Pfenex Receives U.S. FDA Approval for PF708 to Treat Osteoporosis
07 October 2019 - 8:00PM
Pfenex Inc. (NYSE American: PFNX) announced today that the U.S.
Food and Drug Administration (FDA) has approved the new drug
application (“NDA”) for PF708 submitted under the 505(b)(2)
regulatory pathway, with Forteo® (teriparatide injection) as the
reference drug. Like Forteo, the FDA-approved PF708 product is
indicated for the treatment of osteoporosis in certain patients at
high risk for fracture.
“The FDA’s approval of PF708 marks a major milestone in Pfenex’s
history as our first approved commercial product and further
validates our Pfēnex Expression Technology platform. We look
forward to continuing to work with our commercialization partner
Alvogen to launch PF708 in the U.S. We believe PF708 has the
potential to significantly enhance patient access to an important
therapy as a cost-effective alternative to Forteo, which had $1.6
billion in global sales in 2018,” said Eef Schimmelpennink, Chief
Executive Officer of Pfenex.
Pfenex is also asking the FDA to designate PF708 as
therapeutically equivalent (“A” rated) to Forteo, which would
permit PF708 to be automatically substituted for Forteo in many
states. To further support an “A” rating, Pfenex is conducting a
comparative human factors study between PF708 and Forteo as
requested by FDA. Pfenex anticipates submitting the final study
report to the FDA as early as the second half of October 2019 and
believes that this completes the information package required by
the FDA to evaluate the therapeutic equivalence of PF708.
“Looking ahead, we are confident in the planning that Alvogen
has done thus far in preparation for the commercial launch of PF708
and their established sales and marketing teams are excited to
bring PF708 to market. To optimize patient and payer impact, we
currently expect our commercial partner Alvogen to launch PF708
upon an FDA decision on the therapeutic equivalence rating,”
concluded Mr. Schimmelpennink.
About PF708
PF708 is approved in the U.S. under the 505(b)(2) regulatory
pathway, with Forteo® (teriparatide injection) as the reference
drug. The U.S. approved PF708 product is indicated for the
treatment of osteoporosis in certain patients at high risk for
fracture. Pursuant to the Development and License Agreement
with Alvogen, Alvogen is responsible for commercializing and
manufacturing PF708 in the U.S. and for fulfilling all regulatory
requirements associated with maintaining the PF708 NDA. Alvogen
also has exclusive rights to commercialize and manufacture PF708 in
the EU, certain countries in the Middle East and North Africa
(MENA), and the rest of world (ROW) territories (the latter defined
as all countries outside of the EU, U.S. and MENA, excluding
Mainland China, Hong Kong, Singapore, Malaysia and Thailand). PF708
has been filed and accepted with the EMA using the biosimilar
pathway with Forsteo® as the reference medicinal product. Forteo®
and Forsteo® are approved and marketed by Eli Lilly companies for
the treatment of osteoporosis in certain patients with a high risk
of fracture. Forteo® achieved $1.6 billion in global product sales
in 2018.
About Pfenex Inc.
Pfenex is a 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 injection) which has been
approved in the U.S. for the treatment of osteoporosis in certain
patients at high risk of osteoporosis, and for which marketing
authorization applications are pending in other jurisdictions. In
addition, Pfenex is developing hematology/oncology products in
collaboration with Jazz Pharmaceuticals, including PF743, a
recombinant crisantaspase, and PF745, a recombinant crisantaspase
with half-life extension technology. 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; Pfenex’s expectations with regard to future milestones
and royalty payments from Pfenex’s collaboration with Alvogen
statements relating to PF708, including but not limited to
potential market opportunities and the benefits of use of PF708;
the timing of the potential commercial launch of PF708 in the U.S.;
and Pfenex’s expectations regarding the timing and advancement of
the human factors study, including the submission of the study
report to the FDA and Pfenex’s belief that such report completes
the information package required by the FDA to evaluate therapeutic
equivalence. 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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