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Hospira's Inflectra™ (infliximab) the first biosimilar monoclonal antibody to receive positive opinion from EMA's CHMP for

Hospira's Inflectra™ (infliximab) the first biosimilar monoclonal antibody to
      receive positive opinion from EMA's CHMP for rheumatoid arthritis,
               inflammatory bowel disease and plaque psoriasis

  PR Newswire

  LEAMINGTON SPA, England, June 28, 2013

-- Announcement marks a major milestone in a new era of lower-cost biologic
therapies

LEAMINGTON SPA, England, June 28, 2013 /PRNewswire/ -- Hospira (NYSE: HSP),
the world's leading provider of injectable drugs and infusion technologies,
today received a positive opinion from the European Medicines Agency (EMA)
Committee for Medicinal Products for Human Use (CHMP), recommending the
European Commission (EC) approval ofInflectra (infliximab) for rheumatoid
arthritis, inflammatory bowel disease and plaque psoriasis.

Inflectra (infliximab) is a biosimilar medicine to the reference medicinal
product, Remicade® (infliximab), and is the first monoclonal antibody therapy
to reach a positive opinion following review via the EMA biosimilars
regulatory pathway. A biosimilar developed in-line with EU requirements can be
considered a therapeutic alternative to an existing biologic, with comparable
quality, efficacy and safety to the reference product.[1] Remicade® had
European sales of over USD 2bn in 2012.[2]

"Today's announcement is confirmation that Inflectra has met the very rigorous
quality, safety and efficacy requirements that have been established by the
EMA, and provides the next step toward Inflectra being approved for use in
Europe," said Dr. Stan Bukofzer, Corporate Vice President and Chief Medical
Officer, Hospira.

Biologic medicines have led to vast improvements in the treatment of
conditions such as rheumatoid arthritis and inflammatory bowel disease, but
they also represent one of the biggest medical expenditures in many
countries.[3]

"In a time when there is mounting pressure on healthcare budgets worldwide,
Inflectra provides an opportunity to increase patient access to more
affordable biologic therapy while maintaining high quality standards," said
Richard Davies, Senior Vice President and Chief Commercial Officer, Hospira.

Inflectra specifically targets tumour necrosis factor (TNF) alpha, a protein
in the body that contributes to the painful inflammation seen in rheumatoid
arthritis, inflammatory bowel disease and plaque psoriasis. The drug's safety,
efficacy and tolerability have been established through a comprehensive
clinical trial programme. In a phase III randomised, double-blind study,
Inflectra met its primary endpoint of therapeutic equivalence to the reference
product. In the study, 73.4% of patients receiving Inflectra achieved a
greater than 20% improvement in RA symptoms after 30 weeks of treatment (using
the ACR20 scoring system), compared with 69.7% treated with reference
infliximab. The safety and tolerability of Inflectra was also demonstrated to
be comparable to Remicade, supporting its approval.[4]

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, the United States, Canada, Australia and New
Zealand.

The European Commission reviews the recommendations of the CHMP. The final
decision on approval, usually granted within three months of CHMP opinion,
will be applicable to all European Union (EU) and European Economic Area (EEA)
countries.

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™ which was
launched inEuropein early 2008 and Nivestim™, which entered the European
market in 2010 and Australian market in 2011.

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.

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. Immunotherap y. 2012; 4(11): 1167-1179.

[4] Hospira Inc, 2013, Data on file.

Website: http://www.hospira.com
Contact: European media, James Osborn / Tarnia Ross, +44-20-7627-0990; U.S.
media, Dan Rosenberg, +1-224-212-3366; Financial community, Karen King / Ruth
Venning, +1-224-212-2711
 
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