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June 2, 2014
07:39 EDTARIAARIAD announces longer-term follow up from Phase 1, Phase 2 Iclusig trials
ARIAD Pharmaceuticals announced longer-term follow up from its Phase 1 and pivotal Phase 2 trials of Iclusig, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. The studies now show that with a median follow-up of 42.5 months for chronic-phase CML patients in the Phase 1 trial, Iclusig continues to demonstrate anti-leukemic activity in those who had limited treatment options, and that deep and durable responses have been maintained in CP-CML patients in the PACE trial with 87 percent estimated to remain in major cytogenetic response at two years. Longer-term safety data show that careful benefit/risk evaluation should guide the decision to use ponatinib therapy, particularly in patients who may be at increased risk for vascular occlusive events.
News For ARIA From The Last 14 Days
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August 4, 2015
07:34 EDTARIAUBS to hold a symposium
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July 29, 2015
07:47 EDTARIAARIAD to receive $200M through syntehtic-royalty financing with PDL BioPharma
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07:43 EDTARIAARIAD to receive up to $200M through Iclusig synthetic-royalty financing with PDL BioPharma
ARIAD Pharmaceuticals (ARIA) announced that it will receive $100 million in cash – $50 million upon deal execution late yesterday and an additional $50 million in one year – through a synthetic-royalty financing from PDL BioPharma (PDLI) in exchange for paying PDL a mid-single-digit royalty on future sales of Iclusig until PDL receives a fixed internal rate of return. ARIAD also has an option, in its discretion, to receive up to an additional $100 million at any time between 6 and 12 months from the date of the agreement, in one or two tranches on comparable terms. ARIAD intends to use the base funds to conduct a front-line trial of brigatinib, its investigational ALK inhibitor, in patients with non-small cell lung cancer and to support brigatinib commercial readiness, as well as to continue its ongoing Iclusig initiatives. ARIAD is on track to complete enrollment in the pivotal ALTA trial of brigatinib in third quarter 2015, to file for approval in the U.S. next year, and subject to regulatory approval, to launch brigatinib by early 2017. Brigatinib has Breakthrough Designation from the U.S. Food and Drug Administration. “This financing allows us to accelerate initiation of the front-line trial of brigatinib and to ensure launch readiness as early as possible, while retaining strategic flexibility with respect to partnering and long-term commercialization of brigatinib,” said Harvey J. Berger, M.D., chairman and CEO of ARIAD. “We are confident based on the latest clinical data on brigatinib and other ALK‐inhibitors, that brigatinib may be an important new cancer medicine for patients with ALK+ lung cancer. With the funding provided by this royalty transaction, we expect to start the front-line trial by early next year, ahead of our expected filing for initial marketing approval of brigatinib in patients with refractory ALK+ NSCLC.”

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