Pfenex Earns $11 Million Development Milestone under its Development and License Agreement with Jazz Pharmaceuticals
September 05 2019 - 4:05PM
Pfenex Inc. (NYSE American: PFNX) today announced that it has
earned an $11 million development milestone under its development
and license agreement with Jazz Pharmaceuticals. The milestone is
associated with process development activities for PF745, a
recombinant crisantaspase with half-life extension technology.
“We are very pleased with our progress on PF745
and we believe the Jazz collaboration overall further validates the
versatility of our proprietary protein expression platform and the
quality of our development capabilities,” said Eef Schimmelpennink,
Chief Executive Officer of Pfenex. “Similarly, we are appreciative
of the progress recently reported by Jazz on PF743 (JZP-458) with
the completion of the Phase 1 study and announcement of plans to
initiate a Phase 2/3 study later in 2019.”
Under the terms of the development and license
agreement, Pfenex is eligible to receive an aggregate total of up
to $224.5 million in development and sales milestone fees, of which
$177.5 million is still eligible to be received by Pfenex. Of this
$177.5 million, $18.5 million are development milestones, $34
million are regulatory milestones, and $125 million are sales
milestones. Pfenex may also be eligible to receive tiered royalties
on worldwide sales of any products resulting from the
collaboration.
About Pfenex Inc.
Pfenex is a clinical-stage development and
licensing biotechnology company focused on leveraging its Pfēnex
Expression Technology® to develop and improve protein therapies for
unmet patient needs. Using the patented Pfēnex Expression
Technology platform, Pfenex has created an advanced pipeline of
potential therapeutic equivalents, vaccines, biologics and
biosimilars. Pfenex’s lead product candidate is PF708, a
therapeutic equivalent candidate to Forteo® (teriparatide) for the
treatment of osteoporosis. In addition, Pfenex is developing
hematology/oncology products, including PF743, a recombinant
crisantaspase, and PF745, a recombinant crisantaspase with
half-life extension technology, in collaboration with Jazz
Pharmaceuticals. Pfenex also uses its Pfēnex Expression Technology
platform to produce CRM197, a diphtheria toxoid carrier protein
used in prophylactic and therapeutic vaccines.
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/), its
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.
Cautionary Note Regarding Forward-Looking
Statement
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, you can identify forward-looking statements 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 future expectations, strategy,
plans or intentions. Forward-looking statements in this press
release include, but are not limited to, statements regarding the
future potential of Pfenex's product candidates and the company in
general, including future plans to advance, develop, manufacture
and commercialize its product candidates, Jazz’s expectation to
initiate a single arm pivotal Phase 2/3 study later this year, and
Pfenex’s expectations with regard to future milestones and royalty
payments from Pfenex’s collaboration with Jazz Pharmaceuticals.
Pfenex's expectations and beliefs regarding these matters may not
materialize, and actual results in future periods are subject to
risks and uncertainties that could cause actual results to differ
materially from those projected. 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, Pfenex's
ability to successfully demonstrate the efficacy and safety of its
product candidates; the pre-clinical and clinical results for its
product candidates, which may not support further development of
product candidates or may require Pfenex to conduct additional
clinical trials or modify ongoing clinical trials or regulatory
pathways; challenges related to commencement, patient enrollment,
completion, and analysis of clinical trials; difficulties in
achieving and demonstrating biosimilarity in formulations; Pfenex's
ability to manage operating expenses; 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; litigation and other proceedings regarding
intellectual property rights, including potential future litigation
by Eli Lilly and Company with respect to PF708; and difficulties in
obtaining and maintaining intellectual property protection for its
product candidates. Information on these and additional risks,
uncertainties, and other information affecting Pfenex's business
and operating results is contained in Pfenex’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2019 filed with the
Securities and Exchange Commission and in its other filings 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.
Company Contact:Susan A. KnudsonChief Financial
Officer(858) 352-4324sknudson@pfenex.com
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