Cubist Pharmaceuticals, Inc.
) have been on the rise following upbeat preliminary sales
results for the fourth quarter of 2013. The biopharmaceutical
company will release detailed fourth quarter and full year 2013
results on Jan 23, 2014 after the closing bell.
As per the preliminary results, Cubist Pharma expects fourth
quarter 2013 revenues of $299.7 million, up 22%. Fourth quarter
sales are above the current Zacks Consensus Estimate of $281
million. The strong results were driven by impressive sales of
Cubist Pharma's key growth engine, Cubicin (daptomycin), an
antibiotic injection. The preliminary results hinted at a
15% year-over-year growth in Cubicin sales to $248.9 million.
For full year 2013, total revenues climbed 14% to $1.1
billion. According to the preliminary data, Cubicin, accounting
for the bulk of revenues, recorded global sales of more than $1
billion. Cubicin performed very well in the U.S. with sales
climbing 12% to $908 million in 2013.
Cubist Pharma strengthened its antibiotics portfolio further
by acquiring two antibiotic makers, Optimer Pharma and Trius
Therapeutics. The acquisition of Trius added tedizolid phosphate
(TR-701) to Cubist Pharma's pipeline. The candidate is under
priority review in the U.S. for treating acute bacterial skin and
skin structure infections (ABSSSI). A final decision from the
U.S. Food and Drug Administration (FDA) is expected on Jun 20,
2014. European approval of the candidate for the same indication
is expected to be sought by Jun 30, 2014. Following the
acquisition of Optimer, Cubist Pharma has gained full control of
Dificid (Clostridium difficile-associated diarrhea or CDAD. The
company intends to re launch the drug in 2014. Dificid is also
being studied for preventing CDAD in patients undergoing
hematopoietic stem cell transplant (phase IIIb). Another CDAD
candidate in Cubist Pharma's pipeline is surotomycin (phase III).
The top-line data is expected in 2015. Approval in the U.S. and
EU is expected to be sought later compared to the earlier
projection of the second half of 2015.
Ceftolozane/tazobactam is another interesting candidate in
Cubist Pharma's pipeline. The impressive top-line data on
ceftolozane/tazobactam from the phase III studies in the
complicated urinary tract infections (cUTI) and complicated
intra-abdominal infections (cIAI) indications is encouraging. On
the back of positive results from these two phase III studies,
the company intends to submit a New Drug Application (NDA) for
ceftolozane/tazobactam to the FDA in the first half of 2014 for
both indications. Cubist Pharma also intends to do the same in
the EU in the latter half of the year. Approval of
ceftolozane/tazobactam will drive the company's long-term growth.
Furthermore, Cubist Pharma intends to initiate a phase III study
on ceftolozane/tazobactam in patients suffering from in
hospital-acquired bacterial pneumonia
(HABP)/ventilator-associated bacterial pneumonia (VABP) by Jun
Cubist Pharma further said that it has decided to suspend the
phase III efficacy studies on another pipeline candidate
bevenopran in patients suffering from opioid-induced constipation
(OIC). The biopharmaceutical company intends to focus on
completing the long-term safety study on the candidate. The
results of the safety study coupled with the outcome of the Mar
2014 FDA advisory committee meeting on the potential for elevated
cardiovascular events related to mu-opioid antagonists like
bevenopran are expected to decide Cubist Pharma's action plan
regarding the candidate.
We expect investor focus to remain on Cubist Pharma's pipeline
going forward. Cubist Pharma currently carries a Zacks Rank #3
(Hold). Some better-ranked stocks include
). All these stocks carry a Zacks Rank # 1 (Strong Buy).
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