Complete Response Letter Received from FDA for Treosulfan
August 03 2021 - 7:45AM
Medexus Pharmaceuticals Inc. (“
Medexus” or the
“
Company”) (TSX: MDP) (OTCQX: MEDXF) and medac
GmbH (“medac”) announced today that medac, Medexus’ licensor for
treosulfan, has received a Complete Response Letter (CRL) from the
Food and Drug Administration (FDA) in response to its New Drug
Application (NDA) for treosulfan.
As previously disclosed, the NDA was submitted
for use of treosulfan in combination with fludarabine as a
preparative regimen for allogeneic hematopoietic stem cell
transplantation (allo-HSCT), and both Medexus and medac had been
optimistic that a positive decision from the FDA in connection with
a planned Prescription Drug User Fee Act (“PDUFA”) date on August
11th would allow for a commercial launch of treosulfan in U.S.
later this year.
However, 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 and medac are reviewing the letter to determine the
appropriate course of action. Medexus and medac will work closely
with the FDA to understand and address their comments.
Ken d’Entremont, CEO, commented, “Given the
recent Health Canada approval, European Medicines Agency approval
in 2019, as well as supporting data from more than 100
publications, we were all surprised by the FDA’s response. That
being said, Medexus and medac look forward to continuing to work
with the FDA to address their requests in a timely manner, and we
remain optimistic for a future, albeit delayed, approval of
treosulfan in the United States, complete with Orphan Drug
Designation. The current standard of care is not suitable for
numerous at-risk groups, due to the high toxicity effects, and
treosulfan has demonstrated excellent survival data among those
groups. We are hopeful that our future communications with the FDA
will result in a positive outcome, and we look forward to providing
further updates in due course.”
Michael Adelman, General Manager of U.S.
Operations, commented, “We have been working diligently with medac
to prepare for the approval of treosulfan and launch shortly
thereafter. We are disappointed with the immediate result, but are
encouraged by an incredible amount of support from key opinion
leaders and the medical community for use of treosulfan in the
United States. With the extensive launch preparations we have taken
to date, we are well positioned to meet the expected strong demand
for treosulfan. While we work to address all of the FDA’s requests,
we stand poised to execute our comprehensive launch plan for
treosulfan upon approval.”
About medac GmbH
medac GmbH is a privately held, global
pharmaceutical company with a growing pharmaceutical and
diagnostics business. Since its foundation in Germany in 1970,
medac has been specializing in the treatment of diseases within the
indication areas oncology, hematology, urology and autoimmune
disorders. medac is committed to the refinement of existing and the
development of new therapeutic products – always with the focus on
improving patients’ quality of life. medac has become known for
developing innovative products also in less common indications.
This dedication has resulted in a comprehensive portfolio of
pharmaceutical products that help make a difference in the lives of
patients. medac continually invests in its product development and
manufacturing as well as logistic capacities to meet both patients’
needs and the demands of healthcare professionals.
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
next steps in the process for seeking FDA approval of treosulfan in
the United States and plans for a commercial launch thereafter.
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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