Pfenex Inc. (NYSE American: PFNX) and Alvogen today announced that
the European Medicines Agency (EMA) has accepted the Marketing
Authorization Application (MAA) submitted by our partner Alvogen
for PF708 (teriparatide). The product is proposed as a
therapeutic equivalent in the treatment of osteoporosis to Forteo®.
The product is filed with the EMA as a biosimilar in the treatment
of osteoporosis to Forsteo®, which achieved $289 million sales in
the E.U. and $1.6 billion in global product sales in 2018. This
acceptance means the EMA considers the MAA to be complete and
initiates the EMA's formal review process.
“The acceptance of the PF708 MAA filing is an important
milestone for Pfenex and Alvogen and demonstrates that through our
collaborative partnership, we continue making progress towards
potential approvals beyond the United States,” said Eef
Schimmelpennink, Chief Executive Officer of Pfenex. “Subject to
applicable regulatory approvals, for Europe, PF708 will be
commercialized by Theramex, a leading global specialty
pharmaceutical company dedicated to Women’s Health.”
“We are very pleased with the EMA’s acceptance of the MAA for
review. This is an important milestone and underlines the
successful and valuable partnership between Pfenex and Alvogen to
bring biosimilar Teriparatide to market and deliver on our mission
to provide high quality, affordable healthcare for patients. The
EMA will review the application under the centralized marketing
authorization procedure. If approved by the EMA, biosimilar
Teriparatide would receive marketing authorization in all 28 member
states of the European Union (E.U.), as well as in Iceland,
Liechtenstein and Norway,” stated Faysal Kalmoua, Executive Vice
President of Alvogen’s Global Portfolio.
About PF708PF708 is being
developed by Pfenex as a therapeutic equivalent candidate to
Forteo®, which is approved and marketed by Eli Lilly and Company
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. PF708 is being developed pursuant to the 505(b)(2)
regulatory pathway in the U.S. and references Forteo® as the
Reference Listed Drug. PF708 has been filed with EMA using the
biosimilar pathway and references Forsteo® as the Reference
Drug.
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, the Company has
created an advanced pipeline of potential therapeutic equivalents,
novel biologics, vaccine and vaccine components, and biosimilars.
The Company’s lead product candidate is PF708, under development as
a therapeutic equivalent drug candidate to Forteo® (teriparatide)
indicated for the treatment of osteoporosis. In addition, the
Company is developing hematology/oncology products, including
PF743, a recombinant crisantaspase, and PF745, a recombinant
crisantaspase with half-life extension, in collaboration with Jazz
Pharmaceuticals Ireland Limited (Jazz). Both PF743 and PF745 are
being developed for the treatment of Acute Lymphoblastic Leukemia
(ALL). We also use our Pfēnex Expression Technology platform to
produce CRM197, a diphtheria toxoid carrier protein used in
prophylactic and therapeutic vaccine candidates under development
by third parties.
Pfenex investors and others should note that we announce
material information to the public about the Company through a
variety of means, including our website (http://www.pfenex.com/),
our 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 our disclosure
obligations under Regulation FD. We encourage our investors and
others to monitor and review the information we make 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.
About AlvogenAlvogen is a
global, privately owned pharmaceutical company focused on
developing, manufacturing and selling generic, brand,
over-the-counter brands (OTC) and biosimilar products for patients
around the world. The company has commercial operations in 35
countries with 2,800 employees and operates four manufacturing and
development hubs in the U.S., Romania, Korea and Taiwan. North
America is Alvogen’s single largest market and other key markets
include: South Korea, Russia, Romania, Hungary, Ukraine, Taiwan,
Japan and China. Learn more about Alvogen at www.alvogen.com.
About TheramexTheramex is
leading, global specialty pharmaceutical company dedicated to women
and their health. With a broad portfolio of innovative and
established brands covering contraception, fertility, menopause and
osteoporosis, we support women at every stage of their lives. Our
commitment is to listen and understand our patients, serve their
needs, and offer healthcare solutions to help improve their lives.
Our vision is to be a lifetime partner for women and the healthcare
professionals who treat them by providing innovative, effect
solutions that care for and support women as they advance through
each stage of their lives.
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; the possibility of the
potential commercial US launch of PF708 as early as the fourth
quarter of 2019;and Pfenex’s belief that through its collaborative
partnership with Alvogen it could potentially receive approvals
beyond the US for PF708. 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; 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; 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 March 31, 2019
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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