Centocor Ortho Biotech Products and Amgen Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA

HORSHAM, Pa., Feb. 16 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P. and Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include PROCRIT® (Epoetin alfa), Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa).  The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.  

As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs.  To ensure continued access to ESAs for healthcare providers who prescribe, or prescribe and dispense, ESAs to patients with cancer, providers are required to train and enroll in the ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program and to document that a discussion about the risks of ESAs took place with each patient prior to the initiation of each new course of ESA therapy.  The ESA APPRISE Oncology Program will be launched on March 24, 2010.  Direct patient registration or approval prior to ESA administration is not required through the ESA APPRISE Oncology Program.

The goal of the ESA REMS is to support informed decisions between patients and their healthcare providers (HCPs) who are considering treatment with PROCRIT, Aranesp or EPOGEN by educating them on the risks of ESAs.  For treatment of patients with cancer, the goal of the REMS, as implemented through the ESA APPRISE Oncology Program, is to mitigate the risk of decreased survival and/or poorer tumor outcomes.

"We believe it is critical that healthcare providers and their patients have a full and clear understanding of the risks associated with ESA therapy," said Thomas Schaible, vice president, Medical Affairs, Centocor Ortho Biotech.  "This program will help provide information they can use to make the decision that is best for each individual patient."

To support the implementation of the ESA APPRISE Oncology Program, Centocor Ortho Biotech Products and Amgen will distribute a Dear Healthcare Provider letter introducing the program, providing the rationale, program objectives, training and enrollment requirements and consequences for non-enrollment.  Beginning March 24, healthcare providers who prescribe, or prescribe and dispense ESAs for patients with cancer and hospitals that dispense ESAs for patients with cancer will be able to train and enroll in the ESA APPRISE Oncology Program by contacting their local Centocor Ortho Biotech Products or Amgen field representative or by accessing the ESA APPRISE Oncology Program Website, www.esa-apprise.com.  

For information about the complete ESA APPRISE Oncology program, please visit www.centocororthobiotech.com and www.amgen.com.  For full prescribing information and medication guides, please visit www.procrit.com, www.aranesp.com and www.epogen.com.

Important Safety Information

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery.  Depending on the country in which Epoetin alfa is marketed, these indications may differ.  

Aranesp is indicated for the treatment of anemia in patients with most types of cancer receiving chemotherapy as well as in patients with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis.

EPOGEN is indicated for the treatment of anemia in patients with chronic renal failure (CRF) on dialysis. EPOGEN is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Chronic Renal Failure:

• In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.

• Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.

• To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.

• Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp, EPOGEN or PROCRIT to patients with cancer.  To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.  

• Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.

• ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.

• Discontinue following the completion of a chemotherapy course.

Perisurgery: EPOGEN / PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

• ESAs are contraindicated in patients with uncontrolled hypertension.

About Centocor Ortho Biotech Products, L.P.

Centocor Ortho Biotech Products, L.P., redefines the standard of care in immunology, nephrology, and oncology.  Built upon a pioneering history, Centocor Ortho Biotech Products harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options.  Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and healthcare professionals have access to the latest treatment information, support services, and quality care.  Centocor Ortho Biotech is part of the Johnson & Johnson Family of Companies.

Johnson & Johnson Forward Looking Statement

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor Ortho Biotech and/or Johnson & Johnson's expectations and projections.  Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither Centocor Ortho Biotech nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Centocor Ortho Biotech Products, L.P.