Hospira Shares Results From Two Open-label Extension Studies for Biosimilar Infliximab in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis

LAKE FOREST, Ill., Oct. 31, 2013 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, this week shared the results of two open-label extension studies of CT-P13 (infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, which were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego. Hospira's CT-P13, branded as Inflectra^™, was approved by the European Medicines Agency (EMA) in September 2013 as a biosimilar to reference product, Remicade^® (infliximab). Inflectra is not currently approved for use in the United States.

The objective of these open-label extension studies was to confirm long-term efficacy and safety of Inflectra in patients who had completed the original 54-week European Union (EU) clinical studies and to investigate switching from the reference Remicade product to Inflectra.

In one study, 302 of 455 patients with rheumatoid arthritis who completed the Phase III PLANETRA study entered into the open-label extension phase. Of these, 158 were continuously treated with Inflectra (maintenance group) and 144 were switched from Remicade to Inflectra (switch group) for one additional year.  The maintenance group and the switch group at weeks 78 and 102 were similar as measured by American College of Rheumatology (ACR) ACR20/50/70, DAS28-CRP, DAS28-ESR, EULAR-CRP, and EULAR-ESR response rates. Overall incidence of treatment-emergent adverse events (TEAE) was similar in both groups.

In the other study, 174 of 210 patients with ankylosing spondylitis who completed the Phase I PLANETAS study entered into the open-label extension phase. Of these, 88 were continuously treated with Inflectra (maintenance group) and 86 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by ASAS20/ASAS40, ASAS partial remission, and ASDAS-CRP rates. In this study, the adverse event profile for CT-P13 was generally consistent with the originator.

"We're very pleased with the findings of the two-year extension studies," said Dr. Stan Bukofzer, corporate vice president and chief medical officer, Hospira. "We are committed to continuing to build on our biosimilars experience."

Full results of the extension studies, conducted by South Korean-based biopharmaceutical company, Celltrion, were shared as a late-breaker oral presentation at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego on Oct. 29.

In 2009, Hospira entered into an agreement with 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.

View the full results of the studies at:
http://www.acrannualmeeting.org/Content/images/pdf/2013%20ACR%20Late-Breaking%20Accepted%20Abstracts.pdf.

About PLANETRA (Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients)
PLANETRA was a prospective, randomized, double-blind, multicenter, parallel-group, Phase III trial that evaluated CT-P13 (infliximab) biosimilar product relative to the Remicade (infliximab) reference product in 606 patients with active rheumatoid arthritis who were not receiving adequate response to methotrexate alone over at least 3 months. The primary objective of the study was to demonstrate efficacy equivalence between CT-P13 and Remicade groups up to Week 30, as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20). Secondary objectives of this study were to evaluate long-term efficacy, pharmacokinetics, pharmacodynamics, and overall safety of CT-P13 in comparison with Remicade up to Week 54.

PLANETRA is registered on ClinicalTrials.gov and can be accessed at: http://www.clinicaltrials.gov/ct2/show/NCT01217086?term=ct-p13&rank=4

About PLANETAS (Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients)
PLANETAS was a prospective, randomized, double-blind, multicenter, parallel-group Phase I trial which evaluated CT-P13 (infliximab) biosimilar product relative to the Remicade (infliximab) reference product in 250 patients with active ankylosing spondylitis. The primary objective of this study was to demonstrate comparable pharmacokinetics at steady state between CT-P13 and Remicade groups up to Week 30, as measured by area under the concentration-time curve over a dosing interval (AUC) and observed maximum serum concentration at steady state (C_max,ss). Secondary objectives of this study were to assess the long-term efficacy, pharmacokinetics, and overall safety of CT-P13 in comparison with Remicade for up to Week 54.

PLANETAS is registered on ClinicalTrials.gov and can be accessed at: http://www.clinicaltrials.gov/ct2/show/NCT01220518?term=ct-p13&rank=3

Definitions

• ASAS: Assessment in Ankylosing Spondylitis
• ASAS 20: An improvement of > 20% and absolute improvement of > 1 units on a 0–10 scale from baseline in > 3 of the following 4 domains:
  • Patient global assessment (by VAS global assessment)
  • Pain assessment (the average of VAS total and nocturnal pain scores)
  • Function (represented by BASFI)
  • Inflammation (the average of the BASDAI's last two VAS concerning morning stiffness intensity and duration)
• ASDAS: Ankylosing Spondylitis Disease Activity Score
• ASDAS-CRP: Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein
• DAS 28-CRP: Disease Activity Score 28-C-Reactive Protein
• DAS 28-ESR: Disease Activity Score 28- Erythrocyte Sedimentation Rate
• EULAR-CRP: The European League Against Rheumatism-C-Reactive Protein
• EULAR-ESR: The European League Against Rheumatism- Erythrocyte Sedimentation Rate

About Hospira Biosimilars
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™ (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 TNF alpha but not to lymphotoxin alpha (TNF beta). Inflectra is the first monoclonal antibody (mAb) to be approved through the EMA biosimilars regulatory pathway. A biosimilar developed in line with EU requirements can be considered a therapeutic alternative to an existing biologic in Europe. Inflectra is not currently approved for use in the United States.

In the EU, 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 European Public Assessment Report (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.

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 launch of Inflectra. Hospira cautions that these forward-looking statements are subject to risks and uncertainties 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.

SOURCE Hospira, Inc.