Cubist Obtains Remaining Rights to Ceftolozane from Astellas

  Cubist Obtains Remaining Rights to Ceftolozane from Astellas

Agreement Results in Cubist Owning Worldwide Rights to Ceftolozane/Tazobactam

Business Wire

LEXINGTON, Mass. & TOKYO -- March 11, 2013

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Astellas Pharma Inc. (Tokyo:
4503) today announced that they entered into an agreement under which Cubist
obtains the rights to ceftolozane in certain Asia-Pacific and Middle East
territories from Astellas. With the attainment of these rights, Cubist now
owns worldwide rights to develop, manufacture, and commercialize
ceftolozane/tazobactam.

Ceftolozane, in combination with tazobactam (ceftolozane/tazobactam or CXA
201), is currently being studied in two pivotal Phase 3 trials as a potential
first-line intravenous therapy for the treatment of complicated
intra-abdominal infections (cIAI) and complicated urinary tract infections
(cUTI) caused by certain Gram-negative bacteria, including those caused by
multi-drug resistant Pseudomonas aeruginosa. Top-line data readouts from these
two clinical trials are expected in the second-half of 2013. Cubist
anticipates filing a New Drug Application (NDA) for ceftolozane/tazobactam in
cUTI and cIAI approximately six months after announcing top-line results from
the Phase 3 trials. Cubist plans to begin Phase 3 studies in nosocomial
pneumonia around mid-year 2013. The FDA granted a Qualified Infectious Disease
Products (QIDP) designation for all three indications and granted Fast Track
status for ceftolozane/tazobactam in cIAI. As a result of the QIDP
designation, if ceftolozane/tazobactam is ultimately approved by the FDA, it
would also receive a five-year extension of Hatch-Waxman exclusivity.

Cubist previously obtained the rights, outside of these Asia-Pacific and
Middle East territories, to develop and commercialize ceftolozane/tazobactam
through its acquisition of Calixa Therapeutics, Inc. in December 2009.

Under the terms of the agreement, Astellas will receivean upfront payment of
$25 million, and sales of ceftolozane/tazobactam made in the newly-obtained
territories will be counted towards the existing commercial milestone and
royalty terms of the original agreement. Cubist will fund the upfront payment
with cash on hand.

“Today’s agreement underscores our belief that ceftolozane/tazobactam has the
potential to be an important therapy to combat certain serious Gram-negative
bacterial infections,” said Michael Bonney, Chief Executive Officer of Cubist.
“With ownership of the global rights to ceftolozane/tazobactam, Cubist is well
positioned to continue advancing this promising product candidate and capture
the drug’s full potential around the world, if it is approved.”

Astellas hopes this transaction will lead to the contribution to patients
through addressing their unmet medical needs.

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.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. Astellas has
approximately 17,000 employees worldwide. The organization is committed to
becoming a global category leader in Urology, Immunology (including
Transplantation) and Infectious Diseases, Oncology, Neuroscience and DM
Complications and Kidney Diseases. For more information on Astellas Pharma
Inc., please visit the company Website at www.astellas.com/en.

Cubist Safe Harbor Statement

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Any statements contained herein which do not describe
historical facts, including but not limited to, statements regarding: (i) a
five year extension of Hatch-Waxman exclusivity if ceftolozane/tazobactam is
ultimately approved by the FDA and (ii) the development, regulatory filing and
review, including the expected timing of our Phase 3 clinical trials in
nosocomial pneumonia, clinical trial data readouts and NDA filing for
ceftolozane/tazobactam in cUTI and cIAI, and commercial and therapeutic
potential of ceftolozane/tazobactam, are forward-looking statements which
involve risks and uncertainties that could cause actual results to differ
materially from those discussed in such forward-looking statements.

Such risks and uncertainties include, among others: clinical trials of
ceftolozane/tazobactam may not be successful or initiated or conducted in a
timely manner; 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 ceftolozane/tazobactam; we plan
to rely, to a significant extent, on third party contract manufacturers and
suppliers to manufacture and supply ceftolozane/tazobactam on our behalf so
our ability to obtain adequate supplies of ceftolozane/tazobactam 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 ceftolozane/tazobactam; our ability to
successfully develop, gain marketing approval for and commercially launch
ceftolozane/tazobactam for its planned indications and on the timelines that
we expect and those additional factors discussed in our most recent annual
report on Form 10-K filed with the Securities and Exchange Commission. 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:

Cubist Pharmaceuticals, Inc.
INVESTORS:
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Julie DiCarlo, 781-860-8063
Senior Director, Corporate Communications
julie.dicarlo@cubist.com
or
Astellas Pharma Inc.
Corporate Communications
TEL: +81-3-3244-3201, FAX:+81-3-5201-7473
http://www.astellas.com/en
 
Press spacebar to pause and continue. Press esc to stop.