ARIAD Pharma (ARIA) Announces Completion of Strategic Review; Details Growth Strategy, Reaffirms FY16 Outlook

ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced the completion of its strategic review and its plans for future growth and vision to become a leader in the discovery, development and commercialization of precision therapies for patients with rare cancers. ARIAD detailed its new strategy for growth and increased patient and shareholder value, and provided an update on its continued progress in its R&D and commercial programs during the Company’s Analyst & Investor Day, held today in New York City.

Initiated at the beginning of this year, ARIAD’s strategic review included rigorous, quantitative analyses to evaluate the Company’s business in its entirety, with a focus on five key areas: geographic reach, commercial maximization, research and development (R&D) portfolio, cost efficiencies and business development opportunities.

Key outcomes of the strategic review that are focused on achieving rapid progress in transforming the Company’s strategy, culture and financial position include:

• 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.

“We are confident that the completion of our strategic review and our announced decisions throughout the process strongly position ARIAD for growth and an opportunity to deliver increased patient and shareholder value,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We are dedicated to building on our core strengths in precision therapies to treat rare cancers, to potentially becoming a two product commercial company in the near-term, to expanding our market opportunities through our development programs in the mid-term, and to delivering on our drug discovery programs in the long-term.”

Reaffirmed 2016 Financial Guidance

Key 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.

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