Pfenex Inc. (NYSE American: PFNX) today announced that its partner
Alvogen has entered into exclusive commercialization agreements for
PF708 with PharmBio Korea in South Korea, JAMP Pharma in Canada and
Kamada Ltd. in Israel. Furthermore, Alvogen’s partner in the Middle
East and North Africa (MENA) region, SAJA, submitted a Marketing
Authorization Application (MAA) to the Kingdom of Saudi Arabia's
Saudi Food and Drug Authority (SFDA). Additionally, the accepted
MAA for PF708 under review by the European Medicines Agency (EMA)
continues to make progress and Pfenex believes that PF708 could be
approved in the European Union (EU) as early as the second half of
2020, pending marketing authorization by the European Commission
under the EU centralized procedure and other
factors.
“The new commercialization agreements in South
Korea, Canada, and Israel, the filing of the PF708 MAA with the
Saudi Food and Drug Authority, and the progress on Alvogen’s
submission in Europe are important milestones for the PF708
commercialization program,” said Eef Schimmelpennink, Chief
Executive Officer of Pfenex. “These are just the latest steps
forward in our global commercialization strategy for PF708 as we
continue to build positive momentum with our commercial partner,
Alvogen.”
Faysal Kalmoua, Executive Vice President of
Alvogen’s Global Portfolio, added, “We are very pleased with the
latest submissions for PF708 and new commercial agreements with our
partners in Canada, South Korea and Israel. Through our strong
marketing network and growing pipeline of biosimilars, we can
continue to deliver on our mission to provide high quality,
affordable healthcare for patients.”
Subject to applicable regulatory approvals,
PF708 will be commercialized by PharmBio Korea in Korea, JAMP
Pharma in Canada, and Kamada in Israel. Under the terms of the
agreements, Alvogen will be responsible for overseeing the local
activities through PharmBio Korea, JAMP Pharma and Kamada. Pfenex
will be eligible to receive milestone payments and a percentage of
net sales or transfer price.
PharmBio Korea was founded in 1999 by Mr.
Bong-Kil Nam, its Chairman and CEO. With innovative marketing
strategies and constructive partnerships, PharmBio Korea has
developed a pipeline of innovative products and has licensed and
marketed products in collaboration with pharmaceutical companies in
the EU, Japan, and U.S.
JAMP Pharma is a private Canadian company that
was established in 1988 in British Columbia. Its current
headquarters is in Quebec. JAMP Pharma is a key player in the
generic pharmaceutical industry and one of the fastest growing
pharmaceutical companies in Canada.
Kamada Ltd. is a biopharmaceutical company
specializing in the development, manufacture and marketing of
proteins as pharmaceuticals. The Company's headquarters and
laboratories are located in the park of Kiryat Weizmann Institute
of Science in Rehovot, Israel.
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 FDA-approved PF708 product is
indicated for the treatment of osteoporosis in certain patients at
high risk of 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). A marketing authorization application for
PF708 has been filed and accepted with the EMA using the biosimilar
pathway with Forsteo® as the reference medicinal product and has
been filed with the Kingdom of Saudi Arabia's Saudi Food and Drug
Authority (SFDA). 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® and Forsteo®
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). PF708 has been
approved in the U.S. for the treatment of osteoporosis in certain
patients at high risk of fracture, and 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; the possibility that PF708 could be approved in the EU
as early as second half of 2020; and Pfenex’s development and
commercialization strategy for PF708 in collaboration with Alvogen
and others. 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,; 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
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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