Pfenex Inc. (NYSE American: PFNX) announced today the achievement
of several significant milestones across their business portfolio.
Theramex, the European commercialization partner for Pfenex and
Adalvo (formerly Alvogen B2B), received a positive opinion for
PF708 (branded in Europe as Livogiva™) from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA). Additionally, Adalvo recently entered into a
commercialization agreement with a multinational pharmaceutical
company to commercialize PF708, upon receipt of marketing
authorization, in certain countries in Latin America.
Merck recently announced that V114, its
investigational 15-valent pneumococcal conjugate vaccine met safety
and immunogenicity objectives in initial Phase 3 studies in adults.
Also, Serum Institute of India announced its first supply agreement
with UNICEF for Pneumosil™, a 10-valent pneumococcal vaccine
developed to address pneumococcal infection in low- and
middle-income countries. Both V114 and Pneumosil contain
CRM197 produced via license agreements to the Pfenex Expression
Technology, pursuant to which Pfenex may earn development milestone
payments and royalties on net product sales.
“This is an exciting time for Pfenex as we
continue to achieve meaningful clinical, regulatory and commercial
milestones across our pipeline, highlighted today by the positive
opinion on Livogiva from the CHMP and the announcement of positive
results in two of Merck’s Phase 3 studies for the Merck V114
vaccine,” said Pfenex CEO Eef Schimmelpennink. “Over the past few
years, we have had a relentless, laser like focus on our core
portfolio and we believe those efforts are paying off.”
“With Alvogen’s U.S. launch of Teriparatide
Injection and Serum Institute of India’s Pneumosil supply agreement
with UNICEF, we now have two royalty bearing commercial products, a
critical milestone as we continue our transition towards novel
biopharmaceutical development,” said Mr. Schimmelpennink.
Earlier today, StreetAccount issued a release
that erroneously described Livogiva as a Teva product. In
order to address this incorrect information, Pfenex asked the NYSE
to temporarily halt trading in Pfenex’s stock.
PF708: CHMP Positive Opinion & Latin
America Commercial Partner
The Committee for Medicinal Products for Human Use has adopted a
positive opinion recommending marketing authorization for PF708,
which will be branded in Europe as Livogiva™ (teriparatide
injection), a biosimilar product candidate to the reference
medicine Forsteo® (teriparatide injection) indicated for uses
including in postmenopausal women with osteoporosis who are at high
risk for having bone fractures. The CHMP’s recommendation will now
be considered by the European Commission, which typically issues a
decision within 67 days of CHMP’s recommendation.
If the European Commission affirms the CHMP opinion, it will
grant a marketing authorization with unified labeling that is valid
in the more than 25 countries that are members of the European
Union, as well as European Economic Area members, Iceland,
Liechtenstein and Norway. The version of Livogiva that is approved
for marketing in the United States is Teriparatide Injection
(previously referred to as PF708, as well as Bonsity), which the
U.S. Food and Drug Administration (FDA) continues to evaluate for
therapeutic equivalence to its reference drug Forteo®.
In addition, Pfenex announced Adalvo has
partnered with a large, multinational pharmaceutical firm to
commercialize PF708, upon receipt of marketing authorization, in
Brazil, Columbia, Mexico, Ecuador, Paraguay, and Peru in Latin
America.
“The CHMP positive opinion on Livogiva and the
addition of a global, distinguished partner in Latin America are
each important steps in our global regulatory and commercial plans
that aim to provide a teriparatide product to patients in European
and Latin American markets in a cost effective manner,” said Faysal
Kalmoua, Alvogen’s Executive Vice President of Portfolio.
CRM197: Serum Institute of India Supply
Arrangement
Serum Institute of India announced a new arrangement with UNICEF
to supply ten million doses of Pneumosil, a 10-valent pneumococcal
conjugate vaccine, annually for a period of ten years. The
supply arrangement will allow low- and middle-income countries to
access the drug. Pneumococcus bacterium is a leading cause of
severe pneumonia and major cause of morbidity and mortality
worldwide. The arrangement was contracted under UNICEF’s
Vaccine Alliance’s Advance Market Commitment and represented the
first such arrangement between UNICEF and a developing country
manufacturer. Serum Institute currently has a license to the
Pfenex Expression Technology for the production of the carrier
protein CRM197 a key component of the Pneumosil vaccine. In
accordance with the license agreement, Pfenex is eligible to
receive royalties on net sales.
CRM197: Merck V114 Phase 3 Study Readouts
Merck and Co. Inc. announced results from two
initial Phase 3 studies evaluating the safety, tolerability and
immunogenicity of V114, the company’s investigational 15-valent
pneumococcal conjugate vaccine and were published via the
International Symposium on Pneumococci and Pneumococcal Diseases
(ISPPD) online digital library. Merck also announced its plans
to continue to work with the FDA and other regulatory authorities
around the world on filing plans for licensure of this vaccine as
additional data from the Phase 3 program become available.
Merck currently has a license to the Pfenex Expression Technology
for the production of the carrier protein CRM197 a key component of
the V114 vaccine. In accordance with the license agreement Pfenex
is eligible to receive milestone payments and royalties on net
sales.
About PF708
PF708 was approved in the U.S. under the
505(b)(2) regulatory pathway, with Forteo® (teriparatide injection)
as the reference drug, and commercially launched as Teriparatide
Injection. Teriparatide Injection is indicated, among other uses,
for the treatment of osteoporosis in certain patients at high risk
for fracture. Pursuant to the Development and License Agreement
with Alvogen, Pfenex has transferred the new drug application (NDA)
for Teriparatide Injection to Alvogen, and Alvogen is responsible
for manufacturing and commercializing the product in the U.S. and
for fulfilling all regulatory requirements associated with
maintaining the Teriparatide Injection NDA. Alvogen also has
exclusive rights to commercialize and manufacture PF708 in the
European Union (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,
which will be branded in Europe as Livogiva, has been filed
and accepted with the EMA using the biosimilar pathway with
Forsteo® as the reference medicinal product, and the CHMP has
issued a positive opinion; and a marketing authorization
application for PF708 has been filed with the Kingdom of Saudi
Arabia's SFDA.
Pursuant to the Development and License
Agreement with China NT Pharma Group Company Limited (NT Pharma),
we granted an exclusive license to NT Pharma to commercialize PF708
in Mainland China, Hong Kong, Singapore, Malaysia and Thailand and
a non-exclusive license to conduct development activities in such
territories with respect to PF708. Effective April 2020, Pfenex
entered into a Deed of Assignment and Amendment with NT
Pharma. Pursuant to the Deed of Assignment, Pfenex agreed to
allow NT Pharma to assign its rights and obligations under the NT
Pharma agreement with Pfenex to Beijing Kangchen Biological
Technology Co., Ltd. (Kangchen), a wholly-owned subsidiary of
Beijing Konruns Pharmaceutical Co., Ltd.
Forteo® and Forsteo® are approved and marketed
by Eli Lilly and Company for the treatment of osteoporosis in
certain patients with a high risk for fracture. Forteo® and
Forsteo® achieved $1.4 billion in global product sales in 2019.
About Pfenex Inc.
Pfenex is a development and licensing
biotechnology company with commercial products focused on
leveraging its proprietary protein production platform, Pfenex
Expression Technology®, to develop next generation and novel
protein therapeutics to meaningfully improve existing therapies and
create novel therapies for some of the biological targets linked to
critical diseases still waiting to successfully be addressed. Using
the patented Pfenex Expression Technology platform, Pfenex has
created a broad pipeline that is diversified across multiple
assets, including U.S. Food and Drug Administration (FDA) approved,
next generation and novel biopharmaceutical products. Pfenex’s lead
product is Teriparatide Injection (previously referred to as PF708
and Bonsity™), a therapeutic equivalent candidate to Forteo®
(teriparatide injection). Teriparatide Injection has been
commercialized in the U.S. for, among other uses, the treatment of
osteoporosis in certain patients at high risk for fracture, and
marketing authorization applications are pending in other
jurisdictions. In addition, Pfenex is developing hematologic
oncology products in collaboration with Jazz Pharmaceuticals,
including PF743, a recombinant Erwinia asparaginase, and PF745, a
half-life extended recombinant Erwinia asparaginase. Pfenex also
uses its Pfenex Expression Technology platform to produce CRM197, a
diphtheria toxoid carrier protein for use 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
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, 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 developed
products, product candidates, and the company in general, including
the potential to obtain marketing authorization in the European
Union for PF708 (branded in Europe as Livogiva™); the expected
timing of marketing authorization in Europe; the potential to
improve patient access; the potential benefits of PF708; Pfenex’s
expectations with respect to the cost of PF708; potential market
opportunities for PF708; the potential to receive milestone
payments and future royalties; and Pfenex’s expectations with
respect to the potential benefits of Pneumosil. 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 various factors, including: the European Commission
may not affirm the CHMP opinion and grant a centralized marketing
authorization; the FDA may not grant an “A” therapeutic equivalence
designation for Teriparatide Injection; 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; impacts related to the COVID-19 pandemic;
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,
2020 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:
InvestorRelations@pfenex.com
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