Ariad Pharmaceuticals, Inc.
) reported first quarter loss of 36 cents per share, wider than
the year-ago loss of 25 cents per share but narrower than the
Zacks Consensus Estimate of a loss of 37 cents per share.
First quarter revenues were $6.5 million, compared with $0.08
million in the year-ago quarter. Revenues surpassed the Zacks
Consensus Estimate of $4 million.
Research and development expenses increased 43.4% year over
year to $41.3 million. The increase was attributable to the
company's efforts to develop and manufacture Iclusig and AP26113.
Selling, general and administrative expenses increased 161.2%
year over year to $29.5 million. The massive increase was
primarily attributable to the expenses incurred by the company in
preparation of the launch of Iclusig.
By the end of the reported quarter, more than 325 patients in
the US were given Iclusig. We note that in Dec 2012, the US Food
and Drug Administration (FDA) granted accelerated approval to
Iclusig for use in heavily pretreated patients, suffering from
resistant and refractory chronic myeloid leukemia (CML) and
Philadelphia chromosome-positive acute lymphoblastic leukemia
(Ph+ ALL). Iclusig generated $6.4 million of US net sales in the
quarter. Around 300 unique physician prescribers for Iclusig and
above 250 unique accounts using Iclusig were noted at the end of
In Mar 2013, Ariad received a positive opinion from the
Committee for Human Medicinal Products (CHMP) of the European
Medicines Agency (EMA) for Iclusig for the treatment of CML and
Ph+ALL. Ariad expects to gain approval by Jun 2013. Ariad has
filed a Marketing Authorization Application (MAA) for Iclusig in
Switzerland and expects to file for approval in Canada and
Australia in the third quarter of the year.
Iclusig is in the phase III EPIC study, in which it is being
compared to imatinib in patients with newly diagnosed CML. Ariad
is presently enrolling patients for the study with interim data
likely to come out in the third quarter of 2014. Iclusig is in
another phase III study, SPIRIT 3, for which enrollment will
start in the third quarter of 2013.
Meanwhile, the phase I part of the phase I/II study on AP26113
is about to complete. Ariad expects to begin phase II expansion
cohorts by June. Simultaneously, Ariad also plans to start a
pivotal study of AP26113 in ALK-positive non-small-cell lung
carcinoma (NSCLC) patients who are resistant to crizotinib in the
third quarter of the year.
Ariad currently carries a Zacks Rank #3 (Hold). Currently,
Lannett Company, Inc.
Catalyst Pharmaceutical Partners Inc.
) look more attractive with a Zacks Rank #1 (Strong
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