West Coast Editor

A decision from the FDA is expected in October on NRP104 for attention deficit hyperactivity disorder in pediatric patients, but New River Pharmaceuticals Inc. has started screening patients in a pivotal Phase III trial with the compound in adults.

Krish Krishnan, chief financial officer and chief operating officer for Radford, Va.-based New River, said the company intends to file for approval in the new indication in the second quarter 2007.

"The only timeline we've disclosed is the filing of the supplemental new drug application," he said, adding that "once recruitment is over, we'll be in a better position to plan" the finish of the trial and unveiling of data.

Oral NRP104 was developed using New River's Carrierwave technology, which creates conditionally bioreversible derivatives from pharmaceutical ingredients covalently attached to an adjuvant.

Studies have shown that the drug stacks up against ADHD compounds such as Adderall XR, which sold $730 million last year for Basingstoke, UK-based Shire Pharmaceuticals Group plc, and Shire is New River's global marketing partner for NRP104, a modified version of dextroamphetamine, which is one of Adderall's ingredients. The companies entered a potential $500 million deal last year. (See BioWorld Today, Feb. 1, 2005.)

Combining the active drug with an amino acid - New River has not disclosed which one - "imparts a lot of properties," Krishnan said.

"While the compound itself is immediate release, it exhibits extended-release property," making possible once-per-day dosing. What's more, the resulting new chemical entity is pharmacologically inactive until it enters the gastrointestinal tract, "which helps us a lot with the abuse properties of the drug," he said.

Shire and New River hope to put NRP104 up against such stimulants as Ritalin (methylphenidate), from Novartis AG, of Basel, Switzerland, and Concerta (a different formulation of methylphenidate), from Madison, N.J.-based Johnson & Johnson, which get the larger chunk of the market, as well as Strattera, the norepinephrine reuptake inhibitor from Eli Lilly and Co., of Indianapolis, which pulls down 15 percent or 16 percent of market share, Krishnan said.

Strattera "didn't have the stigma of abuse, but the problem with non-stimulants has been long-term efficacy," he said. "The drug has to work in the kid for many years."

In the Shire deal, New River got $50 million in February 2005, and another $50 million in January of this year when the NDA for NRP104 was accepted for filing.

Also making news in the ADHD space lately is Cephalon Inc., of Frazer, Pa., with its Sparlon (modafinil) new drug application awaiting action by the FDA. In March, the agency's Psychopharmacologic Drugs Advisory Committee voted not to recommend FDA approval of Sparlon - a new formulation and dosage of Cephalon's Provigil for sleepiness in adults - as a therapy for ADHD in children and adolescents.

Last month, the FDA extended the action date for reviewing the supplemental new drug application for Sparlon (modafinil) tablets to Aug. 22, after Cephalon submitted new information to the FDA related to a suspected case of Stevens-Johnson syndrome in a child participating in a Phase III trial. Cephalon believes the case does not involve that condition.

"Two and a half years ago, our concern was Sparlon, which has since gone away," Krishnan said, pointing to the FDA "hiccups" met by Cephalon.

"They were supposed to be on the market last year," he said. "We thought it would be our biggest competitor, but we're not as concerned about it at the moment."

Now, the worry involves more noise than signal, Krishnan said.

"There are people who believe that ADHD is not a disease," he said. "Tom Cruise and [others] make comments like, 'Maybe you should treat it by spending more time with your kids,' or some nonsense."

While such an approach might work with some children, the disease is legitimate in others, Krishnan said. New River submitted an NDA in December for use in patients ages 6 through 12, and launch is targeted for January.

"Now the attractive growth [area] is adults" afflicted with ADHD, a sector of which "maybe 80 percent is undiagnosed at the moment," Krishnan said, noting forecast that the market will reach $9 billion to $10 billion by 2010.

New River's amino-acid approach will work with other compounds, as well, he said.

"The toughest part is figuring out what amino acids and what actives, and where and how to attach them," he said. "That's the learning curve in the company."

In August 2004, New River raised $33.6 million through its initial public offering of 4.2 million common shares at $8 apiece. The company's shares (NASDAQ:NRPH) closed Tuesday at $26.40, down 9 cents.

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