Medivation ($MDVN) won FDA approval for MDV3100, setting up the quick commercialization of another prostate cancer drug that will further change an already roiled cancer market. The drug, later dubbed enzalutamide and now called Xtandi, won an OK a full three months ahead of the agency's PDUFA date. Astellas is partnered on the program.
A number of analysts have projected peak sales at $1 billion to $2 billion, making this compound a likely blockbuster. In a call with investors Friday afternoon, CEO David Hung said the drug will cost $7,450 a month, or about $90,000 for a full year. Medivation will co-promote the drug with Astellas, with 150 reps from both companies making the treatment available in mid-September.
Medivation's stock, already swelled by the prospect of an approval, shot up another 8% Friday on the news. And some analysts believe it should go higher than that as Medivation expands Xtandi's approved reach to all patients who don't respond to hormone therapy.
"The need for additional treatment options for advanced prostate cancer continues to be important for patients," said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."
Like Zytiga ahead of it, MDV3100 is approved for post-chemo, castration-resistant patients. But look for the company to aggressively push upstream, to the same pre-chemo market that J&J ($JNJ) has in mind for Zytiga.
Both Zytiga and MDV3100 are designed to do the same thing: remove the fuel for the disease from the equation. But they do it in different ways. Zytiga inhibits an enzyme needed for the production of testosterone; MDV3100 blocks the androgen receptor to prevent cancer cells from reacting to testosterone.
Just days ago Medivation added another set of stellar late-stage data on MDV3100. New Phase III results published in the New England Journal of Medicine indicated that advanced stage, therapy-resistant patients in the drug arm survived 5 months longer than the control group, making this one of the easiest approval calls in the business this year.
The success of J&J and now Medivation has clipped the wings of Dendreon's ($DNDN) Provenge, a groundbreaking but complex prostate cancer therapy that has floundered with the addition of competing oral treatments.
The approval marks a big milestone in the turnaround of Medivation, a biotech company which had been humiliated by the abject failure of its Alzheimer's drug Dimebon, then partnered with Pfizer. Medivation quickly shifted focus to its hopes for MDV3100, or Xtandi, and the approval represents a vindication of sorts for a company that operated under a cloud for some time.
As a post-marketing requirement, Medivation and Astellas noted that they have agreed with the FDA to conduct an open-label safety study of Xtandi--160 mg/day--in patients who are at high risk for seizure, one of the safety issues spotted in studies. Medivation and Astellas agreed to provide the data from this study in 2019.
- here's the press release from the FDA
- and the release from Medivation
- here's the AP report
- get the New York Times report
Special Report: Enzalutamide (formerly MDV3100) – Top 10 Late-Stage Cancer Drugs – 2012