DUBLIN and SAN DIEGO, July 28,
2016 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)
and Pfenex Inc. (NYSE MKT: PFNX) today announced an agreement under
which Pfenex granted Jazz Pharmaceuticals worldwide rights to
develop and commercialize multiple early stage hematology product
candidates. The agreement also includes an option for Jazz
Pharmaceuticals to negotiate a license for a recombinant
pegaspargase product candidate with Pfenex. This early
development stage collaboration demonstrates Jazz Pharmaceuticals'
focus on identifying innovative technologies that may lead to the
development of important therapeutic options for patients with
hematological malignancies.
Under the agreement, Pfenex will receive upfront and option
payments totaling $15 million and may
be eligible to receive additional payments of up to $166 million based on the achievement of certain
development-, regulatory-, and sales-related milestones, including
up to $41 million for certain
non-sales-related milestones. Pfenex may also be eligible to
receive tiered royalties on worldwide sales of any products
resulting from the collaboration. Both parties will be contributing
to development efforts.
"The collaboration with Pfenex, including access to its unique
protein expression technology, demonstrates our emphasis on
diversifying and strengthening our portfolio to provide improved
therapeutic options for patients." said Karen Smith M.D., Ph.D, global head of research
and development and chief medical officer at Jazz Pharmaceuticals
plc. "We look forward to working with Pfenex on the
development of multiple product candidates that have the potential
to broaden our hematology/oncology portfolio."
"Our collaboration with Jazz further validates Pfenex's product
development capability enabled by our protein expression platform
technology. We look forward to working with Jazz on these
assets in support of further advancement in clinical development,"
said Bertrand C. Liang, chief
executive officer of Pfenex.
About Pfenex Inc.
Pfenex Inc. (NYSE MKT: PFNX) is a
clinical-stage biotechnology company engaged in the development of
biosimilar therapeutics and high-value and difficult to manufacture
proteins. The company's lead product candidate is PF582, a
biosimilar candidate to Lucentis (ranibizumab), for the potential
treatment of patients with retinal diseases. Pfenex has
leveraged its Pfēnex Expression
Technology® platform to build a pipeline of
product candidates and preclinical products under development
including other biosimilars, as well as vaccines, therapeutic
equivalents to reference listed drug products, and next generation
biologics. For more information, please visit
www.pfenex.com.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) is an international biopharmaceutical company
focused on improving patients' lives by identifying, developing and
commercializing meaningful products that address unmet medical
needs. The company has a diverse portfolio of products and
product candidates, with a focus in the areas of sleep and
hematology/oncology. In these areas, Jazz Pharmaceuticals
markets Xyrem® (sodium oxybate) oral solution, Erwinaze®
(asparaginase Erwinia chrysanthemi) and Defitelio®
(defibrotide sodium) in the U.S. and markets Erwinase® and
Defitelio® (defibrotide) in countries outside the U.S. For more
information, please visit www.jazzpharmaceuticals.com.
Jazz Pharmaceuticals' "Safe Harbor" Statement under the
Private Securities Litigation Reform Act of 1995
This press
release contains forward-looking statements, including, but not
limited to, statements related to the potential benefits of certain
preclinical product candidates and related development activities,
potential future payments to Pfenex by Jazz Pharmaceuticals, the
potential broadening of Jazz Pharmaceuticals' product portfolio and
other statements that are not historical facts. These
forward-looking statements are based on Jazz Pharmaceuticals'
current plans, objectives, estimates, expectations and intentions,
and inherently involve significant risks and uncertainties.
Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without
limitation, risks and uncertainties associated with the difficulty
and uncertainty of pharmaceutical product development and the
uncertainty of preclinical and clinical success, and the risks and
uncertainties described from time to time under the caption "Risk
Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and
Exchange Commission filings and reports (Commission File No.
001-33500), including the company's Quarterly Report on Form 10-Q
for the quarter ended March 31, 2016
and future filings and reports by the company. Other risks
and uncertainties of which Jazz Pharmaceuticals is not currently
aware may also affect its forward-looking statements and may cause
actual results and timing of events to differ materially from those
anticipated. The forward-looking statements herein are made
only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by Jazz Pharmaceuticals on its website or
otherwise. Jazz Pharmaceuticals does not undertake any
obligation to update or supplement any forward-looking statements
to reflect actual results, new information, future events, changes
in expectations or other circumstances that exist after the date as
of which the forward-looking statements were made.
Pfenex Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements generally
relate to future events or Pfenex's future financial or operating
performance. In some cases, forward-looking statements can be
identified because they contain words such as "may," "will,"
"should," "expects," "plans," "anticipates," "could," "intends,"
"target," "projects," "contemplates," "believes," "estimates,"
"predicts," "potential" or "continue" or the negative of these
words or other similar terms or expressions that concern Pfenex's
expectations, strategy, plans or intentions. Forward-looking
statements in this press release include, but are not limited to,
statements regarding the future potential of the hematology product
candidates, including future plans to develop, manufacture and
commercialize these product candidates; the potential to receive
future milestone and royalty payments under Pfenex's agreements
with Jazz Pharmaceuticals; and the belief that these product
candidates may lead to therapeutic options for patients with
hematological malignancies. Actual results may differ
materially from those indicated by these forward-looking statements
as a result of the uncertainties inherent in the clinical drug
development process, including, without limitation, challenges in
successfully demonstrating the efficacy and safety of product
candidates; the pre-clinical and clinical results for product
candidates, which may not support further development of product
candidates or may require additional clinical trials or
modifications of ongoing clinical trials or regulatory pathways;
challenges related to commencement, patient enrollment, completion,
and analysis of clinical trials; Pfenex's ability to obtain
additional funding to support its business activities and establish
and maintain strategic business alliances and new business
initiatives; Pfenex's dependence on third parties for development,
manufacture, marketing, sales and distribution of products;
unexpected expenditures; and difficulties in obtaining and
maintaining intellectual property protection for product
candidates. Information on these and additional risks,
uncertainties, and other information affecting Pfenex's business
and operating results is contained in Pfenex's Annual Report on
Form 10-K for the year ended December 31, 2015, Pfenex's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, and in Pfenex's subsequent
reports filed with the Securities and Exchange Commission.
The forward-looking statements in this press release are
based on information available to Pfenex as of the date hereof, and
Pfenex disclaims any obligation to update any forward-looking
statements, except as required by law.
Pfenex investors and others should note that Pfenex announces
material information to the public about Pfenex through a variety
of means, including its website (http://www.pfenex.com/), investor
relations website (http://pfenex.investorroom.com/), press
releases, SEC filings, public conference calls, corporate Twitter
account (https://twitter.com/pfenex), Facebook page
(https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/),
and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in
order to achieve broad, non-exclusionary distribution of
information to the public and to comply with its disclosure
obligations under Regulation FD. Pfenex encourages its
investors and others to monitor and review the information Pfenex
makes public in these locations as such information could be deemed
to be material information. Please note that this list may be
updated from time to time.
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