GEORGE TOWN, Grand Cayman–(BUSINESS WIRE)–Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”), a wholly
owned subsidiary of Highland Therapeutics Inc., today announced that the
U.S. Food and Drug Administration (FDA) has accepted the resubmission of
the New Drug Application (NDA) for HLD200, Ironshore’s lead compound
currently under review as a new treatment for Attention Deficit
Hyperactivity Disorder (ADHD) and set a Prescription Drug User Fee Act
(PDUFA) date of August 8, 2018.
HLD200 is a delayed-release and extended-release formulation of
methylphenidate which was developed to be dosed at night to target an
onset of effect in the morning. HLD200 was developed over a 10-year
period and the NDA contains data from nine trials including two pivotal
Phase-3 studies. In both studies, HLD200 achieved statistically
significant improvements in symptoms associated with ADHD on each of the
HLD200 is the first product that leverages Ironshore’s DELEXIS®
technology platform which could have a meaningful impact on health
outcomes in a variety of therapeutic areas including, among others,
central nervous system disorders and inflammatory bowel disease.
While the NDA resubmission for HLD200 has been accepted for review by
the FDA, such acceptance does not mean that HLD200 will be approved by
the FDA for the treatment of ADHD.
About Ironshore Pharmaceuticals & Development, Inc.
Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary
of Highland Therapeutics Inc., is a pharmaceutical company that is
leveraging its technology, DELEXIS®, to optimize the delivery of
previously approved drug products.
Highland Therapeutics Inc. is a client of MaRS Discovery District’s
Health Venture Services group, which provides advisory services,
connections to talent, customer & capital networks, and market
intelligence to high-impact, Ontario-based life sciences ventures,
helping them commercialize their ideas and build globally competitive
This press release contains forward-looking information, which reflects
Ironshore’s current expectations regarding future events.
Forward-looking information is based on a number of assumptions and is
subject to a number of risks and uncertainties, many of which are beyond
Ironshore’s control that could cause actual results and events to differ
materially from those that are disclosed in or implied by such
forward-looking information. These forward-looking statements are made
as of the date of this press release and, except as expressly required
by applicable law, Ironshore assumes no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Ironshore Pharmaceuticals & Development, Inc.
Chief Financial Officer