ARIAD Pharmaceuticals' SUCCEED trial of oral ridaforolimus on track

Nov 5 2009

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter and nine months ended September 30, 2009 and provided an update on corporate developments.

SUCCEED Trial Full Enrollment Expected at Year-End

ARIAD reaffirmed that the global, Phase 3 SUCCEED trial of oral ridaforolimus in patients with metastatic soft tissue and bone sarcomas remains on track for full enrollment around year-end 2009.

The independent Data Monitoring Committee (DMC) of the SUCCEED trial completed the first interim efficacy analysis as specified by the study protocol in September of this year and recommended that this randomized, placebo-controlled trial continue to full patient enrollment and completion. The DMC made this recommendation after reviewing the pre-specified statistical analyses and available data on the safety and efficacy of oral ridaforolimus. The DMC indicated that the safety data from the first interim analysis are consistent with the known safety profile of ridaforolimus, and no modifications to the study protocol were recommended.

The report of the second interim efficacy analysis, which will be based on approximately two-thirds of the total number of progression-free survival (PFS) events in the trial, is expected around the end of the first quarter of 2010, as previously announced. The final analysis of all PFS events is expected at approximately the end of the third quarter of 2010. The complete SUCCEED trial is 90 percent powered to show a 33 percent improvement in median PFS comparing the drug-treated and placebo arms of the trial.

“The recommendation by the DMC to continue the SUCCEED trial to completion was an important step in the development of oral ridaforolimus as a potential new treatment option for patients with metastatic sarcomas, and we are very pleased to be on schedule for full enrollment around the end of the year,” stated Harvey J. Berger, M.D. chairman and chief executive officer of ARIAD.

AP24534 Clinical Data to be Presented at ASH

Leading cancer investigators will present Phase 1 clinical proof-of-concept data on ARIAD’s investigational, pan-BCR-ABL inhibitor, AP24534, in patients with drug-resistant and refractory chronic myeloid leukemia (CML) and other hematological cancers at the upcoming American Society of Hematology annual meeting in December. Preliminary trial results on AP24534 that were announced earlier this quarter provide initial clinical evidence of hematologic, cytogenetic and molecular responses and anti-cancer activity of AP24534 in heavily pretreated patients with resistant and refractory CML and Philadelphia-positive acute lymphoblastic leukemia, including those with the T315I mutant variant of the target protein, BCR-ABL.

More than 40 patients have been enrolled in the trial to date at five medical centers in the United States. All CML patients have been previously treated with the currently available first- and second-generation targeted therapies for CML and, in most instances, other investigational agents as well. Pending further analysis of the results of this trial and discussions with regulatory authorities, ARIAD believes that it will be able to proceed to a registration trial of this product candidate in 2010.

Other Development Progress

In addition to the SUCCEED trial, ARIAD and its ridaforolimus partner, Merck & Co., Inc., are making steady progress in other clinical trials, including:

• Complete enrollment in the Phase 2 clinical trial of oral ridaforolimus in combination with trastuzumab (Herceptin^®) in patients with Her-2 positive, resistant and refractory metastatic breast cancer. Preliminary data from this study were announced earlier this quarter, and updated findings will be presented at the San Antonio Breast Cancer Symposium in December.
• Continuing Phase 2 clinical trials of oral ridaforolimus in patients with advanced endometrial, prostate and non-small cell lung cancers.
• Continuing enrollment in the Phase 1 study of MK-0646, Merck’s IGF-1R human monoclonal antibody, in combination with oral ridaforolimus.

Financial Highlights

For the quarter ended September 30, 2009, ARIAD reported a net loss of $20.8 million, or $0.21 per share, compared to a net loss of $20.0 million, or $0.29 per share, for the same period in 2008. For the nine-month period ended September 30, 2009, ARIAD reported a net loss of $62.0 million, or $0.70 per share, compared to a net loss of $54.3 million, or $0.78 per share for the nine-month period ended September 30, 2008.

These results reflect increases in research and development expenses in 2009 compared to 2008 due to the continued advancement of ARIAD’s development programs for its lead investigational product candidates, ridaforolimus and AP24534, as well as non-cash charges related to revaluation of ARIAD’s warrant liability. These increases and non-cash charges were offset in large part by decreases in general and administrative expenses in 2009 compared to 2008, due to reduction in activities and costs related to corporate and commercial development initiatives and patent litigation.

On August 7, 2009, ARIAD raised net proceeds of $35.6 million in an underwritten offering of 21.85 million shares of its common stock. The purchase price in this offering was $1.75 per share. This offering, along with ARIAD’s offering in February 2009, has resulted in a total of $58.4 million of funding raised this year to support its product development progress.

For the nine-month period ended September 30, 2009, cash used in operations was $36.0 million, compared to $36.4 million for the same period in 2008. ARIAD ended the third quarter of 2009 with cash, cash equivalents and marketable securities of $57.5 million, compared to $39.1 million at December 31, 2008.

Source ARIAD