) recently entered into an exclusive license and development
agreement with a Japanese company, Toyama Chemical Co., Ltd., a
) for an antibiotic candidate, solithromycin (formerly known as
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As per the terms of the agreement, Cempra has licensed Toyama
Chemical exclusive rights to develop and market solithromycin in
Japan in exchange of an upfront payment of $10 million and
milestone payments up to $60 million, depending on the
achievement of certain targets. Cempra will also be eligible to
receive tiered royalties on net sales of solithromycin in Japan.
We note that solithromycin is in development for
community-acquired bacterial pneumonia (CABP) and gonorrhea.
Currently a phase III trial is ongoing evaluating the use of oral
solithromycin in moderate-to-moderately severe CABP. Cempra
expects to release top-line results from the phase III trial in
the first half of 2014.
In the phase II trials evaluating oral solithromycin for CABP,
the candidate demonstrated encouraging efficacy and tolerability
profile. In the phase I dose-escalation studies in healthy
volunteers solithromycin was found to be safe and well tolerated.
The company is also planning to initiate an intravenous-to-oral
solithromycin phase III trial in CABP patients in the second half
Cempra carries a Zacks Rank #3 (Hold). Other stocks with a
favorable Zacks Rank include
Cubist Pharmaceuticals Inc.
). While Alkermes carries a Zacks Rank #1 (Strong Buy), Cubist
Pharma carry a Zacks Rank #2.