There was further good news for Shire Pharmaceuticals yesterday when partner New River Pharmaceuticals filed for approval of another product intended to bolster its attention deficit hyperactivity franchise.
New River submitted a dossier seeking approval to market the new product, called NRP104, for the treatment of ADHD in children aged six to 12. NRP104 is a derivative of amphetamine that is intended to provide better overdose protection and a reduced potential for addiction than currently-marketed amphetamine products.
If approved, NRP104 could join a methylphenidate patch product developed by Shire, called Daytrana, which won the backing of a US Food and Drug Administration (FDA) advisory committee last week.
The active compound in NRP104 is bound to an amino acid carrier, rendering it pharmacologically inactive and only activated when taken as directed. This should also help prevent abuse and diversion, according to New River.
Shire needs new product introductions to shore up its ADHD franchise, currently dominated by top-selling product Adderall XR (mixed amphetamine salts). Adderall XR brought in third quarter sales of $166 million dollars, but is facing generic challenges from a number of companies. Shire has lawsuits ongoing against two generics houses - Barr and Impax - and the cases set to go to court in January and February 2006, respectively.
Shire CEO Matthew Emmens said: “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."
The two companies have a co-promotion and profit-sharing arrangement for NRP104 in the USA, with Shire taking on responsibility to sell the product elsewhere on its own, paying royalties to New River on ex-US sales.
Estimates of the number of children affected by ADHD vary, but the American Psychiatric Association estimates that 3% to 7% of all children are affected with the disorder. According to consultancy firm Frost & Sullivan, rates of treatment fall at the lower end of that age range, suggesting that many children with the disorder may go undiagnosed or untreated.
ADHD has also recently been recognized in adults, and F&S estimates that 4% of adults in the USA, or approximately 8 million people, have the disease.