-----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, FagSiFsIlJnyOrcJs/yZD/ZvEYuiMU4O4/lcO+6Rl3jA58PeTCG/dwH622kSedwA p/7DkRH0OBF9VPpbst3ZEw== 0000950103-07-001717.txt : 20070703 0000950103-07-001717.hdr.sgml : 20070703 20070702192151 ACCESSION NUMBER: 0000950103-07-001717 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070629 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070703 DATE AS OF CHANGE: 20070702 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Shire 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: 07957026 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: - BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: - FORMER COMPANY: FORMER CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC DATE OF NAME CHANGE: 19980302 8-K 1 dp06190e_8k.htm Unassociated 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): June 29, 2007

Shire plc

(Exact name of registrant as specified in its charter)

England and Wales

(State or other jurisdiction of incorporation)
 
 
0-29630
 
98-0484822
 
 
(Commission File Number)
    
(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)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 



 
Item 8.01.  Other Events
 
Shire plc has issued the press releases attached hereto as Exhibit 99.01 and Exhibit 99.02 which are incorporated by reference herein.
 
Item 9.01.  Financial Statements and Exhibits

                  (d)  Exhibits.  The following exhibits are filed herewith:

99.01                Press Release dated June 29, 2007
 
99.02                Press Release dated July 2, 2007


 
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.

 
  SHIRE PLC
     
     
  By: /s/ A C Russell
   
    Name: 
Angus Russell
    Title: 
Chief Financial Officer
 
Dated: July 2, 2007


 
 
EXHIBIT INDEX
 
 
Number
Description
   
99.01
Press Release dated June 29, 2007
99.02
Press Release dated July 2, 2007
 
 
 

 
 
 
EX-99.1 2 dp06190e_ex9901.htm
    EXHIBIT 99.01  
       
 
Hampshire International Business Park
Chineham  Basingstoke
Hampshire RG24 8EP
United Kingdom
Tel +44 (0)1256 894000
Fax +44 (0)1256 894708
www.shire.com
 
       
 
Press Release
   
 
Shire Announces Filing of VYVANSE™
(lisdexamfetamine dimesylate) for the Treatment of ADHD in Adults

Philadelphia, PA – June 29, 2007– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VYVANSE™ (lisdexamfetamine dimesylate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults.  This application is subject to a 10-month FDA review period.

“ADHD is a treatable disorder that affects adults as well as children,” said Matthew Emmens, Shire Chief Executive Officer.  “We are pleased with the results of VYVANSE studies conducted in adults and we believe this product will meet an important need in the adult ADHD marketplace.  VYVANSE is a priority in our ADHD portfolio and we are committed to developing this next generation ADHD medication so that adults diagnosed with ADHD may benefit from treatment with VYVANSE.”

VYVANSE is a prodrug stimulant that is therapeutically inactive until metabolized in the body and active d-amphetamine is released.  VYVANSE is different from other oral long acting stimulants of amphetamine and methylphenidate that rely on delivery systems which may be affected by pH and GI transit time.

Shire plans to announce full results from its phase III clinical trial for the treatment of ADHD in adults at a major scientific conference in Q4 2007.

The FDA approved VYVANSE on February 23, 2007, to treat symptoms of ADHD in children aged 6 to 12.

Additional information about VYVANSE and Full Prescribing Information are available at www.vyvanse.com.

About ADHD
Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC).  ADHD is one of the most common psychiatric disorders in children and adolescents.  The disorder is also estimated to affect approximately 9.8 million adults across the U.S. based on a retrospective survey of adults aged 18 to 34, projected to the full U.S. adult population.  ADHD is a neurobiological
 
 
Registered in England 2883758  Registered Office as above
 
 
 

 
 
disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.  To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.

Although there is no “cure” for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.


For further information on Shire please contact:
Investor Relations
   
Cléa Rosenfeld (Rest of the World)
 
+44 1256 894 160
Eric Rojas (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
 
 
About VYVANSE

Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have.  Inform the doctor immediately if your child develops symptoms that suggest heart problems, such as chest pain or fainting.

VYVANSE should not be taken if your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking VYVANSE if your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility.  Tell the doctor immediately if your child develops any of these conditions or symptoms while taking VYVANSE.

Abuse of amphetamines may lead to dependence.  Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.  These events have also been reported rarely with amphetamine use.

VYVANSE was generally well tolerated in clinical studies.  The most common side effects reported in studies of VYVANSE were decreased appetite, difficulty falling asleep, stomachache, and irritability.
 
 
Registered in England 2883758  Registered Office as above
 
 
 

 
 
Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette’s syndrome have been associated with use of drugs of this type.  Tell the doctor if your child has blurred vision while taking VYVANSE.


Shire plc
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on ADHD, human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
 
Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets 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.
 
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 of those on Shire’s Attention Deficit and 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 INTUNIV (guanfacine) extended release (ADHD); Shire’s ability to secure new products for commercialization and/or development; Shire’s ability to benefit from its acquisition of New River Pharmaceuticals Inc.; the successful development of JUVISTA®, and other risks and uncertainties detailed from time to time in Shire plc’s filings with the Securities and Exchange Commission, particularly Shire plc’s Annual Report on Form 10-K for the year ended December 31, 2006.
 
 
Registered in England 2883758  Registered Office as above
 

 

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    EXHIBIT 99.02  
       
 
Hampshire International Business Park
Chineham  Basingstoke
Hampshire RG24 8EP
United Kingdom
Tel +44 (0)1256 894000
Fax +44 (0)1256 894708
www.shire.com
 
       
 
Press Release
   
 
2 July 2007

Total Voting Rights

In accordance with the Transparency Directive's transitional provision six, Shire plc notifies the market of the following:

At close of business on 29 June 2007, Shire plc's issued voting share capital consisted of 553,226,940 ordinary shares with a nominal value of 5 pence each and 1,234,489 special voting shares of 0.0001 pence each.  Each ordinary share carries one voting right and each special voting share carries three voting rights.   Shire plc does not hold any shares in Treasury.

Therefore the total number of voting rights in Shire plc is 556,930,407.

The above figure (556,930,407) may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Shire plc under the FSA's Disclosure and Transparency Rules.

 
T May
Company Secretary
 
 
For further information please contact:

Investor Relations
Cléa Rosenfeld (Rest of the World)
+44 1256 894 160
 
Eric Rojas (North America)
+1 484 595 8252
 
Notes to editors

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases.  The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions.  Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
 
 
Registered in England 2883758  Registered Office as above
 

 
Shire’s focused strategy is to develop and market products for specialty physicians.  Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets 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.
 
 
 
 
Registered in England 2883758  Registered Office as above
 

 

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