VyvanseTreatment for Attention Deficit Disorder
Update: Vyvanse Now FDA Approved - February 23, 2007
Shire Announces New River Pharmaceuticals Filing of NRP104
PHILADELPHIA, Pennsylvania and BASINGSTOKE, England, December 7, 2005 -- Shire plc announced today that New River Pharmaceuticals, Inc. (NRP) has filed with the U.S. Food and Drug Administration (FDA) a new drug application (NDA) for the investigational compound NRP104 for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric populations (ages 6-12).
"The filing of NRP104 is excellent news for both Shire and New River," said Shire Chief Executive Officer Matthew Emmens. "We are pleased that this application has been submitted on schedule and we look forward to working with New River toward an approval and subsequent launch in 2006."
Shire and New River signed a collaborative agreement to develop and commercialize NRP104 on January 31, 2005. Under the terms of the agreement, the parties collaborate on NRP104 development, manufacturing, marketing and sales in the US. Upon launch, Shire will book the product sales and New River may supply up to 25% of the sales effort under a co-promotion right. New River will be financially and operationally responsible for clinical and manufacturing development.
Upon FDA approval, the parties will divide operating profit in accordance with the following general principles: Shire will retain 75% of profits for the first two years following launch and the parties will share the profits equally thereafter.
Outside the U.S., Shire has a license to develop and commercialize NRP104 and New River will receive a low double-digit royalty on net sales.
Shire paid an initial sum of US$50 million to NRP upon signing of the agreement. An additional US$50 million will be due to NRP upon acceptance of filing of the NDA by the FDA, typically within 60 days of receipt of filing. Additionally, up to US$300 million in milestone payments will be due to New River depending on the characteristics of the FDA-approved product labeling. An additional US$100 million milestone would be payable as a sales bonus upon achieving a significant sales target. Shire plans to expense the second US$50 million payment during the course of the first quarter 2006, and currently expects to capitalize and amortize the potential remaining milestone payments and the potential sales bonus over the life of the product.
Source: Shire plc.
Posted: December 2005
- FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder - January 30, 2015
- Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD - February 7, 2012
- FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents - November 15, 2010
- FDA Approves Labeling Change for Vyvanse (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD - June 1, 2009
- FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults - April 23, 2008
- FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients - January 3, 2008
- Shire Receives FDA Approval of Vyvanse for ADHD - February 26, 2007
- New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse - December 21, 2006
- FDA Issues Approvable Letter for NRP104 (lisdexamfetamine dimesylate) for the Treatment of ADHD - October 6, 2006
- New River Pharmaceuticals Announces NRP104 NDA Accepted for Review - January 27, 2006
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