Medexus Announces Expanded Availability of Trecondyv® (treosulfan) in Canada
September 21 2021 - 5:09PM
Medexus Pharmaceuticals Inc. (the “
Company”
or
“Medexus”) (TSX: MDP) (OTCQX: MEDXF)
announced today that it has initiated its first commercial shipment
of Trecondyv® (treosulfan) in Canada, following the June 28th, 2021
Notice of Compliance by Health Canada, which had previously only
been distributed under the Health Canada Special Access Program.
Trecondyv® is a bifunctional alkylating agent
developed for use as part of a conditioning treatment for patients
undergoing allogeneic hematopoietic stem cell transplantation
(“allo-HSCT”). Trecondyv® is now available
for commercial sale in Canada for the treatment adult patients with
Acute Myeloid Leukemia (“AML”) or Myelodysplastic
Syndromes (“MDS”) who are at increased risk for
standard conditioning therapies, as well as in pediatric patients
older than one year old with AML or MDS.
Kerry Bakewell, Vice President of Specialty
Markets at Medexus, commented, “We are pleased to be able to
provide Trecondyv® on a commercial scale to patients who are in
need of this treatment. We believe that this product has the
potential to become the standard of care in Canada due to its
excellent event-free and overall survival data, particularly among
at-risk groups. We have had a very positive response among the
medical community in Canada thus far and expect sales to ramp up
quickly as a result.”
Dr. Ivan Pasic, Medical Oncologist, Princess
Margaret Cancer Centre, has been using treosulfan under the Special
Access Program for several months. Dr. Pasic commented: “In the
field of allogeneic hematopoietic cell transplantation, we
consistently strive toward reducing transplant-related mortality
and one way of achieving this goal is through a reduction in the
intensity of the conditioning regimens we use. However, the
reduction in conditioning intensity is often accompanied by a
corresponding increase in the risk of relapse. Treosulfan
represents an exception here in that it provides a way of offering
transplantation more safely without a significant increase in
relapse risk. In a recent randomized phase III study by
Beelen et al., the use of treosulfan-based conditioning in
patients with AML or MDS has been associated with a 15% increase in
2-y overall survival and 11% decrease in 2-y transplant-related
mortality, without increased risk of relapse, compared to
busulfan-based conditioning. Because of this study, we are
currently offering treosulfan-based conditioning to all patients
with MDS who are ineligible to receive standard myeloablative
conditioning because of their age and/or comorbidities. We have
been accessing the drug through Health Canada Special Access
Program and are looking forward to the announced commercial
availability as we are considering potential additional indications
at our centre, including its use in patients with AML, in line with
the available phase III evidence.” In March of 2019, Health Canada
granted Medexus authorization to distribute Trecondyv® in
Canada under the Special Access Program, which provides healthcare
practitioners with access to non-marketed drugs to treat patients
with serious or life-threatening conditions when conventional
therapies have failed, are unsuitable, or unavailable. On June 28,
2021, the Company received a Notice of Compliance
(“NOC”) from Health Canada to commercialize
Trecondyv® and began shipping commercially earlier this month.
Medexus continues to assist medac in seeking FDA approval of
treosulfan in the US.
September 30th
Interest Payment
The Company believes it remains well positioned
from a balance sheet perspective, taking into consideration various
catalysts and upcoming growth drivers. Nevertheless, the Company
believes it is prudent at this time to take advantage of all
available options to preserve cash and maintain its healthy balance
sheet. Therefore, in accordance with the terms of the convertible
debenture indenture entered into between Medexus and Computershare
Trust Company of Canada dated as of October 16, 2018 (the
“Indenture”), the Company has elected to issue
common shares in the capital of the Company (the “Common
Shares”), in lieu of cash, to holders of the Company’s
6.0% unsecured convertible debentures (the
“Debentures”) in satisfaction of the $1,246,380
interest payment due to holders of Debentures on September 30, 2021
(the “Interest Payment”). Holders of
Debentures of record as of September 15, 2021 will receive their
pro-rata entitlement of a total of 387,075 Common Shares. The
issuance of the Common Shares is subject to the terms of the
Indenture as well as receipt of the approval of the Toronto Stock
Exchange. Medexus’ decision to satisfy the Interest Payment in
Common Shares reflects the Company’s current focus on protecting
the strength of its balance sheet and mitigating the need to raise
capital in the near term.
About Medexus Pharmaceuticals
Inc.
Medexus is a leader in innovative rare disease
treatment solutions with a strong North American commercial
platform. From a foundation of proven best in class products
we are building a highly differentiated company with a portfolio of
innovative and high value orphan and rare disease products that
will underpin our growth for the next decade. The Company’s vision
is to provide the best healthcare products to healthcare
professionals and patients, through our core values of Quality,
Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals
is focused on the therapeutic areas of hematology, auto-immune
disease, and allergy. The Company’s leading products are: Rasuvo™
and Metoject®, a unique formulation of methotrexate (auto-pen and
pre-filled syringe) designed to treat rheumatoid arthritis and
other auto-immune diseases; IXINITY®, an intravenous recombinant
factor IX therapeutic for use in patients 12 years of age or older
with Hemophilia B – a hereditary bleeding disorder characterized by
a deficiency of clotting factor IX in the blood, which is necessary
to control bleeding; and Rupall®, an innovative prescription
allergy medication with a unique mode of action. The Company has
also licensed treosulfan, a preparative regimen for allogeneic
hematopoietic stem cell transplantation to be used in combination
with fludarabine, from medac GmbH for Canada and the United
States.
For more information, please contact:
Ken d’Entremont, Chief Executive OfficerMedexus Pharmaceuticals
Inc.Tel.: 905-676-0003E-mail: ken.dentremont@medexus.com
Marcel Konrad, Chief Financial OfficerMedexus Pharmaceuticals
Inc.Tel.: 312-548-3139E-mail: marcel.konrad@medexus.com
Investor Relations (U.S.):Crescendo Communications, LLCTel:
+1-212-671-1020E-mail: mdp@crescendo-ir.com
Investor Relations (Canada):Tina ByersAdelaide CapitalTel:
905-330-3275E-mail: tina@adcap.caForward-Looking
Statements
Certain statements made in this press release
contain forward-looking information within the meaning of
applicable securities laws (“forward-looking statements”). The
words “anticipates”, “believes”, “expects”, “will”, “plans” and
similar expressions are often intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Specific forward-looking statements
contained in this news release include, but are not limited to,
statements with respect to issuance of Common Shares in connection
with the upcoming interest payment date for the Debentures and
statements regarding the Company’s future financing needs and
intentions. These statements are based on factors or assumptions
that were applied in drawing a conclusion or making a forecast or
projection, including assumptions based on historical trends,
current conditions and expected future developments. Since
forward-looking statements relate to future events and conditions,
by their very nature they require making assumptions and involve
inherent risks and uncertainties. The Company cautions that
although it is believed that the assumptions are reasonable in the
circumstances, these risks and uncertainties give rise to the
possibility that actual results may differ materially from the
expectations set out in the forward-looking statements. Material
risk factors include those set out in the Company’s materials filed
with the Canadian securities regulatory authorities from time to
time, including the Company’s most recent annual information form
and management’s discussion and analysis. Given these risks, undue
reliance should not be placed on these forward-looking statements,
which apply only as of the date hereof. Other than as specifically
required by law, the Company undertakes no obligation to update any
forward-looking statements to reflect new information, subsequent
or otherwise.
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