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Celgene’s Orphan Drug Pomalidomide For Multiple Myeloma

December 14, 2012

At the December 8 – 11, 2012, Annual American Society of Hematology (ASH) Meeting, in Atlanta, Georgia, Celgene presents data for orphan drug Pomalidomide for the treatment of Multiple Myeloma (MM). The data Celgene presents on Pomalidomide + Low-dose Dexamethasone from a Phase III Study, improves overall survival, progression-free survival, and overall response rate among very sick patients who failed either Revlimid or Velcade :

  1. Median progression-free survival (PFS) of 3.6 months for patients on Pomalidomide and low-dose dexamethasone compared with 1.8 months in a high-dose dexamethasone arm
  2. “High statistically significant improvement in overall survival (OS) that crossed the upper boundary for superiority”
  3. Overall response rate was 21% compared with 3% in the control arm.

Bloomberg reports that Pomalidomide “may draw > $1 billion in annual revenue by 2017, according to the average of 4 analysts’ estimates”.

Multiple Myeloma Market

  1. Takeda’s orphan drug Velcade has 60% share of the MM market in 1st-line therapy & > 50% as a 2nd-line therapy
  2. Celgene’s orphan drug Revlimid is market leader with > 50% market share in front-line use
  3. Onyx Pharmaceuticals’ orphan drug Kyprolis for Multiple Myeloma receives FDA approval in July 2012.

Catalysts

  1. FDA PDUFA date of February 10, 2013
  2. European regulators are to decide in 2nd half of 2013, after filing a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in May 2012.

References

Bloomberg.com December 11, 2012 article titled, ”Celgene’s Pomalidomide Helps in Myeloma after others fail”

Celgene December 11, 2012 Press Release

Celgene Product Pipeline

FierceBiotech.com December 11, 2012 article titled, “ASH: Celgene buoyed by promising data for blockbuster hopeful Pomalidomide”

OncLive.com December 10, 2012 article titled, “Pomalidomide Labeled an Advance in Multiple Myeloma”

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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