-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, W1r2Bo4wcXsi1Sp20gbnz3KvDJ8VhNRTwHMrEzqIvo15T2Zl0dTKTEsGJHlQFvtJ DVvhzd18wbV3jbWiw1rXOQ== 0000950103-03-002065.txt : 20031022 0000950103-03-002065.hdr.sgml : 20031022 20031022152101 ACCESSION NUMBER: 0000950103-03-002065 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20031016 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031022 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC CENTRAL INDEX KEY: 0000936402 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29630 FILM NUMBER: 03951841 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 8-K 1 oct2103_8k.htm Untitled Document

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

     CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 16, 2003

Shire Pharmaceuticals Group plc
(Exact name of registrant as specified in its charter)
   
England and Wales
(State or other jurisdiction of incorporation)
   
0-29630
(Commission File Number)
98-0359573
(IRS Employer Identification No.)
   
Hampshire International Business Park, Chineham, Basingstoke,
Hampshire RG24 8EP England

(Address of principal executive offices) (Zip code)
   
Registrant's telephone number, including area code 44 1256 894 000
   

(Former name or former address, if changed since last report)
   




Item 5.  Other Events

     Shire Pharmaceuticals Group plc has issued the press releases attached as Exhibits 99.1 and 99.2 and which are incorporated by reference herein.

Item 7.  Financial Statements and Exhibits

    (c)   Exhibits. The following exhibits are filed herewith:
     
99.1  

Press Release dated October 16, 2003


99.2  

Press Release dated October 20, 2003


-2-


SIGNATURE

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Dated: October 21, 2003   SHIRE PHARMACEUTICALS GROUP PLC
       
    By: /s/ A C Russell
      Name: Angus Russell
      Title: Group Finance Director




EXHIBIT INDEX

Number   Description
     
99.1  

Press Release dated October 16, 2003

     
99.2   Press Release dated October 20, 2003



EX-99.1 3 exhibits9901.htm

Exhibit 99.1



Q3 2003 RESULTS PRESENTATION – 5 November 2003

Basingstoke, UK - 16 October 2003 - Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY; TSX: SHQ) will announce third quarter 2003 earnings on Wednesday, 5 November 2003.

  Results announcement time: 12:00 GMT / 07:00 ET
  Conference call time: 14:00 GMT / 09:00 ET

Live conference call:
The details of the live conference call are as follows:

  UK dial in + 44 1452 569 393
  US / Canada dial in 1866 434 1089
  Password Shire Pharmaceuticals

Live audio webcast:
There will also be a live audio webcast available, accessible through www.shire.com in the investor relations section. A slide presentation to accompany the call will also be available on the Shire website.

Replay:
A replay of the presentation will be available for 2 weeks. Details are as follows:

  UK International no: + 44 1452 55 00 00
  UK PIN (access) no: 608360#
  US no: 1866 276 1167
  US PIN (access) no: 608360#
  Webcast Replay www.shire.com, in the investor relations section

If you have any problems accessing this, please contact: Souheil Salah on: +44 (0) 1256 894160

End

For further information please contact:

Global Investor Relations  
Cléa Rosenfeld +44 (0)1256 894 160

Notes to editors

Shire Pharmaceuticals Group plc

Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently has a range of projects and products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

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

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Exhibit 99.2


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

Embargoed until 20 October 2003
07:00 BST

SHIRE RECEIVES APPROVABLE LETTER FOR ADULT ADDERALL XR®, FROM US FOOD AND DRUG ADMINISTRATION

Basingstoke, UK 20 October 2003 - Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has received an ‘approvable’ letter from the US Food and Drug Administration (FDA) for ADDERALL XR® once daily treatment for adult Attention Deficit Hyperactivity Disorder (ADHD).

The Supplemental New Drug Application (sNDA), which was submitted to the FDA on 18 December 2002, included a comprehensive clinical programme in adult patients and supplements the largest ever open-label community assessment trial in paediatric ADHD research(1). ADDERALL XR is patented until 2018 and the adult indication is expected to receive a three-year Hatch-Waxman protection.

ADDERALL XR is a once daily formulation containing the same active ingredients as ADDERALL® (mixed salts of a single entity amphetamine product), which was developed by Shire’s drug delivery division, Shire Laboratories Inc., using the Microtrol® oral controlled release technology. Shire already successfully markets ADDERALL XR for paediatric use in the US where it is recognised as the ADHD brand leader.

The adult market is roughly twice the size of the paediatric market2. Approximately 66%2 of children with ADHD will continue to suffer from the disease throughout their adult life. The National Institute of Mental Health reported in 1999 that ADHD affected 8.2 million adults in the US, of which only 360,000 patients were receiving treatment. Non-treated, this disease can lead to psychological maladjustment, as well as occupational and social disability. Appropriate diagnosis and treatment of ADHD in adults helps improve self-esteem, work performance and skills, educational attainment and social competencies.


1



Dr Wilson Totten, Group R&D Director, said: “This is great news for adult ADHD patients and will give them a new choice of treatment which has already been widely successful with children.

“This further step for Shire in the establishment of a broad ADHD portfolio enables us to continue to develop our position as the market leader in the treatment of this important disease. We will work with the FDA in the immediate future to resolve the questions asked in the approvable letter.”

-ENDS-

Enquiries
Cléa Rosenfeld - Global Investor Relations +44 1256 894160
Jessica Mann - Media Europe +44 1256 894160
Michele Roy - Media North America +1 450 978 7938

Notes to editors

About ADDERALL XR

ADDERALL XR has demonstrated clinically effective ADHD symptom control throughout the day with just one morning dose. In the 23 months since its launch in November 2001, ADDERALL XR has quickly become one of the most widely prescribed ADHD treatments in the US, with over 8.6 million prescriptions written3. Combined, over 32.7 million prescriptions3 have been written for ADDERALL and ADDERALL XR over the franchise’s seven-year history. Important benefits of ADDERALL XR include:

  Formulation specifically designed for once-daily dosing

  Potential to directly increase levels of both dopamine and norepinephrine, two of the major neurotransmitters believed to be involved in the pathology of ADHD

  Rapid onset of action

  Proven effectiveness and safety profile

  Dosing flexibility and versatility

About ADHD

ADHD is a significant mental health concern which impacts the patient, their family, and their social circle. It is considered one of the most commonly diagnosed psychiatric disorder among school-aged children. Children with ADHD often are inattentive, impulsive, and hyperactive – difficulties serious enough to interfere with their ability to function normally in home, academic or social settings. These symptoms continue beyond the school day, having an impact on all


2



aspects of the patient’s life. In addition, up to 66% of children with ADHD will continue to show symptoms into adulthood.

Although there is no “cure” for ADHD, physicians, parents, teachers, nurses, and advocates are finding ways to help people with the condition learn to adapt to their academic, social, and work settings. ADHD usually can be successfully managed with a combination of treatments, including educational approaches, psychological and behavioural therapies, and medication. A recent government-sponsored clinical trial found that therapies that include carefully monitored medication are more effective than those that do not, such as behavioural therapy alone. Medication should be considered as part of an overall multi-modal treatment plan for ADHD. Shire supports the use of its medication only after a thorough assessment and accurate diagnosis of ADHD by a physician.

For more information about ADHD, call 1-888-774-3000 or go to www.adhdsupportcompany.com.

1 LADD.CAT is a phase IIIb, open-label, community assessment, 7-week study (with an 8-week extension) involving 2,968 children with ADHD (ages 6-12) in 378 sites in the United States, conducted between June and December 2001.

2 Weiss G, Hechtman L, Milroy T, Perlman T. Psychiatric Status of Hyperactives as Adults: A Controlled Prospective 15-Year Follow-up of 63 Hyperactive Children. J Am Acad Child Adolesc Psychiatry. 1985;24:211-220.

3 IMS data August 2003

Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently has a range of projects and products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal. Shire has operations in the world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire Pharmaceuticals, please visit the company’s website: www.shire.com

An approvable letter is an official communication from the FDA indicating that the agency is prepared to approve the new drug application upon the finalisation of the labelling and satisfaction of any outstanding issues specified in that letter.

THE “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 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 date of lanthanum carbonate (FOSRENOL®), METHYPATCH®, XAGRID® and the adult indication for ADDERALL XR® and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K by Shire with the Securities and Exchange Commission.


3



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