FDAnews Drug Daily Bulletin

NEW RIVER SUBMITS NDA FOR ADDERALL XR FOLLOW-ON

Dec. 19, 2005
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New River Pharmaceuticals has filed its new drug application (NDA) for NRP104, developed as an abuse-resistant follow-on drug to Shire Pharmaceuticals' attention-deficit/hyperactivity disorder (ADHD) drug Adderall XR.

At a recent industry conference, executives from New River, which jointly developed NRP104 with Shire, said the company had filed an NDA Dec. 6 indicating NRP104 for the treatment of ADHD in pediatric patients ages 6 to 12.

New River also unveiled study results that confirm NRP104 is more abuse-resistant than other amphetamine-based ADHD therapies like Adderall XR (amphetamine aspartate/amphetamine sulfate/dextroamphetamine saccharate/dextroamphetamine sulfate). The key is technology that prevents a drug's active ingredient from being released unless it is taken as directed, and which also limits the "high" patients can get from a drug. New River has completed two abuse studies for NRP104; a third is ongoing.

Shire and New River partnered in January to launch NRP104, a potential blockbuster that New River claims is the first ADHD stimulant engineered to prevent abuse or overdose. While there is significant market potential for the drug, its success will depend on whether it is launched after generic Adderall XR hits the market. New River said it will launch NRP104 in 2006, but Merrill Lynch analyst Graham Parry predicts a later launch in first quarter 2007, and a mid-2006 launch of generic Adderall XR. However, a later generic debut could allow NRP104 to double its three-year sales outlook from $450 million to $1 billion, Parry said.

Shire could pay New River as much as $500 million to develop NRP104. New River received $50 million upon signing the agreement, will get an additional $50 million if the FDA accepts the NDA, and could get as much as $400 million more depending on how the FDA labels the product and whether the product meets certain sales targets. Upon FDA approval, Shire will retain 75 percent of profits for the first two years following the launch of NRP104; the parties will share the profits equally thereafter, and New River will receive a royalty on non-U.S. net sales, Shire said.

The commercial potential of New River's drug lies in the fact that studies show ADHD stimulant abuse is growing. Many students have used ADHD stimulants such as Adderall and Ritalin (methylphenidate HCl) without a prescription because they enhance concentration.