Catalyst Biosciences’ Factor IX Granted Orphan Drug Designation in Europe
June 28 2017 - 08:00AM
Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications, today announced that
the European Commission has granted orphan medicinal product
designation to CB 2679d/ISU304, a clinical stage drug candidate for
hemophilia B.
“The many benefits of orphan medicinal product designation
include the potential for conditional marketing authorization and
ten years of market exclusivity,” said Nassim Usman, Ph.D.,
President and Chief Executive Officer of Catalyst. “Hemophilia B
is life-threatening and can be chronically debilitating
for afflicted individuals. With this important designation, we are
optimistic that CB 2679d may provide a significant benefit over
existing treatments that rely on frequent intravenous infusions by
providing simpler subcutaneous dosing and potentially,
normalization of FIX activity.”
Earlier this month, the Company announced that its collaborator,
ISU Abxis completed dosing in the first of up to five patient
cohorts in a Phase 1/2 proof-of-concept study in individuals with
severe hemophilia B. The Companies plan to have data from the trial
by the end of 2017.
About Orphan Designation Orphan designation in
the European Union (EU) is given to products that are intended for
the treatment, prevention or diagnosis of a disease that
is life-threatening or chronically debilitating;
where prevalence of the condition in the EU is less than 5 in
10,000; and where the product represents a significant benefit over
existing treatments. Orphan Designation benefits include protocol
assistance, reduced EU regulatory filing fees and 10 years of
market exclusivity. Designated orphan medicines are also eligible
for conditional marketing authorization.
About Factor IX CB 2679d/ISU304 is a
next-generation coagulation Factor IX variant that is IND-approved
in South Korea. Catalyst believes that CB 2679d/ISU304 may
allow for subcutaneous prophylactic treatment of individuals with
hemophilia B. Learn more about Factor IX.
About Hemophilia and Factor Replacement Therapy
Hemophilia, for which there is no cure, is a rare but serious
bleeding disorder that results from a genetic or an acquired
deficiency of a protein required for normal blood coagulation.
Individuals with hemophilia suffer from spontaneous bleeding
episodes as well as substantially prolonged bleeding times upon
injury. Learn more about hemophilia.
About Catalyst Catalyst is a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications. Catalyst is focused on the field of
hemostasis, including the subcutaneous prophylaxis of hemophilia
and facilitating surgery in individuals with hemophilia. For more
information, visit www.catalystbiosciences.com.
Forward-Looking StatementsThis press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statement of
historical facts, included in this press release regarding our
strategy, future operations, and plans are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to Catalyst’s clinical trial
timelines, including completion of a Phase 1/2 clinical trial for
Factor IX CB 2679d/ISU304, and the potential uses and benefits of
subcutaneously dosed CB 2679d/ISU304. Actual results or events
could differ materially from the plans, intentions, expectations
and projections disclosed in the forward-looking statements.
Various important factors could cause actual results or events to
differ materially from the forward-looking statements that Catalyst
makes, including, but not limited to, the risk that trials and
studies may be delayed and may not have satisfactory outcomes, that
human trials will not replicate the results from animal studies,
that potential adverse effects may arise from the testing or use of
Catalyst’s products, including the generation of antibodies, the
risk that costs required to develop or manufacture Catalyst’s
products will be higher than anticipated, competition and other
factors that affect our ability to successfully develop,
manufacture and commercialize our product candidates described in
the “Risk Factors” section of the Company’s Annual Report on Form
10-K and Quarterly Reports on Form 10-Q filed with the SEC.
Catalyst does not assume any obligation to update any
forward-looking statements, except as required by law.
Contacts:
Investors:
Fletcher Payne, CFO
Catalyst Biosciences
650.871.0761
investors@catbio.com
Media:
Denise Powell
510.703.9491
denise@redhousecomms.com
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