Shire Pharmaceuticals Group plc
Hampshire International Business Park,
Chineham, Basingstoke RG24 8EP UK
Tel +44 1256 894000 Fax +44 1256 894708
http://www.shire.com
12 noon GMT 7am ET
SHIRE BOOSTS ADHD PORTFOLIO WITH ACQUISITION
BASINGSTOKE, UK - 27 FEBRUARY 2003 - Shire Pharmaceuticals Group plc (LSE: SHP,
NASDAQ: SHPGY, TSX: SHQ) announces that it has agreed to acquire from Noven
Pharmaceuticals, Inc. the worldwide sales and marketing rights to
METHYPATCH(R)*, a methylphenidate transdermal delivery system for the once daily
treatment of ADHD (attention deficit and hyperactivity disorder) which was filed
on 27 June 2002 with the US FDA (Food & Drug Administration).
Shire will make an upfront payment to Noven of $25 million followed by separate
milestone payments up to $125 million, which will be dependent on FDA approval
and the achievement of certain sales targets. All payments will be made in cash.
The transaction is expected to be modestly dilutive for the first 18 months and
is expected to be accretive thereafter.
The acquisition is in line with Shire's strategy of maintaining leadership in
the US ADHD market. Shire's current lead product for ADHD, Adderall XR(R), is a
successful new once daily formulation of mixed amphetamine salts, enhancing the
long-established Adderall(R) brand. The acquisition of the METHYPATCH will
enable Shire to develop a significant new presence in the methylphenidate
segment of the market which currently represents 53% of the US ADHD prescription
volume**.
Subject to regulatory approval on the transaction and the NDA application
submitted by Noven, Shire anticipates a US launch for the product in the second
half of 2003. Shire will make use of its existing US sales force to sell the new
product.
Noven will provide manufacturing. Shire will be responsible for post launch
phase-IV trials and will have full international rights to all future METHYPATCH
improvements.
METHYPATCH has a technology patent until 2012 and composition patents in the US
until September 2018 and other key markets until December 2018.
Says Shire Chief Executive, Rolf Stahel:
"This is an acquisition that is core to Shire's strategy. METHYPATCH(R)*
strengthens our position as the leading ADHD company. Over the last twelve
months Adderall XR(R), taken once a day orally, has become the fastest growing
product in the ADHD market, reflecting the positive response to Adderall XR from
doctors and patients alike. METHYPATCH will be the first transdermal drug
delivery based product offered to doctors and patients for the treatment of
ADHD. METHYPATCH provides flexibility as patients can now control the duration
of medication effect by adjusting the wear time of the product. The addition of
METHYPATCH to the Shire portfolio will enable us to more completely serve the
needs of ADHD patients."
Says Noven President, CEO and Chairman, Robert Strauss:
"We are very pleased with the appointment of Shire as our strategic development
and marketing partner for METHYPATCH(R)*. Shire is clearly the leader in ADHD.
They have demonstrated their strong capabilities through the very successful
development and launch of Adderall XR(R). Shire's global development and
marketing ability was another key factor in our decision to select Shire. We are
very proud that our product will lead Shire's expansion into the market for
long-acting methylphenidate products, and view this transaction as the first
step towards a long and successful relationship with the world leader in ADHD
therapy."
FOR FURTHER INFORMATION PLEASE CONTACT:
GLOBAL (OUTSIDE US AND CANADA)
Gordon Ngan - Investor Relations +44 1256 894 160
Jessica Mann - Media +44 1256 894 280
US & CANADA
Michele Roy - Media +1 450 978 7876
NOVEN CONTACT:
Joseph C. Jones
Vice President, Corporate Affairs
Noven Pharmaceuticals, Inc.
11960 SW 144th Street
Miami, Florida 33186
Phone: 305-964-3101
Fax: 305-232-1836
E-mail: jjones@noven.com
NOTES TO EDITORS
* registered trademark of Noven Pharmaceuticals, Inc.
** source IMS monthly data January 2003
SHIRE PHARMACEUTICALS GROUP PLC
Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international
specialty pharmaceutical company with a strategic focus on four therapeutic
areas - central nervous system disorders (CNS), oncology, gastro-intestinal (GI)
and anti-infectives. Shire also has three platform technologies: advanced drug
delivery, lead optimisation for small molecules and biologics. Shire's core
strategy is based on research and development combined with in licensing and a
focus on eight key pharmaceutical markets.
For further information on Shire, please visit the Company's website:
www.shire.com
THE "SAFE HARBOUR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995. The statements made in this press release 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
that such risks or uncertainties materialise, 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 and commercialisation, the impact of
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competitive products, including but not limited to the impact of same on Shire's
ADHD franchise of patents, government regulation and approval, including but not
limited to the expected approval date of lanthanum carbonate (FOSRENOL(TM)) and
other risks and uncertainties detailed from time to time in periodic reports
produced by Shire, including the Annual Report filed on Form 10K by Shire with
the Securities and Exchange Commission.
ABOUT NOVEN
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading
developer of advanced transdermal drug delivery technologies and prescription
transdermal products. Noven's existing products include advanced estrogen
transdermal delivery systems and combination estrogen/progestin transdermal
delivery systems. With a range of additional products in development, including
MethyPatch(R), Noven is committed to becoming the world's premier developer,
manufacturer and marketer of transdermal drug delivery systems. For additional
information on Noven and its licensing opportunities, visit www.noven.com
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