(Adds conference call details, analyst comment; updates share
By Vrinda Manocha
Oct 18 Ariad Pharmaceuticals Inc
discontinued a late-stage trial of its cancer drug after some
patients developed blood clots, sending its shares crashing 42
percent on fears that a version of the drug already on the
market may be withdrawn.
The drug, Iclusig, was granted accelerated approval by the
U.S. Food and Drug Administration in December to treat two rare
forms of blood cancer, but only with labels warning of the
potential for blood clots and liver toxicity.
"People are afraid that they're going to have to take the
drug off the market," Summer Street Research analyst Carol
Werther told Reuters.
"I don't think it will be (withdrawn), because there's a
place for it in patients who have no treatment and the
risk/reward would be beneficial for them."
Iclusig is approved to treats adult patients with chronic
myeloid leukemia (CML) and Philadelphia chromosome positive
acute lymphoblastic leukemia, who are resistant or intolerant to
older drugs. The discontinued trial was testing the drug as a
treatment for patients with newly diagnosed CML.
Ariad's Chief Scientific Officer, Tim Clackson, said he did
not expect the drug to be withdrawn, but that it was likely an
FDA advisory panel would evaluate the risks and benefits of the
drug next year.
He added that Ariad was in discussions with the FDA to
finalize a new label for Iclusig, the company's only drug on the
Ariad said on Oct. 9 that it was halting enrollment across
eight studies involving Iclusig, following reports that patients
in the trials were developing blood clots and heart damage.
Two days later, the regulator recommended that patients
taking the drug and their physicians weigh the benefits of
treatment with Iclusig against the possibly increased risks.
The company said on Friday that enrollment in remaining
seven mid-stage trials were still on hold.
Ariad said the termination of the late-stage trial would not
hurt the European launch of the drug in its two approved forms,
but expected that safety data on the label would be updated.
Iclusig was approved to treat the two rare blood cancers by
European Commission in July.
Ariad shares, which have lost about three-quarters of their
value since Oct.9, were down 38 percent at $2.78 in afternoon
trade on the Nasdaq. They hit a three-year low of $2.62 earlier
in the day.
(Reporting By Vrinda Manocha in Bangalore; Editing by Rodney
Joyce, Maju Samuel)