Tercica plans to target children diagnosed with ISS as possible Increlex candidates

By Jennifer Lanning Drey

Eugene, Ore., June 14 - Tercica, Inc. will target children who have been diagnosed with idiopathic short stature (ISS) as a way to grow the market for Increlex (mecasermin (rDNA origin) injection), said Dr. John A. Scarlett, president and chief executive officer of Tercica, during a presentation at the Pacific Growth Equities 2006 Life Sciences Growth Conference on Wednesday.

The Food and Drug Administration approved Increlex in August 2005 for the long-term treatment of growth failure in children with IGF-1 deficiency (IGFD).

However, children with IGFD are often diagnosed as ISS patients, and may go untreated because of efficacy and reimbursement issues, Scarlett said Wednesday.

"There are significant unmet needs in ISS," he said.

"Physicians and payers are just uncomfortable with the idea of treating anything 'idiopathic,' as opposed to a disease. I think making it clear that we're treating a disease has been one of our keys to success in reimbursement,"

Since its launch, 77% of prescriptions for Increlex have been reimbursed within 31 days, Scarlet said.

"I think you will see a lot of emphasis on ISS as we go forward," he said.

The company believes up to half of all ISS patients have IGFD.

In the future, Tercica also plans to focus on patients with severe primary IGFD, as opposed to those who simply have primary IGFD, Scarlett said.

There are approximately 6,000 patients in the United States and another 6,000 in Europe who have been diagnosed with severe primary IGFD.

The company filed a marketing authorization application for Increlex in December 2005 in Europe and the company recently received orphan drug status designation for the drug.

"We are focused on severe primary IGF-1 deficiency, which really represents the patients with the greatest need. These are children that are going to have adult heights of about 4½ feet," Scarlett said.

Children with severe primary IGFD do not respond to growth hormones but respond very well to IGF-1 treatment, he added.

Tercica also announced in May that it had identified approximately 300 children that pediatric endocrinologists had identified as candidates for Increlex therapy. As of May 5, approximately 30% had completed their evaluation and been prescribed Increlex.

Of the 30% who were prescribed Increlex, 40% had not been treated before.

Tercica is a Brisbane, Calif., biopharmaceutical company developing products to improve endocrine health.

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