Cubist Pharmaceuticals, Inc.
) recently inked a deal with Japanese company
Astellas Pharma Inc.
) to acquire the remaining rights of ceftolozane from the latter.
Ceftolozane is the key component of Cubist Pharma's antibiotic
candidate CXA-201 (ceftolozane/tazobactam).
Following the new agreement, Cubist Pharma gained the rights to
develop and market CXA-201 in certain Asia-Pacific and Middle
East countries. Cubist Pharma now has global rights pertaining to
As per the terms of the new agreement, Cubist Pharma will make an
upfront payment of $25 million to Astellas Pharma. Cubist Pharma
intends to make the payment through its available cash balance.
CXA-201 was added to Cubist Pharma's pipeline following its
acquisition of Calixa Therapeutics, Inc. in 2009. CXA-201 is one
of the most interesting candidates in Cubist Pharma's pipeline.
The candidate is undergoing phase III studies in the complicated
intra-abdominal infections (cIAI) and complicated urinary tract
infections (cUTI) indications.
Cubist Pharma expects to report top-line data from the studies in
the second half of 2013. The company intends to seek US approval
for both indications (cUTI and cIAI) within approximately 6
months of reporting top-line data from both the phase III
Cubist Pharma also intends to evaluate CXA-201 in a phase III
study for treating patients suffering from nosocomial pneumonia.
The study is expected to commence in mid-2013.
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The US Food and Drug Administration (FDA) has already provided
QIDP (qualified infectious disease product) status to CXA-201 for
all the above indications. With the FDA granting CXA-201 QIDP
status for the above indications, the antibiotic qualifies for
multiple benefits including a 5-year extension of Hatch-Waxman
exclusivity (on approval) and priority review.
Cubist Pharma, a biopharmaceutical company, carries a Zacks Rank
#3 (Hold). Biopharma stocks such as
Kythera Biopharmaceuticals, Inc.
) are comparatively well placed and carry a Zacks Rank #2