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The company, which has lost significant revenue in recent years due to high generic competition in the pharmacology market (especially its cholesterol lowering drugs like Lipitor and several others), is relying heavily on its experimental breast cancer therapy palbociclib to regenerate the revenue.
Ian Read, the Chief Executive Officer of Pfizer, said in an interview that he is looking forward to “ big data readouts” for the drug. Prior to the current phase II trial, a preliminary phase II trial of palbociclib revealed positive results, according to a Pfizer press release from April, 2013:
“The Breakthrough Therapy designation was based on preliminary Phase 2 data in this patient population. Interim data presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium showed that women treated with the combination of palbociclib plus letrozole achieved a statistically significant improvement in median progression free survival (PFS) compared to women who received letrozole alone (26.1 months and 7.5 months, respectively).”
The fact that the FDA has given palbociclib the Breakthrough Therapy designation is significant in that it demonstrates that the drug shows strong signs of effectiveness, warranting fast-track approval.
Analysts and experts are confident that the breast cancer drug has the potential to generate more than $3 billion in revenues if the drug performs well in trials and gets approval from the FDA. Since the results of phase 2 clinical trials are expected shortly, the higher management of Pfizer is already planning to speak to Food and Drug Administration in order to seek drug approval for palbociclib.