31st Jan 2005 12:10
Shire and New River announce collaboration on Phase 3 ADHD drug candidate BASINGSTOKE, UK, PHILADELPHIA, PA, US and RADFORD, Va., US January 31, 2005 -Shire Pharmaceuticals Group plc (LSE: SHP; NASDAQ: SHPGY; TSX: SHQ) and NewRiver Pharmaceuticals Inc. (NASDAQ: NRPH) announced today the signing of anagreement for the global commercialization of NRP104, New River's Phase 3compound for treatment of Attention Deficit Hyperactivity Disorder (ADHD), aswell as for other potential indications.Under the terms of the agreement the parties will collaborate on NRP104development, manufacturing, marketing and sales in the US. Shire will book theproduct sales and New River may supply up to 25% of the sales effort under aco-promotion right. New River will be financially and operationally responsiblefor clinical and manufacturing development.Upon U.S. Food and Drug Administration (FDA) approval, the parties will divideoperating profit in accordance with the following general principles: Shirewill retain 75% of profits for the first two years following launch and theparties will share the profits equally thereafter.In the rest of the world, Shire has a license to develop and commercializeNRP104 and New River will receive a low double-digit royalty on net sales.Shire pays an initial sum of US$50 million on signing, a further US$50 millionupon acceptance of filing of the New Drug Application by the FDA and up toUS$300 million in milestone payments depending on the characteristics of theFDA-approved product labeling. An additional US$100 million milestone would bepayable as a sales bonus upon achieving a significant sales target. Shirecurrently plans to expense the first two US$50 million payments, and tocapitalize and amortize the milestone payments and the sales bonus over thelife of the product.Shire may be entitled to refunds of amounts previously paid in the event of adelayed product approval, or upon FDA approval depending on the characteristicsof the approved product labeling.Matthew Emmens, Chief Executive of Shire, said:"This is a strong addition to our ADHD portfolio and complements thedevelopment strategy of Shire and its pipeline. NRP104 is in late stagedevelopment and we are encouraged by the data that we have seen to date andhope that the new drug has similar efficacy of currently marketed ADHDtreatments with potential additional advantages. Importantly, NRP104 couldbecome a global ADHD product. We have structured the financial payments forthis collaboration to reflect the potential of the new drug and look forward toprogressing this product with New River."R.J. Kirk, Chairman and Chief Executive Officer of New River, said:"We are delighted to announce this collaboration with Shire, a company that webelieve will bring substantial value to this project as we plan and hopefullyexecute the commercialization of NRP104. Shire's CNS expertise and leadershipposition in the ADHD market allows them to significantly contribute to thiscollaboration in a manner that we believe will optimally serve the interests ofour shareholders. We therefore believe that Shire will be our ideal partner forthis product and we look forward to working with their outstanding team tofully realize the potential of NRP104."For further information please contact:Shire Pharmaceuticals Group plcInvestor Relations Clĩa Rosenfeld (UK and Europe) +44 1256 894 160 Brian Piper (US and Canada) +1 484 595 8252 Media Jessica Mann (UK and Europe) +44 1256 894 280 Matthew Cabrey (US) +1 484 595 8248 New River Pharmaceuticals Inc.Investor Relations John Quirk +1 646 536 7029 [email protected] Media Zack Kubow +1 646 536 7020 [email protected] Notes to editorsShireShire Pharmaceuticals Group Plc is a global pharmaceutical company with astrategic focus on meeting the needs of the specialist physician and currentlyfocuses on developing projects and marketing products in the areas of centralnervous system, gastrointestinal and renal diseases. Shire has operations inthe world's key pharmaceutical markets (U.S., Canada, U.K., France, Italy,Spain and Germany).For further information on Shire, please visit the Company's website: www.shire.com"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995Statements included herein that are not historical facts are forward-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, Shire's results could be materially affected. Therisks and uncertainties include, but are not limited to, risks associated withthe 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& Hyperactivity Disorder (ADHD) franchise, patents, including but not limitedto, legal challenges relating to Shire's ADHD franchise, government regulationand approval, including but not limited to the expected product approval datesof METHYPATCH⨠(methylphenidate) and NRP104, including its schedulingclassification by the Drug Enforcement Agency in the United States, Shire'sability to secure new products for development, , the implementation of thecurrent reorganization and other risks and uncertainties detailed from time totime in Shire's filings, including its Annual Report on Form 10-K for the yearended December 31, 2003, with the Securities and Exchange Commission.New RiverNew River Pharmaceuticals Inc. is a specialty pharmaceutical company focused ondeveloping novel pharmaceuticals that are safer and improved versions ofwidely-prescribed drugs, including amphetamines and opioids.For further information on New River, please visit the company's website at www.nrpharma.com."SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995This 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. Wordssuch as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)"and similar expressions are intended to identify forward-looking statements.These statements include, but are not limited to, financial projections andestimates and their underlying assumptions; statements regarding plans,objectives and expectations with respect to future operations, products andservices; and statements regarding future performance. Such statements aresubject to certain risks and uncertainties, many of which are difficult topredict and generally beyond the control of New River Pharmaceuticals, thatcould cause actual results to differ materially from those expressed in, orimplied or projected by, the forward-looking information and statements. Theserisks and uncertainties include: those discussed and identified in the NewRiver Pharmaceuticals, Inc. final prospectus filed on August 5, 2004, underRule 424(b) of the Securities Act of 1933, as amended; the ability tosuccessfully execute the collaboration with Shire within a reasonable timeframeor at all; the progress of our product development programs; the status of ourpreclinical and clinical development of potential drugs, the likely success ofour drug products in clinical trials and the regulatory approval process,particularly whether and under what circumstances NRP104 will be approved bythe FDA; the ability to develop, manufacture, launch and market NRP104; ourprojections for future revenues, profitability and ability to achieve certainsales targets; our estimates regarding our capital requirements and our needsfor additional financing; the likely scheduling and labeling of NRP104; ourability to attract partners with acceptable development, regulatory andcommercialization expertise; the likelihood of regulatory approval underSection 505(b)(2) under the Federal Food, Drug, and Cosmetic Act; the expectedbenefits of NRP104 such as efficacy and potential advantages; our ability todevelop safer and improved versions of widely-prescribed drugs; and our abilityto obtain favorable patent claims. Readers are cautioned not to place unduereliance on these forward-looking statements that speak only as of the datehereof. New River Pharmaceuticals does not undertake any obligation torepublish revised forward-looking statements to reflect events or circumstancesafter the date hereof or to reflect the occurrence of unanticipated events.Readers are also urged to carefully review and consider the various disclosuresin New River Pharmaceuticals' final prospectus filed with the SEC on August 5,2004, under Rule 424(b) of the Securities Act of 1933, as amended, as well asother public filings with the SEC.112ENDRelated Shares:
Shire