BASINGSTOKE, England, PHILADELPHIA and RADFORD, Va., Jan. 31 /PRNewswire-
FirstCall/ -- Shire Pharmaceuticals Group plc (LSE: SHP; Nasdaq: SHPGY; TSX:
SHQ) and New River Pharmaceuticals Inc. (Nasdaq: NRPH) announced today the
signing of an agreement for the global commercialization of NRP104, New
River's Phase 3 compound for treatment of Attention Deficit Hyperactivity
Disorder (ADHD), as well as for other potential indications.
Under the terms of the agreement the parties will collaborate on NRP104
development, manufacturing, marketing and sales in the US. Shire will book the
product sales and New River may supply up to 25% of the sales effort under a
co-promotion right. New River will be financially and operationally
responsible for clinical and manufacturing development.
Upon U.S. Food and Drug Administration (FDA) approval, the parties will
divide operating profit in accordance with the following general principles:
Shire will retain 75% of profits for the first two years following launch and
the parties will share the profits equally thereafter.
In the rest of the world, Shire has a license to develop and commercialize
NRP104 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
million upon acceptance of filing of the New Drug Application by the FDA and
up to US$300 million in milestone payments depending on the characteristics of
the FDA-approved product labeling. An additional US$100 million milestone
would be payable as a sales bonus upon achieving a significant sales target.
Shire currently plans to expense the first two US$50 million payments, and to
capitalize and amortize the milestone payments and the sales bonus over the
life of the product.
Shire may be entitled to refunds of amounts previously paid in the event
of a delayed product approval, or upon FDA approval depending on the
characteristics of the approved product labeling.
Matthew Emmens, Chief Executive of Shire, said:
"This is a strong addition to our ADHD portfolio and complements the
development strategy of Shire and its pipeline. NRP104 is in late stage
development and we are encouraged by the data that we have seen to date and
hope that the new drug has similar efficacy of currently marketed ADHD
treatments with potential additional advantages. Importantly, NRP104 could
become a global ADHD product. We have structured the financial payments for
this collaboration to reflect the potential of the new drug and look forward
to progressing 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 we believe will bring substantial value to this project as we plan and
hopefully execute the commercialization of NRP104. Shire's CNS expertise and
leadership position in the ADHD market allows them to significantly contribute
to this collaboration in a manner that we believe will optimally serve the
interests of our shareholders. We therefore believe that Shire will be our
ideal partner for this product and we look forward to working with their
outstanding team to fully realize the potential of NRP104."
For further information please contact:
Shire Pharmaceuticals Group plc
Investor Relations
Clea 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
jquirk@theruthgroup.com
Media
Zack Kubow +1 646 536 7020
zkubow@theruthgroup.com
Notes to editors
Shire
Shire Pharmaceuticals Group Plc is a global pharmaceutical company with a
strategic focus on meeting the needs of the specialist physician and currently
focuses on developing projects and marketing products in the areas of central
nervous system, gastrointestinal and renal diseases. Shire has operations in
the 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:
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 & 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 METHYPATCH(R) (methylphenidate) and
NRP104, including its scheduling classification by the Drug Enforcement Agency
in the United States, Shire's ability to secure new products for development,
the implementation of the current reorganization and other risks and
uncertainties detailed from time to time in Shire's filings, including its
Annual Report on Form 10-K for the year ended December 31, 2003, with the
Securities and Exchange Commission.
New River
New River Pharmaceuticals Inc. is a specialty pharmaceutical company
focused on developing novel pharmaceuticals that are safer and improved
versions of widely-prescribed drugs, including amphetamines and opioids.
For further information on New River, please visit the company's website
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 is
intended 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)" and
similar expressions are intended to identify forward-looking statements.
These statements include, but are not limited to, financial projections and
estimates and their underlying assumptions; statements regarding plans,
objectives and expectations with respect to future operations, products and
services; and statements regarding future performance. Such statements are
subject to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the control of New River Pharmaceuticals, that
could cause actual results to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include: those discussed and identified in the
New River Pharmaceuticals Inc. final prospectus filed on August 5, 2004, under
Rule 424(b) of the Securities Act of 1933, as amended; the ability to
successfully execute the collaboration with Shire within a reasonable
timeframe or at all; the progress of our product development programs; the
status of our preclinical and clinical development of potential drugs, the
likely success of our drug products in clinical trials and the regulatory
approval process, particularly whether and under what circumstances NRP104
will be approved by the FDA; the ability to develop, manufacture, launch and
market NRP104; our projections for future revenues, profitability and ability
to achieve certain sales targets; our estimates regarding our capital
requirements and our needs for additional financing; the likely scheduling and
labeling of NRP104; our ability to attract partners with acceptable
development, regulatory and commercialization expertise; the likelihood of
regulatory approval under Section 505(b)(2) under the Federal Food, Drug, and
Cosmetic Act; the expected benefits of NRP104 such as efficacy and potential
advantages; our ability to develop safer and improved versions of widely-
prescribed drugs; and our ability to obtain favorable patent claims. Readers
are cautioned not to place undue reliance on these forward-looking statements
that speak only as of the date hereof. New River Pharmaceuticals does not
undertake any obligation to republish revised forward-looking statements to
reflect events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events. Readers are also urged to carefully review
and consider the various disclosures in 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 as other public filings with the
SEC.
Hampshire International Business Park,
Chineham, Basingstoke RG24 8EP UK
Tel +44 1256 894000 Fax +44 1256 894708
http://www.shire.com
New River Pharmaceuticals
1881 Grove Avenue
Radford, VA 24141
Tel +1 540 633 7978 Fax: +1 540 633 7979
http://www.nrpharma.com
SOURCE New River Pharmaceuticals Inc.
-0- 01/31/2005
/CONTACT: Investor Relations: Clea Rosenfeld, UK and Europe, +44-1256-894-
160, or Brian Piper, US and Canada, +1-484-595-8252, Media: Jessica Mann, UK
and Europe, +44-1256-894-280, or Matthew Cabrey, US, +1-484-595-8248, all for
Shire Pharmaceuticals Group plc; Investor Relations: John Quirk, +1-646-536-
7029, jquirk@theruthgroup.com; Media: Zack Kubow, +1-646-536-7020,
zkubow@theruthgroup.com, both for New River Pharmaceuticals Inc. /
/Web site: http://www.nrpharma.com
http://www.shire.com /
(SHPGY SHQ. NRPH)
CO: New River Pharmaceuticals Inc.; Shire Pharmaceuticals Group plc
ST: Virginia, Pennsylvania, England
IN: MTC HEA BIO
SU:
DL
-- NYM113 --
2571 01/31/2005 08:30 EST http://www.prnewswire.com
