- Health Canada approves
MyCare Psychiatry Lab Assays for use in diagnostic lab settings to
measure blood levels in patients prescribed six of the most common
antipsychotic drugs
- MyCare Insite point-of-care (POC) device, which measures
the level of antipsychotic drugs in patients' blood, is under
review and could be approved in H1-2021
- Health Canada issued a
Notice of Deficiency for Trinomia
TORONTO, Dec. 16, 2020 /CNW/ - HLS Therapeutics Inc.
("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical
company focusing on central nervous system and cardiovascular
markets, announces updates on its filings with Health Canada for
MyCare and Trinomia.
The Company is pleased to report that Health Canada has approved
five MyCare™ Psychiatry Lab Assay diagnostic tests from Saladax
Biomedical, Inc. ("Saladax") for use in measuring blood levels in
patients taking any of the six most common antipsychotic drugs. HLS
is the exclusive distributor of these products in Canada. Regarding Trinomia, a polypill of
three common medications that is intended for secondary
cardiovascular prevention, Health Canada issued a Notice of
Deficiency ("NOD") indicating that additional scientific data may
be required for approval.
MYCARE LAB ASSAYS AND MYCARE INSITE
The approved
MyCare Psychiatry Lab Assays are diagnostic tools that can
be used on most large high-speed lab analyzers. They allow for the
measuring and monitoring of blood drug concentration levels of
clozapine, risperidone, paliperidone, aripiprazole, olanzapine, and
quetiapine. For the first time, the timely monitoring of those
hematological parameters is possible, and this diagnostic
capability is considered an important step towards optimizing
therapy for patients who are taking those
medications.1
Currently under review at Health Canada is MyCare Insite,
a complementary device that will enable the performance of similar
tests at the point of care. Similar to a blood glucose test,
MyCare Insite will be simple to use and require only a single drop
of blood taken by a finger stick to measure patient drug levels,
providing results in just minutes. Such point-of-care devices have
consistently been shown to improve patient outcomes while also
reducing healthcare costs2,3. Using a point-of-care
device to measure blood levels for common antipsychotic drugs could
provide information to help healthcare practitioners determine if a
patient is taking their medication, if optimal drug concentrations
are being achieved and ultimately whether the proper therapy is
being pursued. Approval of the MyCare Insite point-of-care device
is expected in the first half of 2021.
"The MyCare product line is a natural fit within our CNS
franchise and reflects our commitment to bringing highly valuable
clinical tools to practitioners to help them make informed
decisions and enhance their level of patient care," said
Gilbert Godin, CEO of HLS. "With
this approval, we will leverage our commercial infrastructure in
the Canadian psychiatric market to launch the MyCare line of
diagnostic tests in the first half of 2021 followed by the
introduction of the MyCare Insite device once it is approved."
It is estimated that schizophrenia affects 1% of the population,
or approximately 300,000 Canadians. Schizophrenia interferes with a
person's ability to think clearly, manage emotions, make decisions
and relate to others4. The causes and the course of the
illness is unique for each patient, making the diagnosis of its
causes difficult. Research has linked schizophrenia to a multitude
of possible causes, including aspects of brain chemistry and
structure, as well as environmental causes. No single, simple
course of schizophrenia treatment exists and patients suffering
with the condition face various challenges in the health care
system. Providing practitioners with diagnostic tools like those in
the MyCare product line, which simplify and optimize the treatment
process, could help those who contend with this serious
illness.
Similarly, the MyCare products may be used with bi-polar
disorder patients to measure their blood concentrations of the
indicated drug products. Bi-polar disorder affects up to
2.6%5 of the population, or approximately 910,000
Canadians.
To learn more about MyCare Insite, please visit:
https://mycaretests.com/psychiatry/insite
TRINOMIA
HLS received an NOD from Health Canada for
its pending submission for Trinomia that may require additional
scientific information pertaining to safety and efficacy to support
the approval of the application. In addition, Health Canada
noted that there is an on-going study using Trinomia, and that "…a
regulatory decision for Trinomia should await these study
results."
The ongoing study is titled, Secondary Prevention of
Cardiovascular Disease in the Elderly (SECURE), a prospective
randomized clinical trial comparing a polypill versus standard of
care treatment strategies in post-myocardial infarction elderly
patients, which has an estimated completion date of November 2021.
"HLS is disappointed to learn Health Canada's decision since the
application was submitted after consultation with Health Canada and
its agreement with the defined strategy," said Gilbert Godin, CEO of HLS. "HLS will be working
closely with the licensor of the product to assess the pathway
required to address the deficiency noted by Health Canada, and we
will provide more information as it becomes available. In the
interim the focus of our Cardiovascular franchise will remain
firmly on the success of Vascepa in Canada."
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. For
more information, please visit: www.hlstherapeutics.com
ABOUT SALADAX BIOMEDICAL, INC.
Founded in 2004, Saladax Biomedical, Inc. is a privately held
company headquartered at Ben Franklin
TechVentures® located in Bethlehem, PA.
Saladax develops rapid blood tests for point-of-care and for
laboratory analysers for use in psychiatry and oncology. The
Saladax MyCare Psychiatry line provides drug level tests of the
most commonly prescribed antipsychotics. This line of reagents is
protected by an extensive intellectual property portfolio that
covers the use of rapid testing for antipsychotics drugs. Saladax
believes that truly personalized medicine can only exist when the
right drug is taken at the right dose. Saladax's diagnostic reagent
kits are distributed worldwide and are under development for use in
the United States. Saladax is ISO
13485:2016 certified. For more information,
visit MyCareTests.com
REFERENCES
- Kelly DL, Ben-Yoav H, Payne GF, et al. Blood draw barriers for
treatment with clozapine and development of a point-of-care
monitoring device. Clin Schizophr Relat Psychoses. 2018;12:23–30.
doi:10.3371/CSRP.KEBE.070415
- St John A. The evidence to support point of care testing. Clin
Biochem Rev. 2010;31:111–119
- Price CP, Kricka LJ, Kricka LJ. Improving healthcare
accessibility through point-of-care technologies. Clin Chem. 2007;53:1665–1675.
doi:10.1373/clinchem.2006.084707
- Schizophrenia Society of Canada website
-
https://www150.statcan.gc.ca/n1/pub/82-624-x/2013001/article/tbl/tbl1-eng.htm
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 Company's Annual Information Form dated March 18, 2020 and Management's Discussion and
Analysis dated November 4, 2020, both
of which have 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.
SOURCE HLS Therapeutics Inc.