CAMBRIDGE, Mass. (AP) -- Ariad Pharmaceuticals Inc. said Friday that the Food and Drug Administration approved its pill Iclusig as a treatment for two rare types of leukemia, but shares of the company tumbled after regulators required the addition of warning label alerting patients to potentially serious side effects. Iclusig, which was developed under the name ponatinib, was approved for use against treatment-resistant chronic myeloid leukemia and for patients with acute lymphoblastic leukemia with a type of chromosome abnormality. It is Ariad's first approved product. The company says approximately 5,000 cases of chronic myeloid leukemia are diagnosed in the U.S. each year. The FDA approved the drug sooner than expected, as its decision wasn't due until late March. European Union regulators are also reviewing the drug and are expected to make a decision in the third quarter of 2013. Federal regulators will require Ariad to include a boxed warning that Iclusig may cause blood clots and liver toxicity. Citi Investment Research analyst Jonathan Eckard, who rates the stock a "Buy," noted that he doesn't expect the warning to dramatically affect the drug's adoption since "physicians treating these patients are likely broadly familiar with the adverse effects caused by this disease … Continue reading →

LONDON (Reuters) - European regulators recommended against approval of Sanofi and Isis Pharmaceutical's Kynamro drug for treatment of a rare genetic disorder that causes unusually high cholesterol. The European Medicines Agency said it was concerned about the medicine's safety, noting that a high proportion of patients stopped taking it within two years, mainly due to side effects such as flu-like symptoms, injection site reactions and liver toxicity. The European rebuff contrasts with a green light for the drug, known generically as mipomersen, by a U.S. advisory panel in October. Sanofi's Genzyme unit said it was disappointed by the decision and planned to request a re-examination. A Sanofi spokeswoman said the company expected feedback from the regulator in the second quarter of 2013. Isis founder and Chief Executive Stanley Crooke said on a conference call with analysts he was still optimistic on securing approvals in both the United States and Europe. "Even though I cannot address the specific concerns of the (EU) committee ... I can say that each issue raised by the (committee) was thoroughly reviewed by the FDA," Crooke said. "We do not believe that today's opinion should have a negative impact elsewhere." At 1514 GMT Sanofi shares were … Continue reading →

(Reuters) - The U.S. Food and Drug Administration on Friday granted earlier-than-expected approval to Ariad Pharmaceuticals Inc's drug for two rares types of leukemia, but is requiring that patients be warned of potential side effects, sending the company's shares down nearly 20 percent. The drug, given the brand name Iclusig, was approved three months ahead of time under the FDA's accelerated program for earlier access to promising new drugs. The FDA is requiring a so-called "blackbox" on the drug's label warning of the potential for arterial thrombotic events and liver toxicity, according to Ariad. "While the blackbox warning may impact the pace of adoption initially in the community setting, we expect high volume academic centers to quickly look past the warning," BMO Capital Markets analyst Jim Birchenough said in a research note. The approval covers use of the drug, also known as ponatinib, to treat chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, two types of rare blood and bone marrow cancers, in patients who had been treated with older drugs. "We would be buyers of Ariad into the 2013 Iclusig launch," Guggenheim analyst Bret Holley said in a research note. He forecast a relatively rapid uptake of … Continue reading →