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Jan 23, 2014

Ariad Generates Buzz of Potential Big-Pharma Buyers

  • Days after its leukemia treatment Iclusig® (ponatinib) resumed commercial sales in the United States, Ariad Pharmaceuticals is the center of attention for several would-be acquirers from big biopharma, a British newspaper reported today.

    The Daily Mail, citing unnamed sources it described as “dealers,” said Eli Lilly was “well ahead” of a field of would-be buyers that also includes GlaxoSmithKline and Shire. The rumor was enough to vault Ariad shares up 9.24% or 62 cents a share, to $7.33, in premarket trading this morning as of 9:10 am EST.

    Lilly, GSK, and Shire “have made ‘friendly approaches’ to the Ariad board and are prepared to pay up to $20 a share in cash to gain control,” the Mail reported.

    All three companies are looking to bolster their pipelines, with Shire focusing increasingly on rare disease drugs, and GSK looking to bounce back from several recent late-stage disappointments.

    In recent months, GSK returned to collaboration partners rights to verucirumab for inflammatory bowel disease, and drisapersen for Duchenne muscular dystrophy, while evaluating what to do about heart disease candidate darapladip. Lilly has dealt with mixed results for oncology candidate ramicirumab (positive for gastric cancer, less so for breast cancer) and necitumumab, which showed promising Phase III results in patients with metastatic squamous non-small cell lung cancer, while raising safety concerns such as blood clotting.

    Iclusig returned to the U.S. market earlier this month with a boxed warning and a narrower patient indication of adult patients with refractory chronic myeloid leukemia (CML) and Philadelphia-chromosome-positive acute lymphoblastic leukemia. Iclusig was initially indicated for resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome-positive acute lymphoblastic leukemia patients.

    The FDA approved the changes in December as part of a U.S. Prescribing Information (USPI) change and a revised communications Risk Evaluation and Mitigation Strategy (REMS) for Iclusig. The USPI and REMS allowed for immediate resumption of Iclusig’s marketing and commercial distribution some three months after the company ran afoul of the agency.

    Ariad’s problems with the agency began when the FDA placed a hold October 8 on the company’s Phase III Evaluation of Ponatinib vs. Imatinib in Chronic Myeloid Leukemia (EPIC) trial of Iclusig for patients with newly diagnosed CML. Ten days later, Ariad said it mutually agreed with the FDA to terminate the trial after patients treated with Iclusig experienced increased blood clotting. And in November, Ariad said it would lay off about 40% of its U.S. staff160 employees—by the end of 2013, shrinking its workforce to about 295 employees in the United States and Europe.



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