LEAMINGTON SPA, England,
Sept. 10, 2013 /PRNewswire/ --
Hospira (NYSE: HSP), the world's leading provider of injectable
drugs and infusion technologies, today announced the European
Commission (EC) approval of Inflectra™ (infliximab), Europe's first biosimilar monoclonal antibody
(mAb) therapy. Inflectra has been approved for the treatment of
inflammatory conditions including rheumatoid arthritis (RA),
ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis
(UC), psoriatic arthritis (PsA) and psoriasis.
Inflectra is a biosimilar medicine to the reference medicinal
product, Remicade® (infliximab), and is the first
monoclonal antibody (mAb) to be approved through the European
Medicines Agency (EMA) biosimilars regulatory pathway. A biosimilar
developed in-line with EU requirements can be considered a
therapeutic alternative to an existing biologic.1
Remicade recorded European sales of over USD
2 billion in 2012.2
"The rigorous scientific review and approval process by the EMA
and EC confirms that Inflectra has demonstrated similar quality,
efficacy and safety to Remicade. For over a decade biologic
medicines have been pivotal in treating a range of inflammatory
conditions, so the granting of marketing authorisation in
Europe is a major milestone for
Inflectra, and for the future of biologic therapy," said Dr.
Stan Bukofzer, Corporate Vice
President and Chief Medical Officer, Hospira.
The use of biologic medicines has led to vast improvements in
the treatment of conditions such as RA and IBD (inflammatory bowel
disease), but these drugs are also responsible for some of the
highest medicinal costs for many countries.3 The
introduction of biosimilar mAbs in Europe is expected to deliver savings of up to
€20.4 billion by 2020, with the biggest savings predicted in
France, Germany and the UK.4
"Inflectra offers physicians, patients and healthcare systems a
more affordable treatment option, while maintaining similar
quality, efficacy and safety to its reference product. We are
confident that with lower drug costs, Inflectra can provide an
opportunity for European Union health systems to manage their
budgets more effectively, supporting Hospira's commitment to
provide patients with better access to high-quality, more
affordable care," said Richard
Davies, Senior Vice President and Chief Commercial Officer,
Hospira.
Inflectra was approved by the EC following review of safety,
efficacy and tolerability data from a comprehensive clinical trial
programme. In a phase III randomised, double-blind study, Inflectra
met its primary endpoint of therapeutic equivalence to Remicade. In
the study, 73.4% of patients receiving Inflectra achieved a greater
than or equal to 20% improvement in RA symptoms after 30 weeks of
treatment (measured using the ACR20 scoring system), compared with
69.7% treated with Remicade.5 Safety and
tolerability data also demonstrated Inflectra's equivalence to
Remicade. The most common side effects are viral infections,
headache, upper respiratory-tract infection, sinusitis, nausea,
abdominal pain, infusion-related reactions and pain.
In 2009, Hospira entered into an agreement with South
Korean-based biopharmaceutical company, 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.
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 US-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 TNFα but not to lymphotoxin
α (TNFβ). 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
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.
The head office for Hospira in Europe, Middle
East and Africa is in
Leamington Spa, UK.
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 biosimilars program
and approval in Europe of
Inflectra. Hospira cautions that these forward-looking statements
are subject to risks and uncertainties, including adequate and
sustained progress on the company's quality initiatives and device
strategy 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.
References
1 Weise M. et al. Blood. 2012; 120:
5111-5117
2 Merck and Co, 2012 Annual Report, available from:
http://www.merck.com/investors/financials/annual-reports/. Accessed
June 2013.
3 Bendtzen, K. Immunotherapy. 2012; 4(11):
1167-1179.
4 Haustein R. et al. Saving money in the European
healthcare systems with biosimilars. Generics and Biosimilars
Initiative Journal. 2012; 1(3-4): 120-6.
5 Hospira, Inc., 2013, Data on file.
SOURCE Hospira