Shire Pharmaceuticals - 500 Beiträge pro Seite

[Honarus]

Das oben benannte Unternehmen wird in den folgenden
drei Monaten gute Nachrichten liefern.
MfG
Honarus

[opty]

Woher hast Du diese weissssheit? Was kommt in drei Monaten? Ist eine lange Zeit.
MfG Opty

[Honarus]

Hallo opty
ich bin kein ,,weiser" noch ein Hellseher habe aber den
Überblick aus der ,,Vogelperspektive" .
MfG
Honarus

[Archmage]

First Study Results for Novel Once-A-Day Medication for ADHD Presented At AACAP, New York
ANDOVER, United Kingdom, Oct. 26 /PRNewswire/ -- Shire Pharmaceuticals Group plc (Nasdaq: SHPGY; London: SHP.L) announces results from a new clinical trial indicating that SLI 381, a novel, once-a-day formulation of ADDERALL® (mixed salts of a single-entity amphetamine product) may control symptoms of attention deficit/hyperactivity disorder (ADHD) throughout the day and into the evening. The findings were presented today at the 47th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP), in New York. A New Drug Application (NDA), that includes this study, was submitted to the US Food and Drug Administration on 3 October 2000 to gain marketing approval for SLI 381.

In the study, 51 children with ADHD were randomized to receive 10, 20, or 30 mg of SLI 381, Adderall 10 mg, or placebo. The 44 patients who completed the study took each treatment for a week. Efficacy of treatment was assessed using the SKAMP Rating Scale, which assesses behavior (attention and deportment) specific to place and time, and the PERMP Derived Measures, a 10-minute written maths test taken multiple times in the classroom setting used in this study design.

Compared with placebo, patients given SLI 381 demonstrated significant improvement on both SKAMP (p<0.05) and PERMP (p<0.05) assessments throughout the day and into the evening time points. The effects of SLI 381 on these scales lasted until later in the day and longer than Adderall 10mg.

No serious adverse medical events were reported during the conduct of the study. The most commonly reported side effects in the study were typical of those associated with other ADHD medications, and included nervousness, anorexia, abdominal pain, insomnia, and headache.

The investigators concluded that SLI 381 exhibited both prompt onset and persistence of effect that lasted throughout the day and into the early evening.

``The development of SLI 381, with its unique delivery system is intended to build upon Shire`s success in the US ADHD market with Adderall and provide all appropriate patients with a convenient once-a-day formulation of this widely used medication. We are very pleased with the emerging clinical profile of this product and look forward to hearing the outcome of FDA review`` said Rolf Stahel, Chief Executive of Shire Pharmaceuticals Group plc.

Notes to Editors
About ADHD
ADHD is considered the most commonly diagnosed psychiatric disorder among

children (1). Children with ADHD often are inattentive, impulsive, and
hyperactive -- difficulties serious enough to interfere with their ability to
function normally in academic or social settings. In addition, up to 66
percent of children with ADHD will continue to show symptoms into adulthood
(2).
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 behavioral therapies, and medication. A recent landmark clinical trial found that therapies that include carefully monitored medication are more effective than those that do not, such as behavioral therapy alone (3). Medication should be considered part of an overall multimodal treatment plan for ADHD.

Shire Pharmaceuticals Group plc

Shire is an international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, metabolic diseases, oncology and gastroenterology. The group has a sales and marketing infrastructure with a broad portfolio of products targeting with its own sales force the US, Canada, UK, Republic of Ireland, France, Germany, Italy and Spain, with plans to add Japan by 2004. Shire intends to cover other significant pharmaceutical markets indirectly through distributors. We have already appointed distributors in Australia, Denmark, Finland, Hong Kong, Israel, Malaysia, Norway, Philippines (limited to one third party product licensed to the local distributor), Singapore, South Africa, South Korea, and Thailand.

Shire`s global search and development expertise has to date successfully provided eight marketed products, of which Reminyl for the treatment of Alzheimer`s disease is the latest to be launched in its first market, the UK. The current pipeline of 15 projects includes Reminyl in registration in the US and various other markets and 9 others that are post Phase II. Shire is actively seeking to acquire further marketed products and development projects to enhance the potential for future growth. Shire M&A activity has resulted in five mergers and acquisitions during the last six years.

Shire`s focus and outsourcing policies have resulted in sales per employee of $400,000*, one of the highest ratios in the Pharmaceutical Industry.

Based on 1999 figures
THE ``SAFE HARBOR`` STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties, including but not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialisation, the impact of competitive products, patents, and other risks and uncertainties, including those detailed from time to time in periodic reports, including the F-4 Prospectus and the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission.

References

1. Cantwell DP. Attention Deficit Disorder: A Review of the Past 10 Years. J Am Acad Child Adolesc Psychiatry. 1996;35:978-987.

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. The MTA Cooperative Group. A 14-Month Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder. Arch Gen Psychiatry. 1999;56:1073-1086.

SOURCE: Shire Pharmaceuticals Group