Hospira's Inflectra™ (infliximab) the first biosimilar monoclonal antibody to be approved in Europe

-- European Commission approval is a significant milestone for availability of lower-cost biologic therapy

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 comparable 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.