Synageva BioPharma Corp.
(Synageva) (NASDAQ:GEVA), a biopharmaceutical company developing therapeutic products for rare diseases, today reported second quarter 2013 financial results and provided other business updates.
Synageva appoints Alicia Secor as Chief Operating Officer
The company today announced the appointment of Alicia Secor as Chief Operating Officer and Senior Vice President, reporting to Sanj K. Patel, President and Chief Executive Officer. Alicia joins Synageva with over 20 years of global leadership experience in biotechnology including 15 years at Genzyme, a Sanofi company, where she successfully led the commercial development, product management and global expansion of multiple products across various therapeutic specialties including metabolic diseases and biosurgery. During her time at Genzyme, Ms. Secor held global P&L responsibility and led multiple strategic business development transactions that broadened the product portfolio within specific business units.
“Alicia brings a proven track record to Synageva together with a unique set of leadership skills developed while growing global businesses through various stages of life-cycle development, including pre-launch and late-stage commercial phases,” said Sanj K. Patel, President and Chief Executive Officer of Synageva. “These attributes, combined with her integrity, energy, drive, and commitment to patients, make her an ideal fit for Synageva. I look forward to working with her as we build the company globally.”
Prior to joining Synageva, Alicia held various leadership positions at Genzyme, most recently as Vice President and General Manager of Metabolic Diseases, a global business consisting of five marketed products. Prior to this role, Alicia was Vice President and General Manager of Biosurgical Specialties with global responsibilities of the surgical device portfolio. Prior to Genzyme, Alicia held positions at Alkermes in business development, at Centocor (now part of Johnson & Johnson) in clinical and commercial operations, and began her career at Pfizer as a hospital-based sales representative.
Phase 3 ARISE trial and Phase 1/2 extension study for sebelipase alfa in LAL Deficiency
The ARISE trial (
fficacy), is a randomized, double-blind, placebo-controlled study with sebelipase alfa in children and adults with lysosomal acid lipase deficiency (LAL Deficiency) and is designed to assess the effects of sebelipase alfa on a broad range of abnormalities associated with the disease. Patients enrolled in the trial are randomized to infusions of sebelipase alfa (1 mg/kg, every other week) or placebo during the 20-week, double-blind treatment period and then allowed to enter into a long-term, open-label extension period. The efficacy and safety results from the double-blind treatment period will be used to support submissions for product registration. Dosing of patients in this trial began in February of this year and the company continues to expect enrollment to complete during 2014.
In addition to enrolling the ongoing Phase 3 ARISE trial in children and adults, patients continue to receive infusions with sebelipase alfa in the Phase 1/2 extension trial in adults with LAL Deficiency. One-year data from the Phase 1/2 extension trial with sebelipase alfa presented at the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) meeting in May of this year demonstrated sustained reductions in markers of liver damage with both ALT and AST, frequently into the normal range. In addition, sebelipase alfa improved the dyslipidemia associated with LAL Deficiency as measured by LDL-C, total cholesterol and triglycerides. Most adverse events were mild and unrelated to sebelipase alfa. As previously reported, one patient with a moderate (Grade 2) allergic type infusion-related reaction paused treatment with sebelipase alfa at nine months of the extension study, pending further tests. As an update, this patient has now completed these tests and the safety committee recommended the patient recommence treatment in the extension trial.