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Pharmion (PHRM) announced FDA approval yesterday for its NDA supplement to add intravenous [IV] use as a new route of administration to the instructions in the approved prescribing information for its DNA demethylating agent Vidaza. In May 2004, Vidaza became the first drug approved by the FDA for the treatment of patients with Myelodysplastic Syndromes [MDS] a serious cancer like blood disorder. The FDA approved Vidaza, the first in a new class of drugs called demethylation agents, for treatment of all five MDS subtypes, which include both low-risk and high-risk patients. MDS are a group of diseases in which the blood cells produced by the bone marrow is disrupted. As compared to leukemia’s where the white cells are produced in extremely large quantities.

According to the press release issued yesterday:

“With IV administration, the dosing for Vidaza remains the same as the previously approved subcutaneous [SC] administration at 75 mg/m2 daily, for seven days, every four weeks. Since this approval is for an alternative administration of the existing formulation, Pharmion will begin promoting this IV route of administration immediately.”

The stock rose almost 5% on the news and it at its 52 week high.

PHRM 1-yr chart
PHRM

As I reported earlier, there are a significant number of catalysts for PHRM expected in 2007 and even though the valuation is high at present, these events should move the stock even higher in 2007. The catalysts expected in 2007 are repeated below.

  • The filing in Europe for Satraplatin for hormone refractory prostate cancer [HRPC]
  • The filing in Europe for Vidaza for the treatment of high-risk myelodysplastic syndromes [MDS]
  • Data from the randomized controlled Phase 3 survival study for Vidaza in high-risk MDS, which is expected to be complete in the third quarter of 2007
  • Phase 3 Satraplatin survival data in HRPC
  • Phase 2 Amrubicin data in small cell lung cancer [SCLC]
  • Oral Vidaza bioavailability data
  • Phase 2 MGCD0103 data in a variety of indications
  • Initiation of a pivotal registration trial for MGCD0103 in a hematologic malignancy
  • Initiation of a pivotal registration trial for Amrubicin in second-line SCLC
  • Disclosure: Author has no position in PHRM.

    Source: Pharmion's New Vidaza Approval Sends Stock Soaring