Sequella Acquires Exclusive Worldwide Rights to Pfizer’s Sutezolid,
Currently in Clinical Development for Tuberculosis
Sequella Obtains Development and Commercialization Rights to Sutezolid for All
ROCKVILLE, Md. -- July 17, 2013
Sequella, a clinical-stage pharmaceutical company commercializing novel
antibiotics to treat life-threatening infectious diseases, today announced
that it has licensed Pfizer Inc’s exclusive worldwide rights to develop and
commercialize sutezolid, a Phase 2 oxazolidinone antibiotic currently in
development for the treatment of tuberculosis (TB).
Sutezolid demonstrated potent antibacterial activity against Mycobacterium
tuberculosis in the laboratory and in animal models of TB, an
aerosol-transmitted infection with a prevalence of over 2 billion people
worldwide. It also demonstrated encouraging activity in a Phase 2a Early
Bactericidal Activity (EBA) study in TB patients in South Africa. Under the
terms of the parties’ exclusive license agreement, Sequella will be solely
responsible for completing clinical development and commercializing the
product globally. Financial terms of the transaction were not disclosed.
“We are delighted to bring in a second clinical-phase TB asset that may be
paired with other TB drugs or with SQ109, our drug currently in Phase 2
studies for drug-sensitive TB in Africa and in a pivotal trial for multi-drug
resistant (MDR) TB in Russia. These two drugs, SQ109 and sutezolid, could
potentially anchor a totally new drug combination regimen to treat all forms
of active TB disease,” said Dr. Carol Nacy, CEO of Sequella. “We will pursue
development of sutezolid under its own NDA, and also plan for combination
studies in subsequent clinical trials.”
“As Pfizer continues to concentrate our R&D resources where we believe we can
have the greatest impact, we have evolved our internal infectious disease
focus from treatment to prevention through our leading expertise in vaccine
technology,” said Rod MacKenzie, PhD, Group Senior Vice President and Head of
PharmaTherapeutics R&D at Pfizer. “Given the urgent patient need in TB, we
sought a partner for sutezolid that would bring deep expertise and a strong
commitment to TB patients. We believe Sequella meets these criteria and offers
a portfolio with theimportant potential for combination studies.”
TB, whether drug sensitive or MDR, is always treated with three or more drugs
to reduce emergence of drug resistance. Preclinical laboratory studies
performed independently by both Sequella and Pfizer show SQ109 and sutezolid
to each have activity as single agents, and promising additional activity when
used in combination. A very low natural resistance rate of M. tuberculosis to
either drug, demonstration that both drugs shorten treatment time in animal
models of TB, and their distinct and complementary mechanisms of action on M.
tuberculosis, all suggest that a regimen containing SQ109 and sutezolid could
potentially improve existing therapies with regard to efficacy and containment
Recent market reports estimate a $400-$500 million global peak sales market
for a drug to treat MDR-TB, approximately 5% of TB worldwide and a rising
global public health threat. Sequella intends to commercialize its TB assets
for both drug sensitive and MDR-TB, if and when approved by applicable
regulatory authorities. Sutezolid also has activity on several clinically
important Gram positive bacteria.
Pfizer had been developing an antimicrobial compound, sutezolid (PNU-100480 or
U-480), as a promising new treatment for tuberculosis (TB). Sutezolid is
currently in Phase 2 development and most recently completed a Phase 2a Early
Bactericidal Activity (EBA) study in patients with TB in South Africa. Its
potential indications include multi-drug and extensively drug resistant
tuberculosis (M/XDR-TB), HIV-associated tuberculosis (HIV-TB), drug-sensitive
tuberculosis (DS-TB), and suspected M/XDR latent M.tuberculosis infection
Sutezolid also shows promise for antibiotic-resistant Gram (+) bacterial
infections, including methicillin-resistant Staphylococcus aureus (MRSA) and
vancomycin-resistant Enterococcus (VRE).
Sequella is a privately-held clinical stage anti-infectives company focused on
commercializing novel treatments for antibiotic-resistant infectious diseases.
The company has been in operation for 15 years and has drugs in Phase 2
clinical trials for gastritis (Helicobacter pylori) and TB (Phase 2) and in
IND-directed preclinical development for Clostridium difficile infections.
Sequella leverages its global influence, R&D platforms, and infectious disease
expertise to proactively address emerging health threats. Through focused
execution, clear commercialization pathways, and strategic partnerships,
Sequella intends to commercialize a broad product portfolio designed to treat
global health threats with significant market opportunity.
This press release contains forward-looking statements that are subject to
risks and uncertainties, and includes statements that are not historical
facts. Actual results could differ significantly from results discussed.
Sequella disclaims any intent or obligation to update forward-looking
statements, except as required by law.
AM Media and Marketing
Alicia Moran, 410-991-7027
Alan S. Klein, 301-762-7776
Executive Vice President, Corporate Development
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