JERUSALEM, Jan. 9, 2020 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today provides a business
and clinical update on its development programs with the Company's
proprietary oral drug delivery system, the Accordion
Pill® platform, in a Letter to
Shareholders. The full text of the letter is below.
Dear Fellow Shareholders:
As we close the books on 2019, I wanted to take this opportunity
to review our recent progress and to preview our plans as we move
forward into 2020.
Our overarching mission for 2020 remains to create value by
leveraging the potential of our Accordion
Pill® (AP) platform. With its unique
release profiles and gastric retentive properties, the AP platform
offers an opportunity to enhance the pharmacokinetic
characteristics of a number of proprietary compounds and to develop
innovative approaches to the treatment of diseases. Our growth
strategy remains to advance a mix of internally-led drug
development programs and partnered proprietary programs. We believe
this approach provides a variety of "shots on goal" that will
provide Intec with a growing pipeline and long-term
royalty stream with the potential to create significant value over
time.
Driven by Science
Our innovative Research and Development (R&D) team of
leading drug reformulation experts and engineers continue
to drive our ability to expand our pipeline in order to leverage
the potential of the AP platform. Through their ingenuity and
creativity, we have developed the Accordion Pill platform and its
variety of custom-designed drug delivery systems that are intended
to enhance the therapeutic benefits of a number of approved drugs
and drugs in development.
In addition to the variety of film technologies and release
mechanisms we have developed to date, including those we created
for partners, we continue to innovate and are working on next
generation AP technologies that will increase gastric retention
time (i.e., a 24-hour Accordion Pill). We have also enhanced
our delivery profile capabilities, which provide us with greater
options for designing and constructing new Accordion Pills that can
include films for immediate release, delayed immediate release,
extended release, delayed extended release, etc. This
optionality allows us to develop custom-designed APs that meet
specific PK parameters. We are also working on including larger
molecules in the platform such as peptides, which opens up a
multitude of opportunities for enhanced delivery of these important
therapeutic compounds that are now largely delivered intravenously
or via subcutaneous injection.
The Parkinson's Disease Program
In late July we announced the topline data from our Phase 3
ACCORDANCE clinical trial of the Accordion Pill-Carbidopa/Levodopa
(AP-CD/LD) compared with immediate release levodopa (IR-LD) in
advanced Parkinson's disease (PD) patients. The top-line results
showed that AP-CD/LD was numerically superior in reducing daily OFF
time but was not statistically superior to IR-LD. We believe
the outcome may have been confounded by data from participants who
titrated to the maximum available dose of AP-CD/LD, as well as by
limitations in the trial design. Following this readout, we have
undertaken a partnering process for the late-stage development
and commercialization of this program for a better
baseline levodopa (LD) therapy.
Analysis of the full data set has provided important information
and knowledge that we believe makes AP-CD/LD an attractive
partnership opportunity for late-stage development and
commercialization.
First, the ACCORDANCE results validate the AP platform and
provide very important long-term safety data. Detailed analysis
of the primary and secondary results, as well as subset and
regional analyses have provided key insights for future study
design and dosing that should be invaluable to a potential
partner. With our manufacturing partner, LohmanTherapie-Systeme
(LTS), we have qualified the commercial scale manufacturing
process, which can also be used to provide clinical supply for
the next Phase 3 study. This is a key advantage as Chemistry,
Manufacturing and Controls (CMC) is a critical component in drug
development and one that often delays regulatory submissions at
small companies.
Importantly, there continues to be a large unmet need
for a better baseline LD, which we believe provides a
significant market opportunity of between $200 - $500
million.
We continue to advance the buildout of our commercial scale
manufacturing process with LTS, as having these state-of-the
art commercial scale production facilities in place is expected to
be of great value to any potential partner. We successfully
completed our first primary stability batches and are
currently producing materials at commercial scale. We received
our German Good Manufacturing Practices (GMP) permit for
manufacturing, completed the technology transfer and officially
executed the handover of the large-scale production machinery to
LTS. Consequently, we now plan for LTS to produce the next
stability batches, which will also serve as the clinical material
for the next Phase 3 clinical trial, in the first quarter of
2020.
We look forward to potentially monetizing this late-stage
asset in the first half of 2020, so that a partner can advance
it into a final, pivotal Phase 3 study and move toward
commercialization in order to benefit the multitude of PD patients
suffering from the motor complications associated with the
pulsatile delivery of generic LD formulations.
Novartis Feasibility Agreement
In December 2019, we reported the
termination of our Feasibility and Option Agreement with Novartis
Pharmaceuticals, under which Intec Pharma built a custom-designed
Accordion Pill for one of Novartis' proprietary compounds. The AP
met the technical and pharmacokinetic (PK) clinical specifications
set forth by Novartis. Following an internal and revised commercial
strategic assessment for the therapeutic, Novartis decided that
this program no longer meets Novartis' mid- and long-term strategic
priorities. Novartis has agreed to pay Intec Pharma $1.5 million USD upon conclusion of the
program.
While we are disappointed that Novartis is not moving forward
with this custom AP, the technical and clinical work conducted as
part of this program has added to our growing body of scientific
knowledge relating to the Accordion Pill platform and has expanded
our tool chest of drug-on-film technology. We have enjoyed working
with the Novartis team and, given their enhanced understanding of
the advantages of our gastric retentive AP oral drug delivery
technology, we are currently working with them to identify
additional compounds in the Novartis portfolio that may benefit
from the unique characteristics of the AP platform.
Pipeline Progress
In May 2019, we were very pleased
to partner with Merck & Co. (MSD) on a research collaboration
to develop a custom-designed AP for one of MSD's proprietary
compounds in development. I am delighted to report that our
Intec team has developed an AP for MSD's proprietary compound that
meets the in vitro specifications set forth in the
companies' research collaboration. We are now in discussions
with MSD to determine next steps. This is an exciting
opportunity to leverage the unique drug release profile and gastric
retention of our AP platform in a potentially billion-dollar market
opportunity.
The development of our AP containing synthetic
tetrahydrocannabinol (THC), one of the primary cannabinoids
contained in cannabis, completed an initial PK study earlier in
2019. The results showed that the delivery of THC did not fully
meet our expectations for this program. The development of
custom-designed APs is an iterative process and our ongoing
development work provides a deeper understanding of how to best
apply gastric retention technology to enhance and control the
delivery of this poorly soluble class of molecules. Our R&D
team is nearing completion of refinements to the cannabinoid AP
product. We expect to launch a PK study evaluating the delivery of
THC with the optimized AP later this year.
We remain confident in the potential of this program as we
believe the AP's gastric retentive technology is ideally suited
to extend the absorption phase of THC, with the goal of a slower
rate of rise and more consistent drug plasma levels after oral
delivery. The combination of the slower rate of rise with
sustained and consistent plasma levels is expected to lead to
an improved therapeutic effect and reduce the adverse events that
are correlated with rate of rise and peak THC plasma levels. Also,
given the known analgesic properties of cannabinoids, we remain
enthusiastic about the potential for these programs and believe
our AP-cannabinoids will be applicable to a variety of pain
indications, such as post-operative, opioid-sparing pain
management, fibromyalgia and/or for breakthrough cancer pain
management.
In addition to our current development pipeline, our team
continues to advance discussions with other potential
pharmaceutical partners for the development of custom-designed
APs. The data from our ACCORDANCE trial supports those
discussions as it validates the AP platform and provides essential
long-term safety data. Our goal remains to add one or two new
partner programs per year. We believe this is the most efficient
strategy for building our pipeline and for creating value from our
platform.
Capital Resources
We are prudently managing our expenses to the level
which, in our judgment, is appropriate to advance our pipeline
programs. This includes the restructuring of our clinical
manufacturing group, which we expect will significantly reduce our
burn, while still allowing for ongoing development work and
early-stage clinical production.
We continue to explore different avenues through which to
finance these efforts and are actively pursuing business
development endeavors that may provide non-dilutive financing
and which we anticipate will expand our network of partners to
assist in moving these clinical programs forward.
In addition, we were delighted to recently report our funding
agreement with Aspire Capital, a long-term institutional
investor in Intec Pharma. Under the terms of the
agreement, Aspire Capital is committed to purchase up
to $10 million of Intec Pharma's ordinary
shares over a 30-month period extending into 2022, subject to
certain terms and conditions. Importantly, there are no warrants,
derivatives, or other share classes associated with this
agreement.
We believe this commitment strengthens our negotiating
position with any potential partners for our Parkinson's
disease program and/or for new research collaborations and gives
us the flexibility to access capital when and if we need it.
Controlling the timing and number of shares being sold is key, as
we can use this vehicle to opportunistically strengthen our balance
sheet without unnecessary dilution as we seek to advance our AP
platform programs to key inflection points in 2020.
We ended the third quarter 2019 with approximately $16 million in cash and cash equivalents. Along
with the $1.5 million from Novartis
and the cost cutting measures we've undertaken, we believe our cash
will now take us into the third quarter of 2020, without tapping
into our Aspire commitment.
Closing
We remain steadfast in our commitment to advance the potential
of our AP platform in underserved medical indications with large
market opportunities where we aim to improve the lives of
patients.
On behalf of Intec Pharma's board of directors and our dedicated
team of professionals, I thank you for your continued support of
our company, our strategy, and the important clinical work we are
advancing. I can assure you that all of us at Intec Pharma remain
committed to our mission and to delivering sustained performance on
behalf of all those we serve. We look forward to sharing our
achievements with you as we execute on our strategy to leverage the
potential in our AP platform to create value.
All the best for continued health and prosperity in the new
decade ahead,
Jeffrey A. Meckler
Vice Chairman and Chief Executive Officer
Intec Pharma
About Intec Pharma Ltd.
Intec Pharma is a clinical-stage biopharmaceutical company
focused on developing drugs based on its proprietary Accordion Pill
platform technology. The Company's Accordion Pill is an oral drug
delivery system that is designed to improve the efficacy and safety
of existing drugs and drugs in development by utilizing an
efficient gastric retention and specific release mechanism. The
Company's product pipeline includes two product candidates in
clinical trial stages: Accordion Pill Carbidopa/Levodopa, or
AP-CD/LD, which is in late-stage Phase 3 development for the
treatment of Parkinson's disease symptoms in advanced Parkinson's
disease patients, and AP-cannabinoids, an Accordion Pill to deliver
either or both of the primary cannabinoids contained in Cannabis
sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for
various pain indications. In addition, the Company has a research
collaboration with Merck & Co.
For more information, visit www.intecpharma.com. Intec Pharma
routinely posts information that may be important to investors in
the Investor Relations section of its website.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward looking statements about our
expectations, beliefs and intentions. Forward-looking statements
can be identified by the use of forward-looking words such as
"believe", "expect", "intend", "plan", "may", "should", "could",
"might", "seek", "target", "will", "project", "forecast",
"continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these
statements do not relate strictly to historical matters. These
forward-looking statements are based on assumptions and assessments
made in light of management's experience and perception of
historical trends, current conditions, expected future developments
and other factors believed to be appropriate. Forward-looking
statements in this press release are made as of the date of this
press release, and we undertake no duty to update or revise any
such statements, whether as a result of new information, future
events or otherwise. Forward-looking statements are not guarantees
of future performance and are subject to risks and uncertainties,
many of which are outside of our control. Many factors could cause
our actual activities or results to differ materially from the
activities and results anticipated in forward-looking statements,
including, but not limited to, the following: our limited operating
history and history of operating losses, our ability to continue as
a going concern, our ability to obtain additional financing, our
ability to successfully operate our business or execute our
business plan, the timing and cost of our clinical trials, the
completion and receiving favorable results in our clinical trials,
our ability to obtain and maintain regulatory approval of our
product candidates, our ability to protect and maintain our
intellectual property and licensing arrangements, our ability to
develop, manufacture and commercialize our product candidates, the
risk of product liability claims, the availability of
reimbursement, and the influence of extensive and costly government
regulation. More detailed information about the risks and
uncertainties affecting us is contained under the heading "Risk
Factors" included in our most recent Annual Report on Form 10-K
filed with the SEC on February 27, 2019, and in
other filings that we have made and may make with
the Securities and Exchange Commission in the future.
Intec Pharma Investor Contact:
Anne Marie Fields
VP-Corporate Communications & Investor Relations
646-200-8808
amf@intec-us.com
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SOURCE Intec Pharma Ltd.