LAKE FOREST, Ill., Oct. 31, 2013 /PRNewswire/ -- Hospira, Inc.
(NYSE: HSP), the world's leading provider of injectable drugs and
infusion technologies, this week shared the results of two
open-label extension studies of CT-P13 (infliximab), one in
patients with rheumatoid arthritis, the other in patients with
ankylosing spondylitis, which were presented at the 2013
American College of Rheumatology (ACR)/Association of Rheumatology
Health Professionals (ARHP) Annual Meeting in San Diego. Hospira's CT-P13, branded as
Inflectra™, was approved by the European Medicines
Agency (EMA) in September 2013 as a
biosimilar to reference product, Remicade® (infliximab).
Inflectra is not currently approved for use in the United States.
The objective of these open-label extension studies was to
confirm long-term efficacy and safety of Inflectra in patients who
had completed the original 54-week European Union (EU) clinical
studies and to investigate switching from the reference Remicade
product to Inflectra.
In one study, 302 of 455 patients with rheumatoid arthritis who
completed the Phase III PLANETRA study entered into the open-label
extension phase. Of these, 158 were continuously treated with
Inflectra (maintenance group) and 144 were switched from Remicade
to Inflectra (switch group) for one additional year. The
maintenance group and the switch group at weeks 78 and 102 were
similar as measured by American College of Rheumatology (ACR)
ACR20/50/70, DAS28-CRP, DAS28-ESR, EULAR-CRP, and EULAR-ESR
response rates. Overall incidence of treatment-emergent adverse
events (TEAE) was similar in both groups.
In the other study, 174 of 210 patients with ankylosing
spondylitis who completed the Phase I PLANETAS study entered into
the open-label extension phase. Of these, 88 were continuously
treated with Inflectra (maintenance group) and 86 were switched
from Remicade to Inflectra (switch group) for one additional year.
The maintenance group and the switch group at weeks 78 and 102 were
similar as measured by ASAS20/ASAS40, ASAS partial remission, and
ASDAS-CRP rates. In this study, the adverse event profile for
CT-P13 was generally consistent with the originator.
"We're very pleased with the findings of the two-year extension
studies," said Dr. Stan Bukofzer,
corporate vice president and chief medical officer, Hospira. "We
are committed to continuing to build on our biosimilars
experience."
Full results of the extension studies, conducted by South
Korean-based biopharmaceutical company, Celltrion, were shared as a
late-breaker oral presentation at the 2013 American College of
Rheumatology (ACR)/Association of Rheumatology Health Professionals
(ARHP) Annual Meeting in San Diego
on Oct. 29.
In 2009, Hospira entered into an agreement with Celltrion, which
is developing eight monoclonal antibody biosimilars. Under the
terms of the agreement, Hospira obtained the rights to Inflectra in
Europe and certain CIS
(Commonwealth of Independent States) countries, the United States, Canada, Australia and New
Zealand. Inflectra will be launched throughout Europe at the earliest opportunity taking into
account any relevant patent protection.
View the full results of the studies at:
http://www.acrannualmeeting.org/Content/images/pdf/2013%20ACR%20Late-Breaking%20Accepted%20Abstracts.pdf.
About PLANETRA (Program evaLuating the Autoimmune Disease
iNvEstigational Drug cT-p13 in RA Patients)
PLANETRA was a prospective, randomized, double-blind, multicenter,
parallel-group, Phase III trial that evaluated CT-P13 (infliximab)
biosimilar product relative to the Remicade (infliximab) reference
product in 606 patients with active rheumatoid arthritis who were
not receiving adequate response to methotrexate alone over at least
3 months. The primary objective of the study was to demonstrate
efficacy equivalence between CT-P13 and Remicade groups up to Week
30, as determined by clinical response according to the American
College of Rheumatology (ACR) definition of a 20% improvement
(ACR20). Secondary objectives of this study were to evaluate
long-term efficacy, pharmacokinetics, pharmacodynamics, and overall
safety of CT-P13 in comparison with Remicade up to Week 54.
PLANETRA is registered on ClinicalTrials.gov and can be accessed
at:
http://www.clinicaltrials.gov/ct2/show/NCT01217086?term=ct-p13&rank=4
About PLANETAS (Program evaLuating the Autoimmune Disease
iNvEstigational Drug cT-p13 in AS Patients)
PLANETAS was a prospective, randomized, double-blind, multicenter,
parallel-group Phase I trial which evaluated CT-P13 (infliximab)
biosimilar product relative to the Remicade (infliximab) reference
product in 250 patients with active ankylosing spondylitis. The
primary objective of this study was to demonstrate comparable
pharmacokinetics at steady state between CT-P13 and Remicade groups
up to Week 30, as measured by area under the concentration-time
curve over a dosing interval (AUC) and observed maximum serum
concentration at steady state (Cmax,ss). Secondary
objectives of this study were to assess the long-term efficacy,
pharmacokinetics, and overall safety of CT-P13 in comparison with
Remicade for up to Week 54.
PLANETAS is registered on ClinicalTrials.gov and can be accessed
at:
http://www.clinicaltrials.gov/ct2/show/NCT01220518?term=ct-p13&rank=3
Definitions
- ASAS: Assessment in Ankylosing Spondylitis
- ASAS 20: An improvement of > 20% and absolute improvement of
> 1 units on a 0–10 scale from baseline in > 3 of the
following 4 domains:
- Patient global assessment (by VAS global assessment)
- Pain assessment (the average of VAS total and nocturnal pain
scores)
- Function (represented by BASFI)
- Inflammation (the average of the BASDAI's last two VAS
concerning morning stiffness intensity and duration)
- ASDAS: Ankylosing Spondylitis Disease Activity Score
- ASDAS-CRP: Ankylosing Spondylitis Disease Activity
Score-C-Reactive Protein
- DAS 28-CRP: Disease Activity Score 28-C-Reactive Protein
- DAS 28-ESR: Disease Activity Score 28- Erythrocyte
Sedimentation Rate
- EULAR-CRP: The European League Against Rheumatism-C-Reactive
Protein
- EULAR-ESR: The European League Against Rheumatism- Erythrocyte
Sedimentation Rate
About Hospira Biosimilars
Hospira has many years of experience in the field of biologics and
one of the largest biosimilar pipelines in the industry. It is the
only U.S.-based company with biosimilars on the European market,
including Retacrit™ (epoetin zeta) which was launched
in Europe in early 2008 and Nivestim™ (filgrastim), which
entered the European market in 2010 and Australian market in
2011.
About Inflectra
Inflectra (infliximab) is a chimeric human‑murine monoclonal
antibody that binds with high affinity to both soluble and
transmembrane forms of TNF alpha but not to lymphotoxin alpha
(TNF beta). Inflectra is the first monoclonal antibody (mAb) to be
approved through the EMA biosimilars regulatory pathway. A
biosimilar developed in line with EU requirements can be considered
a therapeutic alternative to an existing biologic in Europe. Inflectra is not currently approved
for use in the United States.
In the EU, Inflectra is indicated for:
Rheumatoid arthritis
Inflectra, in combination with methotrexate, is indicated for
the reduction of signs and symptoms as well as the improvement in
physical function in:
- adult patients with active disease when the response to
disease‑modifying antirheumatic drugs (DMARDs), including
methotrexate, has been inadequate.
- adult patients with severe, active and progressive disease not
previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the
progression of joint damage, as measured by X‑ray, has been
demonstrated.
Adult Crohn's disease
Inflectra is indicated for:
- treatment of moderately to severely active Crohn's disease, in
adult patients who have not responded despite a full and adequate
course of therapy with a corticosteroid and/or an
immunosuppressant; or who are intolerant to or have medical
contraindications for such therapies.
- treatment of fistulising, active Crohn's disease, in adult
patients who have not responded despite a full and adequate course
of therapy with conventional treatment (including antibiotics,
drainage and immunosuppressive therapy).
Paediatric Crohn's disease
Inflectra is indicated for treatment of severe, active Crohn's
disease in children and adolescents aged 6 to 17 years, who have
not responded to conventional therapy including a corticosteroid,
an immunomodulator and primary nutrition therapy; or who are
intolerant to or have contraindications for such therapies.
Infliximab has been studied only in combination with conventional
immunosuppressive therapy.
Ulcerative colitis
Inflectra is indicated for treatment of moderately to severely
active ulcerative colitis in adult patients who have had an
inadequate response to conventional therapy including
corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA),
or who are intolerant to or have medical contraindications for such
therapies.
Paediatric ulcerative colitis
Inflectra is indicated for treatment of severely active ulcerative
colitis in children and adolescents aged 6 to 17 years, who have
had an inadequate response to conventional therapy including
corticosteroids and 6‑MP or AZA, or who are intolerant to or have
medical contraindications for such therapies.
Ankylosing spondylitis
Inflectra is indicated for treatment of severe, active ankylosing
spondylitis, in adult patients who have responded inadequately to
conventional therapy.
Psoriatic arthritis
Inflectra is indicated for treatment of active and progressive
psoriatic arthritis in adult patients when the response to previous
DMARD therapy has been inadequate.
Inflectra should be administered
- in combination with methotrexate
- or alone in patients who show intolerance to methotrexate or
for whom methotrexate is contraindicated.
Infliximab has been shown to improve physical function in
patients with psoriatic arthritis, and to reduce the rate of
progression of peripheral joint damage as measured by X‑ray in
patients with polyarticular symmetrical subtypes of the
disease.
Psoriasis
Inflectra is indicated for treatment of moderate to severe plaque
psoriasis in adult patients who failed to respond to, or who have a
contraindication to, or are intolerant to other systemic therapy
including cyclosporine, methotrexate or psoralen ultra-violet A
(PUVA).
Important Safety Information
There are reports of
serious infections, including tuberculosis (TB), sepsis and
pneumonia, in patients taking INFLECTRA. Some of these infections
have been fatal. Patients should tell their doctors if they have
had recent or past exposure to people with TB. Their doctors will
evaluate them for TB and may perform tests for TB. If patients have
latent (inactive) TB, their doctors should begin TB treatment
before they start INFLECTRA. INFLECTRA can lower patients' ability
to fight infections, so if they are prone to or have a history of
infections, or develop any signs of an infection such as fever,
fatigue, cough, flu-like symptoms or warm, red or painful skin
while taking INFLECTRA, patients should tell their doctors right
away. Also, patients should tell their doctors if they are
scheduled to receive a vaccine or if they have lived in a region
where histoplasmosis, blastomycosis or coccidioidomycosis are
common.
Reports of a type of blood cancer called lymphoma in patients on
INFLECTRA or other TNF blockers are rare, but occur more often than
expected for people in general. People who have been treated for
rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, or
psoriatic arthritis for a long time, particularly those with highly
active disease may be more prone to develop lymphoma. Cancers,
other than lymphoma, have also been reported. Rarely, children and
young adults who have been treated for Crohn's disease or
ulcerative colitis with INFLECTRA in combination with azathioprine
or 6-mercaptopurine have developed a rare type of lymphoma,
hepatosplenic T cell lymphoma (HSTCL) that often results in death.
Patients taking INFLECTRA or other TNF blockers may be at an
increased risk for developing lymphoma or other cancers. Patients
should also tell their doctors if they have had or develop lymphoma
or other cancers or if they have a lung disease called chronic
obstructive pulmonary disease (COPD).
Many people with heart failure should not take INFLECTRA; so
prior to treatment they should discuss any heart condition with
their doctors. Patients should tell their doctors right away if
they develop new or worsening symptoms of heart failure (such as
shortness of breath, swelling of ankles or feet, or sudden weight
gain).
Reactivation of hepatitis B virus has been reported in patients
who are carriers of this virus and are taking TNF blockers, such as
INFLECTRA. Some of these cases have been fatal. All patients should
be screened for signs of an infection and a hepatitis B expert
should be consulted if a patient tests positive for hepatitis B
surface antigen.
There have been rare cases of serious liver injury in people
taking infliximab, some fatal. Patients should tell their doctors
if they have liver problems and contact their doctors immediately
if they develop symptoms such as jaundice (yellow skin and eyes),
dark brown urine, right-sided abdominal pain, fever, or severe
fatigue.
Blood disorders in people taking INFLECTRA have been reported,
some fatal. Patients should tell their doctors if they develop
possible signs of blood disorders such as persistent fever,
bruising, bleeding, or paleness while taking INFLECTRA. Nervous
system disorders have also been reported. Patients should tell
their doctors if they have or have had a disease that affects the
nervous system, or if they experience any numbness, weakness,
tingling, visual disturbances or seizures while taking
INFLECTRA.
Allergic reactions, some severe have been reported during or
after infusions with infliximab. Signs of an allergic reaction
include hives, difficulty breathing, chest pain, high or low blood
pressure, swelling of face and hands, and fever or chills.
INFLECTRA should not be administered to patients with known
hypersensitivity to INFLECTRA or any component of INFLECTRA.
Patients should tell their doctors if they have experienced a
severe allergic reaction. The most common side effects of INFLECTRA
are: viral infections, headache, upper respiratory-tract infection,
sinusitis, nausea, abdominal pain, infusion-related reactions and
pain.
See the Summary of Product Characteristics (also part of the
European Public Assessment Report (EPAR)) for full details.
About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs
and infusion technologies. Through its broad, integrated portfolio,
Hospira is uniquely positioned to Advance Wellness™ by improving
patient and caregiver safety while reducing healthcare costs. The
company is headquartered in Lake Forest,
Ill., and has approximately 16,000 employees. Learn more at
www.hospira.com.
Private Securities Litigation Reform Act of
1995 –
A Caution Concerning Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding Hospira's launch of
Inflectra. Hospira cautions that these forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially from those indicated in the
forward-looking statements. Economic, competitive, governmental,
regulatory, legal, technological, manufacturing supply, quality,
modernizing and streamlining activities, and other factors that may
affect Hospira's operations and may cause actual results to be
materially different from expectations include the risks,
uncertainties and factors discussed under the headings "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in Hospira's latest Annual
Report on Form 10-K and subsequent Forms 10-Q, filed with the
Securities and Exchange Commission, which are incorporated by
reference. Hospira undertakes no obligation to release publicly any
revisions to forward-looking statements as the result of subsequent
events or developments.
SOURCE Hospira, Inc.