New River Pharmaceuticals Inc. (NASDAQ:NRPH)
Industry: Healthcare

Listed 5 Consecutive Market Days. On List as of 10/17/2006 Through 10/24/2006

New River Pharmaceuticals Inc. (New River) is a specialty pharmaceutical company developing pharmaceuticals. Utilizing the Company's Carrierwave technology, it is developing molecular entities that are derivatives of public domain actives, and attempting to address certain deficiencies associated with drugs on the market. The products in New River's pipeline that are the most advanced in their development are NRP104 and NRP290, which are conditionally bioreversible derivatives (CBDs) of d-amphetamine and hydrocodone, respectively, and are designed to provide overdose protection and less potential for abuse while affording comparable efficacy. All of the Company's drug candidates developed by utilizing its Carrierwave technology to date are small molecules designed for oral delivery. Each consists of an active pharmaceutical ingredient, like amphetamine or an opioid, attached to an adjuvant. NRP104 NRP104 is intended to provide a safer, abuse resistant and effective alternative to customary amphetamine-based therapies used to treat attention deficit hyperactivity discorder (ADHD). New River is developing NRP290 to treat acute pain as an alternative to Lortab, Vicodin and Vicoprofen. NRP290 is intended to provide a safer, abuse-resistant and an effective alternative to opioids. New River repositioned the NRP369 program as a backup to NRP290 for the acute pain market and announced that the Company will not advance an Investigational New Drug (IND) on NRP369 until the Company reviews sufficient clinical data on NRP290 to determine that NRP369 could enjoy a differentiated market position relative to NRP290. On January 31, 2005, New River entered into a collaboration agreement with Shire Pharmaceuticals Group PLC (Shire) relating to the global commercialization of NRP104 for treatment of ADHD and other potential indications. On March 31, 2005, the Company and Shire split this agreement into two agreements by entering into a United States Collaboration Agreement and an ROW Territory License Agreement to replace the initial collaboration agreement. The collaboration includes product development, manufacturing, marketing and sales. On December 7, 2005, New River filed with the United States Food and Drug Administration (FDA) a New Drug Application (NDA) for NRP104 for the treatment of ADHD in pediatric populations (ages 6 through 12). On January 26, 2006, the FDA accepted the NDA for review. In May 2005, the Company completed a Phase III clinical trial that compared the efficacy, duration of action and incidence of adverse events of three doses of NRP104 to placebo in the treatment of ADHD in 285 patients ages 6 through 12. NRP290 NRP290 is a CBD of hydrocodone, an opioid widely used in combination with other non-opioid analgesics to treat acute pain. On June 28, 2005, the Company announced the submission of an IND to the FDA for NRP290. The IND became effective for studies of NRP290 in July 2005. On February 11, 2006, the Company announced results of a Phase I/ Phase II study on NRP290 study which compared the bioavailability of two investigational formulations of NRP290 solution (1 x 12 milligrams and 1 x 24 milligrams) relative to Vicodin(R)(1 x 5/500 milligrams and 2 x 5/500 milligrams) hydrocodone bitartrate and acetaminophen tablets in fasted state healthy adult volunteers. NRP409 New River is also engaged in development efforts in the area of hormone replacement therapy, or NRP409 program. Under this program, the Company's Carrierwave triiodothyronine (T3) hormone is being developed as a replacement or supplemental therapy in patients with primary hypothyroidism and other indications. New River expects to file an IND for NRP409 in 2006. Other Development Projects On June 6, 2005, New River entered into a development and license agreement with Depomed, Inc. (Depomed) to create pharmaceutical products using Depomed's patented oral drug delivery technology with the Company's drug compounds. Under terms of the agreement, New River may acquire worldwide rights to use Depomed's Gastric Retention or

Current Quote*
Last: $Unk
Change: 0.000
Book: $Unk
Volume: Unk

As Of: 10/07 00:00 ET
*Quotes delayed by 20min.

BuyIns.Net Alerts for Symbol NRPH

  • No BuyIns.Net Alerts Available for NRPH

Graphs for NRPH


3 Month Graph


6 Month Graph


1 Year Graph