- Specialised Therapeutics receives exclusive license to commercialize rigosertib in Australia and New Zealand
- Onconova to be eligible to receive up to US $30.4 million in clinical, regulatory, and sales-based milestones and tiered double-digit royalties
Onconova
Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a Phase 3-stage
biopharmaceutical company discovering and developing novel products to
treat cancer, with a focus on myelodysplastic syndromes (MDS), today
announced it has entered into a Distribution, License, and Supply
Agreement whereby Specialised Therapeutics Asia (“STA”) shall have the
exclusive rights to commercialize rigosertib in Australia and New
Zealand. In addition, Onconova may be entitled to receive clinical,
regulatory, and sales-based milestone payments up to US $30.4 million
and tiered double-digit royalties on net sales.
“We
are pleased to partner with Specialised Therapeutics Asia, which has a
strong track record of commercializing new products in oncology and
hematology across Australia and New Zealand,” said Dr. Steven Fruchtman,
President and Chief Executive Officer of Onconova. “We look forward to
working together and, pending a successful readout of the ongoing
INSPIRE Trial, potentially providing rigosertib as a new therapeutic
option for patients diagnosed with MDS.”
STA
Chief Executive Officer, Mr. Carlo Montagner, said that “patients with
high-risk MDS have limited treatment options following currently
available first-line treatment. There is no currently approved treatment
following failure of standard chemotherapy with hypomethylating agents.
Patients are left with the option of entering clinical trials, if
available, or supportive care,” he said. “If approved, rigosertib would
address an unmet medical need and may be a valuable inclusion to the STA
therapeutic portfolio. We are delighted to enter into this
collaboration with Onconova and look forward to the results of the
ongoing phase 3 INSPIRE Trial of intravenous (IV) rigosertib.”
MDS
is a group of blood disorders that affect bone marrow function, whereby
the bone marrow cells appear dysplastic and their capacity to produce
cells is defective. As a result, patients with MDS have low blood cell
counts and require frequent blood transfusions. In approximately
one-third of patients, higher-risk MDS can progress to acute myelogenous
leukemia (AML).
Rigosertib,
Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A
key publication in a preclinical model described rigosertib’s ability to
block cellular signaling by targeting RAS effector pathways (Divakar,
S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS
Association with Effector Proteins to Block Signaling." Cell 165, 643).
Onconova is currently in the clinical development stage with oral and IV
rigosertib, including clinical trials studying single agent IV
rigosertib in second-line higher-risk MDS patients (pivotal Phase 3
INSPIRE Trial) and oral rigosertib plus azacitidine in first-line and
refractory higher-risk MDS patients (Phase 2). Patents covering oral
and injectable rigosertib have been issued in the US and are expected to
provide coverage until at least 2037.
The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE,
was finalized following guidance received from the U.S. Food and Drug
Administration and European Medicines Agency. INSPIRE is a global,
multi-center, randomized, controlled study to assess the efficacy and
safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had
progressed on, failed to respond to, or relapsed after previous
treatment with a hypomethylating agent (HMA) within nine cycles over the
course of one year after initiation of HMA treatment. This time-frame
optimizes the opportunity to respond to treatment with an HMA prior to
declaring treatment failure, as per NCCN Guidelines. Patients are
randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best
Supportive Care versus Physician's Choice plus Best Supportive Care.
The primary endpoint of INSPIRE is overall survival. The trial
continued beyond the pre-specified interim analysis and is nearing its
conclusion. Full details of the INSPIRE trial, such as inclusion and
exclusion criteria, as well as secondary endpoints, can be found on
clinicaltrials.gov (NCT02562443).
About Onconova Therapeutics, Inc.
Onconova
Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company
discovering and developing novel small molecule drug candidates to treat
cancer, with a focus on Myelodysplastic Syndromes (MDS). Using a
proprietary chemistry platform, Onconova has created a pipeline of
targeted agents designed to work against specific cellular pathways that
are important in cancer cells. Advanced clinical trials with the
Company’s lead compound, rigosertib, are aimed at what the Company
believes are unmet medical needs of patients with MDS. Onconova has
conducted trials with two other research compounds and has a
pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300.
For more information, please visit http://www.onconova.com.
Headquartered
in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an
international biopharmaceutical company established to commercialise new
therapies and technologies to patients throughout South East Asia, as
well as in Australia and New Zealand. STA and its regional affiliates
collaborate with leading global pharmaceutical and diagnostic companies
to bring novel, innovative and life-changing healthcare solutions to
patients affected by a range of diseases. Its mission is to provide
therapies where there is an unmet need. The company’s broad therapeutic
portfolio currently includes novel agents in oncology, haematology,
neurology, ophthalmology and supportive care.
Additional information can be found at www.stbiopharma.com.
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