ATHLONE, Ireland, March 29, 2017 (GLOBE NEWSWIRE)
-- Innocoll Holdings plc (NASDAQ:INNL) ("Innocoll" or the
"Company"), a global, commercial-stage, specialty pharmaceutical
and medical device company, today announced receipt of formal Type
A Meeting minutes from the United States Food and Drug
Administration (FDA) relating to its New Drug Application (NDA) for
XARACOLL (bupivacaine HCl collagen-matrix implant). XARACOLL
is the company's product in development for the treatment of
postsurgical pain.
Innocoll received a Refusal to File (RTF) Letter
from the FDA in December 2016 pertaining to the XARACOLL NDA
initially submitted on October 31, 2016. In the RTF letter,
the FDA indicated among other things, that XARACOLL should be
characterized as a drug/device combination, which would require
that the Company submit additional information. During the
Type A meeting, representatives of the FDA, after reviewing
information provided by Innocoll to address matters raised in the
RTF letter, provided guidance which was confirmed in the formal FDA
meeting minutes. The minutes serve as the official record of
the FDA response to our proposal to address certain issues raised
in the RTF by conducting an additional short-term pharmacokinetic
study and several short-term non-clinical toxicology and
biocompatibility studies. Innocoll believes, if adequately financed
and successful, such studies may be completed in time for a
resubmission of the NDA at the end of 2017. Data from these
studies, along with additional manufacturing information required
to address the new combination product designation and other
chemistry, manufacturing and control (CMC) issues, are expected to
be included in the resubmission. The acceptability of this
data and other data that we reviewed with FDA during the meeting
will be evaluated by the FDA during its review of the
resubmission.
"I am pleased that we have clarified the data
needed to address the questions raised in the RTF letter. With the
official minutes from the FDA now in hand, we believe that we have
a path forward for a possible resubmission of the XARACOLL NDA by
the end of 2017, assuming adequate financing to commence the
proposed studies, and further assuming positive results," said Tony
Zook, CEO of Innocoll.
About XARACOLL®
XARACOLL is Innocoll's late-stage surgically
implantable and bioresorbable collagen matrix developed to provide
sustained postsurgical pain relief through controlled delivery of
bupivacaine at the surgical site.
About Innocoll Holdings
plc
Innocoll is a global, commercial stage specialty
pharmaceutical and medical device company with late stage
development programs targeting areas of significant unmet medical
need. Innocoll utilizes its proprietary collagen-based technology
platform to develop biodegradable and fully bioresorbable products
and product candidates which can be broken down by the body without
the need for surgical removal or topical application.
Responsibility
Statement
The Directors of the Company accept responsibility
for the information contained in this announcement. To the
best of their knowledge and belief (having taken all reasonable
care to ensure that such is the case), the information contained in
this announcement for which they take responsibility is in
accordance with the facts and does not omit anything likely to
affect the import of such information.
Forward-looking
Statements
Any statements in this press release about our ongoing development
of XARACOLL and our other product candidates; our
interpretation of the data and results from our MATRIX-1 and
MATRIX-2 clinical trials; receiving positive data from additional
studies required to submit a revised NDA, our plans for, and the
expected timing of, our XARACOLL NDA submission with the FDA; our
plans to develop and commercialize XARACOLL and its market
potential; the potential therapeutic and other benefits of XARACOLL
and our other product candidates; Innocoll's current expectations
regarding future events, including statements regarding the
therapeutic benefit, safety profile and commercial value of
XARACOLL, plans and objectives for present and future clinical
trials and results of such trials, the risk that the FDA may not
accept pooled data, plans and objectives for regulatory approval
and other statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend," "goal," "may", "might," "plan,"
"predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors. Such forward-looking
statements involve substantial risks and uncertainties including,
but not limited to, the risk that the FDA and foreign regulatory
authorities may not agree with our interpretation of the data from
our clinical trials of XARACOLL and may require us to conduct
additional clinical trials; such additional trials may not result
in positive data; XARACOLL may not receive regulatory approval or
be successfully commercialized, including as a result of the FDA's
or other regulatory authorities' decisions regarding limitations on
claims that may be made on XARACILL's label and other matters that
could affect its availability or commercial potential; our plans to
develop and manufacture XARACOLL;; the size and growth of the
potential markets for XARACOLL and our ability to serve those
markets; our manufacturing and marketing capabilities; or other
actions and factors discussed in the "Risk Factors" section of our
Annual Report on Form 10-K for the year ended December 31, 2016,
which is on file with the Securities and Exchange Commission. We
may not actually achieve the plans, intentions or expectations
disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. In
addition, the forward-looking statements included in this press
release represent our views as of the date of this release. We
anticipate that subsequent events and developments will cause our
views to change. We do not assume any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law. In
management's opinion, and as previously disclosed, Innocoll's
anticipated expenditures during the next 12 months to advance its
current operations, including plans to conduct further studies to
enable it to submit a revised NDA for XARACOLL and to develop
COLLAGUARD will be greater than the amount of its current cash and
cash equivalents. As a result, Innocoll management has been
investigating and continues to investigate strategic options for
the Company to maximize shareholder value.
The scientific information discussed in this news
release related to Innocoll's product candidates is preliminary and
investigative. Such product candidates are not approved by the FDA,
and no conclusions can or should be drawn regarding the safety or
effectiveness of the product candidates.
Rule 8 - Dealing Disclosure
Requirements
Under the provisions of Rule 8.3 of the Irish
Takeover Rules, if any person is, or becomes, "interested"
(directly or indirectly) in 1% or more of any class of "relevant
securities" of Innocoll, all "dealings" in any "relevant
securities" of Innocoll (including by means of an option in respect
of, or a derivative referenced to, any such "relevant securities")
must be publicly disclosed by not later than 3.30 pm (Irish time)
on the "business day" following the date of the relevant
transaction. This requirement will continue until the date on
which the "offer period" ends. If two or more persons
co-operate on the basis of any agreement, either express or tacit,
either oral or written, to acquire an "interest" in "relevant
securities" of Innocoll, they will be deemed to be a single person
for the purpose of Rule 8.3 of the Irish Takeover Rules.
A disclosure table, giving details of the
companies in whose "relevant securities" "dealings" should be
disclosed can be found on the Irish Takeover Panel's website
at www.irishtakeoverpanel.ie.
"Interests in securities" arise, in summary, when
a person has long economic exposure, whether conditional or
absolute, to changes in the price of securities. In
particular, a person will be treated as having an "interest" by
virtue of the ownership or control of securities, or by virtue of
any option in respect of, or derivative referenced to,
securities.
Terms in quotation marks are defined in the Irish
Takeover Rules, which can be found on the Irish Takeover Panel's
website.
If you are in any doubt as to whether or not you
are required to disclose a "dealing" under Rule 8, please consult
the Irish Takeover Panel's website
at www.irishtakeoverpanel.ie or contact the Irish
Takeover Panel on telephone number +353 (0)1 678 9020; fax number
+353 (0)1 678 9289.
Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Innocoll Holdings plc via Globenewswire
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