- REDUCE-IT is First Outcomes Study to Assess Treatment of
Patients with LDL-C Controlled by Statin Therapy, Persistent
Elevated Triglycerides and Other Cardiovascular Risk
Factors
- Results Specific to Pure EPA Vascepa at 4 Grams
Daily
- HLS has the Rights to Vascepa for the Canadian
Market
- Amarin to Host Conference Call Scheduled for Today,
Monday September 24, 2018 at
8:00 am ET
TORONTO, Sept. 24, 2018 /CNW/ - HLS Therapeutics Inc.
("HLS" or the "Company") (TSX-V:HLS) announces that earlier today,
Amarin Corporation plc (NASDAQ:AMRN), issued topline results from
the Vascepa® cardiovascular ("CV") outcomes trial, REDUCE-IT™, a
global study of 8,179 statin-treated adults with elevated CV risk.
REDUCE-IT met its primary endpoint demonstrating an approximately
25% relative risk reduction, to a high degree of statistical
significance (p<0.001), in major adverse CV events ("MACE") in
the intent-to-treat patient population with use of Vascepa 4
grams/day as compared to placebo. HLS has in-licensed the rights to
Vascepa for the Canadian market.
Patients enrolled in REDUCE-IT had LDL-C between 41-100 mg/dL
(median baseline LDL-C 75 mg/dL) controlled by statin therapy and
various CV risk factors including persistent elevated triglycerides
("TGs") between 150-499 mg/dL (median baseline 216 mg/dL) and
either established CV disease (secondary prevention cohort) or
diabetes mellitus and at least one other CV risk factor (primary
prevention cohort).
Key topline results include:
- Efficacy: Approximately 25% relative risk reduction,
demonstrated to a high degree of statistical significance
(p<0.001), in the primary endpoint composite of the first
occurrence of MACE, including CV death, nonfatal myocardial
infarction ("MI"), nonfatal stroke, coronary revascularization, or
unstable angina requiring hospitalization. This result was
supported by robust demonstrations of efficacy across multiple
secondary endpoints.
- Safety: Vascepa was well tolerated with a safety profile
consistent with clinical experience associated with omega-3 fatty
acids and current FDA-approved labeling. The proportions of
patients experiencing adverse events and serious adverse events in
REDUCE-IT were similar between the active and the placebo treatment
groups. Median follow-up time in REDUCE-IT was 4.9 years.
Amarin will share the REDUCE-IT data in greater detail at the
2018 Scientific Sessions of the American Heart Association ("AHA")
on November 10, 2018 in Chicago, Illinois. The presentation,
classified as late-breaking clinical trial results, is scheduled to
commence at 2:16 pm Central Time and
listed as Main Event 1 for the time frame. This acceptance as a
presentation of late-breaking clinical trial results was granted
based on the ability of REDUCE-IT to address a critical question in
CV prevention.
"We are very pleased with these topline study results and offer
our congratulations to the entire Amarin team that brought the
REDUCE-IT trial to completion," said Greg
Gubitz, CEO of HLS. "Cardiovascular disease is the #1 killer
of men and women worldwide1 and the REDUCE-IT trial
results could lead to a new paradigm in treatment for the millions
of patients in Canada currently at
risk for this disease."
"The release of these results is a major milestone in the
development of HLS's cardiovascular franchise in Canada. We believe that there is strong market
potential for Vascepa in Canada,
where we have in-licensed the rights and where it would become the
first and only prescription product in its class. We look forward
to filing with Health Canada as soon as we have reviewed the final
data, and ultimately to bringing this important new medicine to
Canadians."
For more information on Vascepa and the REDUCE-IT trial, please
see the press release issued today by Amarin, which can be found
at: http://investor.amarincorp.com/press-releases
AMARIN CONFERENCE CALL AND WEBCAST INFORMATION
Amarin
will host a conference call at 8:00 am
ET, September 24, 2018 to
discuss this information. The call will be accessible through the
investor relations section of Amarin's website at
www.amarincorp.com. The call can also be heard via telephone by
dialing 877-407-8033. A replay of the call will be made available
for a period of two weeks following the conference call. To hear a
replay of the call, dial 877-481-4010 (inside the United States) or 919-882-2331 (outside
the United States). A replay of
the call will also be available through Amarin's website shortly
after the call. For both dial-in numbers, please use conference ID
37638.
IMPORTANT CAUTIONARY INFORMATION ABOUT TOPLINE
RESULTS
Existing and prospective investors are cautioned not
to place undue reliance on topline results. As with any topline CV
outcomes study result, further REDUCE-IT data assessment and data
release will yield additional useful information to inform greater
understanding of the study outcome. Aspects that could change and
impact the final evaluation of the totality of the efficacy/safety
data from REDUCE-IT may include: the magnitude of the treatment
benefit on the primary composite endpoint, its components,
secondary endpoints and the primary and secondary risk prevention
cohorts; consideration of which components of the composite or
secondary endpoints have the most clinical significance; the
consistency of the primary and secondary endpoints; the consistency
of the findings across cohorts and subgroups; tolerability and
safety considerations and risk/benefit considerations;
consideration of REDUCE-IT results in the context of other clinical
studies; and study conduct and data quality, integrity and
consistency.
ABOUT HLS THERAPEUTICS INC.
Formed in 2015, HLS is a
specialty pharmaceutical company focused on the acquisition and
commercialization of late stage development, commercial stage
promoted and established branded pharmaceutical products in the
North American markets. HLS's focus is on products targeting the
central nervous system and cardiovascular therapeutic areas. HLS's
management team is composed of seasoned pharmaceutical executives
with a strong track record of success in these therapeutic areas
and at managing products in each of these lifecycle stages.
FORWARD LOOKING INFORMATION
This release includes
forward-looking statements regarding HLS and its business. Such
statements are based on the current expectations and views of
future events of HLS's management. In some cases the
forward-looking statements can be identified by words or phrases
such as "may", "will", "expect", "plan", "anticipate", "intend",
"potential", "estimate", "believe" or the negative of these terms,
or other similar expressions intended to identify forward-looking
statements, including, among others, statements with respect to
HLS's pursuit of additional product and pipeline opportunities in
certain therapeutic markets, statements regarding growth
opportunities and expectations regarding financial performance. The
forward-looking events and circumstances discussed in this release
may not occur and could differ materially as a result of known and
unknown risk factors and uncertainties affecting HLS, including
risks relating to the specialty pharmaceutical industry, risks
related to the regulatory approval process, economic factors and
many other factors beyond the control of HLS. Forward-looking
statements and information by their nature are based on assumptions
and involve known and unknown risks, uncertainties and other
factors which may cause HLS's actual results, performance or
achievements, or industry results, to be materially different from
any future results, performance or achievements expressed or
implied by such forward-looking statement or information.
Accordingly, readers should not place undue reliance on any
forward-looking statements or information. A discussion of the
material risks and assumptions associated with this release can be
found in the joint information circular of HLS and Automodular
Corporation dated February 5, 2018 in
respect of the merger of the two companies by way of a plan of
arrangement, effective March 12,
2018, which has been filed on SEDAR and can be accessed at
www.sedar.com. Accordingly, readers should not place undue reliance
on any forward-looking statements or information. Except as
required by applicable securities laws, forward-looking statements
speak only as of the date on which they are made and HLS undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
or otherwise.
REFERENCES
1 American Heart Association.
Disease and Stroke Statistics-2016 Update
SOURCE HLS Therapeutics Inc.