- A commitment to commercializing brigatinib in the U.S., subject to approval by the U.S. Food and Drug Administration (FDA). The Company announced initiation of its rolling new drug application (NDA) to the FDA today, ahead of previously announced plans.
- A focus on the valuable U.S. market, with the divestiture of the Company's European operations and out-license of Iclusig ® (ponatinib) rights in Europe and other selected countries to Incyte Corporation, while also maintaining future strategic flexibility through a buy-back provision for the licensed Iclusig rights following a change of control of ARIAD. In addition, ARIAD today announced the entry into new distribution agreements for Iclusig in Latin America and the Middle East/North Africa.
- A significant reduction in the Company's expense base, together with more rigorous cost controls, while also planning to commit resources to expand its product pipeline and conducting clinical trials to expand potential market opportunities.
- Changes to its executive leadership team and board of directors.
- A decision to build upon the Company's core strengths in precision small molecule therapies and rare cancers, including investing in potential new opportunities in immuno-oncology, with pharmacologic proof-of-concept achieved against a validated lead target.
Reaffirmed 2016 Financial GuidanceKey progress on ARIAD's strategy include product revenue and royalty revenue guidance of $170-$180 million for 2016; an expected 25 percent reduction in SG&A expense in 2016, compared to 2015, with guidance of $120-$125 million; and R&D expense guidance of $175-180 million to support potential near- to long-term growth through the Company's ongoing OPTIC and OPTIC 2L clinical trials, the ALTA 1L trial and the Phase 1/2 trial of AP32788. In addition, ARIAD expects to end 2016 with a strengthened financial position, with cash, cash equivalents and marketable securities expected to be $280-$290 million. A replay of today's Analyst & Investor Day webcast and a copy of the presentation slides will be archived for one month and can be accessed by visiting the investor relations section of ARIAD's website at http://www.ariad.com/investor. About Iclusig ® (ponatinib) tablets Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD's computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada. In the U.S., Iclusig is a kinase inhibitor indicated for the: • Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). • Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML. IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY See full prescribing information for complete boxed warning • Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy. • Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure. • Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected. Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information. About ARIAD ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is focused on discovering, developing and commercializing precision therapies for patients with rare cancers. ARIAD is working on new medicines to advance the treatment of rare forms of chronic and acute leukemia, lung cancer and other rare cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter ( @ARIADPharm). Forward-Looking Statements This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to statements regarding the outcome of the Company's strategic review and plans for future growth and increased patient and shareholder value; the Company's commitment to commercializing brigatinib in the U.S.; the Company's focus on the valuable U.S. market; the Company's plans to significantly reduce its expense base, while committing resources to expanding its product pipeline and conducting clinical trials to expand potential market opportunities; the Company's decision to build upon its core strengths in precision small molecule therapies and rare cancers, including investing in potential new opportunities in immuno-oncology; the Company's reaffirmed 2016 financial guidance; and the statements made by Mr. Panayiotopoulos, are forward-looking statements that are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to, our ability to successfully commercialize and generate profits from sales of Iclusig and our product candidates, if approved; competition from alternative therapies; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for our products and product candidates and to move new development candidates into the clinic; our ability to execute on our key corporate initiatives; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; our reliance on the performance of third-party manufacturers and specialty pharmacies for the supply and distribution of our products and product candidates; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing, commercialization and other activities; the conduct, timing and results of preclinical and clinical studies of our products and product candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the adequacy of our capital resources and the availability of additional funding; the ability to satisfy our contractual obligations, including under our leases, convertible debt and royalty financing agreements; patent protection and third-party intellectual property claims; litigation; our operations in foreign countries; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.