FDA Grants QIDP Designation to Two Cubist Phase 3 Antibiotic Candidates

  FDA Grants QIDP Designation to Two Cubist Phase 3 Antibiotic Candidates

Business Wire

LEXINGTON, Mass. -- December 06, 2012

Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today announced that the U.S. Food
and Drug Administration (FDA) has designated two of the company’s Phase 3
antibiotic candidates, CXA-201 (ceftolozane/tazobactam) and CB-315, as
Qualified Infectious Disease Products (QIDP). The QIDP designations will
enable Cubist to benefit from certain incentives for the development of new
antibiotics, including priority review, eligibility for fast-track status, and
if CXA-201 or CB-315 are ultimately approved by the FDA, a five year extension
of Hatch-Waxman exclusivity. These incentives are provided under the
Generating Antibiotic Incentives Now Act (GAIN Act), which received strong
bipartisan support in Congress and was signed into law by President Obama in
July 2012 as part of the FDA Safety and Innovation Act (FDASIA), the fifth
authorization of the Prescription Drug User Fee Act.

CXA-201 is currently being studied in pivotal Phase 3 trials as a first-line
intravenous therapy for the treatment of complicated intra-abdominal
infections and complicated urinary tract infections caused by Gram-negative
bacterial infections, including those caused by multi-drug resistant
Pseudomonas aeruginosa. The FDA’s QIDP designation applies to CXA-201’s
treatment of complicated intra-abdominal infections. CB-315 is currently being
investigated in Phase 3 trials as an oral therapy for Clostridium
difficile-associated diarrhea, or CDAD.

“We are delighted that both of our Phase 3 antibiotic candidates,
ceftolozane/tazobactam and CB-315, have received QIDP designation under the
GAIN Act,” said Cubist’s Chief Scientific Officer Steve Gilman. “With
antibiotic resistance rates on the rise and many companies having already left
antibiotic R&D altogether, we believe the provisions of the bipartisan GAIN
Act are a critical first step in our country’s efforts to spur meaningful
investment into this space.”

About The GAIN Act

The GAIN Act, Title VIII (Sections 801 through 806) of the FDASIA, provides
pharmaceutical and biotechnology companies with incentives to develop new
antibacterial and antifungal drugs for the treatment of life-threatening
infectious diseases caused by drug resistant pathogens. Qualifying pathogens
are defined by the GAIN Act to include multi-drug resistant Gram-negative
bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia
coli species; resistant Gram-positive pathogens, including
methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant
Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug
resistant tuberculosis; and Clostridium difficile.

About Gram-negative bacteria

The diseases caused by Gram-negative bacteria include intra-abdominal
infections, urinary tract infections, pneumonia, peritonitis, septicemia,
neonatal meningitis, and burn and wound infections. In the US in 2003,
Gram-negative bacteria were associated with many of the most frequent types of
hospital-acquired infections including 71% of urinary tract infections, 65% of
pneumonia episodes, 34% of surgical site infections, and 24% of bloodstream
infections. Important Gram-negative bacteria include Pseudomonas, Escherichia
coli, Klebsiella, and Acinetobacter.

About CDAD

CDAD is a disease caused by an overgrowth of, and toxin production by C.
difficile, a Gram-positive bacterium naturally found in the lower
gastrointestinal tract. This overgrowth is caused by the use of antibiotics
for the treatment of common community and hospital acquired infections. Many
antibiotics cure the underlying infection but, as a consequence, disrupt the
natural balance of intestinal bacteria which allows C. difficile to overgrow.
The overgrown C. difficile bacteria produce enterotoxin and cytotoxin, two
proteins that can lead to potentially life-threatening severe diarrhea and
sepsis (blood infection). CDAD rates and severity are increasing, due in part
to the spread of a new strain with increased virulence and greater resistance
to fluoroquinolones, a standard of care treatment. According to an article in
the October 2008 issue of the New England Journal of Medicine, during the mid-
and late-1990s, the reported incidence of C. difficile infections in acute
care hospitals in the United States remained stable at 30 to 40 cases per
100,000. However in 2001, this number rose to almost 50, with subsequent
increases to the point that the number of cases that were reported in 2005 (84
per 100,000) was nearly three times the 1996 rate (31 per 100,000).

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
research, development, and commercialization of pharmaceutical products that
address significant unmet medical needs in the acute care environment. Cubist
is headquartered in Lexington, Mass. Additional information can be found at
Cubist’s web site at www.cubist.com.

Cubist Safe Harbor Statement

This press release includes forward-looking statements, including, without
limitation, statements regarding: (i) the anticipated favorable impact
resulting from the FDA’s designating CXA-201 and CB-315 as a QIDP, including
the five year extension of Hatch-Waxman exclusivity if CXA-201 or CB-315 is
ultimately approved by the FDA and (ii) the clinical development of CXA-201.
Each forward-looking statement is subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied by such statement. Applicable risks and uncertainties include, among
others: clinical trials of CXA-201 and CB-315 may not be successful or
initiated or conducted in a timely manner and the timing of initiation and
conduct of subsequent trials is dependent on our ability to successfully work
with regulatory authorities, including the FDA on the design of the trials,
among other things; we plan to rely, to a significant extent, on third party
clinical research organizations, or CROs, to help us conduct clinical trials
so the success and timing of these trials is dependent our ability to work
with such CROs and their performance; technical difficulties or excessive
costs relating to the manufacture or supply of CXA-201 and CB-315; we plan to
rely, to a significant extent, on third party contract manufacturers and
suppliers to manufacture and supply CXA-201 and CB-315 on our behalf so our
ability to obtain adequate supplies of CXA-201 and CB-315 is dependent on our
ability to work with such third parties and on their performance; we may
encounter other unanticipated or unexpected risks with respect to the
development or manufacture of CXA-201 and CB-315; and those additional factors
discussed in Item 1A of our quarterly report on Form 10-Q for the period ended
September 30, 2012 under the caption "Risk Factors" as filed with the
Securities and Exchange Commission on November 5, 2012. We caution investors
not to place considerable reliance on the forward-looking statements contained
in this press release. These forward-looking statements speak only as of the
date of this document, and we undertake no obligation to update or revise any
of these statements.

Contact:

INVESTORS:
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Senior Director, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Cubist Pharmaceuticals, Inc.
Francis G. McLoughlin, 781-860-8777
Director, Corporate Communications
francis.mcloughlin@cubist.com