On December 30, 2014 OncoGenex Pharmaceuticals reported that it has executed an initial agreement with Teva Pharmaceutical Industries to regain rights to custirsen, an investigational compound currently being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers (Filing 8-K , OncoGenex Pharmaceuticals, DEC 30, 2014, View Source [SID:1234501256]). This transfer of rights would occur in connection with the termination of the collaboration agreement between OncoGenex and Teva executed in 2009.

The initial agreement reached by OncoGenex and Teva provides that, following execution of the final agreement to terminate the collaboration between the parties, OncoGenex will receive a $27 million payment from Teva, subject to certain adjustments. In addition, OncoGenex will take over responsibility for all custirsen related expenses, including those related to the ENSPIRIT trial, as well as manufacturing and regulatory activities for custirsen programs, which are currently being managed by Teva. OncoGenex expects that the $27 million payment from Teva will allow for the completion and final results from the AFFINITY trial, as well as continuation of the ENSPIRIT trial through the second interim futility analysis expected in the first half of 2015.

“Teva’s strategic focus has shifted away from oncology research and development. However, OncoGenex remains committed to the continued investigation of custirsen, particularly in patients who have advancing disease despite previous treatments,” said Scott Cormack, President and CEO of OncoGenex. “This agreement provides OncoGenex with greater control of custirsen’s development, including the modification of the ENSPIRIT statistical analysis plan to involve a more rigorous second interim futility analysis to be completed in the second quarter of 2015 that, if passed, would enable the trial to continue with a smaller enrollment requirement, increased confidence in success and shorter time to regulatory submission.”

The Company expects that the $27 million payment from Teva and the Company’s current resources should enable the completion of the AFFINITY trial through data readout in late 2015/early 2016, allow for the continuation of the ENSPIRIT trial through the second interim futility analysis that is expected in the first half of 2015 and the achievement of key apatorsen clinical milestones, such as the completion of patient enrollment in the Borealis-2 trial and final data from the Spruce and Rainier clinical trials.

The Company anticipates a final agreement will be executed in January 2015. Additional terms of the initial agreement with Teva can be found in the Company’s Form 8-K filed today and available at View Source

On December 30, 2014 Idera Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for IMO-8400, an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, for the treatment of Waldenström’s macroglobulinemia (WM) (Press release Idera Pharmaceuticals, DEC 30, 2014, View Source [SID:1234501255]). Additionally, Idera is providing a progress update on the ongoing Phase 1/2 clinical trial being conducted in WM.

Idera is currently conducting a Phase 1/2 clinical trial of IMO-8400 in patients with WM (ClinicalTrials.gov identifier NCT02092909) who have a history of relapse or failure to respond to one or more prior therapies. In B‐cell lymphomas characterized by the MYD88 L265P oncogenic mutation, including WM, preclinical studies have shown that TLR signaling is overactivated, thereby enabling tumor cell survival and proliferation. About 90 percent of WM patients are reported to harbor the MYD88 L265P oncogenic mutation.

The objectives of the trial are to evaluate the compound’s safety, tolerability and potential clinical activity. The protocol includes three dose-escalation cohorts of IMO-8400 administered subcutaneously. The trial’s independent data review committee has completed its review of four-week safety data from the second dose cohort (1.2 mg/kg/week) and has determined that Idera may open enrollment in the third dose cohort (2.4 mg/kg/week). Final 24-week safety and clinical activity data are anticipated in the second half of 2015.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs intended for the treatment of a rare disease or condition that affects fewer than 200,000 people in the United States. This designation provides certain incentives, including eligibility for federal grants, research and development tax credits, waiver of PDUFA filing fees and a seven-year marketing exclusivity period, once the product is approved and as long as orphan drug designation is maintained.

The approval of an orphan drug designation request does not alter the standard regulatory requirements and processes for obtaining marketing approval of an investigational drug. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

On December 30, 2014 ARIAD Pharmaceuticals and Angelini Pharma, through the Austrian subsidiary CSC Pharmaceuticals reported 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 (Press release Ariad, DEC 30, 2014, View Source [SID:1234501254]). 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.

“With this agreement, we continue to move towards having Iclusig available to patients in geographies outside of our own commercial footprint,” said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. “Angelini will be an important partner for us in this region where, according to the EMA, there are approximately 8,000 patients living with chronic myeloid leukemia (CML) who may become resistant or intolerant to other approved tyrosine kinase inhibitors. Angelini has the experience and geographic reach to market and distribute Iclusig in Central and Eastern Europe.”

ARIAD received Marketing Authorization Approval for Iclusig from the European Medicine Agency in July 2013. The commercial launches of Iclusig in these Central and Eastern European countries are expected to begin in 2015.

“By partnering with ARIAD, we will be able to provide this important cancer medicine to patients in Central and Eastern Europe who have difficult-to-treat CML or Ph+ ALL and few options available to them,” said Gianluigi Frozzi, CEO of Angelini Pharma Division. “We look forward to a successful collaboration with ARIAD and to making Iclusig available to refractory CML and Ph+ ALL patients.”