Medexus Schedules Webinar to Discuss FDA Complete Response Letter for Treosulfan
August 04 2021 - 9:58AM
Medexus Pharmaceuticals Inc. (“
Medexus” or the
“
Company”) (TSX: MDP) (OTCQX: MEDXF) today
announced that it has scheduled a webinar on Thursday, August 5,
2021 at 10:00 a.m. Eastern Time to discuss the Complete Response
Letter (CRL) that the Company’s licensor, medac GmbH, recently
received from the Food and Drug Administration (FDA) for
treosulfan.
As previously disclosed, the New Drug
Application (NDA) was submitted in respect of the use of treosulfan
in combination with fludarabine as a preparative regimen for
allogeneic hematopoietic stem cell transplantation (allo-HSCT). As
expressed in the CRL, the FDA has determined that it cannot approve
the NDA in its present form and has provided recommendations
specific to additional clinical/statistical data and analyses
pertaining to the primary and secondary endpoints of the completed
pivotal Phase III study.
Medexus continues to be encouraged by the
potential for approval of treosulfan by the FDA in the United
States due to the acceptance by other agencies around the world and
the excellent survival data that has been demonstrated for at-risk
groups. The Company has scheduled the webinar to discuss the
implications of the CRL and anticipated pathways to FDA approval.
Ken d’Entremont, CEO, and Marcel Konrad, CFO will provide an
overview of the CRL, followed by a question-and-answer period.
Medexus CRL Webinar
DetailsDate: August 5, 2021 Time: 10:00 A.M. Eastern Time
Registration Link: Medexus CRL Webinar
After registering, you will receive a confirmation email
containing information about joining the webinar. Questions may be
asked during the webinar or can be emailed in
to info@adcap.ca. If you are unable to access Zoom, the
webinar will be live streamed and available for replay on YouTube:
Adelaide Capital - YouTube.
About Medexus
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:
+1-212-671-1020Email: mdp@crescendo-ir.com
Investor Relations (Canada):Tina ByersAdelaide CapitalTel:
905-330-3275E-mail: tina@adcap.ca
Forward looking and other cautionary
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 the
potential for FDA approval of treosulfan in the United States,
including next steps in the process for seeking such approval.
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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