ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) and Specialised
Therapeutics Australia Pty Ltd (STA), today announced the marketing
approval of IclusigTM (ponatinib) in Australia by the Therapeutic
Goods Administration (TGA).
The Australian Product Information for Iclusig states that it is
indicated for the treatment of adult patients with:
- Chronic phase, accelerated phase, or
blast phase chronic myeloid leukaemia (CML) whose disease is
resistant to, or who are intolerant of at least two prior tyrosine
kinase inhibitors; or where there is a T315I mutation.
- Philadelphia-chromosome positive acute
lymphoblastic leukaemia (Ph+ ALL) whose disease is resistant to, or
who are intolerant of dasatinib and for whom subsequent treatment
with imatinib is not clinically appropriate; or where there is a
T3151 mutation.
Therapy should be initiated and monitored by a haematologist
with expertise in managing adult leukaemias.
“Up to thirty percent of patients with CML become resistant to
current therapies, and patients with resistant disease eventually
run low on treatment options,” said Professor Timothy Hughes,
Consulting Haematologist at the Royal Adelaide Hospital and one of
the PACE trial investigators. “Iclusig will be a valuable new
therapy for refractory leukaemia patients and treating clinicians
in Australia.”
ARIAD submitted its marketing application for Iclusig in the
third quarter of 2013 to the Therapeutics Goods Administration
(TGA), in Australia. Commercial launch of Iclusig is expected to
occur early in 2015.
“We are very pleased with the approval of Iclusig in Australia
and will work closely with STA to make Iclusig available to
appropriate Philadelphia-positive leukaemia patients as quickly as
possible,” stated Harvey J. Berger, M.D., chairman and chief
executive officer of ARIAD. “We look forward to continuing our
strong collaboration with STA to provide this important treatment
option to refractory CML patients in Australia.”
“Iclusig provides a new treatment option for patients with
difficult-to-treat CML or Ph+ ALL who previously had limited
therapies available to them,” said Carlo Montagner, chief executive
officer at STA. “We look forward to the Pharmaceutical Benefit
Advisory Committee’s decision on Iclusig’s reimbursement for
Australian patients under the Pharmaceutical Benefits Scheme.”
The TGA decision was based on results from the pivotal Phase 2
PACE (Ponatinib Ph+ ALL and CML Evaluation) trial in patients with
CML or Ph+ ALL who were resistant or intolerant to prior tyrosine
kinase inhibitor (TKI) therapy, or who had the T315I mutation of
BCR-ABL. Iclusig demonstrated anti-leukemic activity achieving a
major cytogenetic response (MCyR) in 54 percent of chronic-phase
CML patients and in 70 percent of patients with the T315I
mutation.1, 2 MCyR within the first 12 months was the primary
endpoint of the PACE trial for chronic-phase patients.1, 2
In patients with advanced disease, 57 percent of
accelerated-phase CML patients and 34 percent of blast-phase CML
patients achieved a major hematologic response (MaHR) with Iclusig.
MaHR within the first 6 months was the primary endpoint in the
trial for patients with advanced disease.1, 2
The most common (>1%) serious adverse reactions for Iclusig
were pancreatitis, abdominal pain, decrease in platelet count,
lipase increased, anaemia, cardiac failure, coronary artery
disease, diarrhoea, decreased neutrophil count, febrile
neutropenia, pancytopenia, and pyrexia.2 The most common (≥20%)
adverse reactions of any severity were decrease in platelet count,
rash, dry skin, and abdominal pain.2
CML is a cancer of the white blood cells that is diagnosed in
approximately 330 patients each year in Australia.3 CML and Ph+ ALL
patients treated with TKIs can develop resistance or intolerance
over time to these therapies. Iclusig is a targeted cancer medicine
discovered and developed at ARIAD. It was designed by ARIAD
scientists using ARIAD’s platform of computational chemistry and
structure-based drug design to inhibit BCR-ABL, including
drug-resistant mutants that arise during treatment. Iclusig is the
only TKI that has received an approval in Australia for an
indication that includes CML and Ph+ ALL patients with the T315I
mutation.
For further information, please consult the full Iclusig Product
Information, available at
http://www.specialisedtherapeutics.com.au.
About CML and Ph+ ALL
CML is characterised by an excessive and unregulated production
of white blood cells by the bone marrow due to a genetic
abnormality that produces the BCR-ABL protein. After a chronic
phase of production of too many white blood cells, CML typically
evolves to the more aggressive phases referred to as accelerated
phase and blast crisis. Ph+ ALL is a subtype of acute lymphoblastic
leukaemia that carries the Ph+ chromosome that produces BCR-ABL. It
has a more aggressive course than CML and is often treated with a
combination of chemotherapy and tyrosine kinase inhibitors. The
BCR-ABL protein is expressed in both of these diseases.
About IclusigTM (ponatinib)
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
Minimum Product Information ICLUSIG™ (ponatinib HCl)
Indications: Adult patients with: Chronic phase,
accelerated phase, or blast phase chronic myeloid Ieukaemia (CML)
whose disease is resistant to, or who are intolerant of at least
two prior tyrosine kinase inhibitors; or where there is a
T3151mutation. Philadelphia chromosome positive acute lymphoblastic
Ieukaemia (Ph+ ALL) whose disease is resistant to, or who are
intolerant of dasatinib and for whom subsequent treatment with
imatinib is not clinically appropriate; or where there is a T3151
mutation. Therapy should be initiated and monitored by a
haematologist with expertise in managing adult leukaemias.
Contraindications: Hypersensitivity to ponatinib or
excipients.
WARNING: VASCULAR OCCLUSION AND HEART FAILURE. Vascular Occlusion: Arterial and venous thrombosis
and occlusions have occurred in at least 23% of ICLUSIG treated
patients, including fatal myocardial infarction, stroke, stenosis
of large arterial vessels of the brain, severe peripheral vascular
disease, and the need for urgent revascularisation procedures.
Patients with and without cardiovascular risk factors, including
patients less than 50 years old, experienced these events.
Monitor for evidence of thromboembolism and vascular
occlusion. Interrupt or stop ICLUSIG immediately for
vascular occlusion (see Precautions). Heart Failure, including fatalities,
occurred in 8% of ICLUSIG-treated patients. Monitor cardiac
function. Interrupt or stop ICLUSIG for new or worsening
heart failure (see Precautions)
Precautions: Actively monitor and manage patients for
vascular occlusions, cardiac failure, hypertension, haemorrhage,
myelosuppression, hepatotoxicity, pancreatitis and QT prolongation
before and during treatment. Interrupt, reduce or discontinue
ICLUSIG as clinically indicated (see full PI). Vascular
occlusion: Do not use if history of myocardial infarction,
prior revascularisation or stroke, unless the benefit outweighs the
risk. Monitor cardiovascular status and optimise therapy
throughout. Cardiac failure: Monitor for heart failure and
treat as clinically indicated. Hypertension: Monitor and
treat hypertension to normalise blood pressure. Haemorrhage:
including fatalities occurred. Mostly in patients with grade 4
thrombocytopaenia. Myelosuppression: Severe
thrombocytopenia, neutropenia or anaemia. Perform complete blood
counts every 2 weeks initially. Hepatotoxicity: Including
severe drug induced liver injury and fatal hepatic failure. Monitor
Liver Function Tests (LFT’s) at baseline and at least monthly.
Pancreatitis and serum lipase: Monitor serum lipase every 2
weeks initially. QT prolongation: QT prolongation seen with
other BCR-ABL inhibitors. Lactose: contains lactose.
Special populations: Caution or avoid in patients with
moderate to severe hepatic impairment, pregnancy (category D),
breastfeeding, the elderly, paediatric patients, driving or
operating machinery (see full PI). Interactions with Other
Medicines: Caution with concurrent strong CYP3A inhibitors,
strong CYP3A inducers, substrates of P-glycoprotein (P-gp) and
breast cancer resistance protein (BCRP) (see full PI). Adverse
Effects: Most common (≥ 20%) adverse drug
reactions (ADRs): Platelet count decreased, rash, dry skin,
and abdominal pain. Most common (> 1%)
serious ADRs: Pancreatitis (5.1%), abdominal pain (1.8%),
platelet count decreased (1.8%), lipase increased (1.3%), anaemia
(1.3%), cardiac failure (1.3%), coronary artery disease (1.1%),
diarrhoea (1.1%), neutrophil count decreased (1.1%), febrile
neutropenia (1.1%), pancytopenia (1.1%), and pyrexia (1.1%).
Other very common (>10%) ADRs:
Upper respiratory tract infection, anaemia, neutrophil count
decreased, decreased appetite, insomnia, headache, dizziness,
hypertension, dyspnoea, cough, diarrhoea, vomiting, constipation,
nausea, lipase increased, ALA increased, AST increased, bone pain,
arthralgia, myalgia, pain in extremity, back pain, muscle spasms,
fatigue, asthenia, oedema peripheral, pyrexia, pain. This is not a
full list of adverse effects – refer to full PI for more
information on common (>1%) and uncommon (>0.1%) ADRs.
Dosage and administration: Monitor and manage cardiovascular
risk factors before and throughout treatment. Dose: Starting dose, 45 mg once daily, with
or without food. Dose adjustments based on
disease response: Consider reducing the dose of ICLUSIG to
30 mg or 15 mg for chronic phase (CP) CML patients who have
achieved a major cytogenetic response, especially in subjects at
risk of vascular adverse events. Consider discontinuing ponatinib
if a haematologic response has not occurred by 3 months (90 days)
especially in subjects at risk of vascular adverse event.
Dose adjustments for toxicity:
Consider dose modification or treatment cessation to manage
myelosuppression, vascular occlusion, uncontrolled hypertension,
pancreatitis or elevated serum lipase and other severe adverse
reactions. Provide haematologic support (platelet transfusion or
haematopoietic growth factors) if clinically indicated.
About Specialised Therapeutics Australia Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) is a
biopharmaceutical company dedicated to working with leading
pharmaceutical companies worldwide to provide acute care therapies
for high unmet medical needs to people living in Australia and New
Zealand. The STA therapeutic portfolio and pipeline at present
encompasses oncology, haematology, ophthalmology and infectious
diseases. STA also has interests in the therapeutic areas of
respiratory, dermatology, endocrinology and central nervous system
(CNS). Additional information can be found at
http://www.specialisedtherapeutics.com.au.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilises computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
This press release contains “forward-looking statements” which
are based on management's good-faith expectations and are subject
to certain factors, risks and uncertainties that may cause actual
results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements.
These factors, risks and uncertainties include, but are not limited
to the Company’s ability to manufacture, and supply STA with
Iclusig; the ability of STA to perform the contracted services,
such as obtaining pricing and reimbursement approval for Iclusig in
Australia; STA’s ability to distribute, promote, market and sell
Iclusig in Australia; the timing and scope of the marketing
authorisations, as well as the level of pricing obtained in
Australia; third-party reimbursement; and the timing and success of
sales of Iclusig in Australia. These factors, risks and
uncertainties also include, but are not limited to: the costs
associated with ARIAD’s development and manufacturing, commercial
and other activities; the adequacy of capital resources and the
availability of additional funding; and other factors detailed in
the Company's public filings with the U.S. Securities and Exchange
Commission. The information contained in this press release is
believed to be current as of the date of original issue. After the
date of this document, the Company does not intend to update any of
the forward-looking statements to conform to actual results or to
changes in the Company's expectations, except as required by
law.
Reference:
1. Cortes JE, et al. N Engl J Med. 2013; 369:1783-96.
2. ICLUSIG (ponatinib) Approved Product Information.
3. Leukaemia Foundation,
http://www.leukaemia.org.au/blood-cancers/leukaemias/chronic-myeloid-leukaemia-cml.
For ARIAD InvestorsKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor ARIAD MediaLiza
Heapes, 617-621-2315Liza.heapes@ariad.comorFor Specialised
Therapeutics AustraliaMonsoon CommunicationsEmma Power, 03 9620
3333emmap@monsoon.com.au
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