15, 2007. [4]
* On April 16, 2007, A letter from Dr. Howard Scher, a member of the FDA panel that reviewed Provenge, to the FDA was published in "The Cancer Letter," a weekly oncology paper. The letter reiterated Dr. Scher's position against recommending Provenge approval based on the available data and outlined his concerns about the drug and the panel review and voting process. Dr. Scher was one of the four doctors that voted against recommending approving Provenge on the March 29 review. Excerpt of the letter can be found here.
* On May 9, 2007, the FDA decided not to approve the drug yet, instead issuing an "approvable letter" and asking for additional data in support of its efficacy claim. It also requested more information about chemistry, manufacturing and controls. [5] The sahre price plunged by about 60% following the news to open at $7.20 on May 9, 2007.
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Lapuleucel-T

Lapuleucel-T, also known as Neuvenge works by targetting Her2/neu positive cancers. HER2/neu is a growth factor receptor, and its overexpression has been associated with a number of cancers including breast, ovarian, colon and lung cancers.[6] The drug is currently in Phase I development.

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Other Candidates in pre-Clinical Stages

  • Trp-p8, to treat Prostate, breast lung and colon cancers
  • Carcinoembryonic Antigen (“CEA”), to treat lung, colon and breast cancers. Licensed from Bayer Corporation, Business Group Diagnostics.
  • Carbonic Anhydrase 9 Antigen (“CA-9”), to treat cervical, colon an drenal cancers. Also was licensed from Bayer.
  • Anti-Serine Protease Monoclonal Antibodies to treat various cancers

Source: Form 10-K for the period ending on 12/31/2006, filed on 3/14/2007


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Leadership

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Management

  • Mitchell H. Gold, M.D.: President and Chief Executive Officer
  • David L. Urdal, Ph.D.: Senior Vice President and Chief Scientific Officer
  • Rick Hamm : Senior Vice President, Corporate Development, General Counsel and Secretary
  • Gregory T. Schiffman : Senior Vice President, Chief Financial Officer
  • James V. Caggiano : Vice President, Sales & Marketing
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Board of Directors

  • Susan B. Bayh, J.D.
  • Richard B. Brewer : Chairman
  • Gerardo Canet Chairman, IntegraMed America, Inc.
  • Bogdan Dziurzynski, Ph.D. Consultant in Regulatory Affairs
  • Mitchell H. Gold, M.D. Dendreon Corporation
  • M. Blake Ingle, Ph.D. General Partner, Inglewood Ventures
  • Ruth B. Kunath
  • David L. Urdal, Ph.D. Dendreon Corporation
  • Douglas Watson Pittencrieff Glenn Associates
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News Feed

12/03/08 8:12 am FibroGen hires first chief medical officer (at bizjournals.com)
12/03/08 3:12 am Short Interests in Pfizer and Dendreon Decline - Is Bearish Sentiment Dissipating? (at Seeking Alpha)
12/02/08 11:12 am Another "Short" Story About Pfizer & Dendreon (at CNBC)
12/02/08 3:12 am Nine Pharma Predictions for 2009 (at Seeking Alpha)
12/01/08 2:12 pm Predictions: 9 For '09 In Pharma (at CNBC)
11/27/08 3:11 am Johnson & Johnson Is the Latest FDA Casualty (at Seeking Alpha)
11/26/08 11:11 am Johnson & Johnson Is Latest FDA Casualty (at CNBC)
11/23/08 10:11 am New Emerging Biotech and Pharma Company Index (at Seeking Alpha)
11/21/08 3:11 pm Pharmaceuticals Industry (Zacks.com)
11/19/08 11:11 am Don't Send Your Kids to College (at TheStreet.com)
More News...
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Risks

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Research Links

Blogs
Dendreon Corporation Snapshot
Dendreon Corporation Leadership
Dendreon Corporation Fundamentals
Dendreon Corporation Technical Analysis
Dendreon Corporation Message Boards
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Options

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Notes

  1. ↑ "Dendreon Announces FDA Advisory Committee Reviewed Provenge® for Hormone Refractory Prostate Cancer, Committee Recognizes Substantial Evidence of Efficacy and Safety in this Patient Population," Dendreon company press release, March 29, 2007. Accessed on March 30, 2007.
  2. ↑ Sipuleucel-T product page from denderon.com
  3. ↑ Jacobs, M, "Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints," seekingalpha, March 28, 2007. Accessed on march 30, 2007
  4. ↑ "FDA Panel Favors Dendreon's "Provenge" Cancer Vaccine," seekingalpha, Mar 30th, 2007. Accessed on march 30, 2007.
  5. ↑ Hischler, B., "Dendreon shares plunge on cancer drug blow," Reuters, May 9, 2007. Accessed May 9, 2007.
  6. ↑ Lapuleucel-T product page from denderon.com
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