Pfenex Announces FDA Requests Additional Comparative Use Human Factors Data in Experienced Users in order to Complete PF708 T...
April 14 2020 - 05:04PM
Pfenex Inc. (NYSE American: PFNX) announced today that the U.S.
Food and Drug Administration (FDA), informed Alvogen Malta
Operations Ltd., the Company’s commercialization partner for PF708,
via a General Advice letter that additional comparative use human
factors (CUHF) data, specifically from Forteo® (teriparatide
injection) experienced users, would be required before PF708
Therapeutic Equivalence (TE) could be determined.
“While the previously submitted CUHF study included
Forteo-experienced patients and caregivers, the FDA requested that
a larger number of experienced subjects be studied,” stated Eef
Schimmelpennink, Chief Executive Officer of Pfenex. “In the
correspondence the FDA has indicated that the review of the PF708
TE package continues and provided guidance on study methodology to
generate this additional comparative use human factors data, which
we are confident can be met. We intend to work closely with Alvogen
and the FDA to expeditiously move toward a solution addressing the
Agency’s expressed views, so that we can submit additional data as
soon as possible. Additionally, we will continue to support Alvogen
with its commercial strategy planning in the U.S. while continuing
to seek “A” therapeutic equivalence designation.”
About Pfenex Inc.
Pfenex is a development and licensing biotechnology company
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 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 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
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 expectations to submit additional human factors
data to FDA, the potential commercial launch of PF708 in the U.S.,
and expectations with respect to a comparative use human factor
study that addresses the FDA’s views. 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 not agree with Pfenex's
protocol for a 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; 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, manufacturing,
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 Annual Report on Form 10-K for
the year ended December 31, 2019 filed with the
Securities and Exchange Commission on March 11, 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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