Pfenex Announces Successful Expiration of 45 Day Waiting Period Under Hatch-Waxman Act
April 11 2019 - 8:05AM
Pfenex Inc. (NYSE American: PFNX) a clinical-stage development and
licensing biotechnology company focused on leveraging its Pfēnex
Expression Technology® to improve protein therapies for unmet
patient needs, today announced the expiration of the 45-day period
for Eli Lilly & Co. (“Lilly”) to file a lawsuit under the
Hatch-Waxman Act and stay the approval of PF708 for 30 months.
Because Lilly did not file a lawsuit within this time period, there
will be no 30-month litigation stay delaying approval of PF708, and
if approved by the U.S. Food and Drug Administration (“FDA”),
Pfenex will be able to engage in the commercial manufacture, use,
or sale of PF708.
Pfenex provided notice of Paragraph IV certification (“Notice
Letter”) to Lilly on February 19, 2019 that PF708, which is a
proposed generic version of Lilly’s drug FORTEO® (teriparatide
[rDNA origin] injection) 0.6MG/2.4ML (0.25MG/ML), does not infringe
any valid claim of U.S. Patent No. 7,517,334 (“the ’334 patent”).
The ’334 patent is listed in the Approved Drug Products with
Therapeutic Equivalence Evaluations, known as the Orange Book, for
Lilly’s drug FORTEO®. Under the Hatch-Waxman Act, Lilly had 45 days
from the receipt of the Notice Letter to file a patent infringement
lawsuit against Pfenex that would cause a 30-month litigation stay
of approval for PF708.
“Pfenex is pleased with the outcome of the 45-day waiting period
process for PF708. Pfenex, along with its partner Alvogen, continue
to focus on launch preparation and look forward to the opportunity
of providing access to patients in need of this critical therapy if
approved by the FDA,” states Eef Schimmelpennink, CEO of
Pfenex.
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, Pfenex has created an
advanced pipeline of therapeutic equivalents, vaccines, biologics
and biosimilars. Pfenex also uses its Pfēnex Expression Technology
platform to produce CRM197, a diphtheria toxoid carrier protein
used in prophylactic and therapeutic vaccines. Pfenex’s lead
product candidate is PF708, a therapeutic equivalent candidate to
Forteo® (teriparatide) for the treatment of osteoporosis. In
addition, Pfenex is developing hematology/oncology products,
including PF743, a recombinant crisantaspase, and PF745, a
recombinant crisantaspase with half-life extension technology, in
collaboration with Jazz Pharmaceuticals.
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 StatementsThis 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 Pfenex’s and
its collaboration partner’s focus on launch preparation and ability
to provide access to PF708 if approved by FDA. 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 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
Annual Report on Form10-K for the period ended December 31, 2018
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
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