Key Developments: ARIAD Pharmaceuticals Inc (ARIA.O)
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21 May 2013
$0.91 (+5.48%)
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3,400,540
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Latest Key Developments (Source: Significant Developments)
Ariad Pharmaceuticals Inc Presents New Preclinical Data Showing AP26113 Inhibits Clinically Relevant Mutants Of ALK And ROS1
Ariad Pharmaceuticals Inc announced presentation of preclinical data on AP26113, an investigational inhibitor of anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), and c-ros oncogene 1 (ROS1), at American Association for Cancer Research (AACR) Annual Meeting 2013, in Washington. The study, AP26113 possesses pan-inhibitory activity versus crizotinib-resistant ALK mutants and oncogenic ROS1 fusions, shows that AP26113 inhibits clinically relevant crizotinib-resistant ALK mutants and oncogenic ROS1 fusions recently identified in patients with non-small cell lung cancer (NSCLC). This preclinical research demonstrates that AP26113 inhibits all nine clinically identified crizotinib-resistant ALK mutations, at plasma concentrations known to be clinically achievable, said Timothy P. Clackson, President of research and development and Chief Scientific Officer at ARIAD. Some of these mutations were also shown to be resistant to additional ALK inhibitors other than crizotinib. This supports the potential of AP26113 to offer a pan-ALK inhibitor profile. AP26113 was also shown to inhibit ROS1 fusions as potently as it inhibits ALK, to retain activity against gatekeeper mutation of ROS1, and to substantially suppress the outgrowth of resistant ROS1 cells in a mutation assay, all at clinically achievable plasma concentrations. These data suggest that AP26113 may be able to avoid emergence of drug-resistant mutants in NSCLC patients with these oncogenic gene fusions. Full Article
Ariad Pharmaceuticals Inc Presents New Preclinical Data Showing Ponatinib Is Potent Inhibitor Of RET And FGFR, Two Oncogenic Drivers Of Non-Small Cell Lung Cancer
Ariad Pharmaceuticals Inc announced presentation of preclinical data on ponatinib. The first preclinical study, Ponatinib is a potent inhibitor of activated variants of RET found in MTC and NSCLC, shows that ponatinib inhibits naturally occurring activating mutants of RET found in MTC and NSCLC at clinically achievable plasma concentrations. The potency of ponatinib was found to substantially exceed that of other approved tyrosine kinase inhibitors with RET activity. These results provide support for the clinical evaluation of ponatinib in patients with RET-driven cancers. In the second preclinical study, Ponatinib potently inhibits the activity of mutant variants of FGFR commonly found in endometrial, lung and other cancers, the ability of ponatinib to inhibit a broad panel of naturally occurring mutant variants of FGFR1, 2, 3, and 4 was evaluated. Ponatinib potently blocked a variety of mutant variants of FGFR, with particularly promising activity against mutant variants of FGFR2 that have been observed in endometrial and squamous cell carcinomas (SCCs) of the lung. Specifically, ponatinib inhibits the eight mutants that make up more than 90% of the mutations observed in endometrial cancer patients, and six mutants observed in SCC at clinically achievable plasma concentrations. Ponatinib also shows encouraging activity against FGFR1/3 fusion proteins found in glioblastoma multiforme. Full Article
Ariad Pharmaceuticals Inc Announces Completion of Public Offering
Ariad Pharmaceuticals Inc announced the completion of its previously announced public offering of 15,307,000 shares of common stock at a public offering price of $19.60 per share. In addition, the underwriters have exercised an option to purchase an additional 1,182,893 shares at $19.60 per share to cover over-allotments. The total gross proceeds from the offering are approximately $323 million. Net proceeds to ARIAD are approximately $310 million after deducting underwriting discounts and commissions and estimated offering expenses. J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies & Company, Inc. acted as joint book-running managers and underwriters for the offering. BMO Capital Markets, Leerink Swann LLC, RBC Capital Markets, LLC and UBS Investment Bank acted as co-managers for the offering. Full Article
Ariad Pharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
Ariad Pharmaceuticals Inc announced the pricing of an underwritten public offering of 15,307,000 shares of common stock, at a price to the public of $19.60 per share. The offering is expected to close on or about January 29, 2013. In addition, ARIAD has granted the underwriters a 30-day option to purchase up to 2,296,050 additional shares of common stock to cover over-allotments, if any. J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies & Company, Inc. are acting as joint book-running managers and underwriters for the offering. BMO Capital Markets, Leerink Swann LLC, RBC Capital Markets, LLC and UBS Investment Bank are acting as co-managers for the offering. Full Article
Ariad Pharmaceuticals Inc Announces Proposed Public Offering Of Common Stock
Ariad Pharmaceuticals Inc announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares in the offering are to be sold by ARIAD. J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies & Company, Inc. are acting as joint book-running managers and underwriters for the proposed offering. ARIAD intends to grant the underwriters a 30-day option to purchase up to an additional 15 % of the amount sold to cover over-allotments, if any. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Full Article
Ariad Pharmaceuticals Inc And U.K. National Cancer Research Institute Collaborate On SPIRIT 3 Clinical Study
Ariad Pharmaceuticals Inc and Newcastle University, U.K., on behalf of the U.K. National Cancer Research Institute (NCRI) CML Working Group, announced an agreement to collaborate on a multicenter, randomized Phase 3 trial, named SPIRIT 3, to assess the impact of switching patients with chronic myeloid leukemia (CML) being treated with a first-line tyrosine kinase inhibitor, upon suboptimal response or treatment failure, to ponatinib. The NCRI expects to begin enrollment in the trial of 1,000 patients at approximately 172 clinical research sites in the U.K. in the second quarter of 2013. The SPIRIT 3 trial is a randomized, two-arm, multicenter trial that compares molecular response (MMR) at three years in newly diagnosed patients treated with imatinib to those treated with nilotinib, when patients are rescued with ponatinib upon suboptimal response at three or 12 months or treatment failure. The SPIRIT 3 trial will enroll adult patients with chronic-phase CML diagnosed within three months and previously untreated for CML with any TKI therapy. The primary endpoint of the study is the proportion of patients who have achieved MMR at three years on their initially allocated first line of therapy, regardless of switch to ponatinib. Full Article
Ariad Pharmaceuticals Inc Announces Accelerated Approval by FDA of Iclusig for Patients with CML and Ph+ ALL Resistant or Intolerant to Prior Tyrosine Kinase Inhibitor Therapy
Ariad Pharmaceuticals Inc announced that following a priority review, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy. The FDA approval of Iclusig was based on results from the pivotal Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) trial in patients with CML or Ph+ ALL who were resistant or intolerant to prior TKI therapy, or who had the T315I mutation of BCR-ABL. Iclusig had robust anti-leukemic activity, with 54% of chronic-phase CML patients, including 70% of patients with the T315I mutation, achieving a major cytogenetic response (MCyR) - the primary endpoint of the PACE trial for chronic-phase patients. Full Article
Ariad Pharmaceuticals Inc Announces 12-Month Data From Pivotal PACE Trial Of Ponatinib In Heavily Pretreated Patients
Ariad Pharmaceuticals Inc announced twelve-month follow-up data from the pivotal PACE trial of ponatinib, investigational BCR-ABL inhibitor, in heavily pretreated patients with advanced forms of chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study now shows that 57% of accelerated-phase CML patients in the trial, including 50% of patients with the T315I mutation, achieved hematologic response (MaHR), the primary end-point for patients with advanced disease in the trial. Full Article
Ariad Pharmaceuticals Inc Announces Long-Term Molecular Response Data on Ponatinib
Ariad Pharmaceuticals Inc announced updated molecular response data from its Phase 1 and pivotal Phase 2 trials of ponatinib, its investigational BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The studies now show that 51% of chronic-phase CML patients in the Phase 1 trial achieved a major molecular response (MMR) with a median follow-up of 30 months, and 34% of chronic-phase patients achieved MMR in the PACE trial with a median follow-up of 15 months. Molecular response is a measurement of blood levels of the transcript product of the BCR-ABL oncogene. MMR is defined as a value less than or equal to 0.1% on the accepted International Scale. All patient samples were evaluated for molecular response at a single central laboratory (Molecular MD) using a standardized assay. MMR is a secondary efficacy endpoint for chronic-phase CML patients in ARIAD’s Phase 1 and pivotal Phase 2 PACE trials of ponatinib. The ongoing Phase 1 dose-escalation study of ponatinib enrolled 81 patients with resistant or refractory hematologic cancers, including 43 patients with chronic-phase CML. Sixty-one percent of the chronic-phase CML patients in this study had failed at least three prior tyrosine kinase inhibitors (TKI). Full Article
Ariad Pharmaceuticals Inc Announces 12-Month Data from Pivotal PACE Trial of Ponatinib in Heavily Pretreated Chronic-Phase CML Patients
Ariad Pharmaceuticals Inc announced twelve-month follow-up data from the pivotal PACE trial of ponatinib, its investigational BCR-ABL inhibitor, in heavily pretreated patients with resistant or refractory chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study now shows that 56% of chronic-phase CML patients in the trial, including 70% of patients with a T315I mutation, achieved a major cytogenetic response (MCyR), the primary end-point for chronic-phase CML patients. The data are being featured at 4:30 p.m. (ET) in an oral presentation at the 54th Annual Meeting of the American Society of Hematology (ASH) being held in Atlanta, Georgia. ARIAD filed for regulatory approval of ponatinib in the third quarter of 2012 in the U.S. and in the E.U. based on clinical data from the pivotal PACE trial. Efficacy data were reported at ASH on 444 treated patients in six pre-specified cohorts at 45 mg of ponatinib administered orally once daily, including 267 patients with chronic-phase CML. Findings were based on a minimum follow-up of 12 months in patients remaining on study. Ninety-three percent of the patients in the trial had received at least two tyrosine kinase inhibitors prior to enrollment. Fifty-eight percent of the patients had received three or more tyrosine kinase inhibitors prior to enrollment. Full Article
Ariad gets early FDA approval for leukemia drug
- The U.S. Food and Drug Administration on Friday granted earlier-than-expected approval to Ariad Pharmaceuticals Inc's drug for two rares types of leukemia, but is requiring that patients be warned of potential side effects, sending the company's shares down nearly 20 percent.
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