At this stage, we are more interested in Ariad’s (ARIA) product pipeline than in the financial results of an era where the firm will soon move from a development-stage to a revenue-generating biotech company. Our logic could be the same as that, which led Harvey J. Berger, M.D., chairman and chief executive officer of the firm to begin his financial results’ announcement by writing about the outstanding progress the firm has made towards advancing its pipeline of cancer-drug candidates. The man wrote about the firm’s expectations about the near-term drivers of shareholder value. He wrote about interim data that will be presented later this year on ponatinib trial. More important and impacting is that Merck, the firm’s partner on ridaforolimus has already filed for regulatory approval of the cancer drug with the European Medicines Agency in the European Union, and the firm’s expectation that Merck will submit a new drug application in the U.S. shortly. Another drug, AP26113, will also begin clinical development this quarter.
If approved, ARIAD believes that oral ridaforolimus, an investigational mTOR inhibitor, would be the first molecularly targeted drug for the treatment of patients with metastatic sarcomas and the first sarcoma drug to be approved for use in the maintenance setting. Ariad will get $25 million milestone payment from Merck. Approval of ridaforolimus in the U.S. will secure a $25 million milestone payment and the approval to sell ridaforolimus, including pricing approval, in the European Union will secure a $10 million milestone payment.
Results from Phase 3 SUCCEED trial of oral ridaforolimus in patients with metastatic soft-tissue and bone sarcomas achieved its primary endpoint of a significant improvement in progression-free survival compared to placebo, with an approximately thirty-percent reduction in the risk of progression due to ridaforolimus. A positive trend favoring ridaforolimus has been demonstrated in an interim analysis of the secondary endpoint of overall survival.
With regard to ponatinib, patient enrollment is nearly complete in the pivotal Phase 2 PACE trial. The global PACE trial is being conducted in patients with chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant or intolerant to either of the second-generation CML therapies, or those who have the T315I mutation of BCR-ABL for which no current treatments are known to be effective.
ARIAD expects to file for regulatory approval of ponatinib in the middle of next year, providing the potential for U.S. marketing authorization by the end of 2012.
There is more in the company’s press release, but we are satisfied with the above. To read the whole announcement Click on: READ, or Read it on Ariad's Website.