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Tesamorelin (Egrifta) Now Available to Manage HIV-related Lipodystrophy

Tesamorelin, the recently approved treatment for lipodystrophy, is now commercially available under the brand name Egrifta, according to a recent announcement from EMD Serono. The company will offer a patient assistance program for low-income individuals and a co-pay assistance program for people with insurance, as well as patient training on how to inject the new medication.

Tesamorelin (formerly known as TH9507) is a synthetic growth hormone-releasing factor that stimulates the pituitary gland in the brain to secrete growth hormone; this indirect approach appears to maintain more stable, natural levels. Clinical trials have shown that tesamorelin significantly reduces abdominal fat with fewer side effects than human growth hormone itself, though fat returns after the drug is discontinued.

The U.S. Food and Drug Administration (FDA) approved tesamorelin this past November for treatment of lipodystrophy characterized by excess body fat accumulation in HIV positive people taking antiretroviral therapy.

Below is the text of EMD Serono's recent community announcement about the availability of tesamorelin and patient assistance provided by the company. Full prescribing information is now available online at http://www.egrifta.com.

January 21, 2011 -- EMD Serono, Inc. is proud to announce the full commercial availability of Egrifta (tesamorelin for injection). We are pleased to provide the full Prescribing Information for Egrifta including Patient Information and Patient Instructions for Use. The Prescribing Information has key information about Egrifta, including its full indication and limitations, clinical data and safety information.

Egrifta Patient Support Information

EMD Serono is committed to ensuring that appropriate patients have access to Egrifta. To make this commitment a reality, the following programs and services are now available to support patients in gaining access to and staying on Egrifta.

Patient Assistance Program (PAP)

The PAP program provides free Egrifta for eligible patients who are uninsured or under-insured. Patients must meet other eligibility requirements, including a household income that does not exceed 600% of the Federal Poverty Level (FPL). Patients must also have a diagnosis of the indicated condition and be a resident of the United States. The Egrifta PAP program provides free drug for one year and patients will need to reapply if they seek to continue receiving Egrifta. The Egrifta PAP program is coordinated by the AXIS Center at 877-714-AXIS (2947).

Co-pay Assistance Program

For commercially insured patients with a prescription drug benefit that covers Egrifta, the Co-pay Assistance Program covers up to $2,400 of patients' out of pocket cost over a 12-month period. Patients must use the card for the first time in 2011 and can off-set up to $200 of their co-pay or coinsurance for up to 12 uses prior to 12/31/12, not more than once every 21 days. Patients may not use the Co-pay Assistance Program if they receive drug benefits from state or federal health care initiatives (including Medicare or Medicaid). This program is not valid in the Commonwealth of Massachusetts.

To start the process, licensed healthcare providers must fax a Statement of Medical Necessity (SMN) (i.e., prescription), signed by the healthcare provider, and Patient Authorization, signed by the patient, to the AXIS Center at 866-823-9554. SMNs will be provided by the EMD Serono sales team or can be requested by calling the AXIS Center at 877-714-AXIS (2947).

The AXIS Center

The AXIS Center offers in-home or in-office injection training to every new patient through a national network of Injection Trainers. Every new patient also receives an Education Kit that provides video and print administration guides along with other useful tools. Support continues throughout treatment with product support specialists available 24 hours-a-day/7 days-a-week to answer patients' questions about mixing and injecting Egrifta.

The AXIS Center offers dedicated reimbursement, teaching and adherence support for patients on Egrifta. With a team of dedicated Reimbursement Case Managers, the AXIS Center assists patients throughout the process of getting access to and staying on Egrifta.

We are excited to be launching Egrifta with a comprehensive set of patient support programs. Our aim is to offer the most relevant programs for patients, so, as always, please provide us with any feedback that you may have.

1/28/11