New River Pharmaceuticals And Shire Receive Approvable Letter For VYVANSE™ (lisdexamfetamine Dimesylate) For The Treatment Of ADHD

Main Category: ADHD
Also Included In: Psychology / Psychiatry;  Mental Health;  Pediatrics / Children's Health
Article Date: 04 Jan 2007 - 11:00 PDT

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New River Pharmaceuticals Inc. (NASDAQ: NRPH) and its collaborative partner Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). On October 6, 2006 the FDA issued an approvable letter for VYVANSE and New River Pharmaceuticals submitted a complete response to the FDA on October 24, 2006.

No additional studies have been requested by the FDA as a condition for approval of VYVANSE. The companies will work together to provide full and timely responses to the agency’s request. The data requested are routine, and their provision to the FDA is not expected to delay a launch of VYVANSE in the second quarter of 2007. The U.S. Drug Enforcement Administration’s parallel review of VYVANSE’s scheduling assignment is expected within three months.

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance. This proposal has been submitted to the U.S. Drug Enforcement Administration (DEA). Once VYVANSE is approved by the FDA and receives final scheduling designation by DEA, VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

For more information about ADHD, please visit: www.ShireADHDTreatments.com.

The Collaboration Agreement

In January 2005, New River Pharmaceuticals signed a collaborative agreement with Shire to develop and commercialize VYVANSE. Details on the collaboration agreement are available in previous filings with the U.S. Securities and Exchange Commission.

New River

New River Pharmaceuticals Inc. is a specialty pharmaceutical company developing novel pharmaceuticals that are generational improvements of widely prescribed drugs in large and growing markets. For further information on New River, please visit the Company's Web site at www.nrpharma.com.

Shire plc

Shire’s strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.

Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

For further information on Shire, please visit the Company’s website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release of mixed amphetamine salts) (ADHD), MESAVANCE (mesalamine) with MMX technology (SPD 476) (ulcerative colitis), ELAPRASE (idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.

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