Pfenex Reports Positive Results for PF708 Comparative Use Human Factors Study
October 14 2019 - 8:00AM
Pfenex Inc. (NYSE American: PFNX) announced today it has
successfully completed the PF708 comparative use human factors (HF)
study and submitted the final study report to the FDA. The study
found that the user interface of the FDA-approved PF708 product was
noninferior to that of Forteo® for each critical user task
evaluated in the study. Pfenex believes this submission completes
the information package required by the FDA to evaluate the
therapeutic equivalence of the PF708 product. Pfenex is seeking FDA
designation of the recently-approved product as therapeutically
equivalent (“A” rated) to Forteo, which would permit PF708 to be
automatically substituted for Forteo in many states.
“We are very pleased with the outcome of the human factors
study, which we believe demonstrates noninferiority between the
user interfaces of our product and Forteo,” said Eef
Schimmelpennink, Chief Executive Officer of Pfenex. “We look
forward to the FDA’s review of the study report, along with the
bioequivalence and pharmaceutical equivalence data in our recently
approved NDA. We believe these results complete the information
package required by the FDA to evaluate therapeutic equivalence of
our PF708 product,” commented Mr. Schimmelpennink.
The comparative use HF study was a simulated use study intended
to evaluate the effect of each product’s delivery device and user
interface on critical task performance by untrained osteoporosis
patients and caregivers. The study used a paired design of the
FDA-approved PF708 and the Forteo products.
A total of 102 untrained participants, 52 osteoporosis patients
and 50 caregivers, completed the study. For 67% (12 of 18) of
critical tasks performed in the patient user group, and 83% (15 of
18) performed in the caregiver group, PF708 had fewer or equal user
errors when compared to Forteo. Importantly, in each of the
instances where PF708 had marginally higher user error rates (33%
and 17 % of critical tasks among patients and caregivers,
respectively), the magnitude of the differences was such that no
error difference in either user group exceeded the predetermined
maximum allowable difference. For these reasons, Pfenex believes
the study data demonstrate that the user interface of the
FDA-approved PF708 product is noninferior to that of Forteo. With
submission of the final study report to FDA, the agency can begin
its review of the relevant data to make a therapeutic equivalence
determination.
About PF708
PF708 was 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). Pursuant to
the Development and License Agreement with NT Pharma Group Company
Ltd. (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.
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; and Pfenex’s belief that the comparative use human
factors study 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, the FDA may disagree that the human
factors study report completes the information package and is
sufficient to evaluate therapeutic equivalence; the FDA may not
agree with Pfenex's interpretation of the results of the human
factors study and may not grant an “A” therapeutic equivalence
designation for PF708; 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 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
Pfenex (AMEX:PFNX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pfenex (AMEX:PFNX)
Historical Stock Chart
From Apr 2023 to Apr 2024