22nd Dec 2006 07:00
New River Pharmaceuticals and Shire Receive Approvable Letter for VYVANSE¢â€ž¢ (lisdexamfetamine dimesylate) for the Treatment of ADHD
Launch Expected Q2 2007
Basingstoke, U.K., Philadelphia, PA and Radford, VA - DECEMBER 21, 2006 - NewRiver Pharmaceuticals Inc. and its collaborative partner Shireplc announced today that the U.S. Food andDrug Administration (FDA) has issued a second approvable letter for VYVANSE(lisdexamfetamine dimesylate, formerly known as NRP104) for the treatment ofAttention Deficit Hyperactivity Disorder (ADHD). On October 6, 2006 the FDAissued an approvable letter for VYVANSE and New River Pharmaceuticals submitteda complete response to the FDA on October 24, 2006.No additional studies have been requested by the FDA as a condition forapproval of VYVANSE. The companies will work together to provide full andtimely responses to the agency's request. The data requested are routine, andtheir provision to the FDA is not expected to delay a launch of VYVANSE in thesecond quarter of 2007. The U.S. Drug Enforcement Agency's parallel review ofVYVANCE'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.
For further information on Shire please contact:
Investor Relations Clĩa Rosenfeld (Rest of the World) +44 1256 894 160 Brian Piper (North America) +1 484 595 8252 Media Jessica Mann (Rest of the World) +44 1256 894 280 Matthew Cabrey (North America) +1 484 595 8248
For further information on New River please contact:
Investor Relations John Quirk +1 646-536-7029 [email protected] Media Zack Kubow +1 646-536-7020 [email protected] New RiverNew River Pharmaceuticals Inc. is a specialty pharmaceutical company developingnovel pharmaceuticals that are generational improvements of widely prescribeddrugs in large and growing markets. For further information on New River,please visit the Company's Web site at http://www.nrpharma.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information that isintended to be covered by the safe harbor for "forward-looking statements"provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as"expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" andsimilar expressions are intended to identify forward-looking statements. Thesestatements include, but are not limited to, financial projections and estimatesand their underlying assumptions; statements regarding plans, objectives andexpectations with respect to future operations, products and services; andstatements regarding future performance. Such statements are subject to certainrisks and uncertainties, many of which are difficult to predict and generallybeyond the control of New River Pharmaceuticals, that could cause actualresults to differ materially from those expressed in, or implied or projectedby, the forward-looking information and statements. These risks anduncertainties include: those discussed and identified in the New RiverPharmaceuticals Inc. annual report on Form 10-K, filed with the SEC on March15, 2006, as well as other public filings with the SEC; the timing, progressand likelihood of success of our product research and development programs; thetiming and status of our preclinical and clinical development of potentialdrugs; the likelihood of success of our drug products in clinical trials andthe regulatory approval process; our drug products' efficacy, abuse and tamperresistance, resistance to intravenous abuse, onset and duration of drug action,ability to provide protection from overdose, ability to improve patients'symptoms, incidence of adverse events, ability to reduce opioid tolerance,ability to reduce therapeutic variability, and ability to reduce the risksassociated with certain therapies; the ability to develop, manufacture, launchand market our drug products; our projections for future revenues,profitability and ability to achieve certain threshold sales targets; ourestimates regarding our capital requirements and our needs for additionalfinancing; the likelihood of obtaining favorable scheduling and labeling of ourdrug products; the likelihood of regulatory approval under the Federal Food,Drug, and Cosmetic Act without having to conduct long and costly trials togenerate all of the data which are often required in connection with atraditional new chemical entity; our ability to develop safer and improvedversions of widely prescribed drugs using our Carrierwave (TM) technology; oursuccess in developing our own sales and marketing capabilities for our leadproduct candidate, NRP104; and our ability to obtain favorable patent claims.Readers are cautioned not to place undue reliance on these forward-lookingstatements that speak only as of the date hereof. New River Pharmaceuticalsdoes not undertake any obligation to republish revised forward-lookingstatements to reflect events or circumstances after the date hereof or toreflect the occurrence of unanticipated events. Readers are also urged tocarefully review and consider the various disclosures in New RiverPharmaceuticals' annual report on Form 10-K, filed with the SEC on March 15,2006, as well as other public filings with the SEC.
Shire plc
Shire's strategic goal is to become the leading specialty pharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shire focuses itsbusiness on attention deficit and hyperactivity disorder (ADHD), human genetic therapies(HGT), gastrointestinal (GI) and renal diseases. The structure is sufficientlyflexible to allow Shire to target new therapeutic areas to the extent opportunities arise throughacquisitions. Shire believes that a carefully selected portfolio of products with a strategicallyaligned and relatively small-scale sales force will deliver strong results.Shire's focused strategy is to develop and market products for specialtyphysicians. Shire's in-licensing, merger and acquisition efforts are focused on products in nichemarkets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: 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-lookingstatements.Such forward-looking statements involve a number of risks and uncertainties andare subject to change at any time. In the event such risks or uncertaintiesmaterialize, Shire's results could be materially affected. The risks and uncertainties include, butare not limited to, risks associated with: the inherent uncertainty of pharmaceutical research,product development, manufacturing and commercialization; the impact of competitiveproducts,including, but not limited to the impact of those on Shire's Attention Deficitand Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legalchallenges relating to Shire's ADHD franchise; government regulation and approval, including but notlimited 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 UnitedStates; Shire's ability to secure new products for commercialization and/ordevelopment; and other risks and uncertainties detailed from time to time in Shire's and itspredecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and ExchangeCommission,particularly Shire plc's Annual Report on Form 10-K for the year ended December31, 2005.
SHIRE PLCRelated Shares:
Shire