InflectraTM (Infliximab) Patient Registry Reports Interim Results in the Treatment of Inflammatory Bowel Disease

– Hungarian National Registry reports interim results following Inflectra therapy in 90 patients with Crohn’s disease and ulcerative colitis
– These data add to the growing body of evidence supporting the efficacy and safety of Inflectra treatment in inflammatory bowel disease

BARCELONA and MADRID, Spain, Feb. 19, 2015 — Data have been presented today on the use of Hospira’s Inflectra (infliximab), the world’s first approved biosimilar monoclonal antibody (mAb), at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference. Results show a comparable response in patients treated with Inflectra to that expected with the reference product, Remicade^® (infliximab), for inducing and maintaining remission in Crohn’s disease (CD) and ulcerative colitis (UC).These data add to the body of evidence supporting Inflectra’s use in inflammatory bowel disease (IBD).

Results presented from the ongoing independent, prospective, nationwide study in Hungary show that for the first 90 patients, (57 with CD and 33 with UC) treated with Inflectra, reductions compared with baseline were seen in validated measures of disease activity after both two and six weeks of treatment.¹* C-reactive protein (CRP), a marker of inflammation, was also decreased during induction therapy for UC.¹ Four of the 90 patients showed an allergic reaction to treatment, all of who had previously received anti-TNF medication.¹ The abstract can be found at: P314 Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort.

Professor Peter Lakatos, one of the founders and leader of the Hungarian IBD Study Group said, “The results of this study thus far have been deeply informative to confirm the clinical efficacy and safety of biosimilar infliximab following its introduction to the Hungarian market last year. The induction and maintenance of remission in patients prescribed Inflectra are exactly as we would expect to see with Remicade.”

Another abstract presented at ECCO-ibd by Kim A et al. reports that the introduction of biosimilar infliximab for the treatment of CD alone could lead to savings of between €76 million and €336 million across the United Kingdom, Italy and France within five years.² The abstract can be found at: P137 5 year budget impact analysis of CT-P13 (Infliximab) for the treatment of Crohn’s Disease in UK, Italy and France. Biologic medicines have transformed the lives of people living with debilitating inflammatory diseases such as CD and UC, chronic conditions that affect more than 2.2 million people in Europe.³ However, these medicines are expensive and many eligible patients across Europe have been unable to access the treatments they need to fight the disease.⁴ Biosimilar medicines provide a more affordable alternative to high-cost originator biologic medicines while maintaining the same quality, efficacy and safety.⁵

Dr. Paul Audhya, vice president, Medical Affairs, Europe, Middle East and Africa, Hospira, said, “The introduction of biosimilars provides an opportunity to reduce the high cost of biologic treatment, giving patients access to more affordable care without compromising on quality, safety or efficacy. The dataset collected under the nationwide registry in Hungary further validates the long-established biosimilar regulatory pathway in the EU, and in particular the principle of extrapolation, which is fundamental to the biosimilar concept.”

 The data reported is derived from a network of centres across Hungary and has been compiled since Inflectra entered the Hungarian market in May 2014. The study will follow individual patients with CD for a period of 108 weeks, and patients with UC for a period of 54 weeks, following induction with Inflectra.¹

The Hungarian registry will continue to enrol patients, adding to the evaluation of Inflectra’s use in IBD in a number of ongoing studies assessing safety, adherence, long-term outcomes and cost. Additional abstracts are being presented on the use of biosimilar infliximab (CT-P13) in IBD at the ECCO-ibd conference, in total assessing 272 patients, and can be found at:

https://www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2015.html

Infliximab is a cornerstone treatment for many inflammatory diseases, with more than 15 years of clinical data and experience.⁶ Inflectra is a biosimilar version of the anti-TNFα blockbuster Remicade (infliximab), and is the first biosimilar mAb to be assessed and licensed by the European Commission (EC). A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.⁵ Inflectra was licensed by the European Commission in September 2013 for all indications of its reference product. Inflectra is licensed in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PsO), Crohn’s disease (CD) and ulcerative colitis (UC). Inflectra is also licensed in children and adolescents aged between six and 17 years for CD and UC.⁷ Inflectra is available in 24 European countries.

*For CD: reduction in CD Activity Index (CDAI) score, p˂0.001 compared with baseline; for UC: reduction in partial MAYO (pMAYO) score, from 6.4 to 3.7 (at week 2) and 3.6 (at week 6).

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 NOTES TO EDITORS:

 About Inflectra⁸

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 α (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, and a global leader in biosimilars. 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. Learn more at 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. 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, 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.

Contacts

References

Gecse K, et al. Biosimilar infliximab in inflammatory bowel disease: first interim results from a prospective nationwide observational cohort. Abstract P314. Presented February 2015 at ECCO-ibd, Barcelona, Spain.

Kim J, et al. 5 year budget impact analysis of CT-P13 (infliximab) for the treatment of Crohn’s disease in UK, Italy and France. Abstract P137. Presented February 2015 at ECCO-ibd, Barcelona, Spain.

The European Federation of Crohn’s and Ulcerative Colitis Associations. What is IBD? Available at: http://www.efcca.org/index.php/about-efcca/what-are-ibd. Last accessed February 2015.

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.

Weise M. et al. Biosimilars: what clinicians should know. Blood. 2012; 120: 5111-5117.

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

EMA. Inflectra European Public Assessment Report – Summary for the public. EMA/402688/2013. Available at http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/002778/human_med_001677.jsp. Last accessed January 2015.

Inflectra (infliximab). Summary of Product Characteristics. 2014.