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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the fourth quarter and full year ended December 31, 2012 and provided an update on corporate developments.
“Last year was clearly a landmark period for ARIAD as we transformed into a commercial oncology company,” said
Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We received U.S. approval of Iclusig™ (ponatinib), established a commercial organization in the U.S. and hired our European leadership team. We advanced the development of AP26113 and presented positive clinical proof-of-concept data showing the great promise of AP26113 as our next internally discovered tyrosine kinase inhibitor that overcomes drug resistance. We are now a sustainable, fully integrated global oncology company with the highly differentiated capability to discover, develop and deliver innovative cancer medicines.”
Key Highlights from 2012
In December, we received accelerated approval in the U.S. of Iclusig 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.
We submitted a Marketing Authorization Application (MAA) for Iclusig to the European Medicines Agency seeking marketing approval in the EU of Iclusig in adult patients with resistant or intolerant CML or Ph+ ALL. The Committee for Medicinal Products for Human Use granted ARIAD’s request for accelerated assessment of the MAA.
In Europe, we established early-access programs for Iclusig, established the supply chain in key markets and implemented initial pricing and reimbursement activities. We began building our leadership team in our European headquarters in Lausanne, Switzerland.
We advanced the Phase 1/2 clinical trial of AP26113, our investigational inhibitor of anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), and c-ros oncogene 1 (ROS1). Compelling anti-tumor activity of AP26113 in patients with ALK-positive non-small cell lung cancer (NSCLC) and initial anti-tumor activity in patients with EGFR-mutant NSCLC were presented at the European Society of Medical Oncology meeting. Importantly, AP26113 showed clinical activity in ALK-positive NSCLC patients with brain metastases.
The New England Journal of Medicine published results from the Phase 1 study of Iclusig in heavily pretreated patients with resistant and refractory CML and Ph+ ALL.
We initiated the global, Phase 3 EPIC trial of Iclusig in patients with newly diagnosed CML. This trial compares Iclusig to imatinib and has a primary endpoint of major molecular response at 12 months of treatment.
We initiated a Phase 1/2 clinical trial of Iclusig in resistant or intolerant CML and Ph+ ALL patients in Japan in the second half of 2012. The trial is designed to establish the recommended dose of Iclusig in Japanese patients, confirm its anti-leukemic activity in this patient population, and provide the necessary data required for regulatory approval of Iclusig in Japan.
Recent Progress and Key ObjectivesGlobal Commercialization of Iclusig
All of the key functions in our U.S. commercial organization, including account specialists, market access, and marketing, are in place and implementing the commercial plans for Iclusig.
Our European business is also fully operational. We hired the General Manager of our European operations, along with other key members of our leadership team. Medical science liaisons and sales representatives in each of other major markets in Europe are now being recruited, and we expect to be launch-ready in Europe by July 1, 2013.
We anticipate approval of Iclusig in the EU in the third quarter of 2013 and regulatory submissions in Canada, Switzerland, and Australia in the second half of 2013.
Broadening Iclusig Clinical Development
Patient enrollment is ongoing in the global, Phase 3 EPIC trial of Iclusig in patients with newly diagnosed CML. We anticipate full patient enrollment in the trial by the end of 2013. The study includes an interim analysis of the primary endpoint one year after one-half of the approximately 500 patients in the trial have been enrolled. We anticipate the interim analysis to occur in mid-2014.
We plan to submit for regulatory approval of Iclusig in Japan in mid-2014.
ARIAD and the U.K. National Cancer Research Institute (NCRI) began collaboration on a randomized Phase 3 trial, named SPIRIT 3, to assess the impact of switching patients with CML being treated with a first-line tyrosine kinase inhibitor, upon suboptimal response or treatment failure, to Iclusig. 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.
We plan to begin company-sponsored and investigator-sponsored Phase 2 trials of Iclusig in patients with gastrointestinal stromal tumors (GIST), acute myeloid leukemia, certain molecularly defined types of lung cancer and other solid tumors during 2013. Depending on the clinical findings from these trials and discussions with regulatory agencies, we may begin additional pivotal trials of Iclusig, including, for example, in patients with GIST who have failed prior therapy.
Advancing AP26113 Through Clinical Development
The Phase 1 portion of our Phase 1/2 clinical trial of AP26113 is ongoing, and we expect to transition into the four Phase 2 expansion cohorts during the first half of 2013.
In parallel to the Phase 1/2 trial, we are actively planning the pivotal trial of AP26113 in ALK-positive NSCLC patients resistant to crizotinib. Depending on the clinical findings from the Phase 2 portion of the currently ongoing Phase 1/2 trial and discussions with regulatory agencies, we may begin additional pivotal trials of AP26113, including, for example, in patients with EGFR-mutant NSCLC who have failed prior EGFR inhibitor therapy.
We anticipate presenting clinical updates on AP26113 at the 2013 annual meetings of the American Society of Clinical Oncology and the European Society of Medical Oncology.
2012 Fourth Quarter and Full-Year Financial ResultsNet Income/LossQuarter Ended December 31, 2012
Net loss for the fourth quarter ended December 31, 2012 was $60.5 million, or $0.36 per share, compared to a net loss of $51.8 million, or $0.38 per share, for the same period in 2011. The increase in net loss is primarily due to an increase in operating expenses of $28.8 million, reflecting our preparations for commercial launch of Iclusig, including the hiring of sales personnel and other professional staff, as well as continued development of our product candidates, and a decrease of $20.1 million in the non-cash charge related to the revaluation of our warrant liability.