New River, Shire announce New Drug Application for ADHD-drug NRP104

By E. Janene Geiss

Philadelphia, Dec. 7 - New River Pharmaceuticals Inc. and Shire plc announced Wednesday that New River has filed with the U.S. Food and Drug Administration a new drug application for the investigational compound NRP104 for the treatment of attention deficit hyperactivity disorder in children ages 6 to 12.

"The filing of NRP104 is excellent news for both Shire and New River," Shire chief executive officer Matthew Emmens said in a news release.

Shire and New River signed an agreement to develop and commercialize NRP104 on Jan. 31, 2005. Under the terms of the agreement, the parties are collaborating on NRP104 development, manufacturing, marketing and sales in the United States, officials said.

Upon launch, Shire said it 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, officials said.

Upon FDA approval, the parties will divide operating profit with Shire retaining 75% of profits for the first two years following the launch and both companies to share the profits equally after that, officials said.

Outside the United States, 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 $50 million to New River upon signing of the agreement. An additional $50 million will be due to the company upon acceptance of filing of the NDA by the FDA, typically within 60 days of receipt, officials said.

Additionally, up to $300 million in milestone payments will be due to New River depending on the characteristics of the FDA-approved product labeling, officials said.

An additional $100 million milestone would be payable as a sales bonus upon achieving a significant sales target. Shire plans to expense the second $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, officials said.

New River said it expects an FDA approval and launch of NRP104 in 2006.

The company said it has completed two of three clinical abuse-liability studies that met their objectives. This data also was included in the NDA filing, officials said.

The results of the third abuse-liability study, which is ongoing, are expected to be submitted during the FDA's review period.

Following completion of all three clinical abuse liability studies, New River said it intends to share these results to provide a comprehensive review of NRP104's potential for abuse.

As an additional aspect of the abuse-liability evaluation, New River said it conducted studies examining the extractability of amphetamine from NRP104 using a wide variety of solutions under varying conditions.

The results indicate that drug tampering with NRP104 capsules is difficult and complex.

"These results enhance our confidence in the promise of NRP104 as an improved treatment for ADHD because of its reduced abuse potential relative to other ADHD treatments. We believe that the complexity involved in extracting amphetamine from the NRP104 capsule and the low yields from the extraction process make NRP104 a less attractive drug for tampering," Suma Krishnan, New River vice president of product development, said in the release.

New River is a Radford, Va., specialty pharmaceutical company focused on developing novel pharmaceuticals that are generational improvements of widely prescribed drugs in large and growing markets.

Shire is a Basingstoke, England specialty pharmaceutical company focused on development of central nervous system, gastrointestinal, general products and human genetic therapies.

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