Key Developments For Ariad Pharmaceuticals, Inc.
Ariad Pharmaceuticals, Inc. (ARIA.O) (Consolidated Issue listed on NASDAQ Global Market)
ARIAD Pharmaceuticals, Inc. Announces Clinical Data From Phase 1 Study Of Investigational mTOR Inhibitor, Ridaforolimus, In Combination with Bevacizumab
ARIAD Pharmaceuticals, Inc. announced that the data from a Phase 1 clinical trial evaluating oral ridaforolimus, its investigational mTOR inhibitor, in combination with bevacizumab (Avastin) in heavily pretreated patients with refractory metastatic solid tumors. The data were presented at the Joint Multidisciplinary Congress of the 15th annual European Cancer Organization (ECCO) and the 34th annual European Society of Medical Oncology (ESMO) taking place in Berlin, Germany. There is preclinical evidence demonstrating that vascular endothelial growth factor (VEGF), the target of bevacizumab, activates the mTOR pathway through binding to VEGF receptors on endothelial cells. In addition, mTOR signaling has been shown to promote angiogenesis, and preclinical studies have demonstrated that ridaforolimus inhibits angiogenesis in addition to its effects on cancer cell growth, proliferation and metabolism. The Phase 1 trial was designed to evaluate the safety and tolerability of the combination of the standard dose of oral ridaforolimus and each of the two approved bevacizumab dosing regimens (infusions every two or three weeks) in patients with metastatic solid tumors. A secondary goal of the Phase 1 trial was to determine clinical anti-tumor activity of this combination using RECIST (Response Evaluation Criteria In Solid Tumors) criteria.
ARIAD Pharmaceuticals, Inc. Announces Result Of First Interim Analysis Of Phase 3 Succeed Trial Of Oral Ridaforolimus
ARIAD Pharmaceuticals, Inc. announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the first interim efficacy analysis as specified by the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas 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 review comprised approximately one-third of the total number of progression-free survival events anticipated in the trial. The safety and efficacy of oral ridaforolimus is being evaluated in patients with metastatic soft-tissue and bone sarcomas who have achieved a favorable response to chemotherapy. The primary end-point of the trial is progression-free survival. The DMC indicated that the safety data from the first interim analysis are consistent with the known safety profile of ridaforolimus and that no modifications to the study protocol are recommended. Over 500 patients with metastatic soft-tissue and bone sarcomas have been enrolled in the trial to date. Full patient enrollment is expected to take place by year-end 2009, and the second interim analysis based on approximately two-thirds of the total number of progression-free survival events is expected by the end of the first quarter of 2010.
Court Of Appeals Grants ARIAD Pharmaceuticals, Inc. And Its Co-Plaintiffs Petition For Rehearing En Banc In Eli Lilly and Company NF-kB Patent Lawsuit
ARIAD Pharmaceuticals, Inc. announced that the U.S. Court of Appeals for the Federal Circuit has granted their petition for rehearingen banc and has vacated its April 2009 decision in the appeal that Eli Lilly and Company filed in 2008. All twelve judges of the Federal Circuit will now rehear and reassess the merits of Lilly`s appeal. This decision by the Federal Circuit concerns a judgment holding Lilly liable for infringement of U.S. Patent No. 6,410,516 (`516 patent) licensed to ARIAD by Harvard University, Massachusetts Institute of Technology and the Whitehead Institute for Biomedical Research. ARIAD is the exclusive licensee of the technology and patents.
ARIAD Pharmaceuticals, Inc. Announces Completion Of Public Offering Of Common Stock And Full Exercise of Over Allotment Option
ARIAD Pharmaceuticals, Inc. announced the completion of its previously announced public offering of 19,000,000 shares of its common stock at a price of $1.75 per share. ARIAD also announced that the underwriters have exercised in full their over-allotment option for the purchase of an additional 2,850,000 shares. Net proceeds of the public offering and the over-allotment option, a total of 21,850,000 shares, are approximately $35.6 million after underwriting discounts and commissions and estimated expenses. Oppenheimer & Co. Inc. acted as the sole bookrunner and lead manager for the offering. Lazard Capital Markets, LLC acted as the co-manager of the offering.
ARIAD Pharmaceuticals, Inc. Prices Public Offering of Common Stock
ARIAD Pharmaceuticals, Inc. announced that it has priced a public offering of 19,000,000 shares of its common stock at a price of $1.75 per share. Net proceeds after underwriting discounts and commissions and expenses will be approximately $30.9 million. ARIAD has granted the underwriters a thirty-day option to purchase up to an additional 2,850,000 shares to cover over-allotments, if any which will result in additional net proceeds of approximately $4.7 million, if exercised. The offering is expected to close on or about August 7, 2009. Harvey J. Berger, M.D., Chairman and Chief Executive Officer of ARIAD, will purchase $3 million of stock in this offering. Oppenheimer & Co. Inc. is acting as the sole bookrunner and lead manager for the offering. Lazard Capital Markets, LLC is acting as the co-manager of the offering.
