Tercica, Inc. (Nasdaq:TRCA) today announced the U.S. commercial launch of Increlex(TM) (mecasermin (rDNA origin) injection), the only recombinant human insulin-like growth factor-1 (rhIGF-1) replacement therapy indicated for the long-term treatment of growth failure in children with severe Primary IGFD. Tercica also announced that following its December 2005 submission for marketing approval in the EU, the company is preparing for a potential January 2007 launch of Increlex in Europe. Increlex, which is now available to patients throughout the U.S., represents the first major innovation in treating children with short stature since recombinant human growth hormone was approved 20 years ago.
"With today's commercial launch of Increlex, physicians can now prescribe a safe and effective drug backed by 321 patient-years of clinical trial treatment experience in children affected by severe Primary IGFD," said John A. Scarlett, M.D., President and Chief Executive Officer of Tercica. "In addition to a label with safety and efficacy data representing up to 12.5 years of treatment in some children, Increlex is the most convenient rhIGF-1 replacement therapy product for parents and children to store, transport and administer." Increlex was generally well tolerated and no subjects withdrew from the clinical trials due to adverse events. The most common drug-related adverse events were hypoglycemia, lipohypertrophy, and tonsillar hypertrophy.
Tercica's salesforce, which has been active in the field in the U.S. since October, has been calling on the pediatric endocrine community and discussing this newly understood cause of short stature and Increlex as a treatment option for children afflicted with severe Primary IGFD. In addition, the company has fully implemented TerciCare, its reimbursement support program that will facilitate the exchange of information between patients, healthcare providers, and health insurance companies in order to assist patients inPage: 1 2 Related medicine news :1
Contact: Kathleen Rinehart
Edelman Public Relations
. Tercica presents two pharmacokinetic studies in an oral session at Endocrine Society Meeting2
. Tercica presents pharmacokinetic and safety data from several studies at Endocrine Society Meeting3
. Worlds largest respiratory health study launches next phase4
. Elsevier launches the Clinics on ScienceDirect5
. Elsevier launches Molecular Oncology6
. Kennedy Krieger Institute launches first national online autism registry7
. UW launches study testing adult stem cells for heart damage repair8
. IEEE-USA launches critical infrastructure protection committee9
. Liverpool launches 20 million project to develop medicines for children10
. ESSP launches project on the effects of global environmental change on human health11
. ACP re-launches magazine for hospitalists