Product
Egrifta

Approval Date
November 11, 2010

Release Date
January 2011

Company
Merck KGaA/EMD Serono

Class
Growth hormone releasing factor (GRF) analog

Indication
For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

Active Ingredient
Tesamorelin for injection

Agency Roster
Health4Brands (professional)
IMC2 (digtial)
WCG (PR)

Marketing Strategy/Execution
EMD Serono, a unit of Merck KGaA, is using journals and clinical newspapers to educate specialists during the roll-out of Egrifta. It’s running ads targeting professionals in the Journal of Acquired Immunodeficiency Syndrome, AIDS and Infectious Disease News. When appropriate, the firm said, it will reach out to patients through a variety of vehicles. EMD Serono is postponing direct-to-patient marketing for six months post-approval and is currently preparing a patient-focused launch later this year. In the meantime, the company is offering patients assistance with reimbursement, co-pay help and ongoing treatment support. Among promotional points are the drug’s first-to-market status, as well as the statistically significant reduction in visceral adipose tissues (VAT) and in waist circumference seen in clinical trials. The drug is not indicated for weight loss management—it has a “weight neutral effect”—and there are no data on improved compliance with antiretroviral therapies among Egrifta patients. A synthetic analog of growth hormone-releasing factor, Egrifta is thought to reduce VAT by inducing growth hormone synthesis within the body.

Physician Outlook
Egrifta (tesamorelin) is the first and only FDA approved treatment for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Many HIV/AIDS patients, particularly those who were on certain older antiretroviral agents, develop lipodystrophy – a re-distribution of their body fat. A portion of these patients have developed an excess accumulation of belly fat (nicknamed “Crix” belly,” due to the prevalence of this occurring in patients taking the Protease Inhibitor, Crixivan). Patients report this as one of the most upsetting side effects of HIV therapy. In addition to the negative impact on patient self-image, the accumulation of belly fat may have cardiovascular health consequences for patients Egrifta is administered as a once-daily subcutaneous injection. Well-designed placebo controlled trials have shown a statistically significant 17- 18% likely reduction in visceral fat for those who continue to take the product. Long term studies have not been conducted with Egrifta, but trial results suggest that the effects of the loss in belly fat are reversed when the patient stops taking the product. This raises an unanswered question for physicians about the ramifications of long term use of Egrifta.

-Will Leskin, Senior Vice President, GfK Healthcare

Recent MM&M Coverage
The Top 75: Health4Brands Chelsea

Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: r-metHuLeptin
Manufacturer:Amylin Pharmaceuticals
Indication: Lipodystrophy
Active ingredient: Metreleptin
Phase: Preregistration (fast track)

Source: Wolters Kluwer Pharma Solutions

Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Contradictions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.