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AN3365, A NOVEL ANTIBIOTIC INTENDED TO TREAT INFECTIONS CAUSED BY GRAM-NEGATIVE BACTERIA, COMPLETES PHASE 1 TRIAL AND ACHIEVES PROOF OF CONCEPT IN COLLABORATION WITH GSK
Palo Alto, CAJune 15, 2010Anacor Pharmaceuticals today announced that a
Joint Research Committee, composed of both GlaxoSmithKline (GSK) and Anacor
employees, has determined that AN3365, a novel systemic antibiotic derived from
Anacor’s boron chemistry platform, has achieved proof of concept as defined under the
collaboration agreement between GSK and Anacor. In a Phase 1 clinical trial, AN3365
was shown to be safe and well tolerated. Under the agreement, GSK has 90 days to
review the data and decide whether to exercise its option to license the compound. If
GSK exercises its option, Anacor would receive a $15 million payment, and potentially
would receive commercialization milestones and royalties on product sales.
"We are pleased with the results of the Phase 1 trial," said David Perry, CEO of Anacor
Pharmaceuticals. "AN3365 is a first-in-class antibiotic that demonstrates potent activity
across a wide spectrum of Gram-negative bacteria, including those resistant to many
other antibiotics."
AN3365 Phase 1 Clinical Trial
A Phase 1 randomized, double-blind, placebo-controlled trial evaluated the safety,
tolerability and pharmacokinetics of single and multiple ascending doses of AN3365 in
72 healthy volunteers across nine cohorts. In each dosing cohort, eight healthy
volunteers received either AN3365 or placebo by intravenous infusion. Five single-dose
cohorts and four multiple-dose cohorts were evaluated. At all concentrations across a 15-
fold dosing range, AN3365 was shown to be safe and well tolerated with no serious
adverse events.
About AN3365
AN3365 is a novel boron-based, small-molecule product candidate that targets the
bacterial enzyme leucyl tRNA synthetase. Preclinical studies suggest that AN3365 is a
promising compound for the treatment of infections caused by a broad range of Gramnegative
bacteria, including E. coli, K. pneumoniae, Citrobacter spp, S.marcescens,
P.vulgaris, Providentia spp and Enterobacter spp. AN3365 has demonstrated a potent
effect on strains harboring known resistance to widely-used antibiotics.
Alliance with GSK
In October 2007, Anacor and GSK entered into a worldwide strategic alliance for the discovery, development and commercialization of novel medicines for viral and bacterial
diseases. The collaboration provides GSK access to Anacor's proprietary boron-based
chemistry for use in four target-based project areas. Under the terms of the agreement
with GSK, Anacor retains responsibility for the development of AN3365, and other boron
containing, small molecules through clinical proof of concept, at which point GSK has an
exclusive option to license each compound for further development and
commercialization on a worldwide basis. Contingent on achieving certain milestones,
Anacor is eligible to receive discovery, development, regulatory and commercial
milestones ranging up to $252 million and $331 million for each product candidate, and
tiered double digit royalties, up to the mid-teens, which are dependent on sales achieved.
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company focused on discovering, developing and
commercializing novel small-molecule therapeutics derived from its boron chemistry
platform. Anacor has discovered and is developing five clinical compounds, including its
three lead programs: AN2690, a topical antifungal for the treatment of onychomycosis;
AN2728, a topical anti-inflammatory for the treatment of psoriasis and AN3365, a
systemic antibiotic for the treatment of infections caused by Gram-negative bacteria. The
Company is developing AN3365 and other systemic antibacterial therapeutics under a
research and development agreement with GlaxoSmithKline. For more information visit www.anacor.com.
Forward-Looking Statements
This press release may contain forward-looking statements that relate to future events and
involve known and unknown risks, uncertainties and other factors that could cause actual
levels of activity, performance or achievement to differ materially from those expressed
or implied by these forward-looking statements. These statements reflect the views of
Anacor as of the date of this press release with respect to future events and, except as
required by law, it undertakes no obligation to update or revise publicly any forwardlooking
statements, whether as a result of new information, future events or otherwise
after the date of this press release.
Contact:
Anne Bowdidge
Investor Relations
650-543-7575
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