Valeritas Presents Positive h-Patch™ Apomorphine Study Data at the World Congress of Neurology (WCN 2019)
October 29 2019 - 7:00AM
Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology
company and maker of the V-Go® Wearable Insulin Delivery device,
which uses its proprietary h-Patch™ technology, announced positive
data from its preclinical pharmacokinetic (PK) study of apomorphine
(Apo) subcutaneous infusion was presented today at the 24th World
Congress of Neurology held in Dubai, UAE.
In the poster presentation titled “Delivery of Apomorphine via
Subcutaneous Infusion with the h-Patch™ Wearable Device,” the data
demonstrated that 400ul of a 25mg/ml Apo solution delivered with
the h-Patch™ technology was rapidly absorbed and was detected in
plasma within two hours of the start of infusion. Additionally, Apo
was still detectable in plasma 24 hours after completion of
h-Patch™ infusion, or 48 hours in total.
“Given both the side effects of oral dosing of Levodopa as well
as the lack of small form factor subcutaneous delivery devices to
effectively deliver Apo, we believe there is a significant unmet
need that our wearable h-Patch™ device can satisfy for the
effective delivery of Apo”, said John Timberlake, President and
Chief Executive Officer of Valeritas.
Valeritas’ proprietary h-Patch™ device is a simple all-in-one,
fully disposable, drug delivery technology that can facilitate the
simple and effective subcutaneous delivery of injectable medicines
to patients across a broad range of therapeutic areas. The
Company’s V-Go is the first FDA-approved product that utilizes its
h-Patch™ technology. To date, more than 20 million V-Go insulin
delivery devices have been sold in the United States.
Treatment of advanced Parkinson’s disease (PD) remains
challenging, with fluctuations in motor status often resulting in
patients becoming severely handicapped. The magnitude and pattern
of the motor response to a single dose of subcutaneously
administered Apo are qualitatively comparable to that of oral
levodopa; however, side effects of oral dosing (dizziness, nausea,
vomiting, etc.) can be problematic.
Close to a dozen clinical studies have shown subcutaneous Apo
infusions are successful in aborting “off” periods, reducing
dyskinesias, and improving PD motor scores with the added benefit
of sparing the patient the challenging side effects of oral
Levodopa. However, bulky infusion pumps requiring delivery of
relatively large volumes of therapeutics remain a barrier to the
development of therapeutic products that are patient and caregiver
friendly, which may represent an opportunity for Valeritas’
comparatively smaller h-Patch™ technology.
About Valeritas Holdings, Inc.
Valeritas is a commercial-stage medical technology company
focused on improving health and simplifying life for people with
diabetes by developing and commercializing innovative technologies.
Valeritas’ flagship product, V-Go® Wearable Insulin Delivery
device, is a simple, affordable, all-in-one basal-bolus insulin
delivery option for adult patients requiring insulin that is worn
like a patch and can eliminate the need for taking multiple daily
shots. V-Go administers a continuous preset basal rate of insulin
over 24 hours, and it provides discreet on-demand bolus dosing at
mealtimes. It is the only basal-bolus insulin delivery device on
the market today specifically designed keeping in mind the needs of
type 2 diabetes patients. Headquartered in Bridgewater, New Jersey,
Valeritas operates its R&D functions in Marlborough,
Massachusetts.
More information is available at www.valeritas.com and our
Twitter feed @Valeritas_US, www.twitter.com/Valeritas_US.
Forward-Looking Statements
This press release may contain forward-looking statements.
Statements in this press release that are not purely historical are
forward-looking statements. Such forward-looking statements
include, among other things, references to Valeritas technologies,
business and product development plans and market information.
Actual results could differ from those projected in any
forward-looking statements due to numerous factors. Such factors
include, among others: the ability to raise the additional funding
needed to continue to pursue Valeritas’ business and product
development plans; Valeritas' expected cash burn rate and its
ability to continue to increase new and total prescription growth;
the expected benefits of the debt exchange on Valeritas’ cash
runway and its anticipated operating costs following the debt
exchange (the $2 million minimum debt covenant remains in place
following the debt exchange, which will continue to limit
Valeritas’ ability to finance its operations); the effects of both
the new issuance of Series B Convertible Preferred Stock and the
May 2019 reverse stock split on the trading price of Valeritas’
common stock, in both the short and long-term; the ability to
continue to commercialize the V-Go® Wearable Insulin Delivery
device with limited resources, competition in the industry in which
Valeritas operates and overall market conditions; the inherent
uncertainties associated with developing new products or
technologies; the potential commercial use of the h-Patch™
technology for subcutaneous delivery of GLP-1, Apo or CBD is
dependent on Valeritas’ ability to identify one or more potential
collaboration partners and enter into mutually agreeable
collaboration agreements (neither the delivery of GLP-1, Apo or CBD
by h-Patch™ is currently cleared for use by the FDA); our
statements that (i) subcutaneous Apo infusions appears to offer
qualitatively comparable benefits to that of oral levodopa and (ii)
based on initial studies, subcutaneous infusion of CBD appears to
offer several distinct advantages over oral dosing of CBD, and
other potential benefits of the h-Patch™ technology to deliver
GLP-1, Apo or CBD is based on third-party clinical studies not
conducted by Valeritas; however, additional studies or research may
be needed by our potential partners to demonstrate to the U.S. Food
and Drug Administration (“FDA”) that delivery of GLP-1, Apo or CBD
via the h-Patch™ technology will offer consistent results to the
initial Valeritas study; and the FDA or other regulatory agencies
may require Valeritas’ collaboration partners to demonstrate the
safety or effectiveness of subcutaneous infusion of GLP-1, Apo or
CBD through the h-Patch™ technology before any of those products
can be commercialized, which can be a lengthy, and uncertain
process, and the FDA may delay or require additional information to
provide clearance for use with our RHI or our V-Go SIM product.
Statements or claims made by third parties regarding the efficacy
or functionality of V-Go as compared to other products are
statements made by such individual and should not be taken as
evidence of clinical trial results supporting such statements or
claims. Any forward-looking statements are made as of the date of
this press release, and Valeritas assumes no obligation to update
the forward-looking statements or to update the reasons why actual
results could differ from those projected in the forward-looking
statements, except as required by law. Investors should consult all
of the information set forth herein and should also refer to the
risk factor disclosure set forth in the reports and other documents
Valeritas files with the SEC available at www.sec.gov.
Investor Contacts:Lynn Pieper Lewis or Greg ChodaczekGilmartin
Group646-924-1769ir@valeritas.com
Media Contact:Kevin KnightKnight Marketing Communications,
Ltd.206-451-4823pr@valeritas.com
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