ariad pharmaceuticals inc (ARIA) Key Developments
ARIAD Pharmaceuticals Appoints Thomas J. Desrosier as Executive Vice President, Chief Legal and Administration Officer, and Secretary
Jan 22 15
ARIAD Pharmaceuticals Inc. announced the appointment of Thomas J. DesRosier, Esq. to the position of executive vice president, chief legal and administration officer, and secretary. Mr. DesRosier will be responsible for global legal operations, information technology and other administrative functions. He will report to ARIADâ s chairman and chief executive officer, Harvey J. Berger, M.D. Mr. DesRosier has more than 30 years of global biotechnology and pharmaceutical industry experience and joins ARIAD from Cubist Pharmaceuticals Inc., where he held the same position as the one he will assume at ARIAD.
ARIAD Pharmaceuticals, Inc. Provides Earnings Guidance for the Year 2018; Re-Affirms Earnings Guidance for the Year 2014
Jan 14 15
ARIAD Pharmaceuticals Inc. provided earnings guidance for the year 2018. The company expects to achieve profitability in 2018 through revenue growth and strategic partnerships over the next three years. This includes Iclusig revenue growth in the U.S. and in Europe, as well as Iclusig revenue from Japan and new geographies. The company also anticipates increased cash flow from brigatinib revenue and partnership payments during this time period. Based on the plan, the company expects to achieve sustained profitability based on more than $400 million in anticipated product revenue in 2018.
The company re-affirmed earnings guidance for the year 2014. For the year 2014, the company expects revenues of $580 million to $600 million. Adjusted earnings per share are to be in the range of $3.23 to $3.47.
ARIAD Pharmaceuticals Announces Phase 2 Dose-Ranging Trial of Iclusig (Ponatinib) to Begin by Mid-2015
Jan 6 15
ARIAD Pharmaceuticals Inc. announced that it has concluded consultations with U.S. and European health authorities regarding the design of a randomized, dose-ranging trial to evaluate three starting doses of Iclusig (ponatinib) in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML). The trial is expected to inform the optimal use of Iclusig in these patients and will begin by mid-2015. Approximately 450 patients will be enrolled at clinical sites around the world. This clinical trial is expected to provide important data regarding the efficacy of Iclusig treatment initiating at doses less than the currently approved starting dose and maintaining patients on a lower dose. This study will enroll patients with CP-CML who are resistant to at least two approved tyrosine kinase inhibitors. These patients will be randomized equally to receive once-daily administration of 45 mg (cohort A), 30 mg (cohort B) or 15 mg (cohort C) of Iclusig. Patients in cohorts A and B will have their daily dose reduced to 15 mg upon achievement of major cytogenetic response (MCyR). The primary endpoint of the trial is MCyR by 12 months for each cohort. Secondary endpoints include rate of vascular occlusive events in each dose cohort, rates of adverse events and rates of serious adverse events. Other secondary endpoints include cytogenetic, molecular and hematologic response rates, tolerability, duration of response, time to response, disease control rate, progression-free survival and overall survival.
ARIAD Announces Commercialization Agreement for Iclusig in Seven Central and Eastern European Countries
Dec 30 14
ARIAD Pharmaceuticals Inc. and Angelini Pharma, through the Austrian subsidiary CSC Pharmaceuticals, announced that ARIAD has granted Angelini exclusive rights to commercialize Iclusig (ponatinib) for the indications approved by the European Medicine Agency (EMA) in Central and Eastern Europe. These countries include Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia. With this distributorship in place, Iclusig will be available to patients with resistant and intolerant Philadelphia-positive leukemias in more than 23 countries in Europe. Under the terms of the agreement, ARIAD will remain the Marketing Authorization Holder of Iclusig, and ARIAD will manage this distributorship out of its European headquarters in Lausanne, Switzerland. Angelini will be responsible for sales and marketing, medical affairs, regulatory and reimbursement support. Angelini will book sales of Iclusig while ARIAD will supply packaged drug to Angelini. An upfront payment to ARIAD and milestones associated with commercial launches will total approximately $7.3 million. Additionally, Angelini will provide ARIAD with a substantial share of Iclusig sales in the region.
ARIAD Pharmaceuticals, Inc. and Otsuka Pharmaceutical Co., Ltd. Announce Co-Development and Commercialization Agreement for Iclusig to Treat Leukemias in Japan and Nine Other Asian Countries
Dec 23 14
ARIAD Pharmaceuticals Inc. and Otsuka Pharmaceutical Co., Ltd. announced that they have entered into an agreement for Otsuka to commercialize ARIAD’s Iclusig (ponatinib) in Japan and nine other Asian countries and to fund future clinical trials in those countries. ARIAD will lead the completion of the Japanese New Drug Application (NDA) for Iclusig, and Otsuka will file the NDA on behalf of both companies for regulatory approval in resistant and intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL) in 2015. Iclusig is an approved BCR-ABL inhibitor in the United States, Europe and Australia. The agreement provides for Otsuka to receive exclusive rights to market Iclusig in Japan and nine other Asian countries (Territory) in return for an upfront payment of $77.5 million to ARIAD, a milestone payment upon regulatory approval in Japan for patients with resistant and intolerant Philadelphia-positive leukemias, and additional milestone payments for approval in other indications. Following approvals in the Territory, Otsuka will conduct sales activities and record sales. ARIAD will also receive a substantial share of net product sales.