- Blexten Label Expanded to Include Ages as
Young as 4 Years Old -
- Includes Approval of 2.5mg/mL
Oral Solution and 10mg orodispersible (Quick Melt) Tablet Formats
-
- Commercial Availability of Pediatric Formats
Anticipated During Q1 2022 -
MISSISSAUGA, ON, Aug. 12, 2021 /PRNewswire/ - August 12, 2021 – Nuvo Pharmaceuticals Inc. (TSX:
MRV) (OTCQX: MRVFF) d/b/a Miravo Healthcare (Miravo or the
Company), a Canadian-focused healthcare company with global reach
and a diversified portfolio of commercial products, today announced
Health Canada has issued a Notice of Compliance (NOC) in relation
to the Company's Supplement to New Drug Submission for the
pediatric use of Blexten. The pediatric use includes the
approval of two new dosage formats; a 2.5mg/mL oral solution and a
10mg Quick Melt tablet. Upon commercial launch, which is
anticipated for Q1 2022, the pediatric formats will be available to
patients with a prescription from their healthcare provider.
"The expansion of the Health Canada approved Blexten label for
use in children as young as 4 years old means that Blexten can now
be the single prescription antihistamine of choice for most
Canadian allergy and urticaria patients. The issuance of this
NOC increases the treatable patient population and provides
patients with two additional convenient dosing formats; an oral
solution and Quick Melt tablets, in addition to our existing 20mg
tablet format that is available for patients 12 years of age and
older. This is a great milestone for the Blexten franchise
and I would like to recognize and thank our regulatory, scientific,
tech ops and commercial teams for the hard work that went into
obtaining this approval and working toward launch," said Mr.
Jesse Ledger, Miravo's President and
Chief Executive Officer.
About Blexten
Blexten is a second-generation
antihistamine drug for the symptomatic relief of allergic rhinitis
and chronic spontaneous urticaria. Blexten exerts its effect
through its highly selective inhibition of peripheral histamine H1
receptors and has an efficacy comparable to cetirizine and
desloratadine. In comparative studies, Blexten demonstrated
somnolence rates similar to placebo representing a potentially
non-sedating effect at therapeutic doses. It was developed in
Spain by Faes Farma, S.A.
(Faes). Bilastine, (the active ingredient in Blexten), is
approved in Canada and over 100
countries worldwide, including Japan and most European countries. In
2014, Miravo entered into an exclusive license and supply agreement
with Faes for the exclusive right to sell bilastine in Canada, which is sold under the brand name
Blexten. The exclusive license is inclusive of prescription
and non-prescription rights for Blexten, as well as adult and
pediatric presentations in Canada. In April 2016, Health Canada approved Blexten
(bilastine 20 mg oral tablet) for the treatment of the symptoms of
seasonal allergic rhinitis and chronic spontaneous urticaria (such
as itchiness and hives).
About Miravo Healthcare
Miravo is a Canadian focused,
healthcare company with global reach and a diversified portfolio of
commercial products. The Company's products target several
therapeutic areas, including pain, allergy, neurology and
dermatology. The Company's strategy is to in-license and
acquire growth-oriented, complementary products for Canadian and
international markets. Miravo's head office is located in
Mississauga, Ontario, Canada, the
international operations are located in Dublin, Ireland and the Company's
manufacturing facility is located in Varennes, Québec, Canada. The
Varennes facility operates in a
Good Manufacturing Practices (GMP) environment respecting the U.S,
Canada and E.U. GMP regulations
and is regularly inspected by Health Canada and the U.S. Food and
Drug Administration. For additional information, please visit
www.miravohealthcare.com.
Forward-Looking Statements
This press release
contains "forward-looking information" as defined under Canadian
securities laws (collectively, "forward-looking statements"). The
words "plans", "expects", "does not expect", "goals", "seek",
"strategy", "future", "estimates", "intends", "anticipates", "does
not anticipate", "projected", "believes" or variations of such
words and phrases or statements to the effect that certain actions,
events or results "may", "will", "could", "would", "should",
"might", "likely", "occur", "be achieved" or "continue" and similar
expressions identify forward-looking statements. In addition, any
statements that refer to expectations, intentions, projections or
other characterizations of future events or circumstances contain
forward-looking statements. These forward-looking statements
include statements regarding the anticipated commercial launch of
the pediatric use of Blexten.
Forward-looking statements are not historical facts but
instead represent management's expectations, estimates and
projections regarding future events or circumstances. Such
forward-looking statements are qualified in their entirety by the
inherent risks, uncertainties and changes in circumstances
surrounding future expectations which are difficult to predict and
many of which are beyond the control of the Company.
Forward-looking statements are necessarily based on a number of
estimates and assumptions that, while considered reasonable by
management of the Company as of the date of this press release, are
inherently subject to significant business, economic and
competitive uncertainties and contingencies and may prove to be
incorrect. Material factors and assumptions used to develop the
forward-looking statements, and material risk factors that could
cause actual results to differ materially from the forward-looking
statements, include but are not limited to,
the timing and availability of the pediatric formats of Blexten
from the Company's suppliers to support commercial launch, other
unanticipated delays in the commercial launch, the potential impact
of COVID-19 on the Company's operations, business and financial
results and other factors, many of which are beyond the control of
the Company. Additional factors that could cause the
Company's actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the risk factors included in the Company's
most recent Annual Information Form dated March 5, 2021 under the heading "Risks Factors",
and as described from time to time in the reports and disclosure
documents filed by the Company with Canadian securities regulatory
agencies and commissions. These and other factors should be
considered carefully and readers should not place undue reliance on
the Company's forward-looking statements. Forward-looking
statements should not be read as guarantees of future performance
or results and will not necessarily be accurate indications of
whether or not the times at or by which such performance or results
will be achieved.
All forward-looking statements are based only on information
currently available to the Company and are made as of the date of
this press release. Except as expressly required by applicable
Canadian securities law, the Company assumes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise. All
forward-looking statements in this press release are qualified by
these cautionary statements.
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SOURCE Nuvo Pharmaceuticals Inc.