Hospira launches first biosimilar monoclonal antibody (mAb) Inflectra(TM) (infliximab) in major European markets

LAKE FOREST, Illinois (ots) -

- Major European markets can finally benefit from the availability
of Inflectra following the patent expiry of reference product
Remicade(R) (infliximab)

- Inflectra provides an alternative, potentially more affordable
treatment option for people suffering from severe, debilitating
diseases such as rheumatoid arthritis and inflammatory bowel disease
while maintaining comparable quality, efficacy and safety to the
reference product

- As a result of competition, the large savings expected to be
generated with biosimilars can provide an opportunity to improve
patient access to life-changing medications

Hospira, Inc. (http://www.hospira.com/ ) (NYSE: HSP), a world
leader in the development of biosimilar therapies, today announced
the launch of the first biosimilar monoclonal antibody (mAb),
Inflectra (infliximab), in major European markets. Inflectra is
licensed for the treatment of inflammatory conditions including
rheumatoid arthritis (RA), psoriatic arthritis, ankylosing
spondylitis, adult and paediatric Crohn's disease, adult and
paediatric ulcerative colitis and plaque psoriasis.

Biologic medicines have transformed the lives of people living
with chronic inflammatory conditions, such as RA and inflammatory
bowel disease (IBD). However, biologics are responsible for some of
the biggest medicinal costs across Europe[1] and these high costs can
restrict access to treatment. For example, it has been estimated that
40% of RA patients in Europe have severely restricted access to
biologic treatment.[2] Inflectra can offer a cost-effective
alternative while maintaining the same quality, safety and efficacy
as the reference product.[3],[4]

"With more and more people living with chronic inflammatory
diseases like RA, we need to find more cost-effective treatment
solutions without compromising on quality, safety or efficacy.
Biosimilars could offer one such solution - savings could mean we can
treat more patients within the same healthcare budget," said
Professor Josef Smolen, Chairman of the Division of Rheumatology at
Medical University of Vienna. "Biosimilars that underwent assessment
and approval by the European Commission have been included in the
latest EULAR treatment recommendations."

Infliximab is a cornerstone treatment for many inflammatory
diseases, with over 15 years' worth of clinical data and
experience.[5] Inflectra is a biosimilar medicine to the reference
product, Remicade(R) (infliximab), and is the first biosimilar mAb to
be approved by the European Commission (EC). A biosimilar developed
in-line with EU requirements can be considered a therapeutic
alternative to an existing biologic.[3]

Remicade (infliximab) has been authorized in the EU since 1999 and
recorded European sales of almost EUR2 billion in 2013.[6] The
savings generated by introducing competition in the marketplace could
save the European healthcare system millions of Euros, with
biosimilars expected to produce savings of over EUR20 billion by
2020.[7]

"Inflectra has already been launched in Central and Eastern
Europe, and some smaller Western European markets due to earlier
patent expiry, and has already been prescribed to treat patients in
all its licensed indications. We are delighted that the remaining
European countries, including many of the major EU countries, will
now benefit from the availability of Inflectra. This supports
Hospira's commitment to provide patients with better access to high-
quality, more affordable care," said Paul Greenland, Vice President
Biologics, Hospira.

Inflectra received its license from the EC in September 2013,
following adoption of the EMA Committee for Medicinal Products for
Human Use (CHMP) positive recommendation for granting marketing
authorization. Review by the EMA included detailed analysis of
biophysical properties and safety, efficacy and tolerability data
from an extensive preclinical and clinical trial program.

In a phase III randomized, double-blind study involving 606
patients, Inflectra met its primary endpoint of therapeutic
equivalence to Remicade. In this study, using the ACR20 scoring
system, 73.4% of patients receiving Inflectra achieved a greater than
or equal to 20% improvement in RA symptoms after 30 weeks of
treatment, compared with 69.7% treated with Remicade.[8] In the same
study, 42.3% of patients receiving Inflectra achieved a greater than
or equal to 50% improvement in RA symptoms after 30 weeks of
treatment (measured using the ACR50 scoring system), compared with
40.6% treated with Remicade.[8] Comparable safety and tolerability
data also demonstrated Inflectra's equivalence to Remicade. There
were no marked differences in the immunogenicity profile of the two
products up to 54 weeks, and the impact of anti-drug antibodies on
efficacy and safety was comparable.[8]

Inflectra is being launched in several major European markets,
including Austria, Denmark, France, Germany, Greece, Italy,
Luxembourg, Netherlands, Spain and Sweden. With the launch of the
product in these new markets, Inflectra is now available in 24
European countries. Hospira's partner, Celltrion, has also submitted
an application to the U.S. Food and Drug Administration for
biosimilar infliximab.

With one of the largest biosimilar pipelines in the industry,
Hospira has more than seven years' of market experience in
biosimilars. The company has several biosimilars on the European
market, including Inflectra (infliximab), Retacrit(TM) (epoetin zeta)
and Nivestim(TM) (filgrastim). Hospira has delivered more than 10
million doses of biosimilar medicines to patients worldwide.[9]

About Inflectra[10]

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 ? (TNF beta).
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).

See the Summary of Product Characteristics (also part of the EPAR)
for full details.

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(TM) by improving
patient and caregiver safety while reducing healthcare costs. The
company is headquartered in Lake Forest, Ill. Learn more at
http://www.hospira.com.

The head office for Hospira in Europe, Middle East and Africa is
in Hurley, 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 Quarterly Reports on Forms 10-Q, filed with the U.S.
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, except as required by law.

References

[1] Bendtzen, K. Anti-TNF-alpha Biotherapies: Perspectives for
Evidence- Based Personalized Medicine. Immunotherapy. 2012; 4(11):
1167-1179.

[2] Putrik P, Ramiro S, Kvien TK et al. Inequities in access to
biologic and synthetic DMARDs across 46 European countries. Ann Rheum
Dis. 2014. Jan; 73(1): 198-206.

[3] Weise M, Bielsky MC, Smet K et al. Biosimilars: what
clinicians should know. Blood. 2012; 120: 5111-5117.

[4] European Commission. Consensus Information Paper 2013. What
you need to know about Biosimilar Medicinal Products. Available at ht
tp://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilar
s_report_en.pdf. Accessed February 2015.

[5] Danese S, Colombel J, Reinisch W et al. Review article:
infliximab for crohn's disease treatment 'Äì shifting therapeutic
strategies after 10 years of clinical experience. Alimentary
Pharmacology and Therapeutics. 2011; 33: 857- 869.

[6] Merck and Co, 2013 Annual Report, available from:
http://www.merck.com/investors/financials/form-10-k-2013.pdf.
Accessed January 2015.

[7] Haustein R, Millas C, Hoer A et al. Saving money in the
European healthcare systems with biosimilars. Generics and
Biosimilars Initiative Journal. 2012; 1(3-4): 120-6.

[8] EMA. Inflectra European Public Assessment Report 'Äì Summary
for the public. EMA/402688/2013. Available at http://www.ema.europa.e
u/ema/index.jsp?curl=/pages/medicines/human/medicines/002778/human_me
d_001677.jsp Accessed January 2015.

[9] Hospira, Inc., 2014, Data on file.

[10] Inflectra (infliximab). Summary of Product Characteristics.
2014.

February, 2015. EMEA/INF/13/0005[2]

Contact:
European Media, Jenny Squibbs, 90TEN Healthcare, +44-20- 7627-0990,
or U.S. Media, Ann Fahey-Widman, Hospira, +1-224-212-3294, or
Financial Community, Karen King, Hospira, +1-224-212-2711, or Ruth
Venning, Hospira, +1-224-212-2711