IncrelexTreatment for Primary IGF-1 Deficiency
Tercica Addresses Citizen Petition Filed by Insmed
Company Refutes Competitor's Assertions
BRISBANE, Calif., August 17, 2005 -- Tercica, Inc. today addressed Insmed Incorporated's citizen petition seeking to have the U.S. Food & Drug Administration deny approval of Tercica's New Drug Application for Increlex. The company stated that during the two-year planning process preceding the company's submission of its NDA to the FDA, it had numerous communications with the FDA, and had been aware of the main topics raised in Insmed's petition. The company also stated that Insmed's petition contained inaccurate statements and incorrect assumptions and opinions.
"The main topics raised in Insmed's petition are not new or surprising to us. We considered them long before we submitted the NDA," said John A. Scarlett, M.D., President and Chief Executive Officer of Tercica. "This petition is Insmed's attempt to delay our PDUFA date, and thus, is an abuse of the FDA's citizen petition process. Insmed could have filed their petition months or even years ago, because we believe they have known about these topics for a long time. Instead, they purposely waited until two and a half weeks before our PDUFA date, hoping to slow the FDA's approval process.
We remain very confident in the quality of the investigators and data contained in our NDA, in the thoughtful manner in which the FDA has interacted with us during the last several years, and in the ultimate safety and efficacy profile of Increlex when it is used to treat patients with severe Primary IGF-1 deficiency," said Dr. Scarlett.
A copy of the Citizen Petition filed by Insmed Incorporated is posted to the Tercica web site.
Increlex (mecasermin [rDNA origin] injection) is being developed for the long-term treatment of growth failure in children with severe primary insulin-like growth factor-1 (IGF-1) deficiency (Primary IGFD). IGF-1 is the direct mediator of statural growth and must be present in order for children's bones, cartilage, and organs to grow normally. Primary IGFD is a growth hormone-resistant state characterized by abnormally deficient serum IGF-1 in the presence of normal or elevated endogenous growth hormone levels.
Source: Tercica, Inc.
Posted: August 2005
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- Tercica Announces Insmed Files Citizen Petition with the FDA to Deny Approval of Increlex NDA - August 14, 2005
- FDA Accepts Tercica's Increlex New Drug Application With Priority Review for the Treatment of Short Stature - May 2, 2005
- Tercica Submits New Drug Application for Increlex as a Treatment for Short Stature Caused by Primary IGF-1 Deficiency - February 28, 2005